DOCUMENT AND ENTITY INFORMATION
DOCUMENT AND ENTITY INFORMATION - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Mar. 09, 2023 | Jun. 30, 2022 | |
Cover [Abstract] | |||
Entity Registrant Name | GERON CORP | ||
Entity Central Index Key | 0000886744 | ||
Document Type | 10-K | ||
Document Period End Date | Dec. 31, 2022 | ||
Amendment Flag | false | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | Yes | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
ICFR Auditor Attestation Flag | false | ||
Entity Public Float | $ 503,187,000 | ||
Entity Common Stock, Shares Outstanding | 508,722,486 | ||
Document Fiscal Year Focus | 2022 | ||
Document Fiscal Period Focus | FY | ||
Trading Symbol | GERN | ||
Entity File Number | 000-20859 | ||
Entity Tax Identification Number | 75-2287752 | ||
Entity Shell Company | false | ||
Entity Address, Address Line One | 919 East Hillsdale Blvd. | ||
Entity Address, Address Line Two | Suite 250 | ||
Entity Address, City or Town | Foster City | ||
Entity Address, State or Province | CA | ||
Entity Address, Postal Zip Code | 94404 | ||
City Area Code | 650 | ||
Local Phone Number | 473-7700 | ||
Entity Interactive Data Current | Yes | ||
Title of 12(b) Security | Common Stock, $0.001 par value | ||
Security Exchange Name | NASDAQ | ||
Entity Incorporation, State or Country Code | DE | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Auditor Firm ID | 42 | ||
Auditor Name | Ernst & Young LLP | ||
Auditor Location | San Jose, California | ||
Documents Incorporated by Reference | DOCUMENTS INCORPORATED BY REFERENCE: Document Form 10‑K Portions of the Registrant’s definitive proxy statement for the 2023 annual meeting of stockholders to be filed pursuant to Regulation 14A within 120 days of the Registrant’s fiscal year ended December 31, 2022. III |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 56,845 | $ 34,871 |
Restricted cash | 364 | 364 |
Marketable securities | 115,901 | 148,851 |
Interest and other receivables | 3,144 | 1,763 |
Prepaid and other current assets | 3,992 | 1,357 |
Total current assets | 180,246 | 187,206 |
Noncurrent marketable securities | 28,651 | |
Property and equipment, net | 793 | 650 |
Operating leases, right-of-use assets | 4,147 | 4,727 |
Deposits and other assets | 5,389 | 4,800 |
Total assets | 190,575 | 226,034 |
Current liabilities: | ||
Accounts payable | 10,190 | 6,687 |
Accrued compensation and benefits | 11,534 | 8,099 |
Operating lease liabilities | 925 | 901 |
Debt | 20,945 | |
Accrued liabilities | 33,100 | 29,834 |
Total current liabilities | 76,694 | 45,521 |
Noncurrent operating lease liabilities | 3,671 | 4,267 |
Noncurrent debt | 30,212 | 49,830 |
Total liabilities | 110,577 | 99,618 |
Commitments and contingencies | ||
Stockholders' equity: | ||
Preferred stock, $0.001 par value; 3,000,000 shares authorized; no shares issued and outstanding at December 31, 2022 and 2021 | ||
Common stock, $0.001 par value; 675,000,000 shares authorized; 390,262,524 and 323,731,591 shares issued and outstanding at December 31, 2022 and 2021, respectively | 390 | 324 |
Additional paid-in capital | 1,493,469 | 1,398,006 |
Accumulated deficit | (1,413,642) | (1,271,741) |
Accumulated other comprehensive loss | (219) | (173) |
Total stockholders' equity | 79,998 | 126,416 |
Total liabilities and stockholders' equity | $ 190,575 | $ 226,034 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Dec. 31, 2022 | Dec. 31, 2021 |
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 | 675,000,000 | 675,000,000 |
Common stock, shares issued | 390,262,524 | 323,731,591 |
Common stock, shares outstanding | 390,262,524 | 323,731,591 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Revenues: | |||
License fees and royalties | $ 596 | $ 1,393 | $ 253 |
Operating expenses: | |||
Research and development | 95,518 | 85,727 | 51,488 |
General and administrative | 43,628 | 29,665 | 25,678 |
Total operating expenses | 139,146 | 115,392 | 77,166 |
Loss from operations | (138,550) | (113,999) | (76,913) |
Interest income | 2,529 | 527 | 1,828 |
Interest expense | (6,882) | (3,740) | (760) |
Change in fair value of equity investment | 60 | ||
Other income , net | 1,002 | 1,100 | 168 |
Net loss | $ (141,901) | $ (116,112) | $ (75,617) |
Basic net loss per share | $ (0.37) | $ (0.35) | $ (0.28) |
Diluted net loss per share | $ (0.37) | $ (0.35) | $ (0.28) |
Shares used in computing basic net loss per share | 380,784,846 | 327,631,814 | 271,460,265 |
Shares used in computing diluted net loss per share | 380,784,846 | 327,631,814 | 271,460,265 |
STATEMENTS OF COMPREHENSIVE LOS
STATEMENTS OF COMPREHENSIVE LOSS - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Statement of Comprehensive Income [Abstract] | |||
Net loss | $ (141,901) | $ (116,112) | $ (75,617) |
Net unrealized loss on marketable securities | (68) | (251) | (54) |
Foreign currency translation adjustment | 22 | ||
Comprehensive loss | $ (141,947) | $ (116,363) | $ (75,671) |
CONSOLIDATED STATEMENTS OF STOC
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-In Capital | Accumulated Deficit | Accumulated Other Comprehensive Gain (Loss) |
Balances at Dec. 31, 2019 | $ 135,155 | $ 200 | $ 1,214,835 | $ (1,080,012) | $ 132 |
Balances (in shares) at Dec. 31, 2019 | 199,814,581 | ||||
Increase (Decrease) in Stockholders' Equity | |||||
Net loss | (75,617) | (75,617) | |||
Other comprehensive loss | (54) | (54) | |||
Issuance of common stock, pre-funded warrant and warrants to purchase common stock in public offering, net of issuance costs | 140,184 | $ 107 | 140,077 | ||
Issuance of common stock, pre-funded warrant and warrants to purchase common stock in public offering, net of issuance costs (in shares) | 107,049,375 | ||||
Issuance of common stock in connection with at market offering, net of issuance costs | 4,075 | $ 3 | 4,072 | ||
Issuance of common stock in connection with at market offering, net of issuance costs (in shares) | 3,496,616 | ||||
Issuance of common stock in connection exercise of warrants | 16 | 16 | |||
Issuance of common stock in connection exercise of warrants (in shares) | 12,500 | ||||
Stock-based compensation related to issuance of common stock and options in exchange for services | 85 | 85 | |||
Stock-based compensation related to issuance of common stock and options in exchange for services (in shares) | 17,986 | ||||
Issuances of common stock under equity plans | 208 | 208 | |||
Issuances of common stock under equity plans (in shares) | 175,795 | ||||
Stock-based compensation for equity-based awards to employees and directors | 6,895 | 6,895 | |||
Balances at Dec. 31, 2020 | 210,947 | $ 310 | 1,366,188 | (1,155,629) | 78 |
Balances (in shares) at Dec. 31, 2020 | 310,566,853 | ||||
Increase (Decrease) in Stockholders' Equity | |||||
Net loss | (116,112) | (116,112) | |||
Other comprehensive loss | (251) | (251) | |||
Issuance of common stock in connection with at market offering, net of issuance costs | 20,385 | $ 11 | 20,374 | ||
Issuance of common stock in connection with at market offering, net of issuance costs (in shares) | 10,571,556 | ||||
Issuance of common stock in connection exercise of warrants | 2,479 | $ 2 | 2,477 | ||
Issuance of common stock in connection exercise of warrants (in shares) | 1,906,341 | ||||
