Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Mar. 01, 2019 | Jun. 29, 2018 | |
Document And Entity Information [Abstract] | |||
Entity Registrant Name | GERON CORP | ||
Entity Central Index Key | 886,744 | ||
Document Type | 10-K | ||
Document Period End Date | Dec. 31, 2018 | ||
Amendment Flag | false | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Filer Category | Accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 623,076,000 | ||
Entity Common Stock, Shares Outstanding | 186,392,682 | ||
Document Fiscal Year Focus | 2,018 | ||
Document Fiscal Period Focus | FY | ||
Trading Symbol | GERN |
BALANCE SHEETS
BALANCE SHEETS - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Current assets: | ||
Cash and cash equivalents | $ 10,575 | $ 16,335 |
Restricted cash | 269 | 268 |
Marketable securities | 152,714 | 78,351 |
Interest and other receivables | 1,168 | 436 |
Prepaid assets | 1,332 | 580 |
Total current assets | 166,058 | 95,970 |
Noncurrent marketable securities | 18,582 | 14,241 |
Property and equipment, net | 59 | 102 |
Other assets | 585 | |
Total assets | 185,284 | 110,313 |
Current liabilities: | ||
Accounts payable | 982 | 503 |
Accrued compensation and benefits | 2,642 | 3,385 |
Amount due to Janssen Biotech, Inc. | 2,610 | 1,702 |
Accrued liabilities | 1,317 | 926 |
Total current liabilities | 7,551 | 6,516 |
Commitments and contingencies | ||
Stockholders' equity: | ||
Preferred stock, $0.001 par value; 3,000,000 shares authorized; no shares issued and outstanding at December 31, 2018 and 2017 | ||
Common stock, $0.001 par value; 300,000,000 shares authorized; 186,392,682 and 159,877,239 shares issued and outstanding at December 31, 2018 and 2017, respectively | 186 | 160 |
Additional paid-in capital | 1,189,194 | 1,089,684 |
Accumulated deficit | (1,011,464) | (985,840) |
Accumulated other comprehensive loss | (183) | (207) |
Total stockholders' equity | 177,733 | 103,797 |
Total liabilities and stockholders' equity | $ 185,284 | $ 110,313 |
BALANCE SHEETS (Parenthetical)
BALANCE SHEETS (Parenthetical) - $ / shares | Dec. 31, 2018 | Dec. 31, 2017 |
Statement Of Financial Position [Abstract] | ||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 3,000,000 | 3,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 300,000,000 | 300,000,000 |
Common stock, shares issued | 186,392,682 | 159,877,239 |
Common stock, shares outstanding | 186,392,682 | 159,877,239 |
STATEMENTS OF OPERATIONS
STATEMENTS OF OPERATIONS - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Revenues: | |||
License fees and royalties | $ 1,066,000 | $ 1,065,000 | $ 6,162,000 |
Operating expenses: | |||
Research and development | 13,432,000 | 11,033,000 | 18,047,000 |
General and administrative | 18,707,000 | 19,287,000 | 18,761,000 |
Total operating expenses | 32,139,000 | 30,320,000 | 36,808,000 |
Loss from operations | (31,073,000) | (29,255,000) | (30,646,000) |
Interest and other income | 3,291,000 | 1,416,000 | 1,192,000 |
Gain on settlement | 1,460,000 | ||
Change in fair value of equity investment | (541,000) | ||
Other expense | (154,000) | (77,000) | (83,000) |
Net loss | $ (27,017,000) | $ (27,916,000) | $ (29,537,000) |
Basic and diluted net loss per share | $ (0.15) | $ (0.18) | $ (0.19) |
Shares used in computing basic and diluted net loss per share | 176,504,996 | 159,224,986 | 159,045,644 |
STATEMENTS OF COMPREHENSIVE LOS
STATEMENTS OF COMPREHENSIVE LOSS - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Statement Of Income And Comprehensive Income [Abstract] | |||
Net loss | $ (27,017) | $ (27,916) | $ (29,537) |
Net unrealized gain (loss) on marketable securities | 24 | (154) | 160 |
Comprehensive loss | $ (26,993) | $ (28,070) | $ (29,377) |
STATEMENTS OF STOCKHOLDERS' EQU
STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-In Capital | Accumulated Deficit | Accumulated Other Comprehensive Loss |
Balances at Dec. 31, 2015 | $ 142,126 | $ 159 | $ 1,070,567 | $ (928,387) | $ (213) |
Balances (in shares) at Dec. 31, 2015 | 158,781,359 | ||||
Increase (Decrease) in Stockholders' Equity | |||||
Net loss | (29,537) | (29,537) | |||
Other comprehensive (loss) income | 160 | 160 | |||
Stock-based compensation related to issuance of common stock and options in exchange for services | 156 | 156 | |||
Stock-based compensation related to issuance of common stock and options in exchange for services (in shares) | 21,541 | ||||
Issuances of common stock under equity plans | 1,169 | 1,169 | |||
Issuances of common stock under equity plans (in shares) | 355,736 | ||||
Stock-based compensation for equity- based awards to employees and directors | 8,245 | 8,245 | |||
401(k) contribution | 61 | 61 | |||
Balances at Dec. 31, 2016 | 122,380 | $ 159 | 1,080,198 | (957,924) | (53) |
Balances (in shares) at Dec. 31, 2016 | 159,158,636 | ||||
Increase (Decrease) in Stockholders' Equity | |||||
Net loss | (27,916) | (27,916) | |||
Other comprehensive (loss) income | (154) | (154) | |||
Issuance of common stock in connection with at market offering, net of issuance costs | 1,060 | $ 1 | 1,059 | ||
Issuance of common stock in connection with at market offering, net of issuance costs (in shares) | 614,230 | ||||
Stock-based compensation related to issuance of common stock and options in exchange for services | 200 | 200 | |||
Stock-based compensation related to issuance of common stock and options in exchange for services (in shares) | 72,066 | ||||
Issuances of common stock under equity plans | 51 | 51 | |||
Issuances of common stock under equity plans (in shares) | 32,307 | ||||
Stock-based compensation for equity- based awards to employees and directors | 8,144 | 8,144 | |||
401(k) contribution | 32 | 32 | |||
Balances at Dec. 31, 2017 | $ 103,797 | $ 160 | 1,089,684 | (985,840) | (207) |
Balances (in shares) at Dec. 31, 2017 | 159,877,239 | 159,877,239 | |||
Increase (Decrease) in Stockholders' Equity | |||||
Cumulative effect of accounting principle change | $ 1,393 | 1,393 | |||
Net loss | (27,017) | (27,017) | |||
Other comprehensive (loss) income | 24 | 24 | |||
Issuance of common stock in connection with at market offering, net of issuance costs | 86,017 | $ 23 | 85,994 | ||
Issuance of common stock in connection with at market offering, net of issuance costs (in shares) | 23,278,185 | ||||
Stock-based compensation related to issuance of common stock and options in exchange for services | 191 | 191 | |||
Stock-based compensation related to issuance of common stock and options in exchange for services (in shares) | 73,980 | ||||
Issuances of common stock under equity plans | 6,951 | $ 3 | 6,948 | ||
Issuances of common stock under equity plans (in shares) | 3,163,278 | ||||
Stock-based compensation for equity- based awards to employees and directors | 6,368 | 6,368 | |||
401(k) contribution | 9 | 9 | |||
Balances at Dec. 31, 2018 | $ 177,733 | $ 186 | $ 1,189,194 | $ (1,011,464) | $ (183) |
Balances (in shares) at Dec. 31, 2018 | 186,392,682 | 186,392,682 |
STATEMENTS OF STOCKHOLDERS' E_2
STATEMENTS OF STOCKHOLDERS' EQUITY (Parenthetical) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Statement Of Stockholders Equity [Abstract] | ||
Issuance costs | $ 2,282 | $ 114 |
STATEMENTS OF CASH FLOWS
STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Cash flows from operating activities: | |||
Net loss | $ (27,017) | $ (27,916) | $ (29,537) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation and amortization | 59 | 76 | 81 |
Loss (gain) on retirement/sales of property and equipment | 5 | (16) | |
Accretion and amortization on investments, net | (978) | 273 | 552 |
Change in fair value of equity investment, including foreign currency translation | 604 | ||
Stock-based compensation for services by non-employees | 191 | 200 | 156 |
Stock-based compensation for employees and directors | 6,368 | 8,144 | 8,245 |
Amortization related to 401(k) contributions | 9 | 32 | 61 |
Changes in assets and liabilities: | |||
Interest and other receivables | (528) | 39 | 731 |
Prepaid assets | (752) | (56) | 123 |
Accounts payable | 479 | 278 | 65 |
Accrued compensation and benefits | (743) | 542 | (183) |
Amount due to Janssen Biotech, Inc. | 908 | (1,665) | 1,039 |
Accrued liabilities | 391 | (508) | 314 |
Net cash used in operating activities | (21,009) | (20,556) | (18,369) |
Cash flows from investing activities: | |||
Purchases of property and equipment | (16) | (57) | |
Proceeds from sales of property and equipment | 16 | ||
Purchases of marketable securities | (188,365) | (100,006) | (129,250) |
Proceeds from maturities of marketable securities | 110,663 | 122,976 | 138,054 |
Net cash (used in) provided by investing activities | (77,718) | 22,970 | 8,763 |
Cash flows from financing activities: | |||
Proceeds from issuances of common stock under equity plans | 6,951 | 51 | 1,169 |
Proceeds from issuances of common stock from financings | 86,017 | 1,060 | |
Net cash provided by financing activities | 92,968 | 1,111 | 1,169 |
Net (decrease) increase in cash, cash equivalents and restricted cash | (5,759) | 3,525 | (8,437) |
Cash, cash equivalents and restricted cash at the beginning of the period | 16,603 | 13,078 | 21,515 |
Cash, cash equivalents and restricted cash at the end of the period | $ 10,844 | $ 16,603 | $ 13,078 |
ORGANIZATION AND SUMMARY OF SIG
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 1. ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Organization Geron Corporation, or we or Geron, was incorporated in the State of Delaware on November 28, 1990. We are a late-stage clinical biopharmaceutical company that is focused on the development and commercialization of innovative therapeutics for hematologic myeloid malignancies. We have global rights to imetelstat, a first-in-class telomerase inhibitor, that was discovered and developed at Geron. Principal activities to date have included obtaining financing, securing operating facilities and conducting research and development. In November 2014, we entered into an exclusive collaboration and license agreement, or the Collaboration Agreement, with Janssen Biotech, Inc., or Janssen, to develop and commercialize imetelstat worldwide for all indications in oncology, including hematologic myeloid malignancies, and all other human therapeutic uses. Janssen terminated the Collaboration Agreement effective September 28, 2018. Upon the effective date of termination, we regained the global rights to the imetelstat program. Under the termination provisions of the Collaboration Agreement, Janssen is required to provide certain operational support for the imetelstat program during transition of the program to us. The transition process is expected to occur through September 2019. Each company is responsible for costs incurred related to transition activities unless otherwise specified in the Collaboration Agreement. See Note 4 on License Agreements for additional information on the former Collaboration Agreement with Janssen. Prior Period Reclassifications With the adoption of Accounting Standards Update, or ASU, No. 2016-18, Statement of Cash Flows (Topic 230) Restricted Cash, or ASU No. 2016-18, the prior period presentation of cash and cash equivalents in the statements of cash flows has been updated to conform with current period presentation. See “New Accounting Pronouncements – Recently Adopted” in this Note 1 for further discussion of the adoption of ASU No. 2016-18. In addition, the prior period presentation of certain cash flows from financing activities in the statements of cash flows has been updated to conform with current period presentation. Net Loss Per Share Basic net income Use of Estimates The accompanying financial statements have been prepared in accordance with U.S. generally accepted accounting principles, or GAAP. The preparation of financial statements in conformity with GAAP requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities as of the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. On an ongoing basis, we evaluate our estimates, including those related to accrued liabilities, revenue recognition, fair value of marketable securities and equity investments, income taxes, and stock-based compensation. We base our estimates on historical experience and on various other market specific and relevant assumptions that we believe to be reasonable under the circumstances. Actual results could differ from those estimates. Fair Value of Financial Instruments Cash Equivalents and Marketable Securities We consider all highly liquid investments with an original maturity of three months or less to be cash equivalents. We are subject to credit risk related to our cash equivalents and marketable securities. Our marketable debt securities include U.S. government‑sponsored enterprise securities, commercial paper and corporate notes. We classify our marketable debt securities as available‑for‑sale. We record available‑for‑sale debt securities at fair value with unrealized gains and losses reported in accumulated other comprehensive income (loss) in stockholders’ equity. Realized gains and losses are included in interest and other income and are derived using the specific identification method for determining the cost of securities sold and have been insignificant to date. Dividend and interest income are recognized when earned and included in interest and other income in our statements of operations. We recognize a charge when the declines in the fair values below the amortized cost bases of our available‑for‑sale securities are judged to be other‑than‑temporary. We consider various factors in determining whether to recognize an other‑than‑temporary charge, including whether we intend to sell the security or whether it is more likely than not that we would be required to sell the security before recovery of the amortized cost basis. Declines in market value judged as other‑than‑temporary result in a charge to interest and other income. We have not recorded any other‑than‑temporary impairment charges on our available‑for‑sale securities for the years ended December 31, 2018, 2017 and 2016. See Note 2 on Fair Value Measurements. Equity Investments With the adoption of ASU No. 2016-01, Financial Instruments - Overall: Recognition and Measurement of Financial Assets and Financial Liabilities Revenue Recognition Beginning January 1, 2018, we recognize revenue in accordance with the provisions of Accounting Standards Codification Topic 606, Revenue from Contracts with Customers A performance obligation is a promise in an agreement to transfer a distinct good or service to the customer and is the unit of account in Topic 606. Significant management judgment is required to determine the level of effort required and the period over which completion of the performance obligations is expected under an agreement. If reasonable estimates regarding when performance obligations are either complete or substantially complete cannot be made, then revenue recognition is deferred until a reasonable estimate can be made. Revenue is then recognized over the remaining estimated period of performance using the cumulative catch-up method. We allocate the total transaction price to each performance obligation based on the estimated relative stand-alone selling prices of the promised goods or services underlying each performance obligation. Estimated selling prices for license rights are calculated using an income approach model and include the following key assumptions, judgments and estimates: the development timeline, revenue forecast, commercialization expenses, discount rate and probabilities of technical and regulatory success. Following is a description of the principal activities from which we generate revenue. License fees and royalty revenue primarily represent amounts earned under agreements that out-license our technology to various companies. License and/or Collaboration Agreements We have entered into several license agreements with various oncology, diagnostics, research tools and biologics production companies. Economic terms in these agreements may include non-refundable upfront license payments in cash or equity securities, annual license maintenance fees, cost sharing arrangements, milestone payments, royalties on future sales of products, or any combination of these items. Non-refundable upfront fees, annual license maintenance fees and funding of research and development activities are considered fixed, while milestone payments and royalties are identified as variable consideration. Licenses of Intellectual Property. If we determine the license to intellectual property is distinct from the other performance obligations identified in the agreement and the licensee can use and benefit from the license, we recognize revenue from non-refundable upfront fees allocated to the license upon the completion of the transfer of the license to the licensee. For such licenses, we recognize revenue from annual license maintenance fees upon the start of the new license period. For licenses that are bundled with other performance obligations, we assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable upfront fees or annual license maintenance fees. At each reporting period, we reassess the progress and, if necessary, adjust the measure of performance and related revenue recognition. Milestone Payments . At the inception of each agreement that includes milestone payments, we evaluate whether the milestones are considered probable of being achieved and estimate the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the value of the associated milestone is included in the transaction price. For milestones that we do not deem to be probable of being achieved, the associated milestone payments are fully constrained and the value of the milestone is excluded from the transaction price with no revenue being recognized. Milestone payments that are not within our control, such as regulatory-related accomplishments, are not considered probable of being achieved until those accomplishments have been communicated by the relevant regulatory authority. Once the assessment of probability of achievement becomes probable, we recognize revenue for the milestone payment. At each reporting period, we assess the probability of achievement of each milestone under our current agreements. Royalties . For agreements with sales-based royalties, including milestone payments based on the level of sales, where the license is deemed to be the predominant item to which the royalties relate, we recognize revenue at the later of (a) when the related sales occur, or (b) when the performance obligation, to which some or all of the royalty has been allocated, has been satisfied (or partially satisfied). At each reporting period, we estimate the sales incurred by each licensee based on historical experience and accrue the associated royalty amount. Cost Sharing Arrangements . Research and development and other expenses being shared by both parties under an agreement are recorded as earned or owed based on the performance obligations by both parties under the respective agreement. For arrangements