Document and Entity Information
Document and Entity Information | 9 Months Ended |
Sep. 30, 2020shares | |
Document and Entity Information | |
Document Type | 10-Q |
Document Quarterly Report | true |
Document Transition Report | false |
Document Period End Date | Sep. 30, 2020 |
Entity File Number | 001-36641 |
Entity Registrant Name | BRAINSTORM CELL THERAPEUTICS INC. |
Entity Incorporation, State or Country Code | DE |
Entity Tax Identification Number | 20-7273918 |
Entity Address, Address Line One | 1325 Avenue of Americas, 28th Floor |
Entity Address, City or Town | NY |
Entity Address, State or Province | NY |
Entity Address, Postal Zip Code | 10019 |
City Area Code | 201 |
Local Phone Number | 488-0460 |
Title of 12(b) Security | Common Stock, $0.00005 par value |
Trading Symbol | BCLI |
Security Exchange Name | NASDAQ |
Entity Current Reporting Status | Yes |
Entity Interactive Data Current | Yes |
Entity Filer Category | Accelerated Filer |
Entity Small Business | true |
Entity Emerging Growth Company | false |
Entity Shell Company | false |
Entity Common Stock, Shares Outstanding | 31,567,592 |
Entity Central Index Key | 0001137883 |
Current Fiscal Year End Date | --12-31 |
Document Fiscal Year Focus | 2020 |
Document Fiscal Period Focus | Q3 |
Amendment Flag | false |
INTERIM CONDENSED CONSOLIDATED
INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Current Assets: | ||
Cash and cash equivalents | $ 24,770 | $ 536 |
Short-term deposit (Note 4) | 4,038 | 33 |
Other accounts receivable | 1,473 | 2,359 |
Prepaid expenses and other current assets (Note 5) | 56 | 432 |
Total current assets | 30,337 | 3,360 |
Long-Term Assets: | ||
Prepaid expenses and other long-term assets | 27 | 32 |
Operating lease right of use asset (Note 6) | 1,377 | 2,182 |
Property and Equipment, Net | 950 | 960 |
Total Long-Term Assets | 2,354 | 3,174 |
Total assets | 32,691 | 6,534 |
Current Liabilities: | ||
Accounts payable | 3,283 | 14,677 |
Accrued expenses | 917 | 1,000 |
Operating lease liability (Note 6) | 1,216 | 1,263 |
Other accounts payable | 1,013 | 714 |
Total current liabilities | 6,429 | 17,654 |
Long-Term Liabilities: | ||
Operating lease liability (Note 6) | 284 | 1,103 |
Total long-term liabilities | 284 | 1,103 |
Total liabilities | 6,713 | 18,757 |
Stockholders' Equity (deficit): | ||
Stock capital: (Note 7) Common Stock of $0.00005 par value - Authorized: 100,000,000 shares at September 30, 2020 and December 31, 2019 respectively; Issued and outstanding: 31,567,592 and 23,174,228 shares at September 30, 2020 and December 31, 2019 respectively. | 12 | 11 |
Additional paid-in-capital | 163,238 | 105,042 |
Accumulated deficit | (137,272) | (117,276) |
Total stockholders' equity (deficit) | 25,978 | (12,223) |
Total liabilities and stockholders' equity | $ 32,691 | $ 6,534 |
INTERIM CONDENSED CONSOLIDATE_2
INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Sep. 30, 2020 | Dec. 31, 2019 |
INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS | ||
Common stock, par value (in dollars per share) | $ 0.00005 | $ 0.00005 |
Common stock, shares Authorized | 100,000,000 | 100,000,000 |
Common stock, shares Issued | 31,567,592 | 23,174,228 |
Common stock, shares outstanding | 31,567,592 | 23,174,228 |
INTERIM CONDENSED CONSOLIDATE_3
INTERIM CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (UNAUDITED) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Operating expenses: | ||||
Research and development, net | $ 1,867 | $ 4,008 | $ 13,509 | $ 11,018 |
General and administrative | 2,618 | 1,543 | 6,684 | 4,318 |
Operating loss | (4,485) | (5,551) | (20,193) | (15,336) |
Financial expenses (income), net | 3 | 83 | (197) | 225 |
Net loss | $ (4,488) | $ (5,634) | $ (19,996) | $ (15,561) |
Basic and diluted net loss per share from continuing operations | $ (0.14) | $ (0.25) | $ (0.70) | $ (0.72) |
Weighted average number of shares outstanding used in computing basic and diluted net loss per share | 31,154,101 | 22,254,993 | 28,695,540 | 21,630,007 |
STATEMENTS OF CHANGES IN STOCKH
STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY - USD ($) $ in Thousands | Common Stock [Member] | Additional paid-in capital [Member] | Receipts on account of shares [Member] | Accumulated Deficit [Member] | Total | |
Balance at Dec. 31, 2018 | $ 11 | $ 94,620 | $ 4,408 | $ (94,023) | $ 5,016 | |
Balance (in shares) at Dec. 31, 2018 | 20,757,816 | |||||
Stock-based compensation related to warrants and stock granted to service providers | 25 | 25 | ||||
Stock-based compensation related to warrants and stock granted to service providers (in shares) | 5,908 | |||||
Stock-based compensation related to stock and options granted to directors and employees | 312 | 312 | ||||
Stock-based compensation related to stock and options granted to directors and employees (in shares) | 39,386 | |||||
Exercise and reissuance of warrants | 3,368 | (3,368) | ||||
Exercise and reissuance of warrants (in shares) | 687,500 | |||||
Net loss | (5,027) | (5,027) | ||||
Balance at Mar. 31, 2019 | $ 11 | [1] | 98,325 | 1,040 | (99,050) | 326 |
Balance (in shares) at Mar. 31, 2019 | 21,490,610 | |||||
Balance at Dec. 31, 2018 | $ 11 | 94,620 | 4,408 | (94,023) | 5,016 | |
Balance (in shares) at Dec. 31, 2018 | 20,757,816 | |||||
Net loss | (15,561) | |||||
Balance at Sep. 30, 2019 | $ 11 | 102,796 | (109,584) | (6,777) | ||
Balance (in shares) at Sep. 30, 2019 | 22,605,792 | |||||
Balance at Mar. 31, 2019 | $ 11 | [1] | 98,325 | 1,040 | (99,050) | 326 |
Balance (in shares) at Mar. 31, 2019 | 21,490,610 | |||||
Stock-based compensation related to stock and options granted to directors and employees | $ 0 | 53 | 0 | 53 | ||
Stock-based compensation related to stock and options granted to directors and employees (in shares) | 0 | |||||
Exercise and reissuance of warrants | 1,040 | $ (1,040) | ||||
Exercise and reissuance of warrants (in shares) | 212,499 | |||||
Exercise of options | 5 | 5 | ||||
Exercise of options (in shares) | 5,333 | |||||
Net loss | (4,900) | (4,900) | ||||
Balance at Jun. 30, 2019 | $ 11 | 99,423 | (103,950) | (4,516) | ||
Balance (in shares) at Jun. 30, 2019 | 21,708,442 | |||||
Stock-based compensation related to stock and options granted to directors and employees | 217 | 217 | ||||
Stock-based compensation related to stock and options granted to directors and employees (in shares) | 42,718 | |||||
Exercise and reissuance of warrants | 3,126 | 3,126 | ||||
Exercise and reissuance of warrants (in shares) | 841,300 | |||||
Exercise of options | 30 | 30 | ||||
Exercise of options (in shares) | 13,332 | |||||
Net loss | (5,634) | (5,634) | ||||
Balance at Sep. 30, 2019 | $ 11 | 102,796 | (109,584) | (6,777) | ||
Balance (in shares) at Sep. 30, 2019 | 22,605,792 | |||||
Balance at Dec. 31, 2019 | $ 11 | 105,042 | (117,276) | (12,223) | ||
Balance (in shares) at Dec. 31, 2019 | 23,174,228 | |||||
Stock-based compensation related to stock and options granted to directors and employees | 390 | 0 | 390 | |||
Stock-based compensation related to stock and options granted to directors and employees (in shares) | 54,956 | |||||
Issuance of shares in at-the-market (ATM) offering (Note 7) | $ 1 | 18,971 | 18,972 | |||
Issuance of shares in at-the-market (ATM) offering (Note 7) (in shares) | 3,935,320 | |||||
Issuance of shares and warrants in Registered Direct Offering (Note 7) | 9,957 | 9,957 | ||||
Issuance of shares and warrants in Registered Direct Offering (Note 7) (in shares) | 1,250,000 | |||||