Stock-based compensation related to issuance of common stock and options in exchange for services | 91 | 91 | |||
Stock-based compensation related to issuance of common stock and options in exchange for services (in shares) | 20,783 | ||||
Issuances of common stock under equity plans | 797 | $ 1 | 796 | ||
Issuances of common stock under equity plans (in shares) | 666,058 | ||||
Stock-based compensation for equity-based awards to employees and directors | 8,080 | 8,080 | |||
Balances at Dec. 31, 2021 | $ 126,416 | $ 324 | 1,398,006 | (1,271,741) | (173) |
Balances (in shares) at Dec. 31, 2021 | 323,731,591 | 323,731,591 | |||
Increase (Decrease) in Stockholders' Equity | |||||
Net loss | $ (141,901) | (141,901) | |||
Other comprehensive loss | (68) | (68) | |||
Foreign currency translation adjustment | 22 | 22 | |||
Issuance of common stock, pre-funded warrant and warrants to purchase common stock in public offering, net of issuance costs | 69,916 | $ 53 | 69,863 | ||
Issuance of common stock, pre-funded warrant and warrants to purchase common stock in public offering, net of issuance costs (in shares) | 53,333,334 | ||||
Issuance of common stock in connection exercise of warrants | 15,163 | $ 12 | 15,151 | ||
Issuance of common stock in connection exercise of warrants (in shares) | 11,663,387 | ||||
Stock-based compensation related to issuance of common stock and options in exchange for services | 264 | 264 | |||
Stock-based compensation related to issuance of common stock and options in exchange for services (in shares) | 15,962 | ||||
Issuances of common stock under equity plans | 2,185 | $ 1 | 2,184 | ||
Issuances of common stock under equity plans (in shares) | 1,518,250 | ||||
Stock-based compensation for equity-based awards to employees and directors | 8,001 | 8,001 | |||
Balances at Dec. 31, 2022 | $ 79,998 | $ 390 | $ 1,493,469 | $ (1,413,642) | $ (219) |
Balances (in shares) at Dec. 31, 2022 | 390,262,524 | 390,262,524 |
CONSOLIDATED STATEMENTS OF ST_2
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (Parenthetical) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
At The Market Offering | |||
Issuance costs | $ 470 | $ 144 | |
Public Offering of Common Stock and Warrants | |||
Issuance costs | $ 5,066 | $ 9,808 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Cash flows from operating activities: | |||
Net loss | $ (141,901) | $ (116,112) | $ (75,617) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation and amortization | 288 | 215 | 158 |
Accretion and amortization on investments, net | (965) | 1,424 | 818 |
Amortization of debt issuance costs/debt discount | 1,327 | 893 | 179 |
Gain on sales of available for sale securities | (19) | ||
Net gain on exchange and sales of equity investment | (1,233) | (148) | |
Change in fair value of equity investment, including foreign currency translation | (163) | ||
Stock-based compensation for services by non-employees | 264 | 91 | 85 |
Stock-based compensation for employees and directors | 8,001 | 8,080 | 6,895 |
Amortization of right-of-use assets | 580 | 568 | 777 |
Changes in assets and liabilities: | |||
Interest and other receivables | (1,381) | (1,041) | 80 |
Prepaid and other current assets | (2,630) | 1,317 | (1,286) |
Deposit and other assets | (594) | (3,807) | (206) |
Accounts payable | 3,503 | (232) | 5,731 |
Accrued compensation and benefits | 3,435 | (119) | 3,388 |
Amount due to Janssen Biotech, Inc. | (14,269) | ||
Accrued liabilities | 3,266 | 14,909 | 7,397 |
Operating lease liabilities | (572) | (509) | (452) |
Net cash used in operating activities | (127,379) | (95,556) | (66,652) |
Cash flows from investing activities: | |||
Purchases of property and equipment | (431) | (207) | (401) |
Purchases of marketable securities | (258,007) | (177,434) | (313,201) |
Proceeds from sales of securities available for sale | 7,681 | ||
Proceeds from maturities of marketable securities | 320,505 | 247,994 | 200,262 |
Proceeds from sales of equity investment | 1,594 | 339 | |
Net cash provided by (used in) investing activities | 62,067 | 71,947 | (105,320) |
Cash flows from financing activities: | |||
Proceeds from issuances of common stock from equity plans | 2,185 | 797 | 208 |
Proceeds from issuance of common stock and warrants in public offering, net of paid issuance costs | 69,916 | 140,184 | |
Proceeds from issuances of common stock from at market offerings, net of paid issuance costs | 20,385 | 4,075 | |
Proceeds from exercise of warrants | 15,163 | 2,479 | 16 |
Proceeds from debt financing, net of paid debt issuance costs and debt discounts | 24,895 | 23,863 | |
Net cash provided by financing activities | 87,264 | 48,556 | 168,346 |
Net effect of unrealized gains and exchange rates on cash, cash equivalents and restricted cash | 22 | ||
Net increase (decrease) in cash, cash equivalents and restricted cash | 21,974 | 24,947 | (3,626) |
Cash, cash equivalents and restricted cash at the beginning of the period | 35,235 | 10,288 | 13,914 |
Cash, cash equivalents and restricted cash at the end of the period | $ 57,209 | $ 35,235 | $ 10,288 |
ORGANIZATION AND SUMMARY OF SIG
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 1. ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Organization The terms “Geron”, the “Company”, “we” and “us” as used in this report refer to Geron Corporation. 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 potential commercialization of imetelstat, an innovative therapeutic for hematologic malignancies. We have global rights to imetelstat, a first in class telomerase inhibitor, which was discovered and developed at Geron. Principal activities to date have included obtaining financing, securing operating facilities and conducting research and development. Principles of Consolidation The consolidated financial statements include the accounts of Geron and our wholly-owned subsidiary, Geron UK Limited, or Geron UK, a United Kingdom company. Geron UK was incorporated in September 2021, and its operations commenced in January 2022. We have eliminated intercompany accounts and transactions. We prepare the financial statements of Geron UK using the local currency as the functional currency. We translate the assets and liabilities of Geron UK at rates of exchange at the balance sheet date and translate income and expense items at average monthly rates of exchange. The resultant translation adjustments are included in accumulated other comprehensive income (loss), a separate component of stockholders’ equity, on our consolidated balance sheets. Net Loss Per Share Basic net income (loss) per share is calculated by dividing net income (loss) by the weighted-average number of shares of common stock outstanding for the periods presented without consideration of potential common shares. In April 2022, we entered into an underwriting agreement in connection with a public offering of our common stock, pursuant to which we issued a pre-funded warrant to purchase 18,095,238 shares of our common stock, also known as the 2022 pre-funded warrant, together with accompanying warrants to purchase shares of our common stock. In May 2020, we entered into an underwriting agreement in connection