in which we and our collaboration partner in the agreement are exposed to significant risks and rewards that depend on the commercial success of the activity, we recognize payments between the parties on a net basis and record such amounts as a reduction or addition to research and development expense. For arrangements in which we have agreed to perform certain research and development services for our collaboration partner and are not exposed to significant risks and rewards that depend on the commercial success of the activity, we recognize the respective cost reimbursements as revenue under the collaborative agreement over time in a manner proportionate to the costs we incurred to perform the services using the input method. Restricted Cash Restricted cash consists of funds maintained in a separate certificate of deposit account for credit card purchases. Research and Development Expenses Research and development expenses consist of expenses incurred in identifying, developing and testing product candidates resulting from our independent efforts as well as efforts associated with collaborations. These expenses include, but are not limited to, in‑process research and development acquired in an asset acquisition and deemed to have no alternative future use, payroll and personnel expense, lab supplies, non-clinical studies, clinical trials, including support for investigator‑sponsored clinical trials, raw materials to manufacture clinical trial drugs, manufacturing costs for research and clinical trial materials, sponsored research at other labs, consulting, costs to maintain technology licenses, our proportionate share of research and development costs under cost‑sharing arrangements with collaboration partners and research‑related overhead. Research and development costs are expensed as incurred, including costs incurred under our collaboration and/or license agreements. Until the sponsorship responsibilities for imetelstat transfer from Janssen to us, including the U.S. Investigational New Drug, or IND, application and all foreign regulatory applications, Janssen will continue conducting ongoing clinical trials of imetelstat during the transition of the program to us. For the clinical development activities being conducted by Janssen under the Collaboration Agreement, which was terminated effective September 28, 2018, we monitor patient enrollment levels and related activities to the extent possible through discussions with Janssen personnel and base our estimates of clinical trial costs on the best information available at the time. However, additional information may become available to us which would allow us to make a more accurate estimate in future periods. In this event, we may be required to record adjustments to research and development expenses in future periods when the actual level of activity becomes more certain. Depreciation and Amortization We record property and equipment at cost and calculate depreciation using the straight‑line method over the estimated useful lives of the assets, generally four years. Leasehold improvements are amortized over the shorter of the estimated useful life or remaining term of the lease. Stock‑Based Compensation We maintain various stock incentive plans under which stock options and restricted stock awards are granted to employees, directors and consultants. We also have an employee stock purchase plan for all eligible employees. We recognize stock‑based compensation expense based on the grant-date fair values of service-based instruments on a straight‑line basis over the requisite service period, which is generally the vesting period. For performance-based stock options with vesting based on the achievement of certain strategic milestones, stock-based compensation expense is recognized over the period from the date the performance condition is determined to be probable of occurring through the date the applicable condition is expected to be met and is reduced for estimated forfeitures, as applicable. If the performance condition is not considered probable of being achieved, no stock-based compensation expense is recognized until such time as the performance condition is considered probable of being met, if at all. If that assessment of the probability of the performance condition being met changes, the impact of the change in estimate would be recognized in the period of the change. For our non‑employee stock‑based awards, the measurement date on which the fair value of the stock‑based award is calculated is equal to the earlier of: (i) the date at which a commitment for performance by the counterparty to earn the equity instrument is reached or (ii) the date at which the counterparty’s performance is complete. We recognize stock‑based compensation expense for the fair value of the vested portion of non‑employee stock‑based awards in our statements of operations. For additional information, see Note 7 on Stockholders’ Equity. Accumulated Other Comprehensive Loss Accumulated other comprehensive loss includes certain changes in stockholders’ equity which are excluded from net income (loss). Accumulated other comprehensive loss on our balance sheets as of December 31, 2018 and 2017 is solely comprised of net unrealized gains and losses on marketable securities. Income Taxes We maintain deferred tax assets and liabilities that reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes and are subject to tests of recoverability. Our deferred tax assets include net operating loss carryforwards, research credits and capitalized research and development. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. Our net deferred tax asset has been fully offset by a valuation allowance because of our history of losses. Any potential accrued interest and penalties related to unrecognized tax benefits would be recorded as income tax expense. Concentrations of Customers and Suppliers The majority of our revenues was earned in the United States. Two customers accounted for approximately 59% and 39% of our 2018 and 2017 revenues, respectively. Approximately 81% of our 2016 revenues represented an upfront payment from Janssen Pharmaceuticals, Inc., or Janssen Pharmaceuticals, in connection with a license agreement signed in September 2016, or the License Agreement. Segment Information Our executive management team represents our chief decision maker. We view our operations as a single segment, the development of therapeutic products for oncology. As a result, the financial information disclosed herein materially represents all of the financial information related to our principal operating segment. Recent Accounting Pronouncements New Accounting Pronouncements – Recently Adopted In May 2014, the Financial Accounting Standards Board, or FASB, issued ASU No. 2014-09, which amends the guidance for accounting for revenue from contracts with customers. This ASU superseded the revenue recognition requirements in Accounting Standards Codification Topic 605, Revenue Recognition We adopted Topic 606 on January 1, 2018 using the modified retrospective transition method for those agreements which were not completed as of January 1, 2018. Financial results for the reporting periods beginning after January 1, 2018 are presented under Topic 606, while prior period amounts have not been adjusted and continue to be reported in accordance with our historical accounting under Topic 605. In connection with the adoption of Topic 606, we recognized a cumulative-effect adjustment to our opening balance of accumulated deficit and an increase to interest and other receivables of $204,000 as of January 1, 2018 for projected sales-based royalties on product sales occurring in 2017 for which payments had not yet been received as of December 31, 2017. Such royalties were recognized as revenue in prior periods when payments were received from our licensees. In accordance with Topic 606-10-50-14a, we have elected to exclude providing further information about our sales-based royalties. The adoption of Topic 606 did not result in any changes to the estimated transaction price or the performance obligations for current agreements or the amounts allocated to satisfied performance obligations. We do not have any deferred revenue associated with unsatisfied performance obligations. Since we view our operations as a single segment and all of our revenues are recognized at a point in time from similar license agreements, disaggregated revenue disclosures would not materially provide additional information. In 2018, the application of Topic 606 did not have a material impact on our financial results in comparison to results that would have been realized if we had continued to apply Topic 605. Additionally, we do not expect the application of Topic 606 to have a material impact on our financial results on an ongoing basis in comparison to results that would have been realized if we had continued to apply Topic 605. In January 2016, the FASB issued ASU 2016-01 which requires equity investments to be measured at fair value with changes in fair value recognized in the statements of operations. To further clarify ASU 2016-01, the FASB issued ASU No. 2018-03, Technical Corrections and Improvements to Financial Instruments - Overall (Subtopic 825-10): Recognition and Measurement of Financial Assets and Financial Liabilities in Sienna Cancer Diagnostics Limited, or Sienna we remeasured the fair value of our equity investment in Sienna at each reporting date in 2018 The cumulative-effect adjustments to our January 1, 2018 balance sheet for the adoption of Topic 606 and ASU 2016-01 and ASU 2018-03 were as follows (in thousands): Balance Sheet Balance at December 31, 2017 Adjustments Due to Topic 606 Adjustments Due to ASU 2016-01 and ASU 2018-03 Balance at January 1, 2018 Assets: Interest and other receivables $ 436 $ 204 $ — $ 640 Other assets $ — $ — $ 1,189 $ 1,189 Stockholders’ Equity: Accumulated deficit $ (985,840 ) $ 204 $ 1,189 $ (984,447 ) As of January 1, 2018, we also adopted ASU No. 2016-15, Classification of Certain Cash Receipts and Cash Payments Statement of Cash Flows (Topic 230) Restricted Cash Compensation — Stock Compensation: Scope of Modification Accounting New Accounting Pronouncements – Issued But Not Yet Adopted In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842) Leases (Topic 842): Targeted Improvements We adopted ASU 2016-02 on January 1, 2019 using the modified retrospective method as allowed under ASU 2018-11 by recording a cumulative-effect adjustment to the opening balance of retained earnings on January 1, 2019. In evaluating the impact of adopting the new lease guidance, we have determined that our current operating lease for our office space will require us to record an asset and an obligation for the arrangement of approximately $719,000 upon adoption of ASU 2016-02. We have also evaluated other rental and equipment service contracts and believe such agreements do not contain any embedded lease arrangements. We will elect the practical expedients upon transition that will retain the lease classification and initial direct costs for any leases that existed prior to the adoption of these standards. In June 2016, the FASB issued ASU 2016-13, Measurement of Credit Losses on Financial Instruments Codification Improvements to Topic 326, Financial Instruments - Credit Losses In June 2018, the FASB issued ASU 2018-07, Improvements to Nonemployee Share-Based Payment Accounting In August 2018, the FASB issued ASU 2018-13, Disclosure Framework — Changes to the Disclosure Requirements for Fair Value Measurement, In August 2018, the Securities and Exchange Commission issued Release No. 33-10532 that amends and clarifies certain financial reporting requirements. The principal change to our financial reporting will be the inclusion of the annual disclosure requirement of changes in stockholders’ equity in Rule 3-04 of Regulation S-X to interim periods. We will adopt this new rule beginning with our financial reporting for the quarter ending March 31, 2019. Upon adoption, we will include a Statement of Stockholders’ Equity with each quarterly filing on Form 10-Q. In November 2018, the FASB issued ASU 2018-18, Collaborative Arrangements (Topic 808): Clarifying the Interaction Between Topic 808 and Topic 606 |
FAIR VALUE MEASUREMENTS
FAIR VALUE MEASUREMENTS | 12 Months Ended |
Dec. 31, 2018 | |
Fair Value Disclosures [Abstract] | |
FAIR VALUE MEASUREMENTS | 2. FAIR VALUE MEASUREMENTS Cash Equivalents and Marketable Securities Cash equivalents, restricted cash and marketable securities by security type at December 31, 2018 were as follows: Gross Gross Amortized Unrealized Unrealized Estimated (In thousands) Cost Gains Losses Fair Value Included in cash and cash equivalents: Money market funds $ 7,003 $ — $ — $ 7,003 Restricted cash: Certificate of deposit $ 269 $ — $ — $ 269 Marketable securities: Commercial paper (due in less than one year) $ 57,594 $ 22 $ (29 ) $ 57,587 Corporate notes (due in less than one year) 95,238 7 (118 ) 95,127 Corporate notes (due in one to two years) 18,647 — (65 ) 18,582 $ 171,479 $ 29 $ (212 ) $ 171,296 Cash equivalents, restricted cash and marketable securities by security type at December 31, 2017 were as follows: Gross Gross Amortized Unrealized Unrealized Estimated (In thousands) Cost Gains Losses Fair Value Included in cash and cash equivalents: Money market funds $ 11,030 $ — $ — $ 11,030 Commercial paper 2,242 — — 2,242 Corporate notes 1,750 — (1 ) 1,749 $ 15,022 $ — $ (1 ) $ 15,021 Restricted cash: Certificate of deposit $ 268 $ — $ — $ 268 Marketable securities: Government-sponsored enterprise securities (due in less than one year) $ 12,500 $ — $ (40 ) $ 12,460 Commercial paper (due in less than one year) 10,928 4 (1 ) 10,931 Corporate notes (due in less than one year) 55,067 — (107 ) 54,960 Corporate notes (due in one to two years) 14,303 — (62 ) 14,241 $ 92,798 $ 4 $ (210 ) $ 92,592 Cash equivalents and marketable securities with unrealized losses that have been in a continuous unrealized loss position for less than 12 months and 12 months or longer at December 31, 2018 and 2017 were as follows: Less Than 12 Months 12 Months or Greater Total Gross Gross Gross Estimated Unrealized Estimated Unrealized Estimated Unrealized (In thousands) Fair Value Losses Fair Value Losses Fair Value Losses As of December 31, 2018: Commercial paper (due in less than one year) $ 22,628 $ (29 ) $ — $ — $ 22,628 $ (29 ) Corporate notes (due in less than one year) 66,557 (82 ) 14,221 (36 ) 80,778 (118 ) Corporate notes (due in one to two years) 18,582 (65 ) — — 18,582 (65 ) $ 107,767 $ (176 ) $ 14,221 $ (36 ) $ 121,988 $ (212 ) As of December 31, 2017: Government-sponsored enterprise securities (due in less than one year) $ — $ — $ 12,460 $ (40 ) $ 12,460 $ (40 ) Commercial paper (due in less than one year) 7,717 (1 ) — — 7,717 (1 ) Corporate notes (due in less than one year) 55,210 (106 ) 1,499 (2 ) 56,709 (108 ) Corporate notes (due in one to two years) 14,241 (62 ) — — 14,241 (62 ) $ 77,168 $ (169 ) $ 13,959 $ (42 ) $ 91,127 $ (211 ) The gross unrealized losses related to government‑sponsored enterprise securities, commercial paper and corporate notes as of December 31, 2018 and 2017 were due to changes in interest rates. We determined that the gross unrealized losses on our cash equivalents and marketable securities as of December 31, 2018 and 2017 were temporary in nature. We review our investments quarterly to identify and evaluate whether any investments have indications of possible impairment. Factors considered in determining whether a loss is temporary include the length of time and extent to which the fair value has been less than the cost basis and whether we intend to sell the security or whether it is more likely than not that we would be required to sell the security before recovery of the amortized cost basis. We currently do not intend to sell these securities before recovery of their amortized cost bases. Fair Value on a Recurring Basis We categorize financial instruments recorded at fair value on our balance sheets based upon the level of judgment associated with inputs used to measure their fair value. The categories are as follows: Level 1 — Inputs are unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date. An active market for the asset or liability is a market in which transactions for the asset or liability occur with sufficient frequency and volume to provide pricing information on an ongoing basis. Level 2 — Inputs (other than quoted market prices included in Level 1) are either directly or indirectly observable for the asset or liability through correlation with market data at the measurement date and for the duration of the instrument’s anticipated life. Level 3 — Inputs reflect management’s best estimate of what market participants would use in pricing the asset or liability at the measurement date. Consideration is given to the risk inherent in the valuation technique and the risk inherent in the inputs to the model. A financial instrument’s categorization within the valuation hierarchy is based upon the lowest level of input that is significant to the fair value measurement. Below is a description of the valuation methodologies used for financial instruments measured at fair value on our balance sheets, including the category for such financial instruments. Money market funds are categorized as Level 1 within the fair value hierarchy as their fair values are based on quoted prices available in active markets. U.S. government‑sponsored enterprise securities, commercial paper, corporate notes and equity investments are categorized as Level 2 within the fair value hierarchy as their fair values are estimated by using pricing models, quoted prices of securities with similar characteristics or discounted cash flows. The following table presents information about our financial instruments that are measured at fair value on a recurring basis as of December 31, 2018 and 2017 and indicates the fair value category assigned. Fair Value Measurements at Reporting Date Using Quoted Prices in Significant Active Markets for Significant Other Unobservable Identical Assets Observable Inputs Inputs (In thousands) Level 1 Level 2 Level 3 Total As of December 31, 2018: Money market funds ( 1) $ 7,003 $ — $ — $ 7,003 Commercial paper ( 2) — 57,587 — 57,587 Corporate notes ( 2)(3) — 113,709 — 113,709 Equity investment ( 4) — 585 — 585 Total $ 7,003 $ 171,881 $ — $ 178,884 As of December 31, 2017: Money market funds ( 1) $ 11,030 $ — $ — $ 11,030 Government-sponsored enterprise securities ( 2) — 12,460 — 12,460 Commercial paper ( 1)(2) — 13,173 — 13,173 Corporate notes ( 1)(2)(3) — 70,950 — 70,950 Total $ 11,030 $ 96,583 $ — $ 107,613 (1) Included in cash and cash equivalents on our balance sheets. (2) Included in current portion of marketable securities on our balance sheets. (3) Included in noncurrent portion of marketable securities on our balance sheets. (4) Included in other assets on our balance sheets. See “Equity Investment” in this Note 2 for further discussion of this equity investment. Equity Investment In December 2007, we received 13,842,625 ordinary shares in Sienna in connection with a license we granted to them for our human telomerase reverse transcriptase, or hTERT, technology for use in human diagnostics. Upon receipt, the shares were connection with Sienna’s initial public offering under Australian securities regulations, we signed a Due to this trading restriction, under the cost method of accounting, we maintained a zero cost basis for our shares in Sienna as of December 31, 2017. With the adoption of ASU 2016-01 and ASU 2018-03 on January 1, 2018, as described in Note 1 on Organization and Summary of Significant Accounting Policies, our equity investment in Sienna must be reported at fair value and therefore, we recorded a cumulative-effect adjustment of $1,189,000 on our balance sheet for the fair value of our shares in Sienna, as measured using the closing stock price reported on the ASX and converted to U.S. dollars as of January 1, 2018. In accordance with ASU 2016-01, we remeasure the fair value of our shares in Sienna at the end of each reporting period, and as of December 31, 2018, the fair value of our shares in Sienna was $585,000, resulting in a decrease in fair value of $604,000 for the year ended December 31, 2018, including a loss of $63,000 related to foreign currency translation. Credit Risk We currently place our cash, restricted cash, cash equivalents and marketable securities with four financial institutions in the United States. Generally, these deposits may be redeemed upon demand and therefore, bear minimal risk. Deposits with banks may exceed the amount of insurance provided on such deposits. Financial instruments that potentially subject us to concentrations of credit risk consist primarily of cash equivalents and marketable securities. Cash equivalents and marketable securities currently consist of money market funds, commercial paper and corporate notes. Our investment policy, approved by the audit committee of our board of directors, limits the amount we may invest in any one type of investment issuer, thereby reducing credit risk concentrations. |