Exercise of options | 29 | 0 | 29 | |||
Exercise of options (in shares) | 9,333 | |||||
Net loss | (8,114) | (8,114) | ||||
Balance at Mar. 31, 2020 | $ 12 | 134,389 | (125,390) | 9,011 | ||
Balance (in shares) at Mar. 31, 2020 | 28,423,837 | |||||
Balance at Dec. 31, 2019 | $ 11 | 105,042 | (117,276) | (12,223) | ||
Balance (in shares) at Dec. 31, 2019 | 23,174,228 | |||||
Net loss | (19,996) | |||||
Balance at Sep. 30, 2020 | $ 12 | 163,238 | (137,272) | 25,978 | ||
Balance (in shares) at Sep. 30, 2020 | 31,567,592 | |||||
Balance at Mar. 31, 2020 | $ 12 | 134,389 | (125,390) | 9,011 | ||
Balance (in shares) at Mar. 31, 2020 | 28,423,837 | |||||
Stock-based compensation related to stock and options granted to directors and employees | 791 | 791 | ||||
Stock-based compensation related to stock and options granted to directors and employees (in shares) | 79,491 | |||||
Issuance of shares in at-the-market (ATM) offering (Note 7) | 7,411 | 7,411 | ||||
Issuance of shares in at-the-market (ATM) offering (Note 7) (in shares) | 1,162,527 | |||||
Exercise of options | 3 | 3 | ||||
Exercise of options (in shares) | 4,000 | |||||
Net loss | (7,394) | (7,394) | ||||
Balance at Jun. 30, 2020 | $ 12 | 142,594 | (132,784) | 9,822 | ||
Balance (in shares) at Jun. 30, 2020 | 29,669,855 | |||||
Stock-based compensation related to stock and options granted to directors and employees | 1,017 | 1,017 | ||||
Stock-based compensation related to stock and options granted to directors and employees (in shares) | 45,797 | |||||
Issuance of shares in at-the-market (ATM) offering (Note 7) | 13,307 | 13,307 | ||||
Issuance of shares in at-the-market (ATM) offering (Note 7) (in shares) | 947,627 | |||||
Exercise of options | 20 | 20 | ||||
Exercise of options (in shares) | 4,313 | |||||
Exercise of warrants | 6,300 | 6,300 | ||||
Exercise of warrants (in shares) | 900,000 | |||||
Net loss | (4,488) | (4,488) | ||||
Balance at Sep. 30, 2020 | $ 12 | $ 163,238 | $ (137,272) | $ 25,978 | ||
Balance (in shares) at Sep. 30, 2020 | 31,567,592 | |||||
[1] | Represents an amount less than $1. |
INTERIM CONDENSED CONSOLIDATE_4
INTERIM CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Cash flows from operating activities: | ||||
Net loss | $ (4,488) | $ (5,634) | $ (19,996) | $ (15,561) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||||
Depreciation | 56 | 37 | 155 | 114 |
Shares and options granted to service providers | 25 | |||
Stock-based compensation related to options granted to employees and directors | 1,017 | 217 | 2,198 | 582 |
Changes in operating lease liability | (11) | 49 | (61) | 187 |
Decrease (increase) in other accounts receivable and prepaid expenses | (1,095) | 290 | 1,267 | 938 |
Increase (decrease) in trade payables | (1,321) | 379 | (11,394) | 4,596 |
Increase (decrease) in other accounts payable and accrued expenses | (1,082) | 1,036 | 216 | 1,150 |
Total net cash used in operating activities | (6,924) | (3,626) | (27,615) | (7,969) |
Cash flows from investing activities: | ||||
Purchase of property and equipment | (88) | (102) | (145) | (127) |
Changes in short-term deposit | 2 | 1,541 | (4,005) | 6,088 |
Total net cash provided by (used in) investing activities | (86) | 1,439 | (4,150) | 5,961 |
Cash flows from financing activities: | ||||
Proceeds from exercise of options | 20 | 30 | 52 | 35 |
Proceeds from issuance of shares in at-the-market (ATM) offering (Note 7) | 13,307 | 39,690 | ||
Proceeds from exercise of warrants | 6,300 | 6,300 | ||
Exercise and reissuance of warrants | 3,126 | 3,126 | ||
Proceeds from issuance of shares and warrants in Registered Direct Offering (Note 7) | 9,957 | |||
Total net cash provided by financing activities | 19,627 | 3,156 | 55,999 | 3,161 |
Increase in cash and cash equivalents | 12,617 | 969 | 24,234 | 1,153 |
Cash and cash equivalents at the beginning of the period | 12,153 | 1,126 | 536 | 942 |
Cash and cash equivalents at end of the period | $ 24,770 | $ 2,095 | $ 24,770 | $ 2,095 |
GENERAL
GENERAL | 9 Months Ended |
Sep. 30, 2020 | |
GENERAL | |
GENERAL | NOTE 1 - GENERAL A. Brainstorm Cell Therapeutics, Inc. (the “Company”) was incorporated in the State of Delaware on November 15, 2006, and previously was incorporated in the State of Washington. In October 2004, the Company formed its wholly owned subsidiary, Brainstorm Cell Therapeutics Ltd. (“BCT”) in Israel, which currently conducts all the research and development activities of the Company. BCT formed wholly owned subsidiaries Brainstorm Cell Therapeutics UK Ltd., in the United Kingdom on February 19, 2013 (currently inactive), Advanced Cell Therapies Ltd. in Israel on June 21, 2018 and Brainstorm Cell Therapeutics Limited in Ireland on October 1, 2019. The Company’s Common Stock is publicly traded on the Nasdaq Capital Market under the symbol “BCLI”. B. The Company, through BCT, holds rights to commercialize certain stem cell technology developed by Ramot of Tel Aviv University Ltd. ("Ramot"), (see Note 3). Using this technology, the Company has been developing novel adult stem cell therapies for debilitating neurodegenerative disorders such as Amyotrophic Lateral Sclerosis (ALS, also known as Lou Gehrig’s Disease), Progressive Multiple Sclerosis (PMS), Alzheimer's disease (AD) and other neurodegenerative diseases. The Company developed a proprietary manufacturing process, called NurOwn®, for the propagation of autologous (‘self’) Mesenchymal Stem Cells and their differentiation into neurotrophic factor secreting cells. These cells are then administered by intrathecal injection at or near the site of damage, offering the hope of more effectively treating neurodegenerative diseases. C. NurOwn® is in late-stage clinical development for the treatment of ALS. The Company has completed two single dose clinical trials of NurOwn® in Israel, a Phase 1/2 trial with 12 patients and a Phase 2a trial with additional 12 patients. In July 2016 the Company announced the results of its Phase 2 trial which was conducted in three major medical centers in the US. This single dose trial included 48 patients randomized in a 3:1 ratio to receive NurOwn® or placebo. D. The Company has made significant progress in the past 12 months advancing NurOwn®, its late stage differentiated autologous mesenchymal stem cell therapy, into a 200 patient Phase 3 trial for the treatment of ALS. Enrollment in this randomized, double-blind, placebo-controlled, multi-dose clinical trial of NurOwn® for ALS was completed in October 2019 and the trial continued to provide necessary treatments to study participants despite severe constraints in the affected healthcare institutions due to COVID-19. As of July 2, 2020, the study completed dosing of all participants in the Phase 3 ALS trial. Topline data from this trial is expected by the end of November this year. This Phase 3 trial builds upon the promising efficacy seen in prior trials including the randomized Phase 2 trial conducted in the U.S. E. The Phase 3 ALS trial pre-specified interim safety analysis by an independent Data Safety Monitoring Board (DSMB) was successfully completed in August 2018. The DSMB successfully completed its second pre-specified interim analysis of safety outcomes for 106 participants treated with NurOwn® in the Phase 3 ALS trial on October 28, 2019. F. On December 15, 2018, the Company was granted FDA clearance for its NurOwn® IND Application for Progressive Multiple Sclerosis (PMS) indication (ClinicalTrials.gov Identifier NCT03799718). The U.S. Phase 2 PMS trial faced slight delays in enrollment due to the COVID-19 pandemic. Scheduled March and April 2020 new participant enrollments were deferred to May 2020 due to site closures related to COVID-19. As of June 2020, all the trial sites were back on track to continue with the trial. All 20 study participants have been enrolled in the study. The Company is currently completing the collection of clinical and biomarker data from treated patients as specified in the protocol. Dosing of all participants is expected to be completed in the fourth quarter of 2020. NOTE 1 – GENERAL (Cont.): G. On June 24, 2020, the Company announced a new clinical program focused on the development of NurOwn® as a treatment for AD. As part of the newly announced program, the Company is planning a multi-national Phase 2 clinical trial in Europe to evaluate the safety and preliminary efficacy of NurOwn® treatment in patients with prodromal to mild AD. H. The Company received Good Manufacturing Practice (GMP) approval from the Israel Ministry of Health (MoH) for our Israeli contract manufacturing facility at the Hadassah Medical Center in Jerusalem. The GMP certificate confirms the Company's manufacturing site compliance with Israeli GMPs which are recognized as equivalent to EU standards. GOING CONCERN: Since its inception, the Company has devoted substantially all of its efforts to research and development. The Company is still in its development and clinical stage and has not yet generated revenues. The extent of the Company's future operating losses and the timing of becoming profitable are uncertain. Additional funding will be required to begin the commercialization efforts and to achieve a level of sales adequate to support the Company's cost structure. To meet its capital needs, the Company is considering multiple alternatives, including, but not limited to, additional public and private sales of its Common Stock and warrants, the exercise of warrants, the issuance of convertible promissory notes, sales of Common Stock via its ATM program and other funding transactions. While the Company has been successful in raising financing recently and in the past, there can be no assurance that it will be able to do so in the future on a timely basis on terms acceptable to the Company, or at all. The COVID-19 pandemic may continue to adversely disrupt the Company's operations, including the ability to complete the ongoing clinical trials and may have other adverse effects on Company's business and operations. In addition, this pandemic has caused substantial disruption in the financial markets and may adversely impact economies worldwide, both of which could result in adverse effects on Company's business, operations and ability to raise capital. Management expects that the Company will continue to generate losses from the clinical development and regulatory activities, which will result in a negative cash flow from operating activity. The Company currently has sufficient cash to complete its ongoing Phase 3 ALS, Phase 2 PMS and Phase 2 AD clinical trials. Over the longer term, if the Company is granted a BLA approval, additional capital raise will be needed in connection with strategic partnerships and to commercialize Nurown® for ALS, and to conduct additional trials for other indications. If the Company is not able to raise additional capital for these purposes, management may need to slow the pace of commercialization or the Company may not be able to continue to function as a going concern. The Company's consolidated financial statements do not reflect any adjustments that might result from the outcome of this uncertainty. |
BASIS OF PRESENTATION AND SIGNI
BASIS OF PRESENTATION AND SIGNIFICANT ACCOUNTING POLICIES | 9 Months Ended |
Sep. 30, 2020 | |
BASIS OF PRESENTATION AND SIGNIFICANT ACCOUNTING POLICIES | |
BASIS OF PRESENTATION AND SIGNIFICANT ACCOUNTING POLICIES | NOTE 2 - BASIS OF PRESENTATION AND SIGNIFICANT ACCOUNTING POLICIES A. Unaudited Interim Financial Statements The accompanying unaudited interim condensed financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 10 of U.S. Securities and Exchange Commission Regulation S-X. Accordingly, they do not include all the information and footnotes required by generally accepted accounting principles for complete financial statements. In the opinion of management, all adjustments considered necessary for a fair presentation have been included (consisting only of normal recurring adjustments except as otherwise discussed). For further information, reference is made to the consolidated financial statements and footnotes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019. NOTE 2 - BASIS OF PRESENTATION AND SIGNIFICANT ACCOUNTING POLICIES (Cont.): Operating results for the nine months ended September 30, 2020, are not necessarily indicative of the results that may be expected for the year ending December 31, 2020. B. Significant Accounting Policies The significant accounting policies followed in the preparation of these unaudited interim condensed consolidated financial statements are identical to those applied in the preparation of the latest annual financial statements. C. Recent Accounting Standards The Company reviews new accounting standards as issued. Although some of these accounting standards issued or effective after the end of the Company's previous fiscal year may be applicable, the Company has not identified any standards that the Company believes merit further discussion. The Company believes that none of the new standards will have a significant impact on the financial statements. D. Use of estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ from those estimates. |
RESEARCH AND LICENSE AGREEMENT
RESEARCH AND LICENSE AGREEMENT | 9 Months Ended |
Sep. 30, 2020 | |
RESEARCH AND LICENSE AGREEMENT | |
RESEARCH AND LICENSE AGREEMENT | NOTE 3 - RESEARCH AND LICENSE AGREEMENT In 2004, the Company entered into a Research and License Agreement, as amended and restated, with Ramot (the “License Agreement”). Pursuant to the remuneration terms of the License Agreement, the Company has agreed to pay Ramot royalties on Net Sales of the Licensed Product as follows : a) So long as the making, producing, manufacturing, using, marketing, selling, importing or exporting (collectively, the “Commercialization”) of such Licensed Product is covered by a Valid Claim or is covered by Orphan Drug Status, the Company shall pay Ramot a royalty of 5% of the Net Sales received by the Company and resulting from such Commercialization; and b) In the event the Commercialization of the Licensed Product is neither covered by a Valid Claim nor by Orphan Drug status, the Company shall pay Ramot a royalty of 3% of the Net Sales received by the Company resulting from such Commercialization. This royalty shall be paid from the First Commercial Sale of the Licensed Product and for a period of fifteen ( 15 ) years thereafter. Capitalized terms set forth above which are not defined shall have the meanings attributed to them under the License Agreement. |
SHORT TERM DEPOSITS
SHORT TERM DEPOSITS | 9 Months Ended |
Sep. 30, 2020 | |
SHORT TERM DEPOSITS | |
SHORT TERM DEPOSITS | NOTE 4 - SHORT TERM DEPOSITS Short term deposits on September 30, 2020 and December 31, 2019 include bank deposits bearing annual interest rates varying from 0.15%to 1.75%, with maturities of up to 12 months as of September 30, 2020 and December 31, 2019. |