with a public offering of our common stock, pursuant to which we issued a pre-funded warrant to purchase 8,335,239 shares of our common stock, or the 2020 pre-funded warrant, together with accompanying warrants to purchase shares of our common stock. The 2022 pre-funded warrant and 2020 pre-funded warrant each are exercisable immediately at an exercise price of $ 0.001 per share. We included the 2022 pre-funded warrant and 2020 pre-funded warrant in the computation of basic net loss per share, as applicable, since their exercise price is negligible, and they may be exercised at any time. See Note 9 on Stockholders' Equity for further discussion of the April 2022 public offering. Diluted net income per share would be calculated by adjusting the weighted-average number of shares of common stock outstanding for the dilutive effect of additional shares of common stock that would have been outstanding if potentially dilutive securities had been issued, as determined using the treasury-stock method. Potential dilutive securities consist of outstanding stock options and warrants to purchase our common stock. Diluted net loss per share excludes potential dilutive securities for all periods presented as their effect would be anti-dilutive. Accordingly, basic and diluted net loss per share is the same for all periods presented in the accompanying consolidated statements of operations. Since we incurred a net loss for 2022, 2021, and 2020 , the diluted net loss per share calculation excludes potential dilutive securities of 145,726,765 , 105,725,875 and 101,881,391 shares, respectively, related to outstanding stock options and warrants as their effect would have been anti-dilutive. Use of Estimates The accompanying consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States, or U.S. GAAP. The preparation of financial statements in conformity with U.S. 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, operating leases, right-of-use assets, lease liabilities, 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. Treasury securities, municipal securities, 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 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 income on our consolidated 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 income. We have not recorded any other‑than‑temporary impairment charges on our available‑for‑sale securities for the years ended December 31, 2022, 2021 and 2020. See Note 2 on Fair Value Measurements. Equity Investments We measure our investment in equity securities at fair value at each reporting date. Changes in fair value resulting from observable price changes are included in change in fair value of equity investment and changes in fair value resulting from foreign currency translation are included in other expense on our consolidated statements of operations. Leases At the inception of an arrangement, we determine whether the arrangement is or contains a lease based on the unique facts and circumstances present. Operating leases are included in operating leases, right-of-use assets and lease liabilities on our consolidated balance sheets. Right-of-use assets represent our right to use an underlying asset for the lease term and lease liabilities represent our obligation to make lease payments arising from the lease. Operating lease liabilities and their corresponding right-of-use assets are recorded based on the present value of remaining lease payments over the expected lease term. The present value of remaining lease payments within the 12 months following the balance sheet date are classified as current lease liabilities. The present value of lease payments not within the 12 months following the balance sheet date are classified as noncurrent lease liabilities. The interest rate implicit in lease contracts is typically not readily determinable. As such, to calculate the net present value of lease payments, we apply our incremental borrowing rate, which is the estimated rate to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment as of the lease commencement date. We may adjust the right-of-use assets for certain adjustments, such as initial direct costs paid or incentives received. In addition, we include any options to extend or terminate the lease in the expected lease term when it is reasonably certain that we will exercise any such option. Lease expense is recognized on a straight-line basis over the expected lease term. For lease agreements entered into after January 1, 2019 that include lease and non-lease components, such components are generally accounted for separately. We have also elected not to recognize on our consolidated balance sheets leases with terms of one year or less. Debt Issuance Costs and Debt Discounts Debt issuance costs include legal fees, accounting fees, and other direct costs incurred in connection with the execution of our debt financing. Debt discounts represent costs paid to the lenders. Debt issuance costs and debt discounts are deducted from the carrying amount of the debt liability and are amortized to interest expense over the term of the related debt using the effective interest method. Revenue Recognition We recognize revenue in accordance with the provisions of Accounting Standards Codification Topic 606, Revenue from Contracts with Customers, or Topic 606. In determining the appropriate amount and timing of revenue to be recognized under this guidance, we perform the following five steps: (i) identify the contract(s) with our customer; (ii) identify the promised goods or services in the agreement and determine whether they are performance obligations, including whether they are distinct in the context of the agreement; (iii) measure the transaction price, including the constraint on variable consideration; (iv) allocate the transaction price to the performance obligations based on stand-alone selling prices; and (v) recognize revenue when (or as) we satisfy each performance obligation. 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 Agreements In connection with the divestiture of Geron’s human embryonic stem cell assets, including intellectual property and proprietary technology, to Lineage Cell Therapeutics, Inc. (formerly BioTime, Inc. which acquired Asterias Biotherapeutics, Inc.) in 2013, we are entitled to receive royalties on sales of certain research or commercial products utilizing Geron’s divested intellectual property. 