PROPERTY AND EQUIPMENT
PROPERTY AND EQUIPMENT | 12 Months Ended |
Dec. 31, 2018 | |
Property Plant And Equipment [Abstract] | |
PROPERTY AND EQUIPMENT | 3. PROPERTY AND EQUIPMENT Property and equipment, stated at cost, is comprised of the following: December 31, (In thousands) 2018 2017 Furniture and computer equipment $ 727 $ 711 Leasehold improvements 111 111 838 822 Less accumulated depreciation and amortization (779 ) (720 ) $ 59 $ 102 |
LICENSE AGREEMENTS
LICENSE AGREEMENTS | 12 Months Ended |
Dec. 31, 2018 | |
License Agreement Disclosure [Abstract] | |
LICENSE AGREEMENTS | 4. LICENSE AGREEMENTS Janssen Biotech, Inc. Collaboration and License Agreement On November 13, 2014, we and Janssen entered into the Collaboration Agreement under which we granted to Janssen exclusive worldwide rights to develop and commercialize imetelstat for all human therapeutic uses, including hematologic myeloid malignancies. Upon the effectiveness of the Collaboration Agreement, we received $35,000,000 from Janssen as an upfront payment, which we classified as deferred revenue upon receipt. Under the Collaboration Agreement, Janssen was wholly responsible for the development, manufacturing, seeking regulatory approval for and commercialization of, imetelstat worldwide. Janssen has been conducting two clinical trials of imetelstat: a Phase 2 trial in myelofibrosis, referred to as IMbark, and a Phase 2/3 trial in myelodysplastic syndromes, referred to as IMerge. Development costs for IMbark and IMerge were shared between us and Janssen on a 50/50 basis. Additionally, under the terms of the Collaboration Agreement, we remained responsible for prosecuting, at Janssen’s direction, the patents licensed to Janssen at the time we entered into the Collaboration Agreement, with costs shared between us and Janssen on a 50/50 basis. The cost‑sharing arrangement with Janssen began in January 2015. Janssen terminated the Collaboration Agreement effective September 28, 2018. Upon the effective date of termination, we regained the global rights to the imetelstat program and plan to continue development of imetelstat on our own. As a result of the termination of the Collaboration Agreement, we will not receive any further milestone payments or royalties from Janssen for the development or commercialization of imetelstat, including any clinical development or sales milestones, and Janssen has no further obligations to us or any third parties, such as clinical sites or vendors, to fund any potential future imetelstat clinical trials. Under the termination provisions of the Collaboration Agreement, Janssen is required to provide certain operational support for the imetelstat program during transition of the program to us. The transition process is expected to occur through September 2019 to enable the orderly transfer of all ongoing clinical, regulatory, medical affairs and non-clinical activities to us, including the transfer of the sponsorship of ongoing imetelstat clinical trials from Janssen to us. Each company is responsible for costs incurred related to transition activities unless otherwise specified in the Collaboration Agreement. In addition, Janssen is expected to supply imetelstat to us for up to 24 months during a transition period for clinical manufacturing and such supply will be charged to us at Janssen’s cost plus a premium. Until the sponsorship responsibilities for imetelstat transfer from Janssen to us, including the U.S. Investigational New Drug, or IND, application and all foreign regulatory applications, Janssen will continue conducting ongoing clinical trials of imetelstat. After September 28, 2018, the effective termination date of the Collaboration Agreement, our responsibility for imetelstat development costs, including continuing conduct of ongoing clinical trials of imetelstat, and costs for the prosecution of patents that were licensed to Janssen under the Collaboration Agreement increased from 50% to 100%. As of December 31, 2018, the amount due to Janssen of $2,610,000 on our balance sheet primarily represents the amount owed to Janssen for operational support of the imetelstat program for the three months ended December 31, 2018. Janssen Pharmaceuticals, Inc. License Agreement On September 15, 2016, we entered into the License Agreement with Janssen Pharmaceuticals whereby we granted to Janssen Pharmaceuticals an exclusive worldwide license, or the Exclusive License, under our proprietary patents for the research, development and commercialization of products based on specialized oligonucleotide backbone chemistry and novel amidates for ribonucleic acid interference, or RNAi, for the prevention, treatment and/or diagnosis of any and all human disorders, excluding cancers originating from the blood or bone marrow, and products whose predominant or primary mechanism of action is telomerase inhibition. In addition to the Exclusive License, we granted to Janssen Pharmaceuticals a non‑exclusive worldwide license, or the Non‑Exclusive License, under our patents covering the synthesis of monomers, which are the building blocks of oligonucleotides, and certain know‑how necessary for the research, development and commercialization of products under the Exclusive License. Under the terms of the License Agreement, Janssen Pharmaceuticals, at its sole expense, is required to use reasonable efforts to perform research, development and commercialization activities to obtain at least one licensed product to be researched, developed and commercialized under the License Agreement. We remain responsible for prosecuting the patent rights under the Exclusive License, with reasonable input provided by Janssen Pharmaceuticals, and the costs for such prosecution will be shared between us and Janssen Pharmaceuticals on a 50/50 basis. Under the terms of the License Agreement, we received $5,000,000 from Janssen Pharmaceuticals as a non‑refundable upfront payment. We are also eligible to receive additional potential payments of up to an aggregate maximum total of $75,000,000 for the achievement of certain development and regulatory milestones and tiered royalties in the low single digit percentage range on worldwide net sales of each licensed product commercialized under the License Agreement in any countries where there are valid claims under the patent rights licensed to Janssen Pharmaceuticals. The License Agreement will remain in effect until the expiration of the last‑to‑expire patent, unless terminated earlier. Janssen Pharmaceuticals may also terminate the License Agreement at will upon prior written notice to us. In the event of an early termination of the License Agreement, all licenses to Janssen Pharmaceuticals would terminate. The license rights granted to Janssen Pharmaceuticals are the only performance obligation for us under the License Agreement. In addition, we concluded that Janssen Pharmaceuticals can use and benefit from the license rights without any further performance from us due to their specific knowledge of oligonucleotide chemistry, and sufficient capital to independently research, develop and commercialize products under the License Agreement on a global basis. Accordingly, we fully recognized the $5,000,000 upfront payment from Janssen Pharmaceuticals as license fee revenue on our statements of operations in the third quarter of 2016 upon the completion of the transfer of the license rights to Janssen Pharmaceuticals. We have determined that each of the additional potential development and regulatory milestone payments to us under the License Agreement represent fully constrained variable consideration under Topic 606 as achievement of these milestones has not been deemed probable as of December 31, 2018 |
ACCRUED LIABILITIES
ACCRUED LIABILITIES | 12 Months Ended |
Dec. 31, 2018 | |
Payables And Accruals [Abstract] | |
ACCRUED LIABILITIES | 5. ACCRUED LIABILITIES Accrued liabilities consisted of the following: December 31, (In thousands) 2018 2017 Professional legal and accounting fees $ 327 $ 272 Clinical trial costs 529 516 Other 461 138 $ 1,317 $ 926 |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 12 Months Ended |
Dec. 31, 2018 | |
Commitments And Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | 6. COMMITMENTS AND CONTINGENCIES Indemnifications to Officers and Directors Our corporate bylaws require that we indemnify our directors, as well as those who act as directors and officers of other entities at our request, against expenses, judgments, fines, settlements and other amounts actually and reasonably incurred in connection with any proceedings arising out of their services to Geron. In addition, we have entered into separate indemnification agreements with each of our directors and officers which provide for indemnification of these directors and officers under similar circumstances and under additional circumstances. The indemnification obligations are more fully described in our bylaws and the indemnification agreements. We purchase standard insurance to cover claims or a portion of the claims made against our directors and officers. Since a maximum obligation is not explicitly stated in our bylaws or in our indemnification agreements and will depend on the facts and circumstances that arise out of any future claims, the overall maximum amount of the obligations cannot be reasonably estimated. Operating Lease Commitment On September 21, 2017, we amended the lease agreement for our premises at 149 Commonwealth Drive, Menlo Park, California, to extend the lease term from February 2018 through January 2020. As of December 31, 2018, operating lease obligations under the amended lease agreement include aggregate future minimum payments of approximately $757,000, of which payments of approximately $699,000 and $58,000 are due in 2019 and 2020, respectively. Rent expense under our operating leases was approximately $703,000, $691,000 and $708,000 for the years ended December 31, 2018, 2017 and 2016, respectively. Severance Plan We have an Amended and Restated Severance Plan, or Severance Plan, that applies to all employees that are not subject to performance improvement plans, and provides for, among other benefits: (i) a severance payment upon a Change of Control Triggering Event and Separation from Service and (ii) a severance payment for each non‑executive employee upon a Non‑Change of Control Triggering Event and Separation from Service. As defined in the Severance Plan, a Change of Control Triggering Event and Separation from Service requires a “double trigger” where: (i) an employee is terminated by us without cause in connection with a change of control or within 12 months following a change of control provided, however, that if an employee is terminated by us in connection with a change of control but immediately accepts employment with our successor or acquirer, the employee will not be eligible for the benefits outlined in the Severance Plan, (ii) an employee resigns because in connection with a change of control, the offered terms of employment (new or continuing) by us or our successor or acquirer within 30 days after the change of control results in a material change in the terms of employment, or (iii) after accepting (or continuing) employment with us after a change of control, an employee resigns within 12 months following a change of control due to a material change in the terms of employment. Under the Severance Plan, a Non‑Change of Control Triggering Event and Separation from Service is defined as an event where a non‑executive employee is terminated by us without cause. Severance payments range from two to 18 months of base salary, depending on the employee’s position with us, payable in a lump sum payment. The Severance Plan also provides that the provisions of employment agreements entered into between us and executive or non‑executive employees supersede the provisions of the Severance Plan. As of December 31, 2018, all our executive officers have employment agreements with provisions that may provide greater severance benefits than those in the Severance Plan. Gain on Settlement From November 2010 to September 2012, we owned 40% of ViaGen, Inc., or ViaGen, a company with in-house breeding services and expertise in advanced reproductive technologies for animal cloning. In September 2012, we and the other shareholders of ViaGen executed a Share Purchase Agreement, or SPA, and sold our equity interests to Trans Ova Genetics, L.C., or Trans Ova. Under the SPA, we and the other ViaGen shareholders would receive potential payments aggregating up to $6,000,000 upon Trans Ova reaching certain commercial milestones. We and the other ViaGen shareholders were also eligible to receive potential proceeds upon the sale by Trans Ova of a non-marketable equity investment originally held by ViaGen. Payments under the SPA would be shared amongst the ViaGen shareholders according to their original equity interests in ViaGen prior to the sale to Trans Ova. In July 2018, we and the other former shareholders of ViaGen filed an arbitration claim against Trans Ova for alleged violations under the SPA, including failure to make payments under certain conditions. In December 2018, we and the other former shareholders of ViaGen agreed to settle the dispute for a one-time payment of $3,650,000, of which we received $1,460,000, which represents our 40% share of the settlement amount. With this settlement, Trans Ova has been released from any further obligations under the SPA, including any future payments. |
STOCKHOLDERS' EQUITY
STOCKHOLDERS' EQUITY | 12 Months Ended |
Dec. 31, 2018 | |
Stockholders Equity Note [Abstract] | |
STOCKHOLDERS' EQUITY | 7. STOCKHOLDERS’ EQUITY Sales Agreements On August 28, 2015, we entered into an At Market Issuance Sales Agreement, or the 2015 Sales Agreement, with MLV & Co. LLC, or MLV, under which we could elect to issue and sell shares of our common stock having an aggregate offering price of up to $50,000,000. Pursuant to the 2015 Sales Agreement, common stock was sold at market prices prevailing at the time of sale through MLV as our sales agent. We paid MLV an aggregate commission rate equal to up to 3.0% of the gross proceeds of the sales price per share for common stock sold through MLV under the 2015 Sales Agreement. In December 2017, we sold an aggregate of 614,230 shares of our common stock pursuant to the 2015 Sales Agreement, resulting in net cash proceeds to us of approximately $1,060,000 after deducting sales commissions and offering expenses payable by us. From January 2018 through April 2018, we completed the sale of the remaining common stock subject to the 2015 Sales Agreement and issued an aggregate of 13,195,106 shares of our common stock, resulting in net cash proceeds to us of approximately $47,651,000 after deducting sales commissions and offering expenses payable by us. No further shares of common stock may be sold under the 2015 Sales Agreement. On May 18, 2018, we entered into an At Market Issuance Sales Agreement, or the 2018 Sales Agreement, with B. Riley FBR, Inc., or B. Riley FBR, pursuant to which we may elect to issue and sell shares of our common stock having an aggregate offering price of up to $100,000,000 in such quantities and on such minimum price terms as we set from time to time through B. Riley FBR as our sales agent. We pay B. Riley FBR an aggregate commission rate equal to up to 3.0% of the gross proceeds of the sales price per share for common stock sold through B. Riley FBR under the 2018 Sales Agreement. From May 2018 through July 2018, we sold an aggregate of 10,083,079 shares of our common stock pursuant to the 2018 Sales Agreement, resulting in net cash proceeds to us of approximately $38,366,000 after deducting sales commissions and offering expenses payable by us. The 2018 Sales Agreement will expire upon the earlier of: (a) the sale of all common stock subject to the 2018 Sales Agreement and (b) May 18, 2021. Warrant In connection with each disbursement under a previous loan agreement with the California Institute for Regenerative Medicine, or CIRM, we were obligated to issue to CIRM a warrant to purchase Geron common stock. Such warrants and the underlying common stock were unregistered. We have no further obligations to issue any additional warrants to CIRM. As of December 31, 2018, a warrant to purchase 537,893 shares of our common stock remained outstanding. The warrant was issued to CIRM in August 2011 at an exercise price of $3.98 per share and expires in August 2021. Equity Plans 2002 Equity Incentive Plan The 2002 Equity Incentive Plan, or 2002 Plan, expired in May 2012. Upon the adoption of the 2011 Incentive Award Plan in May 2011 (see below), no further grants of options or stock purchase rights were made from the 2002 Plan. Options granted under the 2002 Plan expire no later than ten years from the date of grant. Option exercise prices were equal to 100% of the fair market value of the underlying common stock on the date of grant. Service‑based stock options under the 2002 Plan generally vested over a period of four years from the date of the option grant. Other stock awards (restricted stock awards and restricted stock units) had variable vesting schedules which were determined by our board of directors on the date of grant. All outstanding awards granted under the 2002 Plan remain subject to the terms of the 2002 Plan and the individual award agreements thereunder. 