PREPAID EXPENSES
PREPAID EXPENSES | 9 Months Ended |
Sep. 30, 2020 | |
PREPAID EXPENSES | |
PREPAID EXPENSES | NOTE 5 - PREPAID EXPENSES In November 2017 the Company contracted with City of Hope’s Center for Biomedicine and Genetics ("COH") to produce clinical supplies of NurOwn® adult stem cells for the Company’s ongoing Phase 3 clinical study. In 2017 the Company paid COH $2,665 in an advance payment. The advance was recorded as prepaid expense and is amortized over the term of the agreement. As of December 31, 2019, $276 were recorded as current prepaid expense. As of September 30, 2020, the prepaid expenses from COH advance payment were fully reduced. |
LEASES
LEASES | 9 Months Ended |
Sep. 30, 2020 | |
LEASES | |
LEASES | NOTE 6 - LEASES On January 1, 2019 the Company adopted ASU 2016-02, Leases (Topic 842) (“ASU 2016-02”) using the modified retrospective approach for all lease arrangements at the beginning of the period of adoption. Leases existing for the reporting period beginning January 1, 2019 are presented under ASU 2016-02. The Company leases facilities, clinical research rooms, and vehicles under operating leases. At September 30, 2020, the Company’s ROU assets and lease liabilities for operating leases totaled $1,377 and $1,500, respectively. The impact of adopting the new lease standard was not material to the Company’s condensed consolidated statement of operations for the periods presented. Supplemental cash flow information related to operating leases was as follows (unaudited): Nine Months Ended September 30, 2020 Cash payments for operating leases $ 979 New operating lease assets obtained in exchange for operating lease liabilities $ 1,377 As of September 30, 2020, the Company’s operating leases had a weighted average remaining lease term of 1.24 years and a weighted average discount rate of 8.25%. Future lease payments under operating leases as of September 30, 2020 were as follows (unaudited): Operating Leases Remainder of 2020 $ 328 2021 1,252 Total future lease payments 1,580 Less imputed interest (80) Total lease liability balance $ 1,500 |
STOCK CAPITAL
STOCK CAPITAL | 9 Months Ended |
Sep. 30, 2020 | |
STOCK CAPITAL | |
STOCK CAPITAL | NOTE 7 - STOCK CAPITAL The rights of Common Stock are as follows: Holders of the Company’s Common Stock have the right to receive notice to participate and vote in general meetings of the Company, the right to a share in the excess of assets upon liquidation of the Company and the right to receive dividends, if declared. Private placements and public offerings: 2018 Warrant Exercise Agreement: On June 6, 2018, the Company entered into a Warrant Exercise Agreement (the “2018 Warrant Exercise Agreement”) with certain holders (the “2018 Warrant Holders”) of warrants (the “2015 Warrants”) to purchase Common Stock. The 2015 Warrants were originally issued in the Company’s January 8, 2015 private placement. Pursuant to the 2018 Warrant Exercise Agreement, the 2018 Warrant Holders exercised their 2015 Warrants for a total of 2,458,201 shares of Common Stock at an amended exercise price of $5 per share. The warrant exercises generated gross cash proceeds to the Company of $12.3 million. In addition, the Company issued new warrants to the 2018 Warrant Holders to purchase an aggregate 2,458,201 unregistered shares of Common Stock, at an exercise price of $9.00, with an expiration date of December 31, 2020 (the “2018 NOTE 7 - STOCK CAPITAL (Cont.): Warrants”). In connection with the issuance of the 2019 Warrants (described below), certain 2018 Warrants were amended on August 2, 2019 to reduce the exercise price to $7.00 per share and to extend the expiration date to December 31, 2021 (the “Amended 2018 Warrants”). Between July 20, 2020 and July 24, 2020, 2018 Warrant Holders exercised an aggregate of 280,000 shares of the Amended 2018 Warrants (the “2018 Exercised Shares”), which exercises generated gross cash proceeds to the Company of $1.96 million. The 2018 Warrants have not been registered under the Securities Act of 1933, as amended (the Securities Act), or state securities laws. The shares issuable upon exercise of the Amended 2018 Warrants have been registered for resale on the Company’s registration statement on Form S-3 (File No. 333-225995). The exercised shares have been registered for resale on the Company’s registration statement on Form S-3 (File No. 333-201704). The issuance of the exercised shares and 2018 Warrants was exempt from the registration requirements of the Securities Act pursuant to the exemption for transactions by an issuer not involving any public offering under Section 4(a)(2) of the Securities Act and Rule 506 of Regulation D promulgated under the Securities Act. The Company made this determination based on the representations that each party is an “accredited investor” within the meaning of Rule 501 of Regulation D. 2019 Warrant Exercise Agreement: On August 2, 2019, the Company entered into a Warrant Exercise Agreement which generated gross cash proceeds to the Company of approximately $3.3 million. Pursuant to the agreement, certain holders (the “2019 Warrant Holders”) of the 2018 Warrants agreed to exercise 842,000 shares of Common Stock of their 2018 Warrants, at an amended exercise price of $3.90 per share, and the Company agreed to issue new warrant shares to the Holders to purchase 842,000 shares of Common Stock (the “2019 Warrants”), at an exercise price of $7.00, with an expiration date of December 31, 2021. The 2018 Warrants held by the 2019 Warrant Holders, to the extent not exercised, were also amended to reduce the exercise price to $7.00 per share and to extend the expiration date to December 31, 2021 (the “Amended 2018 Warrants”). Between July 15, 2020 and July 24, 2020, 2019 Warrant Holders exercised an aggregate of 620,000 shares of the 2019 Warrants (the “2019 Exercised Shares”), which exercises generated gross cash proceeds to the Company of $ 4.34 million. NOTE 7 - STOCK CAPITAL (Cont.): The Amended 2018 Warrants and 2019 Warrants have not been registered under the Securities Act of 1933, as amended (the Securities Act), or state securities laws. The shares issuable upon exercise of the 2019 Warrants have been registered for resale on the Company’s registration statement on Form S-3 (File No. 333-233349), and the shares issuable upon exercise of the Amended 2018 Warrants have been registered for resale on the Company’s registration statement on Form S-3 (File No. 333-225995). The exercised shares have been registered for resale on the Company’s registration statement on Form S-3 (File No. 333-225995). The issuance of the exercised shares, Amended 2018 Warrants and 2019 Warrants is exempt from the registration requirements of the Securities Act pursuant to the exemption for transactions by an issuer not involving any public offering under Section 4(a)(2) of the Securities Act and Rule 506 of Regulation D promulgated under the Securities Act. The Company made this determination based on the representations that each party is an “accredited investor” within the meaning of Rule 501 of Regulation D. At-the-market (ATM) Offerings: On June 11, 2019, the Company entered into a distribution agreement with Raymond James & Associates, Inc. ("Raymond James"), pursuant to which the Company sold, through the Raymond James, shares of Common Stock having an aggregate offering amount of $20,000,000 (the "June 11, 2019 ATM") in an "at the market" offering as defined in Rule 415 promulgated under the Securities Act, including, without limitation, by sales made directly on the Nasdaq Capital Market, on any other existing trading market for the Shares, through a market maker or as otherwise agreed by the Company and Raymond James. On March 6, 2020, the Company entered into a new distribution agreement with Raymond James (the “Agent”), pursuant to which the Company was able to sell from time to time, through the Agent, shares of Common Stock, having an aggregate offering price of up to $50,000,000 (the “March 6, 2020 ATM”). Sales under the March 6, 2020 ATM were made by any method permitted by law that is deemed to be an “at the market” offering as defined in Rule 415 promulgated under the Securities Act, including, without limitation, sales made directly on the Nasdaq Capital Market, on any other existing trading market for the Shares, through a market maker or as otherwise agreed by the Company and Raymond James. During the quarter ended September 30, 2020, the Company sold an aggregate of 947,627 shares of Common Stock pursuant to the March 6, 2020 ATM at an average price of $14.48 per share, raising gross proceeds of approximately $13.71 million. On September 25, 2020, the Company entered into an Amended and Restated Distribution Agreement (the “Distribution Agreement”) with SVB Leerink LLC (“Leerink”) and Raymond James & Associates (together with Leerink, the “Agents”) pursuant to which the Company may sell from time to time, through the Agents, shares of Common Stock, having an aggregate offering price of up to $45,000,000, which aggregate amount includes amount unsold pursuant to the March 6, 2020 ATM (the “September 25, 2020 ATM”). Sales under the September 25, 2020 ATM are to be made by any method permitted by law that is deemed to be an “at the market” offering as defined in Rule 415 promulgated under the Securities Act, including, without limitation, sales made directly on the Nasdaq Capital Market, on any other existing trading market for the Shares, through a market maker or as otherwise agreed by the Company and the Agents. The Distribution Agreement amends and restates in its entirety the Company’s prior agreement with Raymond James entered on March 6, 2020 (the “March 6, 2020 ATM”). The Company previously sold 2,446,641 shares of Common Stock for gross proceeds of approximately $23.11 million of Common Stock under the March 6, 2020 ATM. NOTE 7 - STOCK CAPITAL (Cont.): The Company has no obligation under the September 25, 2020 ATM to sell any shares and may at any time suspend sales or terminate the September 25, 2020 ATM in accordance with its terms. Subject to the terms and conditions of the Distribution Agreement, the Agents will use their commercially reasonable efforts to sell on the Company’s behalf, from time to time consistent with its normal sales and trading practices, such Shares based upon instructions from the Company (including any price, time or size limits or other customary parameters or conditions the Company may impose). The Company has provided the Agents with customary indemnification rights, and the Agents will be entitled to a fixed commission of 3.0% of the aggregate gross proceeds from the Shares sold. The Distribution Agreement contains customary representations and warranties, and the Company is required to deliver customary closing documents and certificates in connection with sales of the Shares. Shares sold under the ATMs are issued pursuant to the Company’s existing Shelf Registration Statement, and the Prospectus Supplement to the Registration Statements filed June 11, 2019, March 6, 2020 and September 25, 2020, respectively. Registered Direct Offering: On March 6, 2020, the Company entered into and closed a $10.0 million registered direct offering of 1,250,000 shares of common stock at a per share purchase price equal to $8.00. The purchaser also received a three-year warrant to purchase up to 250,000 shares of Common Stock at any exercise price of $15.00 per share. Since its inception and as of September 30, 2020 the Company raised approximately $121 million, gross in cash in consideration for issuances of Common Stock and warrants in private placements and public offerings as well as proceeds from warrants exercises. Stock Plans: As of September 30, 2020, the Company had outstanding awards for stock options under four stockholder approved plans: (i) the 2004 Global Stock Option Plan and the Israeli Appendix thereto (the “2004 Global Plan”) (ii) the 2005 U.S. Stock Option and Incentive Plan (the “2005 U.S. Plan,” and together with the 2004 Global Plan, the “Prior Plans”); (iii) the 2014 Global Share Option Plan and the Israeli Appendix thereto (which applies solely to participants who are residents of Israel) (the “2014 Global Plan”); and (iv) the 2014 Stock Incentive Plan (the “2014 U.S. Plan” and together with the 2014 Global Plan, the “2014 Plans”). The 2004 Global Plan and 2005 U.S. Plan expired on November 25, 2014 and March 28, 2015, respectively. Grants that were made under the Prior Plans remain outstanding pursuant to their terms. The 2014 Plans were approved by the stockholders on August 14, 2014 (at which time the Company ceased to issue awards under each of the 2005 U.S. Plan and 2004 Global Plan) and amended on June 21, 2016 and November 29, 2018. Unless otherwise stated, option grants prior to August 14, 2014 were made pursuant to the Company’s Prior Plans, and grants issued on or after August 14, 2014 were made pursuant to the Company’s 2014 Plans, and expire on the tenth anniversary of the grant date. The 2014 Plans have a shared pool of 4,000,000 shares of Common Stock available for issuance. As of September 30, 2020, 1,232,613 shares were available for future issuances under the 2014 Plans. The exercise price of the options granted under the 2014 Plans may not be less than the nominal value of the shares into which such options are exercised. Any options under the 2014 Plans that are canceled or forfeited before expiration become available for future grants. The Governance, Nominating and Compensation Committee (the “GNC Committee”) of the Board of Directors of the Company administers the Company’s stock incentive compensation and equity-based plans. Share-based compensation to employees and to directors: Under the 2014 Plans, the Company may award stock options to certain employees, officers, directors, and/or service providers. The stock options vest in accordance with such conditions and restrictions determined by the GNC Committee. NOTE 7 - STOCK CAPITAL (Cont.): These conditions and restrictions may include the achievement of certain performance goals and/or continued employment with the Company through a specified period. Stock options awarded are valued based upon the Black-Scholes option pricing model and the Company recognizes this value as stock compensation expense over the periods in which the options vest. Use of the Black Scholes option-pricing model requires that the Company make certain assumptions, including expected volatility, risk-free interest rate, expected dividend yield, and the expected life of the options. The Company granted stock options to purchase 698,666 shares during the nine months ended September 30, 2020. Stock options fair value assumptions for the stock options granted during the nine months ended September 30, 2020 are as follows: For the Nine