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 date, 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. For example, 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 date, we assess the probability of achievement of each milestone under any 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 date, we estimate the sales incurred by each licensee during the reporting period based on historical experience and accrue the associated royalty amount. Restricted Cash Restricted cash consists of funds maintained in separate money market or certificate of deposit accounts for credit card purchases. Research and Development Expenses Research and development expenses currently consist of expenses incurred in developing and testing imetelstat and research related to potential next generation telomerase inhibitors. These expenses include, but are not limited to, payroll and personnel expense, lab supplies, non-clinical studies, clinical trials, including support for investigator-led 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 and research-related overhead. Our current imetelstat clinical trials are being supported by contract research organizations, or CROs, and other vendors. We accrue expenses for clinical trial activities performed by CROs based upon the estimated amount of work completed on each trial. For clinical trial expenses and related expenses associated with the conduct of clinical trials, the significant factors used in estimating accruals include the number of patients enrolled, the number of active clinical sites, and the duration for which the patients have been enrolled in the trial. We monitor patient enrollment levels and related activities to the extent possible through internal reviews, review of contractual terms and correspondence with CROs. We base our estimates on the best information available at the time. However, additional information may become available to us which will allow us to make a more accurate estimate in future periods. In that 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 can be granted to employees, non-employee directors and consultants. We also have an employee stock purchase plan for all eligible employees. We recognize stock-based compensation expense based on grant-date fair values of service-based stock options 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 the assessment of probability of the performance condition changes, the impact of the change in estimate would be recognized in the period of the change. The determination of grant-date fair values for our service-based and performance-based stock options and employee stock purchases using the Black Scholes option pricing model is affected by our stock price as well as assumptions regarding a number of complex and subjective variables. The grant-date fair value for service-based restricted stock awards is determined using the fair value of our common stock on the date of grant. We evaluate whether an adjustment to the assumptions of fair value of our common stock and historical volatility are required if observed prices of our common stock materially differ from historical information. We measure share-based payments to non-employees based on the grant-date fair value of the equity awards to be issued. We recognize stock-based compensation expense for the fair value of the vested portion of non-employee stock-based awards on our consolidated statements of operations. For additional information, see Note 9 on Stockholders’ Equity. Accumulated Other Comprehensive Gain (Loss) Accumulated other comprehensive gain (loss) includes certain changes in stockholders’ equity which are excluded from net income (loss). Accumulated other comprehensive loss on our consolidated balance sheets as of December 31, 2022 and 2021 , respectively, is comprised of net unrealized losses on marketable securities and cumulative translation adjustments. 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, federal and state tax 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. 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 – Issued But Not Yet Adopted In June 2016, the FASB issued ASU 2016-13, Measurement of Credit Losses on Financial Instruments , or ASU 2016-13. The main objective of ASU 2016-13 is to provide financial statement users with more decision-useful information about an entity's expected credit losses on financial instruments and other commitments to extend credit at each reporting date. To achieve this objective, the amendments in this update replace the incurred loss impairment methodology currently used today with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to develop credit loss estimates. Subsequent to issuing ASU 2016-13, the FASB issued ASU 2018-19, Codification Improvements to Topic 326, Financial Instruments – Credit Losses , or ASU 2018-19, for the purpose of clarifying certain aspects of ASU 2016-13. In May 2019, the FASB issued ASU 2019-05, Financial Instruments – Credit Losses (Topic 326): Targeted Transition Relief , or ASU 2019-05, to provide entities with more flexibility in applying the fair value option on adoption of the credit impairment standard. In November 2019, the FASB issued ASU 2019-11, Codification Improvements to Topic 326, Financial Instruments – Credit Losses , which expands the scope of the practical expedient that allows entities to exclude the accrued interest component of amortized cost from various disclosure. Entities that elect to apply the practical expedient must disclose the total amount of accrued interest that they exclude from their disclosures of amortized cost. ASU 2018-19, ASU 2019-05 and ASU 2019-11 have the same effective date and transition requirements as ASU 2016-13. ASU 2016-13 will be effective for fiscal years beginning after December 15, 2022, using a modified retrospective approach, for smaller reporting companies. Early adoption is permitted. We plan to adopt ASU 2016-13 and related updates as of January 1, 2023. We do not expect the adoption of this standard to have a material impact on our financial statements. In August 2020, the FASB issued ASU 2020-06, Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity , or ASU 2020-06. The key elements of ASU 2020-06 aim to reduce unnecessary complexity in GAAP for certain financial instruments with characteristics of liabilities and equity. In addressing the complexity, the FASB focused on amending the guidance on convertible instruments and the guidance on the derivatives scope exception for contracts in an entity’s own equity. For convertible instruments, the FASB decided to reduce the number of accounting models for convertible debt instruments and convertible preferred stock. For contracts in an entity’s own equity, the FASB observed that the application of the derivatives scope exception guidance results in accounting for some contracts as derivatives while accounting for economically similar contracts as equity. The FASB also decided to improve and amend the related earnings per share guidance. ASU 2020-06 is effective for fiscal years beginning after December 15, 2021, and interim periods within those fiscal years for public business entities that are not smaller reporting companies. For all other entities, ASU 2020-06 is effective for fiscal years beginning after December 15, 2023, and interim periods within those fiscal years. We plan to adopt ASU 2020-06 as of January 1, 2024. We do not expect the adoption of this standard to have a material impact on our financial statements. Other recent accounting pronouncements issued by the FASB did not or are not believed by management to have a material impact on our financial statements. |
FAIR VALUE MEASUREMENTS
FAIR VALUE MEASUREMENTS | 12 Months Ended |
Dec. 31, 2022 | |