2011 Incentive Award Plan In May 2011, our stockholders approved the adoption of the 2011 Incentive Award Plan, or 2011 Plan. The 2011 Plan provided for grants of either incentive stock options or nonstatutory stock options and stock purchase rights to employees (including officers and employee directors) and consultants (including non‑employee directors). Upon the adoption of the 2018 Equity Incentive Plan in May 2018 (see below), no further grants of options or stock purchase rights were made from the 2011 Plan. Options granted under the 2011 Plan expire no later than ten years from the date of grant. Option exercise prices were equal to the fair market value of the underlying common stock on the date of grant. Service‑based stock options under the 2011 Plan generally vested over a period of four years from the date of the option grant. Other stock awards (restricted stock awards and restricted stock units) had variable vesting schedules which were determined by our board of directors on the date of grant. All outstanding awards granted under the 2011 Plan remain subject to the terms of the 2011 Plan and the individual award agreements thereunder. Under certain circumstances, options may be exercised prior to vesting, subject to our right to repurchase the shares underlying such option at the exercise price paid per share. Our repurchase rights would generally terminate on a vesting schedule identical to the vesting schedule of the exercised option. During 2018, we have not repurchased any shares under the 2011 Plan. As of December 31, 2018, we have no shares outstanding subject to repurchase under the 2011 Plan. 2018 Equity Incentive Plan On May 15, 2018, our stockholders approved the adoption of the 2018 Equity Incentive Plan, or 2018 Plan, as the successor to the 2011 Plan. The 2018 Plan provides for the grant of incentive stock options, nonstatutory stock options, stock appreciation rights, restricted stock awards, restricted stock unit awards, other stock awards, and performance awards that may be settled in cash, stock, or other property. Eligible participants under the 2018 Plan include our employees, consultants and directors. The number of shares reserved for issuance under the 2018 Plan (subject to adjustment for certain changes in capitalization) is equal to the sum of (i) the unallocated shares of common stock remaining available for grant under the 2011 Plan as of May 15, 2018, (ii) 10,000,000 newly reserved shares of common stock and (iii) the number of shares subject to awards granted under the 2002 Plan, and the 2011 Plan as such shares become available from time to time, referred to as the Prior Plans’ Returning Shares. Such Prior Plans’ Returning Shares become available for issuance under the 2018 Plan if outstanding stock awards granted under the 2002 Plan and the 2011 Plan, after May 15, 2018, expire or terminate for any reason prior to exercise or settlement or are forfeited, cancelled or otherwise returned to us because of the failure to meet a contingency or condition required for the vesting of such shares, or, subject to certain exceptions, are reacquired or withheld (or not issued) by us to satisfy a tax withholding obligation in connection with a stock award. Options granted under the 2018 Plan expire no later than ten years from the date of grant. Option exercise prices shall be equal to the fair market value of the underlying common stock on the date of grant. If, at the time we grant an option, the optionee directly or by attribution owns stock possessing more than 10% of the total combined voting power of all classes of our stock, the option exercise price shall be at least 110% of the fair market value of the underlying common stock and shall not be exercisable more than five years after the date of grant. We grant service-based and performance-based stock options to employees under the 2018 Plan. Service-based options generally vest over a period of four years from the date of the option grant. Performance-based options vest upon the achievement of specified milestones. Other stock awards (restricted stock awards and restricted stock units) have variable vesting schedules as determined by our board of directors on the date of grant. Under certain circumstances, options may be exercised prior to vesting, subject to our right to repurchase the shares underlying such option at the exercise price paid per share. Our repurchase rights would generally terminate on a vesting schedule identical to the vesting schedule of the exercised option. During 2018, we have not repurchased any shares under the 2018 Plan. As of December 31, 2018, we have no shares outstanding subject to repurchase under the 2018 Plan. As of December 31, 2018, our Non‑Employee Director Compensation Policy adopted by our board of directors in March 2014 and amended by our board of directors in February 2015, May 2015, February 2016, January 2018, May 2018, October 2018 and January 2019 provides for the automatic grant to non‑employee directors of the following types of equity awards under the 2018 Plan: First Director Option. Each person who becomes a non‑employee director, whether by election by our stockholders or by appointment by our board of directors to fill a vacancy, will automatically be granted an option to purchase 120,000 shares of common stock, or First Director Option, on the date such person first becomes a non‑employee director. The First Director Option vests annually over three years upon each anniversary date of appointment to our board of directors. Subsequent Director Option. Each non‑employee director (other than any director receiving a First Director Option on the date of the annual meeting) will automatically be granted a subsequent option to purchase 70,000 shares of common stock, a Subsequent Director Option, on the date of the annual meeting of stockholders in each year during such director’s service on our board of directors. The Subsequent Director Option vests in full on the earlier of: (i) the date of the next annual meeting of our stockholders or (ii) the first anniversary of the date of grant. 2006 Directors’ Stock Option Plan The 2006 Directors’ Stock Option Plan, or 2006 Directors Plan, was terminated by our board of directors and replaced by the 2011 Plan in March 2014. No further grants of options were made from the 2006 Directors Plan upon the 2006 Directors Plan’s termination. All outstanding awards granted under the 2006 Directors Plan remain subject to the terms of the 2006 Directors Plan and the individual award agreements thereunder. The options granted to non‑employee directors under the 2006 Directors Plan were nonstatutory stock options, and they expire no later than ten years from the date of grant. The option exercise price was equal to the fair market value of the underlying common stock on the date of grant. The First Director Option granted to non‑employee directors under the 2006 Directors Plan vested annually over three years upon each anniversary date of appointment to the board of directors. The Subsequent Director Option granted to non‑employee directors on the date of the annual meeting of stockholders in each year during such director’s service on our board of directors under the 2006 Directors Plan vested one year from the date of grant. 2018 Inducement Award Plan In December 2018, our board of directors approved the adoption of the 2018 Inducement Award Plan, or the Inducement Plan, pursuant to which we reserved 3,000,000 shares of Geron common stock (subject to customary adjustments in the event of a change in capital structure) to be used exclusively for grants of inducement awards to individuals who were not previously Geron employees or directors, other than following a bona fide period of non-employment. The Inducement Plan provides for the grant of nonstatutory stock options, stock appreciation rights, restricted stock awards, restricted stock units and other stock awards, and all awards under the Inducement Plan are intended to meet the standards under Rule 5635(c)(4) of the Nasdaq Listing Rules. The terms and conditions of the Inducement Plan and the inducement awards to be granted thereunder are substantially similar to the 2018 Plan. As of December 31, 2018, we had not granted any awards under the Inducement Plan Directors’ Market Value Stock Purchase Plan In October 2018, our board of directors adopted a Directors’ Market Value Stock Purchase Plan, or the Directors Market Plan. A total of 1,000,000 shares of Geron common stock has been reserved for the Directors Market Plan. Under the Directors Market Plan, non-employee directors may purchase shares of Geron common stock at the prevailing market price on the purchase date with cash compensation payable to them for their services as a board member. As stated in Geron’s Non-Employee Director Compensation Policy, each non-employee director receives annual cash compensation, payable quarterly in arrears, for their services on the board and various committees of the board. As provided in the Non-Employee Director Compensation Policy, a non-employee director may elect to receive fully vested shares of common stock in lieu of cash and such shares shall be issuable from the Directors Market Plan. As of December 31, 2018, we have not issued any shares under the Directors Market Plan. Aggregate option and award activity for the 2002 Plan, 2011 Plan, 2018 Plan, 2006 Directors Plan, Inducement Plan and Directors Market Plan is as follows: Outstanding Options Weighted Average Aggregate Shares Weighted Average Remaining Intrinsic Available Number of Exercise Price Contractual Life Value For Grant Shares Per Share (In years) (In thousands) Balance at December 31, 2017 6,202,727 22,408,529 $ 2.96 Additional shares authorized 14,000,000 — $ — Options granted (9,265,000 ) 9,265,000 (1) $ 2.07 Awards granted (139,652 ) — $ — Options exercised — (3,144,878 ) $ 2.20 Options cancelled/forfeited/expired 1,166,324 (1,242,699 ) $ 3.48 Balance at December 31, 2018 11,964,399 27,285,952 (1) $ 2.72 6.71 $ — Options exercisable at December 31, 2018 16,464,746 $ 3.13 5.10 $ — Options fully vested and expected to vest at December 31, 2018 26,293,625 $ 2.75 6.61 $ — (1) Includes 4,500,000 performance-based stock options that have not achieved certain strategic milestones. The aggregate intrinsic value in the preceding table represents the total intrinsic value, based on Geron’s closing stock price of $1.00 per share as of December 31, 2018, which would have been received by the option holders had all the option holders exercised their options as of that date. We have not granted any options with an exercise price below or greater than the fair market value of our common stock on the date of grant in 2018, 2017 or 2016. As of December 31, 2018, 2017 and 2016, there were 16,464,746, 17,249,032 and 14,074,457 exercisable options outstanding at weighted average exercise prices per share of $3.13, $3.03 and $2.99, respectively. The total pretax intrinsic value of stock options exercised during 2018, 2017 and 2016 was $8,812,000, $15,000 and $595,000, respectively. Cash received from the exercise of options in 2018, 2017 and 2016 totaled approximately $6,929,000, $18,000 and $493,000, respectively. Information about stock options outstanding as of December 31, 2018 is as follows: Options Outstanding Weighted Average Weighted Average Remaining Number of Exercise Price Contractual Life Exercise Price Range Shares Per Share (In years) $1.10 - $1.72 10,290,050 $ 1.61 7.04 $1.73 - $2.45 7,144,384 $ 2.27 7.65 $2.54 - $5.01 8,055,105 $ 3.95 6.06 $5.09 - $7.31 1,796,413 $ 5.33 4.03 $1.10 - $7.31 27,285,952 (1) $ 2.72 6.71 (1) Includes 4,500,000 performance-based stock options that have not achieved certain strategic milestones. Aggregate restricted stock activity for the 2011 Plan and the 2018 Plan is as follows: Weighted Average Weighted Average Grant Date Remaining Number of Fair Value Contractual Term Shares Per Share (In years) Non-vested restricted stock at December 31, 2017 — $ — — Granted 73,980 $ 1.91 Vested (73,980 ) $ 1.91 Non-vested restricted stock at December 31, 2018 — $ — — The weighted average grant date fair value of restricted stock granted during the years ended December 31, 2018, 2017 and 2016 was $1.91, $2.20 and $2.44 per share, respectively. The total fair value of restricted stock that vested during 2018, 2017 and 2016 was $141,000, $159,000 and $54,000, respectively. Employee Stock Purchase Plan In March 2014, our board of directors adopted the 2014 Employee Stock Purchase Plan, or 2014 Purchase Plan. The 2014 Purchase Plan was approved by our stockholders in May 2014. The 2014 Purchase Plan replaced the 1996 Employee Stock Purchase Plan, or 1996 Purchase Plan, which was terminated effective as of the date the 2014 Purchase Plan was approved by our stockholders. Under the 2014 Purchase Plan, we are authorized to sell to eligible employees up to an aggregate of 1,000,000 shares of Geron common stock. As of December 31, 2018, an aggregate of 123,092 shares of our common stock have been issued under the 2014 Purchase Plan since its adoption. The 2014 Purchase Plan is comprised of a series of offering periods, each with a maximum duration (not to exceed 12 months) with new offering periods commencing on January 1st and July 1st of each year. The date an employee enters the offering period will be designated as the entry date for purposes of that offering period. An employee may participate only in one offering period at a time. Each offering period consists of two consecutive purchase periods of six months’ duration, with the last day of such period designated a purchase date. Under the terms of the 2014 Purchase Plan, employees can choose to have up to 10% of their annual salary withheld to purchase our common stock. An employee may not make additional payments into such account or increase the withholding percentage during the offering period. The purchase price per share at which common stock is purchased by the employee on each purchase date within the offering period is equal to 85% of the lower of (i) the fair market value per share of Geron common stock on the employee’s entry date into that offering period or (ii) the fair market value per share of Geron common stock on the purchase date. If the fair market value per share of Geron common stock on the purchase date is less than the fair market value at the beginning of the offering period, a new 12 month offering period will automatically begin on the first business day following the purchase date with a new fair market value. Stock‑Based Compensation for Employees and Directors We measure and recognize compensation expense for all share‑based payment awards made to employees and directors, including employee stock options, restricted stock awards and employee stock purchases, based on grant‑date fair values for these instruments. We use the Black Scholes option‑pricing model to estimate the grant‑date fair value of our service-based and performance-based stock options and employee stock purchases. The fair value for service‑based restricted stock awards is determined using the fair value of our common stock on the date of grant. As stock‑based compensation expense recognized in the statements of operations for the years ended December 31, 2018, 2017 and 2016 is based on awards ultimately expected to vest, it has been reduced for estimated forfeitures, but at a minimum, reflects the grant‑date fair value of those awards that actually vested in the period. Forfeitures have been estimated at the time of grant based on historical data and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. With the adoption of Accounting Standards Update No. 2016-09, Improvements to Employee Share Based Payment Accounting In 2018, our board of directors awarded performance-based stock options to certain employees. These performance-based stock options are included in the outstanding options table above. Performance-based options vest only upon achievement of discrete strategic milestones. Stock-based compensation expense for performance-based options is recognized over the period from the date the performance condition is determined to be probable of occurring through the date the applicable condition is expected to be met and is reduced for estimated forfeitures, as applicable. If the performance condition is not considered probable of being achieved, no stock-based compensation expense is recognized until such time as the performance condition is considered probable of being met, if ever. We recognize stock‑based compensation expense for service-based stock options on a straight‑line basis over the requisite service period, which is generally the vesting period. We have not recognized any stock-based compensation expense for performance-based stock options in our statements of operations for the year ended December 31, 2018, as the achievement of the specified strategic milestones was not considered probable during that time. The following table summarizes the stock‑based compensation expense related to service-based stock options, restricted stock awards and employee stock purchases for the years ended December 31, 2018, 2017 and 2016 which was allocated as follows: Year Ended December 31, (In thousands) 2018 2017 2016 Research and development $ 949 $ 988 $ 1,275 General and administrative 5,419 7,156 6,970 Stock-based compensation expense included in operating expenses $ 6,368 $ 8,144 $ 8,245 The fair value of stock options granted in 2018, 2017 and 2016 has been estimated at the date of grant using the Black Scholes option‑pricing model with the following assumptions: Year Ended December 31, 2018 2017 2016 Dividend yield 0% 0% 0% Expected volatility range 0.821 to 0.990 0.884 to 0.892 0.888 to 0.890 Risk-free interest rate range 2.55% to 3.11% 1.98% to 1.99% 1.21% to 1.38% Expected term range 5.25 - 6.62 yrs 5.5 yrs 5.5 yrs The fair value of employee stock purchases in 2018, 2017 and 2016 has been estimated using the Black Scholes option‑pricing model with the following assumptions: Year Ended December 31, 2018 2017 2016 Dividend yield 0% 0% 0% Expected volatility range 0.437 to 0.475 0.577 to 0.641 0.641 to 0.684 Risk-free interest rate range 1.53% to 1.76% 0.45% to 0.89% 0.28% to 0.45% Expected term range 6 - 12 mos 6 - 12 mos 6 - 12 mos Dividend yield is based on historical cash dividend payments and Geron has paid no cash dividends to date. The expected volatility range is based on historical volatilities of our stock since traded options on Geron common stock do not correspond to option terms and the trading volume of options is limited. The risk‑free interest rate range is based on the U.S. Zero Coupon Treasury Strip Yields for the expected term in effect on the date of grant for an award. The expected term of options is derived from actual historical exercise and post‑vesting cancellation data and represents the period of time that options granted are expected to be outstanding. The expected term of employees’ purchase rights is equal to the purchase period. Based on the Black Scholes option‑pricing model, the weighted average estimated fair value of stock options granted during the years ended December 31, 2018, 2017 and 2016 was $1.52, $1.58 and $1.83 per share, respectively. The weighted average estimated fair value of employees’ purchase rights for the years ended December 31, 2018, 2017 and 2016 was $0.56, $0.75 and $1.01 per share, respectively. As of December 31, 2018, total compensation cost related to unvested share‑based payment awards not yet recognized, net of estimated forfeitures and assuming no probability of achievement for outstanding performance-based stock options, was $8,814,000, which is expected to be recognized over the next 27 months on a weighted‑average basis. 