months ended September 30, 2020 Option life (years) 10 Risk free interest rate 0.33%-1.73% Dividend yield 0 Expected volatility 58%-63% Expected life (years) 5.04 -5.50 years A summary of the Company's option activity related to options to employees and directors, and related information as of September 30, 2020 is as follows: For the Nine months ended September 30, 2020 Weighted average Aggregate Amount of exercise intrinsic options * price value $ $ Outstanding at December 31, 2019 1,293,007 3.0142 Granted 698,666 7.1448 Exercised (17,646) 2.9267 Cancelled (4,000) 3.7500 Outstanding at September 30, 2020 1,970,027 3.9676 25,516,661 Exercisable at September 30, 2020 829,027 1.7226 12,599,092 * Represents Employee Stock Options only (not including RSUs). The aggregate intrinsic value in the table above represents the total intrinsic value (the difference between the fair market value of the Company's shares on September 30, 2020, multiplied by the number of in-the-money options on those dates) that would have been received by the option holders had all option holders exercised their options on those dates. Compensation expense recorded by the Company in respect of its stock-based employees and directors compensation awards in accordance with ASC 718-10 for the nine months ended September 30, 2020 and 2019 amounted to $2,198 and $582, respectively. NOTE 7 - STOCK CAPITAL (Cont.): Restricted Stock: The Company awards stock and restricted stock to certain employees, officers, directors, and/or service providers. The restricted stock vests in accordance with such conditions and restrictions determined by the GNC Committee. These conditions and restrictions may include the achievement of certain performance goals and/or continued employment with the Company through a specified restricted period. The purchase price (if any) of shares of restricted stock is determined by the GNC Committee. If the performance goals and other restrictions are not attained, the grantee will automatically forfeit their unvested awards of restricted stock to the Company. Compensation expense for restricted stock is based on fair market value at the grant date. Weighted Average Remaining Number of Shares Weighted Average Contractual of Restricted Grant Date Fair Term Stock Value (Years) Nonvested as of December 31, 2019 201,385 4.00 1.95 Granted 180,410 8.47 Vested 109,781 4.93 Nonvested as of September 30, 2020 272,015 6.58 1.30 Compensation expense recorded by the Company in respect of its stock and restricted stock awards to certain employees, officers, directors, and/or service providers for the three months ended September 30, 2020 amounted to $441. Total Stock-Based Compensation Expense The total stock-based compensation expense, related to shares, options and warrants granted to employees, directors and service providers was comprised, at each period, as follows: Nine months ended September 30, 2020 2019 Research and development 1,065 91 General and administrative 1,133 516 Total stock-based compensation expense 2,198 607 |
RESEARCH AND DEVELOPMENT, NET
RESEARCH AND DEVELOPMENT, NET | 9 Months Ended |
Sep. 30, 2020 | |
RESEARCH AND DEVELOPMENT, NET | |
RESEARCH AND DEVELOPMENT, NET | NOTE 8 - RESEARCH AND DEVELOPMENT, NET Composition: Nine months ended September 30, 2020 2019 Research and development 17,146 17,397 Less: Participation by CIRM (1,862) (3,290) Less: Participation by Israeli Hospital Exemption regulatory pathway (816) (2,412) Less: Participation by the Israel Innovation Authorities (885) (618) Less: Participation by other grants (74) (59) 13,509 11,018 |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 9 Months Ended |
Sep. 30, 2020 | |
SUBSEQUENT EVENTS | |
SUBSEQUENT EVENTS | NOTE 9 – SUBSEQUENT EVENTS In December 2019, a novel strain of coronavirus, surfaced in Wuhan, China. Since then, COVID-19 has spread to multiple countries, including the United States, Europe and Israel, where the Company conducts its operations, as well as its clinical trials for NurOwn®. In response to the spread of COVID-19 and to ensure safety of employees and continuity of business operations, we closed our offices, with our administrative employees continuing their work remotely and limited the number of staff in any given research and development laboratory. Our research and development laboratory in Israel and manufacturing sites in the U.S. and in Israel remain open. As of June 20, 2020, all the trial sites for the Company’s U.S. Phase 2 PMS trial were back on track to continue with the trial. All 20 study participants have been enrolled in the study. The Company is currently completing the collection of clinical and biomarker data from treated patients as specified in the protocol. Dosing of all participants is expected to be completed in the fourth quarter of 2020. The Phase 3 ALS clinical trial continued to provide necessary treatments to study participants despite severe constraints in the affected healthcare institutions due to COVID-19. As of July 2, 2020, the study completed dosing of all the participants in the Phase 3 ALS trial. The Phase 3 ALS trial is expected to generate top-line data by the end of November this year. On June 24, 2020, the Company announced a new clinical program focused on the development of NurOwn® as a treatment for AD. As part of the newly announced program, the Company is planning a multi-national Phase 2 clinical trial in Europe to evaluate the safety and preliminary efficacy of NurOwn® treatment in patients with prodromal to mild AD. From September 25, 2020 through October 14, 2020, the Company sold an aggregate of 294,723 additional shares of Common Stock pursuant to the September 25, 2020 ATM, at an average price of $17.21 per share, raising gross proceeds of approximately $5.07 million. Because of the COVID-19 outbreak, the Company may, in the future, experience disruptions that could severely impact its business, including clinical trial activities; participant enrollment; or any currently unforeseen delays in completion of study timelines. The full extent to which the COVID-19 pandemic will directly or indirectly impact the Company's business, results of operations and financial condition will depend on future developments that are highly uncertain and cannot be accurately predicted at this time, including new information that may emerge concerning COVID-19, the actions taken to contain it or treat its impact and the economic impact on local, regional, national and international markets. The Company's management team is actively monitoring this situation and the possible effects on the financial condition, liquidity, operations, suppliers, industry, and workforce. In accordance with ASC 855 “Subsequent Events” the Company evaluated subsequent events through the date the condensed consolidated financial statements were issued. The Company concluded that no other subsequent events have occurred that would require recognition or disclosure in the condensed consolidated financial statements. |
BASIS OF PRESENTATION AND SIG_2
BASIS OF PRESENTATION AND SIGNIFICANT ACCOUNTING POLICIES (Policies) | 9 Months Ended |
Sep. 30, 2020 | |
BASIS OF PRESENTATION AND SIGNIFICANT ACCOUNTING POLICIES | |