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, 2022 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 $ 39,771 $ — $ — $ 39,771 $ 39,771 $ — $ — $ 39,771 Restricted cash: Money market fund $ 93 $ — $ — $ 93 Certificate of deposit 271 — — 271 $ 364 $ — $ — $ 364 Marketable securities: U.S. Treasury securities (due in $ 12,983 $ — $ ( 62 ) $ 12,921 Municipal securities (due in less than one year) 3,000 — ( 24 ) 2,976 Government-sponsored enterprise securities 9,860 — ( 14 ) 9,846 Commercial paper (due in less than one year) 64,285 6 ( 92 ) 64,199 Corporate notes (due in less than one year) 26,014 — ( 55 ) 25,959 $ 116,142 $ 6 $ ( 247 ) $ 115,901 Cash equivalents, restricted cash and marketable securities by security type at December 31, 2021 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 $ 24,207 $ — $ — $ 24,207 Commercial paper 7,499 — — 7,499 $ 31,706 $ — $ — $ 31,706 Restricted cash: Money market fund $ 93 $ — $ — $ 93 Certificate of deposit 271 — — 271 $ 364 $ — $ — $ 364 Marketable securities: U.S. Treasury securities (due in $ 15,585 $ — $ ( 18 ) $ 15,567 U.S. Treasury securities (due in 1,524 — ( 3 ) 1,521 Municipal securities (due in 3,000 — ( 15 ) 2,985 Government-sponsored enterprise securities 12,500 — ( 7 ) 12,493 Commercial paper (due in less than one year) 84,398 2 ( 38 ) 84,362 Corporate notes (due in less than one year) 36,444 2 ( 17 ) 36,429 Corporate notes (due in one to two years) 24,224 — ( 79 ) 24,145 $ 177,675 $ 4 $ ( 177 ) $ 177,502 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, 2022 and 2021 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, 2022: U.S. Treasury $ 11,424 $ ( 57 ) $ 1,497 $ ( 5 ) $ 12,921 $ ( 62 ) Municipal securities — — 2,976 ( 24 ) 2,976 ( 24 ) Government-sponsored 9,845 ( 14 ) — — 9,845 ( 14 ) Commercial paper 52,454 ( 92 ) — — 52,454 ( 92 ) Corporate notes (due in 1,998 ( 2 ) 23,962 ( 53 ) 25,960 ( 55 ) $ 75,721 $ ( 165 ) $ 28,435 $ ( 82 ) $ 104,156 $ ( 247 ) As of December 31, 2021: U.S. Treasury $ 15,567 $ ( 18 ) $ — $ — $ 15,567 $ ( 18 ) U.S. Treasury 1,521 ( 3 ) — — 1,521 ( 3 ) Municipal securities 2,985 ( 15 ) — — 2,985 ( 15 ) Government-sponsored 1,500 — 4,993 ( 7 ) 6,493 ( 7 ) Commercial paper 66,872 ( 38 ) — — 66,872 ( 38 ) Corporate notes (due in 16,001 ( 17 ) — — 16,001 ( 17 ) Corporate notes (due in 24,145 ( 79 ) — — 24,145 ( 79 ) $ 128,591 $ ( 170 ) $ 4,993 $ ( 7 ) $ 133,584 $ ( 177 ) The gross unrealized losses related to U.S. Treasury securities, municipal securities, government-sponsored enterprise securities, commercial paper and corporate notes as of December 31, 2022 and 2021 were due to changes in interest rates and not credit risk. We determined that the gross unrealized losses on our cash equivalents and marketable securities as of December 31, 2022 and 2021 were temporary in nature. Our exposure to unrealized losses may increase in the future due to the economic pressures or uncertainties associated with local or global economic recessions as a result of the ongoing COVID-19 pandemic and ongoing geopolitical events, such as the current military conflict between Ukraine and Russia, as well as recent and potential future disruptions in access to bank deposits or lending commitments due to bank failure. We review our investments quarterly to identify and evaluate whether any investments have indications of possible other-than-temporary 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 amortized 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 consolidated 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 consolidated balance sheets, including the category for such financial instruments. Money market funds and certificates of deposit are categorized as Level 1 within the fair value hierarchy as their fair values are based on quoted prices available in active markets. Commercial paper, U.S. Treasury securities, municipal securities, government-sponsored enterprise securities and corporate notes 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, 2022 and 2021 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, 2022: Money market funds (1)(2) $ 39,864 $ — $ — $ 39,864 Certificate of deposit (2) 271 — — 271 U.S. Treasury securities (3) — 12,921 — 12,921 Municipal securities (3) — 2,976 — 2,976 Government-sponsored enterprise securities (3) — 9,846 — 9,846 Commercial paper (3) — 64,199 — 64,199 Corporate notes (3) — 25,959 — 25,959 Total $ 40,135 $ 115,901 $ — $ 156,036 As of December 31, 2021: Money market funds (1) $ 24,207 $ — $ — $ 24,207 U.S. Treasury securities (3)(4) — 17,088 — 17,088 Municipal securities (4) — 2,985 — 2,985 Government-sponsored enterprise securities (3) — 12,493 — 12,493 Commercial paper (1)(3) — 91,861 — 91,861 Corporate notes (3)(4) — 60,574 — 60,574 Total $ 24,207 $ 185,001 $ — $ 209,208 (1) Included in cash and cash equivalents on our consolidated balance sheets. (2) Included in restricted cash on our consolidated balance sheets. (3) Included in current portion of marketable securities on our consolidated balance sheets. (4) Included in noncurrent portion of marketable securities on our consolidated balance sheets. Equity Investment In December 2007, we received 13,842,625 ordinary shares in Sienna Cancer Diagnostics Limited, or Sienna, in connection with a license we granted to them for our hTERT technology for use in human diagnostics. The shares, which represented less than 20 % ownership, were recorded at a zero cost basis under the cost method of accounting, upon receipt. Since the adoption of ASU 2016-01 on January 1, 2018, we reassessed the fair value of our equity investment in Sienna at each reporting date and any resulting change in fair value was recognized on our consolidated statements of operations. In April 2020, Sienna announced its merger with BARD1 Life Sciences Limited, or BARD1, subject to approval by Sienna’s shareholders. Effective August 3, 2020, the merger was complete, and we received 13 BARD1 shares for every five shares of Sienna ordinary shares, resulting in our ownership of 35,990,825 shares of BARD1. During the first quarter of 2021, we sold all of our holdings in BARD1 and recognized a net gain of approximately $ 1,233,000 from the sales, including gains from foreign currency translation adjustments, which has been included in other income and expense on our consolidated statements of operations. As of March 31, 2021, no value remained for our equity investment in BARD1. Credit Risk We currently place our cash, restricted cash, cash equivalents and marketable securities with five 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, government-sponsored enterprise securities, U.S. Treasury securities, municipal securities, 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. However, we are exposed to credit risk in the event of default by the financial institutions holding our cash and cash equivalents to the extent recorded in our consolidated balance sheets. We have not experienced any losses in such accounts and we believe that we are not exposed to significant credit risk of our financial position at the depository institutions in which those deposits are held. |
PROPERTY AND EQUIPMENT
PROPERTY AND EQUIPMENT | 12 Months Ended |
Dec. 31, 2022 | |
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) 2022 2021 Furniture and computer equipment $ 1,554 $ 1,171 Leasehold improvements 135 129 1,689 1,300 Less accumulated depreciation and amortization ( 896 ) ( 650 ) $ 793 $ 650 |
LICENSE AGREEMENT