401(k) Plan Matching Contributions We sponsor a defined‑contribution savings plan under Section 401(k) of the Internal Revenue Code covering all full‑time U.S. employees, or the Geron 401K Plan. Participating employees may contribute up to the annual Internal Revenue Service contribution limit. The Geron 401K Plan also permits us to provide discretionary matching and profit sharing contributions. Prior to 2014, our board of directors approved matching contributions for the Geron 401K Plan in our common stock, which vested ratably over four years for each year of service completed by our employees, commencing from the date of hire. Stock‑Based Compensation to Service Providers We grant stock options and restricted stock awards to consultants from time to time in exchange for services performed for us. In general, the stock options and restricted stock awards vest over the contractual period of the consulting arrangement. The fair value of stock options and restricted stock awards held by consultants is recorded as operating expenses over the vesting term of the respective equity awards. In addition, we will record any increase in the fair value of the stock options and restricted stock awards as the respective equity award vests. We recorded stock‑based compensation expense of $50,000, $41,000 and $104,000 for the vested portion of the fair value of stock options and restricted stock awards held by consultants in 2018, 2017 and 2016, respectively. We have also issued common stock to non‑employee directors and consultants. For stock issuances where services are to be performed for us, we record a prepaid asset equal to the fair market value of the shares on the date of issuance and amortize the fair value of the shares to our operating expenses on a pro‑rata basis as services are performed. For stock issuances where services have been performed for us, we record the fair market value of the shares on the date of issuance to offset the amounts owed. In 2018, 2017 and 2016, we issued 73,980, 72,066 and 21,541 shares of common stock, respectively, in exchange for services provided. In 2018, 2017 and 2016, we recognized approximately $141,000, $159,000 and $52,000, respectively, of expense in connection with stock grants to non‑employee directors and consultants. Common Stock Reserved for Future Issuance Common stock reserved for future issuance as of December 31, 2018 is as follows: Outstanding stock options 27,285,952 Options and awards available for grant 11,964,399 Employee stock purchase plan 876,908 Warrant outstanding 537,893 Total 40,665,152 |
INCOME TAXES
INCOME TAXES | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
INCOME TAXES | 8. INCOME TAXES Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Significant components of our deferred tax assets are as follows: December 31, 2018 2017 (In thousands) Net operating loss carryforwards $ 192,100 $ 187,700 Research credits 35,500 34,300 Capitalized research and development 2,500 2,500 License fees — 100 Other-net 7,000 8,200 Total deferred tax assets 237,100 232,800 Valuation allowance for deferred tax assets (237,100 ) (232,800 ) Net deferred tax assets $ — $ — We record net deferred tax assets to the extent we believe these assets will more likely than not be realized. In making such determination, we consider all available positive and negative evidence, including scheduled reversals of deferred tax liabilities, projected future taxable income, tax planning strategies and recent financial performance. Forming a conclusion that a valuation allowance is not required is difficult when there is negative evidence such as cumulative losses in recent years. Because of our history of losses, the net deferred tax assets have been fully offset by a valuation allowance. The valuation allowance increased by $4,300,000 and $9,600,000 for the years ended December 31, 2018 and 2016, respectively, and decreased by $89,400,000 during the year ended December 31, 2017. No income tax benefit was realized from stock options exercised in 2018 because our net deferred tax assets have been fully offset by a valuation allowance. As of December 31, 2018, we had domestic federal net operating loss carryforwards of approximately $816,800,000. Of this, $788,500,000 will expire at various dates beginning in 2019 through 2037 and the remaining will carryforward indefinitely under the new tax laws, but is subject to an 80% taxable income limitation. As of December 31, 2018, we had state net operating loss carryforwards of approximately $294,800,000 expiring at various dates beginning in 2028 through 2038, if not utilized. We also had federal research and development tax credit carryforwards of approximately $35,500,000 expiring at various dates beginning in 2019 through 2038, if not utilized. Our state research and development tax credit carryforwards of approximately $19,200,000 carry forward indefinitely. Due to the change of ownership provisions of the Tax Reform Act of 1986, utilization of a portion of our domestic net operating loss and tax credit carryforwards may be limited in future periods. Further, a portion of the carryforwards may expire before being applied to reduce future income tax liabilities. On December 22, 2017, the Tax Cuts and Jobs Act of 2017, or 2017 Tax Act, was signed into law. Among other things, the 2017 Tax Act permanently lowers the corporate federal income tax rate to 21% from the previous maximum rate of 35%, effective for tax years including or commencing January 1, 2018. In accordance with GAAP, we remeasured the carrying value of our deferred tax assets as of December 31, 2017 using the new enacted corporate federal income tax rate of 21%. This remeasurement reduced our aggregate deferred tax assets and correspondingly reduced the valuation allowance by approximately $102,300,000. The remeasurement did not impact our financial statements. In accordance with Staff Accounting Bulletin 118, as of December 31, 2017, we made a reasonable estimate of the effects of the 2017 Tax Act on our existing deferred tax assets. Our preliminary estimate and the remeasurement of our deferred tax assets was subject to further analysis related to certain matters, such as developing interpretations of the provisions of the 2017 Tax Act, changes to certain estimates and the filing of our tax returns. U.S. Treasury regulations, administrative interpretations or court decisions interpreting the 2017 Tax Act may require further adjustments and changes in our estimates. In the fourth quarter of 2018, we completed our analysis to determine the effect of the 2017 Tax Act. No material adjustments were noted from the completion of the analysis as of December 31, 2018. We adopted the provision of the standard for accounting for uncertainties in income taxes on January 1, 2007. Upon adoption, we recognized no material adjustment in the liability for unrecognized tax benefits. At December 31, 2018, we had approximately $16,400,000 of unrecognized tax benefits, none of which would currently affect our effective tax rate if recognized due to our deferred tax assets being fully offset by a valuation allowance. A reconciliation of the beginning and ending amounts of unrecognized tax benefits is as follows (in thousands): Balance as of December 31, 2017 $ 15,900 Decrease related to prior year tax positions (100 ) Increase related to current year tax positions 600 Balance as of December 31, 2018 $ 16,400 If applicable, we would classify interest and penalties related to uncertain tax positions in income tax expense. Through December 31, 2018, there has been no interest expense or penalties related to unrecognized tax benefits. We do not currently expect any significant changes to unrecognized tax benefits during the fiscal year ended December 31, 2019. In certain cases, our uncertain tax positions are related to tax years that remain subject to examination by the relevant tax authorities. Tax years for which we have carryforward net operating loss and credit attributes remain subject to examination by federal and most state tax authorities. |
STATEMENTS OF CASH FLOWS DATA
STATEMENTS OF CASH FLOWS DATA | 12 Months Ended |
Dec. 31, 2018 | |
Supplemental Cash Flow Elements [Abstract] | |
STATEMENTS OF CASH FLOWS DATA | 9. STATEMENTS OF CASH FLOWS DATA Year Ended December 31, 2018 2017 2016 (In thousands) Supplemental investing activities: Net unrealized gain (loss) on marketable securities $ 24 $ (154 ) $ 160 We have not made any cash payments for taxes or interest for the years ended December 31, 2018, 2017 and 2016. |
SELECTED QUARTERLY FINANCIAL IN
SELECTED QUARTERLY FINANCIAL INFORMATION (UNAUDITED) | 12 Months Ended |
Dec. 31, 2018 | |
Quarterly Financial Information Disclosure [Abstract] | |
SELECTED QUARTERLY FINANCIAL INFORMATION (UNAUDITED) | First Second Third Fourth Quarter Quarter Quarter Quarter (In thousands, except per share amounts) Year Ended December 31, 2018: Revenues $ 318 $ 208 $ 165 $ 375 Operating expenses 7,755 7,450 6,970 9,964 Net loss (7,186 ) (6,934 ) (5,597 ) (7,300 ) Basic and diluted net loss per share $ (0.04 ) $ (0.04 ) $ (0.03 ) $ (0.04 ) Year Ended December 31, 2017: Revenues $ 537 $ 174 $ 163 $ 191 Operating expenses 8,031 6,905 7,407 7,977 Net loss (7,183 ) (6,405 ) (6,899 ) (7,429 ) Basic and diluted net loss per share $ (0.05 ) $ (0.04 ) $ (0.04 ) $ (0.05 ) Basic and diluted net loss per share are computed independently for each of the quarters presented. Therefore, the sum of the quarters may not be equal to the full year net loss per share amounts. |
SUBSEQUENT EVENT
SUBSEQUENT EVENT | 12 Months Ended |
Dec. 31, 2018 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENT | 11. SUBSEQUENT EVENT We have engaged Parexel as our contract research organization to support imetelstat clinical development activities. Parexel will provide contract research services related to clinical trials conducted by us, in accordance with the terms of the Master Services Agreement, or the MSA, that we entered into with Parexel on January 30, 2019, and related work orders. We may terminate the MSA and/or any work order without cause on prior written notice to Parexel. Contemporaneously with entering the MSA, we entered into a first work order with Parexel, under which Parexel will provide services related to IMerge. Under the first work order, we will pay Parexel service fees and pass-through expenses estimated to be approximately $33 million in the aggregate for Parexel’s services related to IMerge. |
ORGANIZATION AND SUMMARY OF S_2
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Dec. 31, 2018 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Prior Period Reclassifications | Prior Period Reclassifications With the adoption of Accounting Standards Update, or ASU, No. 2016-18, Statement of Cash Flows (Topic 230) Restricted Cash, or ASU No. 2016-18, the prior period presentation of cash and cash equivalents in the statements of cash flows has been updated to conform with current period presentation. See “New Accounting Pronouncements – Recently Adopted” in this Note 1 for further discussion of the adoption of ASU No. 2016-18. In addition, the prior period presentation of certain cash flows from financing activities in the statements of cash flows has been updated to conform with current period presentation. |
Net Loss Per Share | Net Loss Per Share Basic net income |
Use of Estimates | Use of Estimates The accompanying financial statements have been prepared in accordance with U.S. generally accepted accounting principles, or GAAP. The preparation of financial statements in conformity with GAAP requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities as of the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. On an ongoing basis, we evaluate our estimates, including those related to accrued liabilities, revenue recognition, fair value of marketable securities and equity investments, income taxes, and stock-based compensation. We base our estimates on historical experience and on various other market specific and relevant assumptions that we believe to be reasonable under the circumstances. Actual results could differ from those estimates. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments Cash Equivalents and Marketable Securities We consider all highly liquid investments with an original maturity of three months or less to be cash equivalents. We are subject to credit risk related to our cash equivalents and marketable securities. Our marketable debt securities include U.S. government‑sponsored enterprise securities, commercial paper and corporate notes. We classify our marketable debt securities as available‑for‑sale. We record available‑for‑sale debt securities at fair value with unrealized gains and losses reported in accumulated other comprehensive income (loss) in stockholders’ equity. Realized gains and losses are included in interest and other income and are derived using the specific identification method for determining the cost of securities sold and have been insignificant to date. Dividend and interest income are recognized when earned and included in interest and other income in our statements of operations. We recognize a charge when the declines in the fair values below the amortized cost bases of our available‑for‑sale securities are judged to be other‑than‑temporary. We consider various factors in determining whether to recognize an other‑than‑temporary charge, including whether we intend to sell the security or whether it is more likely than not that we would be required to sell the security before recovery of the amortized cost basis. Declines in market value judged as other‑than‑temporary result in a charge to interest and other income. We have not recorded any other‑than‑temporary impairment charges on our available‑for‑sale securities for the years ended December 31, 2018, 2017 and 2016. See Note 2 on Fair Value Measurements. Equity Investments With the adoption of ASU No. 2016-01, Financial Instruments - Overall: Recognition and Measurement of Financial Assets and Financial Liabilities |
Revenue Recognition | Revenue Recognition Beginning January 1, 2018, we recognize revenue in accordance with the provisions of Accounting Standards Codification Topic 606, Revenue from Contracts with Customers A performance obligation is a promise in an agreement to transfer a distinct good or service to the customer and is the unit of account in Topic 606. Significant management judgment is required to determine the level of effort required and the period over which completion of the performance obligations is expected under an agreement. If reasonable estimates regarding when performance obligations are either complete or substantially complete cannot be made, then revenue recognition is deferred until a reasonable estimate can be made. Revenue is then recognized over the remaining estimated period of performance using the cumulative catch-up method. We allocate the total transaction price to each performance obligation based on the estimated relative stand-alone selling prices of the promised goods or services underlying each performance obligation. Estimated selling prices for license rights are calculated using an income approach model and include the following key assumptions, judgments and estimates: the development timeline, revenue forecast, commercialization expenses, discount rate and probabilities of technical and regulatory success. Following is a description of the principal activities from which we generate revenue. License fees and royalty revenue primarily represent amounts earned under agreements that out-license our technology to various companies. License and/or Collaboration Agreements We have entered into several license agreements with various oncology, diagnostics, research tools and biologics production companies. Economic terms in these agreements may include non-refundable upfront license payments in cash or equity securities, annual license maintenance fees, cost sharing arrangements, milestone payments, royalties on future sales of products, or any combination of these items. Non-refundable upfront fees, annual license maintenance fees and funding of research and development activities are considered fixed, while milestone payments and royalties are identified as variable consideration. Licenses of Intellectual Property. If we determine the license to intellectual property is distinct from the other performance obligations identified in the agreement and the licensee can use and benefit from the license, we recognize revenue from non-refundable upfront fees allocated to the license upon the completion of the transfer of the license to the licensee. For such licenses, we recognize revenue from annual license maintenance fees upon the start of the new license period. For licenses that are bundled with other performance obligations, we assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable upfront fees or annual license maintenance fees. At each reporting period, we reassess the progress and, if necessary, adjust the measure of performance and related revenue recognition. Milestone Payments . At the inception of each agreement that includes milestone payments, we evaluate whether the milestones are considered probable of being achieved and estimate the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the value of the associated milestone is included in the transaction price. For milestones that we do not deem to be probable of being achieved, the associated milestone payments are fully constrained and the value of the milestone is excluded from the transaction price with no revenue being recognized. Milestone payments that are not within our control, such as regulatory-related accomplishments, are not considered probable of being achieved until those accomplishments have been communicated by the relevant regulatory authority. Once the assessment of probability of achievement becomes probable, we recognize revenue for the milestone payment. At each reporting period, we assess the probability of achievement of each milestone under our current agreements. Royalties . For agreements with sales-based royalties, including milestone payments based on the level of sales, where the license is deemed to be the predominant item to which the royalties relate, we recognize revenue at the later of (a) when the related sales occur, or (b) when the performance obligation, to which some or all of the royalty has been allocated, has been satisfied (or partially satisfied). At each reporting period, we estimate the sales incurred by each licensee based on historical experience and accrue the associated royalty amount. Cost Sharing Arrangements . Research and development and other expenses being shared by both parties under an agreement are recorded as earned or owed based on the performance obligations by both parties under the respective agreement. For arrangements in which we and our collaboration partner in the agreement are exposed to significant risks and rewards that depend on the commercial success of the activity, we recognize payments between the parties on a net basis and record such amounts as a reduction or addition to research and development expense. For arrangements in which we have agreed to perform certain research and development services for our collaboration partner and are not exposed to significant risks and rewards that depend on the commercial success of the activity, we recognize the respective cost reimbursements as revenue under the collaborative agreement over time in a manner proportionate to the costs we incurred to perform the services using the input method. |