Unaudited Interim Financial Statements | A. Unaudited Interim Financial Statements The accompanying unaudited interim condensed financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 10 of U.S. Securities and Exchange Commission Regulation S-X. Accordingly, they do not include all the information and footnotes required by generally accepted accounting principles for complete financial statements. In the opinion of management, all adjustments considered necessary for a fair presentation have been included (consisting only of normal recurring adjustments except as otherwise discussed). For further information, reference is made to the consolidated financial statements and footnotes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019. NOTE 2 - BASIS OF PRESENTATION AND SIGNIFICANT ACCOUNTING POLICIES (Cont.): Operating results for the nine months ended September 30, 2020, are not necessarily indicative of the results that may be expected for the year ending December 31, 2020. |
Significant Accounting Policies | B. Significant Accounting Policies The significant accounting policies followed in the preparation of these unaudited interim condensed consolidated financial statements are identical to those applied in the preparation of the latest annual financial statements. |
Recent Accounting Standards | C. Recent Accounting Standards The Company reviews new accounting standards as issued. Although some of these accounting standards issued or effective after the end of the Company's previous fiscal year may be applicable, the Company has not identified any standards that the Company believes merit further discussion. The Company believes that none of the new standards will have a significant impact on the financial statements. |
Use of estimates | D. Use of estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ from those estimates. |
LEASES (Tables)
LEASES (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
LEASES | |
Schedule of supplemental cash flow information related to operating leases | Supplemental cash flow information related to operating leases was as follows (unaudited): Nine Months Ended September 30, 2020 Cash payments for operating leases $ 979 New operating lease assets obtained in exchange for operating lease liabilities $ 1,377 |
Schedule of future lease payments under operating leases | Operating Leases Remainder of 2020 $ 328 2021 1,252 Total future lease payments 1,580 Less imputed interest (80) Total lease liability balance $ 1,500 |
STOCK CAPITAL (Tables)
STOCK CAPITAL (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
STOCK CAPITAL | |
Schedule of fair value assumptions used for the stock options granted | Stock options fair value assumptions for the stock options granted during the nine months ended September 30, 2020 are as follows: For the Nine months ended September 30, 2020 Option life (years) 10 Risk free interest rate 0.33%-1.73% Dividend yield 0 Expected volatility 58%-63% Expected life (years) 5.04 -5.50 years |
Summary of the Company's option activity | A summary of the Company's option activity related to options to employees and directors, and related information as of September 30, 2020 is as follows: For the Nine months ended September 30, 2020 Weighted average Aggregate Amount of exercise intrinsic options * price value $ $ Outstanding at December 31, 2019 1,293,007 3.0142 Granted 698,666 7.1448 Exercised (17,646) 2.9267 Cancelled (4,000) 3.7500 Outstanding at September 30, 2020 1,970,027 3.9676 25,516,661 Exercisable at September 30, 2020 829,027 1.7226 12,599,092 * Represents Employee Stock Options only (not including RSUs). |
Schedule of compensation expense for restricted stock is based on fair market value at the grant date | Weighted Average Remaining Number of Shares Weighted Average Contractual of Restricted Grant Date Fair Term Stock Value (Years) Nonvested as of December 31, 2019 201,385 4.00 1.95 Granted 180,410 8.47 Vested 109,781 4.93 Nonvested as of September 30, 2020 272,015 6.58 1.30 |
Schedule of total stock-based compensation expense | The total stock-based compensation expense, related to shares, options and warrants granted to employees, directors and service providers was comprised, at each period, as follows: Nine months ended September 30, 2020 2019 Research and development 1,065 91 General and administrative 1,133 516 Total stock-based compensation expense 2,198 607 |
RESEARCH AND DEVELOPMENT, NET (
RESEARCH AND DEVELOPMENT, NET (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
RESEARCH AND DEVELOPMENT, NET | |
Schedule of Research and development, Net | Nine months ended September 30, 2020 2019 Research and development 17,146 17,397 Less: Participation by CIRM (1,862) (3,290) Less: Participation by Israeli Hospital Exemption regulatory pathway (816) (2,412) Less: Participation by the Israel Innovation Authorities (885) (618) Less: Participation by other grants (74) (59) 13,509 11,018 |
RESEARCH AND LICENSE AGREEMENT
RESEARCH AND LICENSE AGREEMENT (Details) | 9 Months Ended |
Sep. 30, 2020 | |
RESEARCH AND LICENSE AGREEMENT | |
Percentage Of Royalty Payment If Licensed Product Covered By Valid Claim Or Orphan Drug Status | 5.00% |
Percentage Of Royalty Payment If Licensed Product Not Covered By Valid Claim Or Orphan Drug Status | 3.00% |
Validity Of Royalty Payment Not Covered By Valid Claim Or Orphan Drug Status | 15 years |
SHORT TERM DEPOSITS (Details)
SHORT TERM DEPOSITS (Details) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2020 | Dec. 31, 2019 | |
Cash and Cash Equivalents [Line Items] | ||
Maturity of short term deposits | 12 months | 12 months |
Minimum | ||
Cash and Cash Equivalents [Line Items] | ||
Annual interest rate on bank deposits | 0.15% | 0.15% |
Maximum | ||
Cash and Cash Equivalents [Line Items] | ||
Annual interest rate on bank deposits | 1.75% | 1.75% |
PREPAID EXPENSES (Details)
PREPAID EXPENSES (Details) - USD ($) $ in Thousands | 1 Months Ended | |
Nov. 30, 2017 | Dec. 31, 2019 | |
Prepaid Expense, Current | $ 276 | |
City of Hope | ||
Payments to Suppliers | $ 2,665 |
LEASES - Supplemental cash flow
LEASES - Supplemental cash flow information related to operating leases (Details) $ in Thousands | 9 Months Ended |
Sep. 30, 2020USD ($) | |
LEASES | |
Cash payments for operating leases | $ 979 |
New operating lease assets obtained in exchange for operating lease liabilities | $ 1,377 |
LEASES - Future lease payments
LEASES - Future lease payments under operating leases (Details) $ in Thousands | Sep. 30, 2020USD ($) |
LEASES | |
Remainder of 2020 | $ 328 |
2021 | 1,252 |
Total future lease payments | 1,580 |
Less imputed interest | (80) |
Total lease liability balance | $ 1,500 |
LEASES - Additional information
LEASES - Additional information (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
LEASES | ||
Operating Lease, Right-of-Use Asset | $ 1,377 | $ 2,182 |
Operating Lease, Liability | $ 1,500 | |
Operating Lease, Weighted Average Remaining Lease Term | 1 year 2 months 26 days | |
Operating Lease, Weighted Average Discount Rate, Percent | 8.25% |
STOCK CAPITAL - Stock option fa
STOCK CAPITAL - Stock option fair value assumptions (Details) | 9 Months Ended |
Sep. 30, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Option life (years) | 10 years |
Risk free interest rate(max) | 1.73% |
Dividend yield | 0.00% |
Expected volatility(min) | 58.00% |
Expected volatility(max) | 63.00% |
Minimum | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Risk free interest rate(min) | 0.33% |
Expected life (years) | 5 years 14 days |
Maximum | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Expected life (years) | 5 years 6 months |
STOCK CAPITAL - Employee Stock