LICENSE AGREEMENT | 12 Months Ended |
Dec. 31, 2022 | |
License Agreement Disclosure [Abstract] | |
LICENSE AGREEMENT | 4. LICENSE AGREEMENT 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. 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. This agreement was terminated effective April 2021. |
ACCRUED LIABILITIES
ACCRUED LIABILITIES | 12 Months Ended |
Dec. 31, 2022 | |
Payables and Accruals [Abstract] | |
ACCRUED LIABILITIES | Accrued liabilities consisted of the following: December 31, (In thousands) 2022 2021 CRO and clinical trial costs $ 17,040 $ 22,804 Manufacturing activities 5,321 4,123 Professional legal and accounting fees 9,668 2,030 Interest payable 561 336 Other 510 541 $ 33,100 $ 29,834 |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 12 Months Ended |
Dec. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | 6. COMMITMENTS AND CONTINGENCIES Purported Securities Lawsuits Between January 23, 2020 and March 5, 2020, three securities class action lawsuits were filed against us and certain of our officers. One of the lawsuits was voluntarily dismissed on March 19, 2020. The other two lawsuits, filed in the U.S. District Court, or the Court, for the Northern District of California, or the Northern District, were consolidated by the Court on May 14, 2020, and on August 20, 2020, the lead plaintiffs filed a consolidated class action complaint. The consolidated class action complaint alleges violations of the Securities Exchange Act of 1934, as amended, or the Exchange Act, in connection with allegedly false and misleading statements made by us related to IMbark during the period from March 19, 2018, to September 26, 2018. The consolidated class action complaint alleges, among other things, that we violated Sections 10(b) and 20(a) of the Exchange Act and SEC Rule 10b-5 by failing to disclose facts related to the alleged failure of IMbark to meet the two primary endpoints of the trial, spleen response rate and Total Symptom Score, and that our stock price dropped when such information was disclosed. The plaintiffs in the consolidated class action complaint seek damages and interest, and an award of reasonable costs, including attorneys’ fees. On October 22, 2020, lead plaintiffs filed an amended consolidated class action complaint. We filed a motion to dismiss the amended consolidated class action complaint on November 23, 2020. On April 12, 2021, the Court granted in part and denied in part our motion to dismiss. Our answer to the amended consolidated class action complaint was filed on May 13, 2021. On September 30, 2021, lead plaintiffs filed their motion for class certification, and on April 2, 2022, the Court granted the lead plaintiffs’ motion for class certification. On September 2, 2022 , the parties agreed to a settlement and entered into a Stipulation and Agreement of Settlement, or the Stipulation, which is subject to court approval. On October 13, 2022, the Court preliminarily approved the parties’ settlement, permitted notice to be distributed to the class members, and scheduled a final approval hearing for March 30, 2023. Final approval of the settlement is subject to a number of conditions and contingencies out of our control. There can be no guarantee that all of these conditions and contingencies will occur. Should a material condition or contingency to the settlement fail to occur, one or both of the parties to the settlement may exercise their right to terminate the settlement agreement. Under the terms of the Stipulation, in exchange for the release and dismissal with prejudice of all claims against the defendants in the consolidated class action complaint, we agreed to pay and/or to cause our insurance carriers to pay a total of $ 24,000,000 , comprised of $ 17,000,000 in cash, which was paid into an escrow account under our available D&O insurance coverage and, at our election, $ 7,000,000 in either shares of our common stock and/or cash which is payable after final approval of the settlement by the Court. The proposed settlement does not constitute an admission of fault or wrongdoing by Geron or our Chief Executive Officer. The proposed settlement remains subject to final approval by the Court and certain other conditions. As of December 31, 2022, our portion of the settlement amount of $ 7,000,000 has been included in accrued liabilities on our consolidated balance sheets and recognized as general and administrative expense on our consolidated statements of operations for the year ended December 31, 2022. Between April 23, 2020 and June 8, 2021, seven shareholder derivative actions were filed, naming as defendants certain of our current officers and certain current and former members of our board. Of these actions, or the Derivative Lawsuits, two were filed in the Northern District, two were filed in the Court of Chancery of the State of Delaware, two were filed in the U.S. District Court for the District of Delaware, and one was filed in the Superior Court of California for the County of San Mateo, respectively. The plaintiffs in the Derivative Lawsuits allege breach of fiduciary duty and/or violations of Section 14 of the Exchange Act, based on the same underlying facts as the consolidated class action lawsuit described above. The plaintiffs seek damages, corporate governance reforms, equitable relief, restitution, and an award of reasonable costs, including attorneys’ fees. The status of the seven Derivative Lawsuits is currently as follows: • On July 2, 2021, we filed a motion to dismiss the consolidated shareholder derivative actions filed in the Court of Chancery of the State of Delaware, or the Chancery Court Derivative Lawsuits. On September 1, 2021, the plaintiffs filed a consolidated amended complaint in the Chancery Court Derivative Lawsuits. On October 12, 2021, we filed our motion to dismiss the consolidated amended complaint. The Court of Chancery of the State of Delaware heard oral argument on the motion on February 15, 2022, and, on June 22, 2022, issued an order staying its decision on our motion to dismiss until after final resolution of the consolidated class action lawsuit described above. On December 21, 2022, the parties in the Chancery Court Derivative Lawsuits entered into a Stipulation of Settlement, or the Derivative Stipulation, that, subject to final approval by the Court of Chancery of the State of Delaware, will resolve the Chancery Court Derivative Lawsuits. A final approval hearing regarding the Derivative Stipulation has been scheduled for May 17, 2023. Final approval of the settlement is subject to a number of conditions and contingencies out of our control. There can be no guarantee that all of these conditions and contingencies will occur. Should a material condition or contingency to the settlement fail to occur, one or more of the parties to the settlement may exercise their right to terminate the settlement agreement; • The consolidated shareholder derivative actions filed in the U.S. District Court for the District of Delaware have been stayed pending the ruling on our motion to dismiss the Chancery Court Derivative Lawsuits. On December 21, 2022 , the parties in the consolidated District of Delaware derivative actions entered into