Restricted Cash | Restricted Cash Restricted cash consists of funds maintained in a separate certificate of deposit account for credit card purchases. |
Research and Development Expenses | Research and Development Expenses Research and development expenses consist of expenses incurred in identifying, developing and testing product candidates resulting from our independent efforts as well as efforts associated with collaborations. These expenses include, but are not limited to, in‑process research and development acquired in an asset acquisition and deemed to have no alternative future use, payroll and personnel expense, lab supplies, non-clinical studies, clinical trials, including support for investigator‑sponsored clinical trials, raw materials to manufacture clinical trial drugs, manufacturing costs for research and clinical trial materials, sponsored research at other labs, consulting, costs to maintain technology licenses, our proportionate share of research and development costs under cost‑sharing arrangements with collaboration partners and research‑related overhead. Research and development costs are expensed as incurred, including costs incurred under our collaboration and/or license agreements. Until the sponsorship responsibilities for imetelstat transfer from Janssen to us, including the U.S. Investigational New Drug, or IND, application and all foreign regulatory applications, Janssen will continue conducting ongoing clinical trials of imetelstat during the transition of the program to us. For the clinical development activities being conducted by Janssen under the Collaboration Agreement, which was terminated effective September 28, 2018, we monitor patient enrollment levels and related activities to the extent possible through discussions with Janssen personnel and base our estimates of clinical trial costs on the best information available at the time. However, additional information may become available to us which would allow us to make a more accurate estimate in future periods. In this event, we may be required to record adjustments to research and development expenses in future periods when the actual level of activity becomes more certain. |
Depreciation and Amortization | Depreciation and Amortization We record property and equipment at cost and calculate depreciation using the straight‑line method over the estimated useful lives of the assets, generally four years. Leasehold improvements are amortized over the shorter of the estimated useful life or remaining term of the lease. |
Stock-Based Compensation | Stock‑Based Compensation We maintain various stock incentive plans under which stock options and restricted stock awards are granted to employees, directors and consultants. We also have an employee stock purchase plan for all eligible employees. We recognize stock‑based compensation expense based on the grant-date fair values of service-based instruments on a straight‑line basis over the requisite service period, which is generally the vesting period. For performance-based stock options with vesting based on the achievement of certain strategic milestones, stock-based compensation expense is recognized over the period from the date the performance condition is determined to be probable of occurring through the date the applicable condition is expected to be met and is reduced for estimated forfeitures, as applicable. If the performance condition is not considered probable of being achieved, no stock-based compensation expense is recognized until such time as the performance condition is considered probable of being met, if at all. If that assessment of the probability of the performance condition being met changes, the impact of the change in estimate would be recognized in the period of the change. For our non‑employee stock‑based awards, the measurement date on which the fair value of the stock‑based award is calculated is equal to the earlier of: (i) the date at which a commitment for performance by the counterparty to earn the equity instrument is reached or (ii) the date at which the counterparty’s performance is complete. We recognize stock‑based compensation expense for the fair value of the vested portion of non‑employee stock‑based awards in our statements of operations. For additional information, see Note 7 on Stockholders’ Equity. |
Accumulated Other Comprehensive Loss | Accumulated Other Comprehensive Loss Accumulated other comprehensive loss includes certain changes in stockholders’ equity which are excluded from net income (loss). Accumulated other comprehensive loss on our balance sheets as of December 31, 2018 and 2017 is solely comprised of net unrealized gains and losses on marketable securities. |
Income Taxes | Income Taxes We maintain deferred tax assets and liabilities that reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes and are subject to tests of recoverability. Our deferred tax assets include net operating loss carryforwards, research credits and capitalized research and development. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. Our net deferred tax asset has been fully offset by a valuation allowance because of our history of losses. Any potential accrued interest and penalties related to unrecognized tax benefits would be recorded as income tax expense. |
Concentrations of Customers and Suppliers | Concentrations of Customers and Suppliers The majority of our revenues was earned in the United States. Two customers accounted for approximately 59% and 39% of our 2018 and 2017 revenues, respectively. Approximately 81% of our 2016 revenues represented an upfront payment from Janssen Pharmaceuticals, Inc., or Janssen Pharmaceuticals, in connection with a license agreement signed in September 2016, or the License Agreement. |
Segment Information | Segment Information Our executive management team represents our chief decision maker. We view our operations as a single segment, the development of therapeutic products for oncology. As a result, the financial information disclosed herein materially represents all of the financial information related to our principal operating segment. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements New Accounting Pronouncements – Recently Adopted In May 2014, the Financial Accounting Standards Board, or FASB, issued ASU No. 2014-09, which amends the guidance for accounting for revenue from contracts with customers. This ASU superseded the revenue recognition requirements in Accounting Standards Codification Topic 605, Revenue Recognition We adopted Topic 606 on January 1, 2018 using the modified retrospective transition method for those agreements which were not completed as of January 1, 2018. Financial results for the reporting periods beginning after January 1, 2018 are presented under Topic 606, while prior period amounts have not been adjusted and continue to be reported in accordance with our historical accounting under Topic 605. In connection with the adoption of Topic 606, we recognized a cumulative-effect adjustment to our opening balance of accumulated deficit and an increase to interest and other receivables of $204,000 as of January 1, 2018 for projected sales-based royalties on product sales occurring in 2017 for which payments had not yet been received as of December 31, 2017. Such royalties were recognized as revenue in prior periods when payments were received from our licensees. In accordance with Topic 606-10-50-14a, we have elected to exclude providing further information about our sales-based royalties. The adoption of Topic 606 did not result in any changes to the estimated transaction price or the performance obligations for current agreements or the amounts allocated to satisfied performance obligations. We do not have any deferred revenue associated with unsatisfied performance obligations. Since we view our operations as a single segment and all of our revenues are recognized at a point in time from similar license agreements, disaggregated revenue disclosures would not materially provide additional information. In 2018, the application of Topic 606 did not have a material impact on our financial results in comparison to results that would have been realized if we had continued to apply Topic 605. Additionally, we do not expect the application of Topic 606 to have a material impact on our financial results on an ongoing basis in comparison to results that would have been realized if we had continued to apply Topic 605. In January 2016, the FASB issued ASU 2016-01 which requires equity investments to be measured at fair value with changes in fair value recognized in the statements of operations. To further clarify ASU 2016-01, the FASB issued ASU No. 2018-03, Technical Corrections and Improvements to Financial Instruments - Overall (Subtopic 825-10): Recognition and Measurement of Financial Assets and Financial Liabilities in Sienna Cancer Diagnostics Limited, or Sienna we remeasured the fair value of our equity investment in Sienna at each reporting date in 2018 The cumulative-effect adjustments to our January 1, 2018 balance sheet for the adoption of Topic 606 and ASU 2016-01 and ASU 2018-03 were as follows (in thousands): Balance Sheet Balance at December 31, 2017 Adjustments Due to Topic 606 Adjustments Due to ASU 2016-01 and ASU 2018-03 Balance at January 1, 2018 Assets: Interest and other receivables $ 436 $ 204 $ — $ 640 Other assets $ — $ — $ 1,189 $ 1,189 Stockholders’ Equity: Accumulated deficit $ (985,840 ) $ 204 $ 1,189 $ (984,447 ) As of January 1, 2018, we also adopted ASU No. 2016-15, Classification of Certain Cash Receipts and Cash Payments Statement of Cash Flows (Topic 230) Restricted Cash Compensation — Stock Compensation: Scope of Modification Accounting New Accounting Pronouncements – Issued But Not Yet Adopted In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842) Leases (Topic 842): Targeted Improvements We adopted ASU 2016-02 on January 1, 2019 using the modified retrospective method as allowed under ASU 2018-11 by recording a cumulative-effect adjustment to the opening balance of retained earnings on January 1, 2019. In evaluating the impact of adopting the new lease guidance, we have determined that our current operating lease for our office space will require us to record an asset and an obligation for the arrangement of approximately $719,000 upon adoption of ASU 2016-02. We have also evaluated other rental and equipment service contracts and believe such agreements do not contain any embedded lease arrangements. We will elect the practical expedients upon transition that will retain the lease classification and initial direct costs for any leases that existed prior to the adoption of these standards. In June 2016, the FASB issued ASU 2016-13, Measurement of Credit Losses on Financial Instruments Codification Improvements to Topic 326, Financial Instruments - Credit Losses In June 2018, the FASB issued ASU 2018-07, Improvements to Nonemployee Share-Based Payment Accounting In August 2018, the FASB issued ASU 2018-13, Disclosure Framework — Changes to the Disclosure Requirements for Fair Value Measurement, In August 2018, the Securities and Exchange Commission issued Release No. 33-10532 that amends and clarifies certain financial reporting requirements. The principal change to our financial reporting will be the inclusion of the annual disclosure requirement of changes in stockholders’ equity in Rule 3-04 of Regulation S-X to interim periods. We will adopt this new rule beginning with our financial reporting for the quarter ending March 31, 2019. Upon adoption, we will include a Statement of Stockholders’ Equity with each quarterly filing on Form 10-Q. In November 2018, the FASB issued ASU 2018-18, Collaborative Arrangements (Topic 808): Clarifying the Interaction Between Topic 808 and Topic 606 |
ORGANIZATION AND SUMMARY OF S_3
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Schedule of cumulative effect adjustments for the adoption of Topic 606 and ASU 2016-01 and ASU 2018-03 | The cumulative-effect adjustments to our January 1, 2018 balance sheet for the adoption of Topic 606 and ASU 2016-01 and ASU 2018-03 were as follows (in thousands): Balance Sheet Balance at December 31, 2017 Adjustments Due to Topic 606 Adjustments Due to ASU 2016-01 and ASU 2018-03 Balance at January 1, 2018 Assets: Interest and other receivables $ 436 $ 204 $ — $ 640 Other assets $ — $ — $ 1,189 $ 1,189 Stockholders’ Equity: Accumulated deficit $ (985,840 ) $ 204 $ 1,189 $ (984,447 ) |
FAIR VALUE MEASUREMENTS (Tables
FAIR VALUE MEASUREMENTS (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Fair Value Disclosures [Abstract] | |
Schedule of cash equivalents, restricted cash and marketable securities by security type | Cash equivalents, restricted cash and marketable securities by security type at December 31, 2018 were as follows: Gross Gross Amortized Unrealized Unrealized Estimated (In thousands) Cost Gains Losses Fair Value Included in cash and cash equivalents: Money market funds $ 7,003 $ — $ — $ 7,003 Restricted cash: Certificate of deposit $ 269 $ — $ — $ 269 Marketable securities: Commercial paper (due in less than one year) $ 57,594 $ 22 $ (29 ) $ 57,587 Corporate notes (due in less than one year) 95,238 7 (118 ) 95,127 Corporate notes (due in one to two years) 18,647 — (65 ) 18,582 $ 171,479 $ 29 $ (212 ) $ 171,296 Cash equivalents, restricted cash and marketable securities by security type at December 31, 2017 were as follows: Gross Gross Amortized Unrealized Unrealized Estimated (In thousands) Cost Gains Losses Fair Value Included in cash and cash equivalents: Money market funds $ 11,030 $ — $ — $ 11,030 Commercial paper 2,242 — — 2,242 Corporate notes 1,750 — (1 ) 1,749 $ 15,022 $ — $ (1 ) $ 15,021 Restricted cash: Certificate of deposit $ 268 $ — $ — $ 268 Marketable securities: Government-sponsored enterprise securities (due in less than one year) $ 12,500 $ — $ (40 ) $ 12,460 Commercial paper (due in less than one year) 10,928 4 (1 ) 10,931 Corporate notes (due in less than one year) 55,067 — (107 ) 54,960 Corporate notes (due in one to two years) 14,303 — (62 ) 14,241 $ 92,798 $ 4 $ (210 ) $ 92,592 |
Schedule of cash equivalents and marketable securities with unrealized losses | Cash equivalents and marketable securities with unrealized losses that have been in a continuous unrealized loss position for less than 12 months and 12 months or longer at December 31, 2018 and 2017 were as follows: Less Than 12 Months 12 Months or Greater Total Gross Gross Gross Estimated Unrealized Estimated Unrealized Estimated Unrealized (In thousands) Fair Value Losses Fair Value Losses Fair Value Losses As of December 31, 2018: Commercial paper (due in less than one year) $ 22,628 $ (29 ) $ — $ — $ 22,628 $ (29 ) Corporate notes (due in less than one year) 66,557 (82 ) 14,221 (36 ) 80,778 (118 ) Corporate notes (due in one to two years) 18,582 (65 ) — — 18,582 (65 ) $ 107,767 $ (176 ) $ 14,221 $ (36 ) $ 121,988 $ (212 ) As of December 31, 2017: Government-sponsored enterprise securities (due in less than one year) $ — $ — $ 12,460 $ (40 ) $ 12,460 $ (40 ) Commercial paper (due in less than one year) 7,717 (1 ) — — 7,717 (1 ) Corporate notes (due in less than one year) 55,210 (106 ) 1,499 (2 ) 56,709 (108 ) Corporate notes (due in one to two years) 14,241 (62 ) — — 14,241 (62 ) $ 77,168 $ (169 ) $ 13,959 $ (42 ) $ 91,127 $ (211 ) |
Schedule of financial instruments measured at fair value on recurring basis | The following table presents information about our financial instruments that are measured at fair value on a recurring basis as of December 31, 2018 and 2017 and indicates the fair value category assigned. Fair Value Measurements at Reporting Date Using Quoted Prices in Significant Active Markets for Significant Other Unobservable Identical Assets Observable Inputs Inputs (In thousands) Level 1 Level 2 Level 3 Total As of December 31, 2018: Money market funds ( 1) $ 7,003 $ — $ — $ 7,003 Commercial paper ( 2) — 57,587 — 57,587 Corporate notes ( 2)(3) — 113,709 — 113,709 Equity investment ( 4) — 585 — 585 Total $ 7,003 $ 171,881 $ — $ 178,884 As of December 31, 2017: Money market funds ( 1) $ 11,030 $ — $ — $ 11,030 Government-sponsored enterprise securities ( 2) — 12,460 — 12,460 Commercial paper ( 1)(2) — 13,173 — 13,173 Corporate notes ( 1)(2)(3) — 70,950 — 70,950 Total $ 11,030 $ 96,583 $ — $ 107,613 (1) Included in cash and cash equivalents on our balance sheets. (2) Included in current portion of marketable securities on our balance sheets. (3) Included in noncurrent portion of marketable securities on our balance sheets. (4) Included in other assets on our balance sheets. See “Equity Investment” in this Note 2 for further discussion of this equity investment. |
PROPERTY AND EQUIPMENT (Tables)
PROPERTY AND EQUIPMENT (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Property Plant And Equipment [Abstract] | |
Schedule of property and equipment, stated at cost | Property and equipment, stated at cost, is comprised of the following: December 31, (In thousands) 2018 2017 Furniture and computer equipment $ 727 $ 711 Leasehold improvements 111 111 838 822 Less accumulated depreciation and amortization (779 ) (720 ) $ 59 $ 102 |
ACCRUED LIABILITIES (Tables)
ACCRUED LIABILITIES (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Payables And Accruals [Abstract] | |