STOCK CAPITAL - Employee Stock Option (Details) - Employee Stock Option [Member] | 9 Months Ended | |
Sep. 30, 2020USD ($)$ / sharesshares | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Amount of options, Outstanding at beginning of period | shares | 1,293,007 | [1] |
Amount of options, Granted | shares | 698,666 | [1] |
Amount of options, Exercised | shares | (17,646) | [1] |
Amount of options, Cancelled | shares | (4,000) | [1] |
Amount of options, Outstanding at end of period | shares | 1,970,027 | [1] |
Amount of options, Vested and expected-to-vest at end of period | shares | 829,027 | [1] |
Weighted average exercise price, Outstanding at beginning of period (in dollars per share) | $ / shares | $ 3.0142 | |
Weighted average exercise price, Granted (in dollars per share) | $ / shares | 7.1448 | |
Weighted average exercise price, Exercised (in dollars per share) | $ / shares | 2.9267 | |
Weighted Average exercise Price, Cancelled (in dollars per share) | $ / shares | 3.7500 | |
Weighted average exercise price, Outstanding at end of period (in dollars per share) | $ / shares | 3.9676 | |
Weighted average exercise price, Vested and expected-to-vest at end of period (in dollars per share) | $ / shares | $ 1.7226 | |
Aggregate intrinsic value, Outstanding at end of period (in dollars) | $ | $ 25,516,661 | |
Aggregate intrinsic value, Vested and expected-to-vest at end of period (in dollars) | $ | $ 12,599,092 | |
[1] | Represents Employee Stock Options only (not including RSUs). |
STOCK CAPITAL - Restricted Stoc
STOCK CAPITAL - Restricted Stock (Details) - Restricted Stock [Member] - $ / shares | 9 Months Ended | 12 Months Ended |
Sep. 30, 2020 | Dec. 31, 2019 | |
Number of Shares of Restricted Stock, Nonvested at beginning of period | 201,385 | |
Granted | 180,410 | |
Vested | 109,781 | |
Number of Shares of Restricted Stock, Nonvested at end of period | 272,015 | 201,385 |
Weighted Average Grant Date Fair Value, Nonvested at beginning of period | $ 4 | |
Granted | 8.47 | |
Vested | 4.93 | |
Weighted Average Grant Date Fair Value, Nonvested at end of period | $ 6.58 | $ 4 |
Weighted Average Remaining Contractual Term (Years), Nonvested | 1 year 3 months 18 days | 1 year 11 months 12 days |
STOCK CAPITAL - Stock-Based Com
STOCK CAPITAL - Stock-Based Compensation Expense (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2020 | Sep. 30, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Total stock-based compensation expense | $ 2,198 | $ 607 |
Research and development | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Total stock-based compensation expense | 1,065 | 91 |
General and administrative | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Total stock-based compensation expense | $ 1,133 | $ 516 |
STOCK CAPITAL - Additional info
STOCK CAPITAL - Additional information (Details) - USD ($) | Sep. 25, 2020 | Jul. 24, 2020 | Jul. 24, 2020 | Mar. 06, 2020 | Aug. 02, 2019 | Jun. 11, 2019 | Jun. 06, 2018 | Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||
Aggregate offering amount | $ 10,000,000 | $ 9,957,000 | ||||||||||||
Aggregate shares sold | 1,250,000 | |||||||||||||
Average Price | $ 8 | |||||||||||||
Gross Proceeds | $ 121,000,000 | |||||||||||||
Warrant term (in years) | 3 years | |||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 250,000 | |||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 15 | |||||||||||||
Proceeds from Warrant Exercises | 9,957,000 | |||||||||||||
Proceeds from exercise of warrants | $ 6,300,000 | $ 6,300,000 | ||||||||||||
Common Stock, Capital Shares Reserved for Future Issuance | 1,232,613 | 1,232,613 | ||||||||||||
Stock or Unit Option Plan Expense | $ 1,017,000 | $ 217,000 | $ 2,198,000 | $ 582,000 | ||||||||||
Share-based Compensation | $ 2,198,000 | $ 607,000 | ||||||||||||
2018 Warrant | ||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 842,000 | 2,458,201 | ||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 5 | |||||||||||||
Warrants Issued To Purchase Of Common Stock | 2,458,201 | |||||||||||||
Proceeds from Warrant Exercises | $ 12,300,000 | |||||||||||||
2018 Amended Warrants | ||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 280,000 | 280,000 | ||||||||||||
Proceeds from Warrant Exercises | $ 1,960,000 | |||||||||||||
2019 Warrant | ||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 620,000 | 620,000 | 842,000 | |||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 7 | |||||||||||||
Proceeds from Warrant Exercises | $ 4,340,000 | $ 3,300,000 | ||||||||||||
Employee Stock Option [Member] | ||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||
Options granted | [1] | 698,666 | ||||||||||||
Share-based Compensation Arrangements by Share-based Payment Award, Options, Grants in Period, Weighted Average Exercise Price | $ 7.1448 | |||||||||||||
Restricted Stock [Member] | ||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Grants in Period | 180,410 | |||||||||||||
Share-based Compensation | $ 441,000 | |||||||||||||
Director [Member] | Employee Stock Option [Member] | ||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||
Options granted | 698,666 | |||||||||||||
Global Share Option Plan 2014 And US Stock Option And Incentive Plan 2014 [Member] | ||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||
Stock Issued During Period, Shares, Issued for Services | 4,000,000 | |||||||||||||
Common Stock [Member] | ||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||
Aggregate shares sold | 1,250,000 | |||||||||||||
Issuance Of Share Value | 947,627 | 1,162,527 | 3,935,320 | |||||||||||
Common Stock [Member] | 2018 Warrant | ||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | 9 | |||||||||||||
Common Stock [Member] | 2019 Warrant | ||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 7 | $ 3.90 | ||||||||||||
At Market Offering [Member] | ||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||
Aggregate offering amount | $ 45,000,000 | $ 50,000,000 | $ 20,000,000 | |||||||||||
Aggregate shares sold | 2,446,641 | 947,627 | ||||||||||||
Average Price | $ 14.48 | $ 14.48 | ||||||||||||
Gross Proceeds | $ 23,110,000 | $ 13,710,000 | ||||||||||||
Fixed Commission Percentage | 3.00% | |||||||||||||
[1] | Represents Employee Stock Options only (not including RSUs). |
RESEARCH AND DEVELOPMENT, NET_2
RESEARCH AND DEVELOPMENT, NET (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Research And Development Arrangement [Line Items] | ||||
Research and development | $ 17,146 | $ 17,397 | $ 17,146 | $ 17,397 |
Research and Development Expense | $ 1,867 | $ 4,008 | 13,509 | 11,018 |
CIRM | ||||
Research And Development Arrangement [Line Items] | ||||
Less : Participation | (1,862) | (3,290) | ||
Israeli Hospital Exemption regulatory pathway | ||||
Research And Development Arrangement [Line Items] | ||||
Less : Participation | (816) | (2,412) | ||
Israel Innovation Authorities | ||||
Research And Development Arrangement [Line Items] | ||||
Less : Participation | (885) | (618) | ||
Other | ||||
Research And Development Arrangement [Line Items] | ||||
Less : Participation | $ (74) | $ (59) |
SUBSEQUENT EVENTS (Details)
SUBSEQUENT EVENTS (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | |
Oct. 14, 2020 | Mar. 06, 2020 | |
Subsequent Event [Line Items] | ||
Average Price | $ 8 | |
Subsequent Event | ||
Subsequent Event [Line Items] | ||
Aggregate of additional shares of common stock | 294,723 | |
Average Price | $ 17.21 | |
Gross proceeds | $ 5,070 |