the Derivative Stipulation, that, subject to final approval by the Court of Chancery of the State of Delaware, will resolve the consolidated District of Delaware derivative actions; • The consolidated shareholder derivative actions filed in the Northern District were initially stayed through the ruling on our motion to dismiss in the consolidated class action lawsuit described above and then subsequently were stayed through the ruling on the lead plaintiffs’ motion for class certification in the consolidated class action lawsuit. Subsequent to the grant of class certification in the consolidated class action lawsuit, on May 3, 2022, the Northern District entered an order providing plaintiffs until June 7, 2022, to file an amended complaint. On June 7, 2022, plaintiffs filed an amended shareholder derivative complaint. On July 6, 2022, the Northern District entered an order staying the consolidated shareholder derivative actions filed in the Northern District until the earlier of either a public announcement of a settlement in the consolidated class action lawsuit or a final, non-appealable judgment in the consolidated class action lawsuit. The stay has subsequently been extended on a number of occasions and the case is currently stayed through March 31, 2023. On December 21, 2022, the parties in the consolidated derivative actions in the Northern District entered into the Derivative Stipulation, that, subject to final approval by the Court of Chancery of the State of Delaware, will resolve the consolidated derivative actions in the Northern District; and • Our motion to dismiss the shareholder derivative action pursuant to the forum selection clause in our amended and restated bylaws was filed in the Superior Court of California for the County of San Mateo on August 5, 2021. At the hearing on the motion to dismiss on November 2, 2021, the court granted our motion to dismiss and stayed the case until April 19, 2022. At the case management conference on April 19, 2022, the court continued the stay until June 14, 2022. At the case management conference on June 14, 2022, the court continued the stay until December 13, 2022. On December 13, 2022, the court dismissed the action without prejudice. Under the terms of the Derivative Stipulation, in exchange for the release and dismissal with prejudice of all claims against the defendants in the consolidated shareholder derivative actions filed in the Northern District, we agreed to pay and/or to cause our insurance carriers to pay a total of $ 1,350,000 , comprised of $ 525,000 in cash, which is payable under our available D&O insurance coverage and $ 825,000 in cash payable by us. The proposed settlement remains subject to final approval by the Court and certain other conditions, upon which the settlement amounts are payable. The proposed settlement does not constitute an admission of fault or wrongdoing by our current officers or current and former members of our board. As of December 31, 2022, we have recorded the total settlement amount of $ 1,350,000 as accrued liabilities and $ 525,000 as interest and other receivables on our consolidated balance sheets. For the year ended December 31, 2022, we have recognized our portion of the settlement of $ 825,000 as general and administrative expense on our consolidated statements of operations. The pending lawsuits and any other related lawsuits are subject to inherent uncertainties, and the actual defense and disposition costs will depend upon many unknown factors. The outcome of the pending lawsuits and any other related lawsuits is necessarily uncertain. We could be forced to expend significant resources in the defense against the pending lawsuits and any other related lawsuits, and we may not prevail. In addition, we have and may continue to incur substantial legal fees and costs in connection with such lawsuits. As discussed above, we have recorded the total settlement amount for the Derivative Stipulation on our consolidated balance sheets as of December 31, 2022 and our portion of the settlement amount under the Stipulation remains accrued on our consolidated balance sheets as of December 31, 2022. We currently are not able to estimate the possible additional costs to us, if any, from these matters, and we cannot be certain how long it may take to resolve the pending lawsuits or the possible amount of any damages or legal costs that we may be required to pay. Such amounts could be material to our consolidated financial statements if we do not prevail in the defense against the pending lawsuits and any other related lawsuits, or even if we do prevail. We have not established any reserve for any potential liability relating to the pending lawsuits and any other related lawsuits, other than settlement amounts under the Stipulation and the Derivative Stipulation. It is possible that we could, in the future, incur judgments or enter into settlements of claims for monetary damages. 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. Severance Plan We have an Amended and Restated Severance Plan, or Severance Plan, that applies to all employees that are (i) above the Vice President level, (ii) hired by the Company before January 1, 2022, or (iii) 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 three 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, 2022, all our executive officers have employment agreements with provisions that may provide greater severance benefits than those in the Severance Plan. Risks Related to Global Economic Conditions, COVID-19 and the Military Conflict Between Ukraine and Russia As of the date of this filing, significant uncertainty exists concerning the ultimate duration and severity of the COVID-19 pandemic and the military conflict between Ukraine and Russia. Both of these events have caused widespread, continually evolving and unpredictable impacts on global societies, economies, financial markets and business practices. With respect to the COVID-19 pandemic, we are closely monitoring the impact of the pandemic, the identification of new variants of the COVID-19 virus and related developments, and our focus remains on promoting employee health and safety while continuing to advance the development of imetelstat. For both our Phase 3 clinical trials, IMerge and IMpactMF, we have limited ongoing clinical trial activity in Ukraine and Russia, but we have experienced, and may continue to experience, delays and suspensions in clinical trial activities at clinical sites in Ukraine and Russia due to the current political and civil unrest conditions. With support from our CRO, we are monitoring the impact of the conflict on our clinical trial activities. Due to the dynamic and unpredictable effects of the COVID-19 pandemic, we have had and expect to continue to have disruptions and/or delays in our imetelstat development program, including with respect to our ability to initiate trial sites, enroll and assess patients, maintain patient enrollment, ensure patient clinical and lab collection visits, conduct monitoring visits, supply study drug, report trial results, and interact with regulators or other important agencies due to limitations in employee resources or otherwise. Restrictions on