Schedule of accrued liabilities | December 31, (In thousands) 2018 2017 Professional legal and accounting fees $ 327 $ 272 Clinical trial costs 529 516 Other 461 138 $ 1,317 $ 926 |
STOCKHOLDERS' EQUITY (Tables)
STOCKHOLDERS' EQUITY (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Stockholders Equity Note [Abstract] | |
Schedule of aggregate option and award activity | Aggregate option and award activity for the 2002 Plan, 2011 Plan, 2018 Plan, 2006 Directors Plan, Inducement Plan and Directors Market Plan is as follows: Outstanding Options Weighted Average Aggregate Shares Weighted Average Remaining Intrinsic Available Number of Exercise Price Contractual Life Value For Grant Shares Per Share (In years) (In thousands) Balance at December 31, 2017 6,202,727 22,408,529 $ 2.96 Additional shares authorized 14,000,000 — $ — Options granted (9,265,000 ) 9,265,000 (1) $ 2.07 Awards granted (139,652 ) — $ — Options exercised — (3,144,878 ) $ 2.20 Options cancelled/forfeited/expired 1,166,324 (1,242,699 ) $ 3.48 Balance at December 31, 2018 11,964,399 27,285,952 (1) $ 2.72 6.71 $ — Options exercisable at December 31, 2018 16,464,746 $ 3.13 5.10 $ — Options fully vested and expected to vest at December 31, 2018 26,293,625 $ 2.75 6.61 $ — (1) Includes 4,500,000 performance-based stock options that have not achieved certain strategic milestones. |
Schedule of information about stock options outstanding by exercise price range | Information about stock options outstanding as of December 31, 2018 is as follows: Options Outstanding Weighted Average Weighted Average Remaining Number of Exercise Price Contractual Life Exercise Price Range Shares Per Share (In years) $1.10 - $1.72 10,290,050 $ 1.61 7.04 $1.73 - $2.45 7,144,384 $ 2.27 7.65 $2.54 - $5.01 8,055,105 $ 3.95 6.06 $5.09 - $7.31 1,796,413 $ 5.33 4.03 $1.10 - $7.31 27,285,952 (1) $ 2.72 6.71 (1) Includes 4,500,000 performance-based stock options that have not achieved certain strategic milestones. |
Schedule of aggregate restricted stock activity | Aggregate restricted stock activity for the 2011 Plan and the 2018 Plan is as follows: Weighted Average Weighted Average Grant Date Remaining Number of Fair Value Contractual Term Shares Per Share (In years) Non-vested restricted stock at December 31, 2017 — $ — — Granted 73,980 $ 1.91 Vested (73,980 ) $ 1.91 Non-vested restricted stock at December 31, 2018 — $ — — |
Summary of allocation of stock-based compensation expense related to share-based payment awards | Year Ended December 31, (In thousands) 2018 2017 2016 Research and development $ 949 $ 988 $ 1,275 General and administrative 5,419 7,156 6,970 Stock-based compensation expense included in operating expenses $ 6,368 $ 8,144 $ 8,245 |
Schedule of assumptions used to estimate the fair value of stock options granted | The fair value of stock options granted in 2018, 2017 and 2016 has been estimated at the date of grant using the Black Scholes option‑pricing model with the following assumptions: Year Ended December 31, 2018 2017 2016 Dividend yield 0% 0% 0% Expected volatility range 0.821 to 0.990 0.884 to 0.892 0.888 to 0.890 Risk-free interest rate range 2.55% to 3.11% 1.98% to 1.99% 1.21% to 1.38% Expected term range 5.25 - 6.62 yrs 5.5 yrs 5.5 yrs |
Schedule of assumptions used to estimate the fair value of employee stock purchases under the purchase plan | The fair value of employee stock purchases in 2018, 2017 and 2016 has been estimated using the Black Scholes option‑pricing model with the following assumptions: Year Ended December 31, 2018 2017 2016 Dividend yield 0% 0% 0% Expected volatility range 0.437 to 0.475 0.577 to 0.641 0.641 to 0.684 Risk-free interest rate range 1.53% to 1.76% 0.45% to 0.89% 0.28% to 0.45% Expected term range 6 - 12 mos 6 - 12 mos 6 - 12 mos |
Schedule of common stock reserved for future issuance | Common stock reserved for future issuance as of December 31, 2018 is as follows: Outstanding stock options 27,285,952 Options and awards available for grant 11,964,399 Employee stock purchase plan 876,908 Warrant outstanding 537,893 Total 40,665,152 |
INCOME TAXES (Tables)
INCOME TAXES (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
Schedule of significant components of the entity's deferred tax assets | Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Significant components of our deferred tax assets are as follows: December 31, 2018 2017 (In thousands) Net operating loss carryforwards $ 192,100 $ 187,700 Research credits 35,500 34,300 Capitalized research and development 2,500 2,500 License fees — 100 Other-net 7,000 8,200 Total deferred tax assets 237,100 232,800 Valuation allowance for deferred tax assets (237,100 ) (232,800 ) Net deferred tax assets $ — $ — |
Schedule of reconciliation of the beginning and ending amounts of unrecognized tax benefits | A reconciliation of the beginning and ending amounts of unrecognized tax benefits is as follows (in thousands): Balance as of December 31, 2017 $ 15,900 Decrease related to prior year tax positions (100 ) Increase related to current year tax positions 600 Balance as of December 31, 2018 $ 16,400 |
STATEMENTS OF CASH FLOWS DATA (
STATEMENTS OF CASH FLOWS DATA (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Supplemental Cash Flow Elements [Abstract] | |
Supplemental schedule of non-cash operating and investing activities | Year Ended December 31, 2018 2017 2016 (In thousands) Supplemental investing activities: Net unrealized gain (loss) on marketable securities $ 24 $ (154 ) $ 160 |
SELECTED QUARTERLY FINANCIAL _2
SELECTED QUARTERLY FINANCIAL INFORMATION (UNAUDITED) (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Quarterly Financial Information Disclosure [Abstract] | |
Schedule of selected quarterly financial information (unaudited) | First Second Third Fourth Quarter Quarter Quarter Quarter (In thousands, except per share amounts) Year Ended December 31, 2018: Revenues $ 318 $ 208 $ 165 $ 375 Operating expenses 7,755 7,450 6,970 9,964 Net loss (7,186 ) (6,934 ) (5,597 ) (7,300 ) Basic and diluted net loss per share $ (0.04 ) $ (0.04 ) $ (0.03 ) $ (0.04 ) Year Ended December 31, 2017: Revenues $ 537 $ 174 $ 163 $ 191 Operating expenses 8,031 6,905 7,407 7,977 Net loss (7,183 ) (6,405 ) (6,899 ) (7,429 ) Basic and diluted net loss per share $ (0.05 ) $ (0.04 ) $ (0.04 ) $ (0.05 ) |
ORGANIZATION AND SUMMARY OF S_4
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - ANTI-DILUTIVE SHARES (Details) - shares | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Stock options and warrants excluded from diluted net loss per share calculation due to net loss position | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share | |||
Potential dilutive securities excluded from diluted earnings (loss) per share calculation (in shares) | 27,823,845 | 22,946,422 | 19,663,180 |
ORGANIZATION AND SUMMARY OF S_5
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - USEFUL LIVES OF ASSETS (Details) | 12 Months Ended |
Dec. 31, 2018 | |
Depreciation [Abstract] | |
Estimated useful lives of assets | 4 years |
ORGANIZATION AND SUMMARY OF S_6
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - CONCENTRATIONS OF CUSTOMERS AND SUPPLIERS (Details) - customer | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Concentration risk | |||
Number of customers | 2 | 2 | |
Customer | Revenue | |||
Concentration risk | |||
Concentration risk percentage | 59.00% | 39.00% | 81.00% |
ORGANIZATION AND SUMMARY OF S_7
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - CUMULATIVE EFFECT ADJUSTMENT (Details) - USD ($) $ in Thousands | Jan. 01, 2019 | Jan. 01, 2018 |
New Accounting Pronouncements Or Change In Accounting Principle [Line Items] | ||
Adjustment to accumulated deficit | $ 204 | |
ASU 2016-02 | Subsequent Event | ||
New Accounting Pronouncements Or Change In Accounting Principle [Line Items] | ||
Operating lease asset and obligation | $ 719 |
ORGANIZATION AND SUMMARY OF S_8
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - CUMULATIVE EFFECT ADJUSTMENTS FOR THE ADOPTION OF TOPIC 606 AND ASU 2016-01 AND ASU 2018-03 (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Jan. 01, 2018 | Dec. 31, 2017 |
ASSETS | |||
Interest and other receivables | $ 1,168 | $ 640 | $ 436 |
Other assets | 585 | 1,189 | |
Stockholders' equity: | |||
Accumulated deficit | $ (1,011,464) | (984,447) | $ (985,840) |
ASU 2014-09 | Adjustments Due to Topic 606 | |||
ASSETS | |||
Interest and other receivables | 204 | ||
Stockholders' equity: | |||
Accumulated deficit | 204 | ||
Adjustments Due to ASU 2016-01 and ASU 2018-03 | |||
ASSETS | |||
Other assets | 1,189 | ||
Stockholders' equity: | |||
Accumulated deficit | $ 1,189 |
FAIR VALUE MEASUREMENTS - SECUR
FAIR VALUE MEASUREMENTS - SECURITY TYPE (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Included in cash and cash equivalents: | ||
Amortized Cost | $ 15,022 | |
Gross Unrealized Losses | (1) | |
Estimated Fair Value | 15,021 | |
Restricted cash: | ||
Amortized Cost | $ 269 | 268 |
Marketable securities: | ||
Amortized Cost | 171,479 | 92,798 |
Gross Unrealized Gains | 29 | 4 |
Gross Unrealized Losses | (212) | (210) |
Estimated Fair Value | 171,296 | 92,592 |
Money market funds | ||
Included in cash and cash equivalents: | ||
Amortized Cost | 7,003 | 11,030 |
Estimated Fair Value | 7,003 | 11,030 |
Corporate notes | ||
Included in cash and cash equivalents: | ||
Amortized Cost | 1,750 | |
Gross Unrealized Losses | (1) | |
Estimated Fair Value | 1,749 | |
Certificate of deposit | ||
Restricted cash: | ||
Amortized Cost | 269 | 268 |
Estimated Fair Value | 269 | 268 |
Commercial paper (due in less than one year) | ||
Marketable securities: | ||
Amortized Cost | 57,594 | 10,928 |
Gross Unrealized Gains | 22 | 4 |
Gross Unrealized Losses | (29) | (1) |
Estimated Fair Value | 57,587 | 10,931 |
Corporate notes (due in less than one year) | ||
Marketable securities: | ||
Amortized Cost | 95,238 | 55,067 |
Gross Unrealized Gains | 7 | |
Gross Unrealized Losses | (118) | (107) |
Estimated Fair Value | 95,127 | 54,960 |
Corporate notes (due in one to two years) | ||
Marketable securities: | ||
Amortized Cost | 18,647 | 14,303 |
Gross Unrealized Losses | (65) | (62) |
Estimated Fair Value | $ 18,582 | 14,241 |
Commercial paper | ||
Included in cash and cash equivalents: | ||
Amortized Cost | 2,242 | |
Estimated Fair Value | 2,242 | |
Government-sponsored enterprise securities (due in less than one year) | ||
Marketable securities: | ||
Amortized Cost | 12,500 | |
Gross Unrealized Losses | (40) | |
Estimated Fair Value | $ 12,460 |
FAIR VALUE MEASUREMENTS - SEC_2
FAIR VALUE MEASUREMENTS - SECURITIES WITH UNREALIZED LOSSES (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Available for sale securities with unrealized losses | ||
Less Than 12 Months - Estimated Fair Value | $ 107,767 | $ 77,168 |
Less Than 12 Months - Gross Unrealized Losses | (176) | (169) |
12 Months or Greater - Estimated Fair Value | 14,221 | 13,959 |
12 Months or Greater - Gross Unrealized Losses | (36) | (42) |
Total - Estimated Fair Value | 121,988 | 91,127 |
Total - Gross Unrealized Losses | (212) | (211) |
Commercial paper (due in less than one year) | ||
Available for sale securities with unrealized losses | ||
Less Than 12 Months - Estimated Fair Value | 22,628 | 7,717 |
Less Than 12 Months - Gross Unrealized Losses | (29) | (1) |
Total - Estimated Fair Value | 22,628 | 7,717 |
Total - Gross Unrealized Losses | (29) | (1) |
Corporate notes (due in less than one year) | ||
Available for sale securities with unrealized losses | ||
Less Than 12 Months - Estimated Fair Value | 66,557 | 55,210 |
Less Than 12 Months - Gross Unrealized Losses | (82) | (106) |
12 Months or Greater - Estimated Fair Value | 14,221 | 1,499 |
12 Months or Greater - Gross Unrealized Losses | (36) | (2) |
Total - Estimated Fair Value | 80,778 | 56,709 |
Total - Gross Unrealized Losses | (118) | (108) |
Corporate notes (due in one to two years) | ||
Available for sale securities with unrealized losses | ||
Less Than 12 Months - Estimated Fair Value | 18,582 | 14,241 |
Less Than 12 Months - Gross Unrealized Losses | (65) | (62) |
Total - Estimated Fair Value | 18,582 | 14,241 |
Total - Gross Unrealized Losses | $ (65) | (62) |
Government-sponsored enterprise securities (due in less than one year) | ||
Available for sale securities with unrealized losses | ||
12 Months or Greater - Estimated Fair Value | 12,460 | |
12 Months or Greater - Gross Unrealized Losses | (40) | |
Total - Estimated Fair Value | 12,460 | |
Total - Gross Unrealized Losses | $ (40) |
FAIR VALUE MEASUREMENTS - RECUR
FAIR VALUE MEASUREMENTS - RECURRING BASIS (Details) - Recurring basis - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Fair Value on a Recurring Basis | ||
Total | $ 178,884 | $ 107,613 |
Money market funds | ||
Fair Value on a Recurring Basis | ||
Total | 7,003 | 11,030 |
Commercial paper | ||
Fair Value on a Recurring Basis | ||
Total | 57,587 | 13,173 |
Corporate notes | ||
Fair Value on a Recurring Basis | ||
Total | 113,709 | 70,950 |
Equity Investment | ||
Fair Value on a Recurring Basis | ||
Total | 585 | |
US Government-sponsored Enterprises Debt Securities | ||
Fair Value on a Recurring Basis | ||
Total | 12,460 | |
Level 1 | ||
Fair Value on a Recurring Basis | ||
Total | 7,003 | 11,030 |
Level 1 | Money market funds | ||
Fair Value on a Recurring Basis | ||
Total | 7,003 | 11,030 |
Level 2 | ||
Fair Value on a Recurring Basis | ||
Total | 171,881 | 96,583 |
Level 2 | Commercial paper | ||
Fair Value on a Recurring Basis | ||
Total | 57,587 | 13,173 |
Level 2 | Corporate notes | ||
Fair Value on a Recurring Basis | ||
Total | 113,709 | 70,950 |
Level 2 | Equity Investment | ||
Fair Value on a Recurring Basis | ||
Total | $ 585 | |
Level 2 | US Government-sponsored Enterprises Debt Securities | ||
Fair Value on a Recurring Basis | ||
Total | $ 12,460 |
FAIR VALUE MEASUREMENTS - EQUIT
FAIR VALUE MEASUREMENTS - EQUITY INVESTMENT (Details) - Sienna - Equity Investment - USD ($) | Aug. 03, 2017 | Dec. 31, 2018 | Jan. 01, 2018 | Dec. 31, 2017 | Dec. 31, 2007 |
Equity Investments [Line Item] | |||||
Number of shares owned | 13,842,625 | ||||
Cost method investments cost basis | $ 0 | $ 0 | |||
Trading restriction period | 24 months | ||||
Fair value of equity investment | $ 585,000 | ||||
Change in fair value of equity investment | 604,000 | ||||
Loss related to foreign currency translation | $ 63,000 | ||||
Accounting Standards Update 2016-01 and 2018-03 | |||||
Equity Investments [Line Item] | |||||
Cumulative effect adjustment | $ 1,189,000 |
FAIR VALUE MEASUREMENTS - CREDI
FAIR VALUE MEASUREMENTS - CREDIT RISK (Details) | Dec. 31, 2018Institution |
Credit Risk | |
Number of financial institutions | 4 |
PROPERTY AND EQUIPMENT (Details
PROPERTY AND EQUIPMENT (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | $ 838 | $ 822 |
Less accumulated depreciation and amortization | (779) | (720) |
Property and equipment, net | 59 | 102 |
Furniture and computer equipment | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 727 | 711 |
Leasehold improvements | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | $ 111 | $ 111 |
LICENSE AGREEMENTS (Details)
LICENSE AGREEMENTS (Details) | Sep. 28, 2018 | Sep. 27, 2018 | Sep. 15, 2016USD ($)item | Dec. 15, 2014USD ($)item | Dec. 31, 2018USD ($) | Sep. 30, 2018USD ($) | Jun. 30, 2018USD ($) | Mar. 31, 2018USD ($) | Dec. 31, 2017USD ($) | Sep. 30, 2017USD ($) | Jun. 30, 2017USD ($) | Mar. 31, 2017USD ($) | Sep. 30, 2016USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||
Amount due to Janssen Biotech, Inc. | $ 2,610,000 | $ 1,702,000 | $ 2,610,000 | $ 1,702,000 | ||||||||||||
License fees and royalties | 375,000 | $ 165,000 | $ 208,000 | $ 318,000 | $ 191,000 | $ 163,000 | $ 174,000 | $ 537,000 | 1,066,000 | $ 1,065,000 | $ 6,162,000 | |||||
Janssen Biotech | License agreements | ||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||
Upfront payment received | $ 35,000,000 | |||||||||||||||
Number of agreed upon studies | item | 2 | |||||||||||||||
Percentage of costs to be paid by Geron | 50.00% | |||||||||||||||
Percentage of costs to be paid by Janssen | 50.00% | |||||||||||||||
Maximum period to supply imetelstat during transition period | 24 months | |||||||||||||||
Percentage of costs to be paid by Geron before termination of Collaboration Agreement | 50.00% | |||||||||||||||
Percentage of costs to be paid by Geron after termination of Collaboration Agreement | 100.00% | |||||||||||||||
Amount due to Janssen Biotech, Inc. | $ 2,610,000 | $ 2,610,000 | ||||||||||||||
Janssen Biotech | License Arrangement IP Exclusively Licensed | ||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||
Percentage of costs to be paid by Geron | 50.00% | |||||||||||||||
Percentage of costs to be paid by Janssen | 50.00% | |||||||||||||||
Janssen Pharmaceuticals Inc | License agreements | ||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||
Least number of products under License Agreement | item | 1 | |||||||||||||||
Upfront payment received under license agreement | $ 5,000,000 | |||||||||||||||
Aggregate maximum total payments for development and regulatory milestones under license agreement | $ 75,000,000 | |||||||||||||||
Tiered royalties percentage range | low single digit | |||||||||||||||
License fees and royalties | $ 5,000,000 | |||||||||||||||
Janssen Pharmaceuticals Inc | License Arrangement IP Exclusively Licensed | ||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||
Percentage of costs to be paid by Geron | 50.00% | |||||||||||||||
Percentage of costs to be paid by Janssen Pharmaceuticals | 50.00% |
ACCRUED LIABILITIES (Details)
ACCRUED LIABILITIES (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Payables And Accruals [Abstract] | ||
Professional legal and accounting fees | $ 327 | $ 272 |
Clinical trial costs | 529 | 516 |
Other | 461 | 138 |
Accrued liabilities | $ 1,317 | $ 926 |
COMMITMENTS AND CONTINGENCIES -
COMMITMENTS AND CONTINGENCIES - Operating Leases (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Commitments And Contingencies Disclosure [Abstract] | |||
Amended operating lease obligation, aggregate future minimum payments | $ 757,000 | ||
Amended operating lease obligation, aggregate future minimum payments due in 2019 | 699,000 | ||
Amended operating lease obligation, aggregate future minimum payments due in 2020 | 58,000 | ||
Rent expense under operating leases | $ 703,000 | $ 691,000 | $ 708,000 |
COMMITMENTS AND CONTINGENCIES_2
COMMITMENTS AND CONTINGENCIES - Severance Plan (Details) | 12 Months Ended |
Dec. 31, 2018 | |
Severance Plan | |
Period within which employee is terminated by entity without cause following a change of control | 12 months |
Period within which no comparable employment is offered by the entity following a change of control | 30 days |
Period within which employee resigns following a change of control due to material change in terms of employment | 12 months |
Minimum | |
Severance Plan | |
Period of base salary to be considered for severance payments | 2 months |
Maximum | |
Severance Plan | |
Period of base salary to be considered for severance payments | 18 months |
COMMITMENTS AND CONTINGENCIES_3
COMMITMENTS AND CONTINGENCIES - Gain on Settlement (Details) - USD ($) | 1 Months Ended | 12 Months Ended | |
Dec. 31, 2018 | Sep. 30, 2012 | Dec. 31, 2018 | |
Gain Contingencies [Line Items] | |||
Potential milestone payments receivable | $ 6,000,000 | ||
Dispute settlement | $ 3,650,000 | ||
Gain related to litigation settlement | $ 1,460,000 | $ 1,460,000 | |
Share of settlement percentage | 40.00% | ||
ViaGen, Inc | |||
Gain Contingencies [Line Items] | |||
Ownership percentage | 40.00% |
STOCKHOLDERS' EQUITY - SALES AG
STOCKHOLDERS' EQUITY - SALES AGREEMENTS (Details) - USD ($) | May 18, 2018 | Aug. 28, 2015 | Dec. 31, 2017 | Jul. 31, 2018 | Apr. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 |
At Market Issuance Sales Agreements [Line Items] | |||||||
Net cash proceeds from issuance of common stock after deducting sales commissions and offering costs | $ 86,017,000 | $ 1,060,000 | |||||
2015 Sales Agreement | |||||||
At Market Issuance Sales Agreements [Line Items] | |||||||
Aggregate offering price of common stock | $ 50,000,000 | ||||||
Maximum commission rate (as a percent) | 3.00% | ||||||
Issuance of common stock in connection with at market offering (in shares) | 614,230 | 13,195,106 | |||||
Net cash proceeds from issuance of common stock after deducting sales commissions and offering costs | $ 1,060,000 | $ 47,651,000 | |||||
2018 Sales Agreement | |||||||
At Market Issuance Sales Agreements [Line Items] | |||||||
Aggregate offering price of common stock | $ 100,000,000 | ||||||
Maximum commission rate (as a percent) | 3.00% | ||||||
Issuance of common stock in connection with at market offering (in shares) | 10,083,079 | ||||||
Net cash proceeds from issuance of common stock after deducting sales commissions and offering costs | $ 38,366,000 |
STOCKHOLDERS' EQUITY - WARRANT
STOCKHOLDERS' EQUITY - WARRANT (Details) - CIRM - Warrants issued in August 2011 | Dec. 31, 2018$ / sharesshares |
Warrants | |
Exercise Price (in dollars per share) | $ / shares | $ 3.98 |
Number of shares into which warrant is converted upon exercise of warrant (in shares) | shares | 537,893 |
STOCKHOLDERS' EQUITY - EQUITY P
STOCKHOLDERS' EQUITY - EQUITY PLANS (Details) - USD ($) | 12 Months Ended | ||||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Oct. 31, 2018 | May 15, 2018 | |
STOCKHOLDERS' EQUITY | |||||
Common stock, shares newly reserved for future issuance | 40,665,152 | ||||
Aggregate Intrinsic Value - Options Outstanding | |||||
Closing stock price (in dollars per share) | $ 1 | ||||
Total pretax intrinsic value of stock options exercised (in dollars) | $ 8,812,000 | $ 15,000 | $ 595,000 | ||
Cash received from exercise of options (in dollars) | $ 6,929,000 | $ 18,000 | $ 493,000 | ||
Number of Shares - Options Outstanding | |||||
Options exercisable at the end of the period (in shares) | 16,464,746 | 17,249,032 | 14,074,457 | ||
Weighted Average Exercise Price Per Share - Options Outstanding | |||||
Options exercisable at the end of the period (in dollars per share) | $ 3.13 | $ 3.03 | $ 2.99 | ||
2002 Plan | |||||
STOCKHOLDERS' EQUITY | |||||
Vesting period of options | 4 years | ||||
Exercise price as a percentage of fair market value | 100.00% | ||||
2002 Plan | Maximum | |||||
STOCKHOLDERS' EQUITY | |||||
Expiration term of options from date of grant | 10 years | ||||
2011 Plan | |||||
STOCKHOLDERS' EQUITY | |||||
Vesting period of options | 4 years | ||||
2011 Plan | Maximum | |||||
STOCKHOLDERS' EQUITY | |||||
Expiration term of options from date of grant | 10 years | ||||
2018 Plan | |||||
STOCKHOLDERS' EQUITY | |||||
Vesting period of options | 4 years | ||||
Common stock, shares newly reserved for future issuance | 10,000,000 | ||||
Minimum percentage of ownership required for granting options at least 110% of fair market value of common stock | 10.00% | ||||
Minimum exercise price as a percentage of fair market value for employees having more than 10 % outstanding common stock | 110.00% | ||||
Maximum expiration term of options granted to employees having more than 10 % outstanding common stock | 5 years | ||||
2018 Plan | First Director Option | |||||
STOCKHOLDERS' EQUITY | |||||
Vesting period of options | 3 years | ||||
Options to be granted to purchase shares upon appointment (shares) | 120,000 | ||||
2018 Plan | Subsequent Director Option | |||||
STOCKHOLDERS' EQUITY | |||||
Options to be granted to purchase shares (in shares) | 70,000 | ||||
2018 Plan | Maximum | |||||
STOCKHOLDERS' EQUITY | |||||
Expiration term of options from date of grant | 10 years | ||||
2006 Directors Plan | First Director Option | |||||
STOCKHOLDERS' EQUITY | |||||
Vesting period of options | 3 years | ||||
2006 Directors Plan | Subsequent Director Option | |||||
STOCKHOLDERS' EQUITY | |||||
Vesting period of options | 1 year | ||||
2006 Directors Plan | Maximum | |||||
STOCKHOLDERS' EQUITY | |||||
Expiration term of options from date of grant | 10 years | ||||
2018 Inducement Award Plan | |||||
STOCKHOLDERS' EQUITY | |||||
Common stock, shares newly reserved for future issuance | 3,000,000 | ||||
Directors’ Market Value Stock Purchase Plan | |||||
STOCKHOLDERS' EQUITY | |||||
Common stock, shares newly reserved for future issuance | 1,000,000 |
STOCKHOLDERS' EQUITY - EQUITY_2
STOCKHOLDERS' EQUITY - EQUITY PLANS - SCHEDULE OF AGGREGATE OPTION AND AWARD ACTIVITY (Details) - $ / shares | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Shares Available For Grant | |||
Balance at the beginning of the period (in shares) | 6,202,727 | ||
Additional shares authorized (in shares) | 14,000,000 | ||
Options granted (in shares) | (9,265,000) | ||
Awards granted (in shares) | (139,652) | ||
Options cancelled/forfeited/expired (in shares) | 1,166,324 | ||
Balance at the end of the period (in shares) | 11,964,399 | 6,202,727 | |
Number of Shares - Options Outstanding | |||
Balance at the beginning of the period (in shares) | 22,408,529 | ||
Options granted (in shares) | 9,265,000 | ||
Options exercised (in shares) | (3,144,878) | ||
Options cancelled/forfeited/expired (in shares) | (1,242,699) | ||
Balance at the end of the period (in shares) | 27,285,952 | 22,408,529 | |
Options exercisable at the end of the period (in shares) | 16,464,746 | 17,249,032 | 14,074,457 |
Options fully vested and expected to vest at the end of the period (in shares) | 26,293,625 | ||
Weighted Average Exercise Price Per Share - Options Outstanding | |||
Balance at the beginning of the period (in dollars per share) | $ 2.96 | ||
Options granted (in dollars per share) | 2.07 | ||
Options exercised (in dollars per share) | 2.20 | ||
Options cancelled/forfeited/expired (in dollars per share) | 3.48 | ||
Balance at the end of the period (in dollars per share) | 2.72 | $ 2.96 | |
Options exercisable at the end of the period (in dollars per share) | 3.13 | $ 3.03 | $ 2.99 |
Options fully vested and expected to vest at the end of the period (in dollars per share) | $ 2.75 | ||
Weight Average Remaining Contractual Life (in years) - Options Outstanding | |||
Balance at the end of the period | 6 years 8 months 15 days | ||
Options exercisable at the end of the period | 5 years 1 month 6 days | ||
Options fully vested and expected to vest at the end of the period | 6 years 7 months 9 days |
STOCKHOLDERS' EQUITY - EQUITY_3
STOCKHOLDERS' EQUITY - EQUITY PLANS - SCHEDULE OF AGGREGATE OPTION AND AWARD ACTIVITY (Parenthetical) (Details) | 12 Months Ended |
Dec. 31, 2018shares | |
STOCKHOLDERS' EQUITY | |
Options granted (in shares) | 9,265,000 |
Performance-Based Stock Options | |
STOCKHOLDERS' EQUITY | |
Options granted (in shares) | 4,500,000 |
STOCKHOLDERS' EQUITY - STOCK OP
STOCKHOLDERS' EQUITY - STOCK OPTIONS OUTSTANDING (Details) | 12 Months Ended |
Dec. 31, 2018$ / sharesshares | |
Performance-Based Stock Options | |
Options Outstanding | |
Number of Shares | shares | 4,500,000 |
$1.10 - $1.72 | |
Exercise Price Range | |
Exercise price, low end of range (in dollars per share) | $ 1.10 |
Exercise price, high end of range (in dollars per share) | $ 1.72 |
Options Outstanding | |
Number of Shares | shares | 10,290,050 |
Weighted Average Exercise Price Per Share (in dollars per share) | $ 1.61 |
Weighted Average Remaining Contractual Life (In years) | 7 years 14 days |
$1.73 - $2.45 | |
Exercise Price Range | |
Exercise price, low end of range (in dollars per share) | $ 1.73 |
Exercise price, high end of range (in dollars per share) | $ 2.45 |
Options Outstanding | |
Number of Shares | shares | 7,144,384 |
Weighted Average Exercise Price Per Share (in dollars per share) | $ 2.27 |
Weighted Average Remaining Contractual Life (In years) | 7 years 7 months 24 days |
$2.54 - $5.01 | |
Exercise Price Range | |
Exercise price, low end of range (in dollars per share) | $ 2.54 |
Exercise price, high end of range (in dollars per share) | $ 5.01 |
Options Outstanding | |
Number of Shares | shares | 8,055,105 |
Weighted Average Exercise Price Per Share (in dollars per share) | $ 3.95 |
Weighted Average Remaining Contractual Life (In years) | 6 years 21 days |
$5.09 - $7.31 | |
Exercise Price Range | |
Exercise price, low end of range (in dollars per share) | $ 5.09 |
Exercise price, high end of range (in dollars per share) | $ 7.31 |
Options Outstanding | |
Number of Shares | shares | 1,796,413 |
Weighted Average Exercise Price Per Share (in dollars per share) | $ 5.33 |
Weighted Average Remaining Contractual Life (In years) | 4 years 10 days |
$1.10 - $7.31 | |
Exercise Price Range | |
Exercise price, low end of range (in dollars per share) | $ 1.10 |
Exercise price, high end of range (in dollars per share) | $ 7.31 |
Options Outstanding | |
Number of Shares | shares | 27,285,952 |
Weighted Average Exercise Price Per Share (in dollars per share) | $ 2.72 |
Weighted Average Remaining Contractual Life (In years) | 6 years 8 months 15 days |
STOCKHOLDERS' EQUITY - RESTRICT
STOCKHOLDERS' EQUITY - RESTRICTED STOCK ACTIVITY (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Number of Shares | |||
Granted (in shares) | 139,652 | ||
Restricted stock awards | |||
Number of Shares | |||
Granted (in shares) | 73,980 | ||
Vested (in shares) | (73,980) | ||
Weighted Average Grant Date Fair Value Per Share | |||
Granted (in dollars per share) | $ 1.91 | $ 2.20 | $ 2.44 |
Vested (in dollars per share) | $ 1.91 | ||
Other disclosures | |||
Total fair value of restricted stock that vested | $ 141,000 | $ 159,000 | $ 54,000 |
STOCKHOLDERS' EQUITY - EMPLOYEE
STOCKHOLDERS' EQUITY - EMPLOYEE STOCK PURCHASE PLAN (Details) - Employee Stock Purchase Plan | 12 Months Ended |
Dec. 31, 2018itemshares | |
Employee Stock Purchase Plan | |
Shares of common stock authorized for issuance | shares | 1,000,000 |
Aggregate shares issued under plan | shares | 123,092 |
Maximum duration of offering period | 12 months |
Number of offering periods in which an employee can participate at a time | item | 1 |
Number of consecutive purchase periods in an offering period | item | 2 |
Duration of the purchase period | 6 months |
Maximum percentage of annual salary that can be withheld | 10.00% |
Percentage applied to common stock market value in calculating purchase price under purchase plan | 85.00% |
Duration of the new offering period | 12 months |
STOCKHOLDERS' EQUITY - STOCK-BA
STOCKHOLDERS' EQUITY - STOCK-BASED COMPENSATION EXPENSE FOR EMPLOYEES AND DIRECTORS (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Stock-Based Compensation Expense | |||
Stock-based compensation expense included in operating expenses | $ 6,368 | $ 8,144 | $ 8,245 |
Research and development | |||
Stock-Based Compensation Expense | |||
Stock-based compensation expense included in operating expenses | 949 | 988 | 1,275 |
General and administrative | |||
Stock-Based Compensation Expense | |||
Stock-based compensation expense included in operating expenses | $ 5,419 | $ 7,156 | $ 6,970 |
STOCKHOLDERS' EQUITY - PRICING
STOCKHOLDERS' EQUITY - PRICING MODEL ASSUMPTIONS (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Compensation cost related to unvested stock awards not yet recognized | |||
Compensation cost not yet recognized, net of estimated forfeitures (in dollars) | $ 8,814,000 | ||
Period for recognition of compensation cost on weighted average basis | 27 months | ||
Stock Options | |||
Assumptions used to estimate fair value of awards | |||
Dividend yield (as a percent) | 0.00% | 0.00% | 0.00% |
Expected volatility range, minimum (as a percent) | 82.10% | 88.40% | 88.80% |
Expected volatility range, maximum (as a percent) | 99.00% | 89.20% | 89.00% |
Risk-free interest rate range, minimum (as a percent) | 2.55% | 1.98% | 1.21% |
Risk-free interest rate range, maximum (as a percent) | 3.11% | 1.99% | 1.38% |
Expected term range | 5 years 6 months | 5 years 6 months | |
Additional disclosures | |||
Weighted average estimated fair value of employee stock options granted (in dollars per share) | $ 1.52 | $ 1.58 | $ 1.83 |
Stock Options | Minimum | |||
Assumptions used to estimate fair value of awards | |||
Expected term range | 5 years 3 months | ||
Stock Options | Maximum | |||
Assumptions used to estimate fair value of awards | |||
Expected term range | 6 years 7 months 13 days | ||
Employee Stock Purchase Plan | |||
Assumptions used to estimate fair value of awards | |||
Dividend yield (as a percent) | 0.00% | 0.00% | 0.00% |
Expected volatility range, minimum (as a percent) | 43.70% | 57.70% | 64.10% |
Expected volatility range, maximum (as a percent) | 47.50% | 64.10% | 68.40% |
Risk-free interest rate range, minimum (as a percent) | 1.53% | 0.45% | 0.28% |
Risk-free interest rate range, maximum (as a percent) | 1.76% | 0.89% | 0.45% |
Additional disclosures | |||
Weighted average estimated fair value of purchase rights (in dollars per share) | $ 0.56 | $ 0.75 | $ 1.01 |
Employee Stock Purchase Plan | Minimum | |||
Assumptions used to estimate fair value of awards | |||
Expected term range | 6 months | 6 months | 6 months |
Employee Stock Purchase Plan | Maximum | |||
Assumptions used to estimate fair value of awards | |||
Expected term range | 12 months | 12 months | 12 months |
STOCKHOLDERS' EQUITY - 401(k) P
STOCKHOLDERS' EQUITY - 401(k) PLAN (Details) | 12 Months Ended |
Dec. 31, 2013 | |
401(k) Plan | |
Period of vesting of matching contributions | 4 years |
STOCKHOLDERS' EQUITY - STOCK-_2
STOCKHOLDERS' EQUITY - STOCK-BASED COMPENSATION TO SERVICE PROVIDERS (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Stock-Based Compensation to Service Providers | |||
Stock-based compensation for services by non-employees | $ 191,000 | $ 200,000 | $ 156,000 |
Common Stock | |||
Stock-Based Compensation to Service Providers | |||
Shares issued (in shares) | 73,980 | 72,066 | 21,541 |
Consultants | Stock Options | |||
Stock-Based Compensation to Service Providers | |||
Stock-based compensation for services by non-employees | $ 50,000 | $ 41,000 | $ 104,000 |
Directors and Consultants | Common Stock | |||
Stock-Based Compensation to Service Providers | |||
Stock-based compensation for services by non-employees | $ 141,000 | $ 159,000 | $ 52,000 |
Shares issued (in shares) | 73,980 | 72,066 | 21,541 |
STOCKHOLDERS' EQUITY - COMMON S
STOCKHOLDERS' EQUITY - COMMON STOCK RESERVED FOR FUTURE ISSUANCE (Details) - shares | Dec. 31, 2018 | Dec. 31, 2017 |
STOCKHOLDERS' EQUITY | ||
Outstanding stock options (in shares) | 27,285,952 | 22,408,529 |
Options and awards available for grant (in shares) | 11,964,399 | 6,202,727 |
Warrant outstanding (in shares) | 537,893 | |
Common stock reserved for future issuance (in shares) | 40,665,152 | |
Employee Stock | ||
STOCKHOLDERS' EQUITY | ||
Common stock reserved for future issuance (in shares) | 876,908 |
INCOME TAXES - DEFERRED TAXES (
INCOME TAXES - DEFERRED TAXES (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Significant components of deferred tax assets | |||
Net operating loss carryforwards | $ 192,100,000 | $ 187,700,000 | |
Research credits | 35,500,000 | 34,300,000 | |
Capitalized research and development | 2,500,000 | 2,500,000 | |
License fees | 100,000 | ||
Other-net | 7,000,000 | 8,200,000 | |
Total deferred tax assets | 237,100,000 | 232,800,000 | |
Valuation allowance for deferred tax assets | (237,100,000) | (232,800,000) | |
Valuation allowance | |||
Increase (decrease) in valuation allowance | $ 4,300,000 | $ (89,400,000) | $ 9,600,000 |
INCOME TAXES - OPERATING LOSS C
INCOME TAXES - OPERATING LOSS CARRYFORWARDS (Details) | Dec. 31, 2018USD ($) |
Federal | |
Operating Loss Carryforwards [Line Items] | |
Net operating loss carryforwards | $ 816,800,000 |
Net operating loss carryforwards, expire beginning 2019 through 2037 | 788,500,000 |
State | |
Operating Loss Carryforwards [Line Items] | |
Net operating loss carryforwards | $ 294,800,000 |
INCOME TAXES - TAX CREDIT CARRY
INCOME TAXES - TAX CREDIT CARRYFORWARDS (Details) - Research and Development | Dec. 31, 2018USD ($) |
Federal | |
Tax Credit Carryforward [Line Items] | |
Tax credit carryforwards | $ 35,500,000 |
State | |
Tax Credit Carryforward [Line Items] | |
Tax credit carryforwards | $ 19,200,000 |
INCOME TAXES - TAX CUT AND JOBS
INCOME TAXES - TAX CUT AND JOBS ACT (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | ||
Federal corporate tax rate | 21.00% | 35.00% |
Impact on deferred tax assets due to corporate tax rate reduction | $ 102,300,000 |
INCOME TAXES - UNRECOGNIZED TAX
INCOME TAXES - UNRECOGNIZED TAX BENEFITS (Details) | 12 Months Ended |
Dec. 31, 2018USD ($) | |
Unrecognized tax benefits | |
Unrecognized tax benefits, if recognized would impact effective tax rate | $ 16,400,000 |
Balance at the beginning of the period | 15,900,000 |
Decrease related to prior year tax positions | (100,000) |
Increase related to current year tax positions | 600,000 |
Balance at the end of the period | $ 16,400,000 |
STATEMENTS OF CASH FLOWS DATA_2
STATEMENTS OF CASH FLOWS DATA (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Supplemental investing activities: | |||
Net unrealized gain (loss) on marketable securities | $ 24 | $ (154) | $ 160 |
SELECTED QUARTERLY FINANCIAL _3
SELECTED QUARTERLY FINANCIAL INFORMATION (UNAUDITED) (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Quarterly Financial Information Disclosure [Abstract] | |||||||||||
Revenues | $ 375 | $ 165 | $ 208 | $ 318 | $ 191 | $ 163 | $ 174 | $ 537 | $ 1,066 | $ 1,065 | $ 6,162 |
Operating expenses | 9,964 | 6,970 | 7,450 | 7,755 | 7,977 | 7,407 | 6,905 | 8,031 | 32,139 | 30,320 | 36,808 |
Net loss | $ (7,300) | $ (5,597) | $ (6,934) | $ (7,186) | $ (7,429) | $ (6,899) | $ (6,405) | $ (7,183) | $ (27,017) | $ (27,916) | $ (29,537) |
Basic and diluted net loss per share | $ (0.04) | $ (0.03) | $ (0.04) | $ (0.04) | $ (0.05) | $ (0.04) | $ (0.04) | $ (0.05) | $ (0.15) | $ (0.18) | $ (0.19) |
SUBSEQUENT EVENT (Details)
SUBSEQUENT EVENT (Details) $ in Millions | Jan. 30, 2019USD ($) |
Subsequent Event | Parexel | Master Services Agreement First Work Order | |
Subsequent Event [Line Items] | |
Service fees and pass-through expenses | $ 33 |