travel, availability of site personnel, and diversion of hospital staff and resources to COVID-19 patients, have disrupted our trial operations, as well as patient recruitment in many areas, resulting in a slowdown in patient enrollment and/or deviations from or disruptions in key clinical trial activities, such as clinical trial site initiation and monitoring. If the effects of the COVID-19 pandemic continue and/or become more severe, we could experience significant disruptions to our clinical development timelines, delays in clinical site initiation and patient enrollment in IMpactMF, IMproveMF and the investigator-led trial IMpress, and other disruptions that could severely impact our business and the imetelstat development program. We have taken and intend to take those actions with regard to COVID-19 that may be required by federal, state or local authorities or that we determine are in the best interests of our patients, investigators, employees and stockholders. In response to the COVID-19 pandemic and previous “shelter in place” and similar orders issued by state and local governments, we have allowed voluntary access to our offices in California and New Jersey to employees who have been vaccinated, and almost all of our employees continue to work remotely without any significant disruption to our business. Our increased reliance on personnel working remotely could increase our cybersecurity risk, create data accessibility concerns and make us more susceptible to communication disruptions, any of which could adversely impact our business operations. These and similar, and perhaps more severe, disruptions in our operations could occur which would negatively impact our business and business prospects, our financial condition and the future of imetelstat. The effects of the COVID-19 pandemic and the military conflict between Ukraine and Russia, including the significant sanctions imposed against Russia, as well as broader economic conditions, including inflation, rising interest rates, the prospects for recession, and recent and potential future disruptions in access to bank deposits or lending commitments due to bank failure have increased market volatility and could result in a significant long-term disruption of global financial markets, reducing or eliminating our ability to raise additional capital, which could negatively affect our liquidity, our ability to complete IMpactMF, IMproveMF and the investigator-led trial IMpress and to commence, conduct and complete any other potential future clinical trials of imetelstat. In addition, the global economic slowdown caused by, among other things, the COVID-19 pandemic and the military conflict between Ukraine and Russia, as well as inflation, rising interest rates, the prospects for recession, and recent and potential future disruptions in access to bank deposits or lending commitments due to bank failures could materially and adversely affect our business and the value of our common stock. The extent to which global economic conditions, including those resulting from the COVID-19 pandemic, the military conflict between Ukraine and Russia and recent and potential future bank failures, ultimately impact our business, our regulatory and clinical development activities, clinical supply chain and other business operations, as well as the value of and market for our common stock, will depend on future developments that are highly uncertain and cannot be predicted with confidence at this time, such as the ultimate duration and severity of the pandemic, travel restrictions, quarantines, social distancing and business closure requirements in the United States, or U.S., and in other countries, the effectiveness of actions taken globally to contain and treat COVID-19, whether the military conflict between Ukraine and Russia resolves in a timely manner, or at all, and whether the U.S. and/or international banking system stabilizes in light of recent and potential future bank failures. Accordingly, we do not yet know the full extent of potential delays or impacts on our business, our regulatory and clinical development activities, clinical supply chain and other business operations or the global economy as a whole. However, these effects could materially and adversely affect our business and business prospects, our financial condition and the future of imetelstat. |
OPERATING LEASES
OPERATING LEASES | 12 Months Ended |
Dec. 31, 2022 | |
Leases [Abstract] | |
OPERATING LEASES | 7. OPERATING LEASES New Jersey Office Space Lease In April 2019, we entered into an operating lease agreement for office space located at 3 Sylvan Way, Parsippany, New Jersey, or the New Jersey Lease. The initial term of the New Jersey Lease is 11 years with an option to extend for an additional five years and a one-time option to terminate the New Jersey Lease without cause as of the 103 rd month anniversary of the commencement date of the lease . The New Jersey Lease commenced on October 1, 2019, upon our control of the office space on that date. Based on the initial term of the New Jersey Lease of 11 years, the right-of-use asset and corresponding operating lease liability was approximately $ 2,356,000 , which represented the present value of lease payments over the initial lease term, net of a seven-month rent abatement period, using an incremental borrowing rate of 8 % based on information available as of October 1, 2019. Under the New Jersey Lease, we are also obligated to pay certain variable expenses separately from the base rent, including electricity and common area maintenance. Such costs are being expensed in the period they are incurred. As of December 31, 2022 , the remaining lease term for the New Jersey Lease is 7.8 years. Foster City Office Space Lease In October 2019, we entered into an operating lease agreement for office space located at 919 East Hillsdale Boulevard, Foster City, California, or the Foster City Lease. The initial term of the Foster City Lease is 87 months with an option to extend for an additional five years . The Foster City Lease commenced on March 10, 2020, upon the substantial completion of all tenant improvements. As of the lease commencement date, the right-of-use asset and corresponding operating lease liability was approximately $ 3,426,000 , which represented the present value of remaining lease payments using an incremental borrowing rate of 7 % over the initial lease term of 87 months, net of a three-month rent abatement period. Under the Foster City Lease, we are also obligated to pay certain variable expenses separately from the base rent, including taxes and common area maintenance. Such costs are considered non-lease components and have been excluded from the calculation of the right-of-use asset and corresponding operating lease liability and are being expensed in the period they are incurred. As of December 31, 2022 , the remaining lease term for the Foster City Lease is 4.5 years. The components of lease costs included in operating expenses on our consolidated statements of operations for the New Jersey Lease, the Foster City Lease and a lease from a former location in Menlo Park, California, were as follows: Year Ended December 31, (In thousands) 2022 2021 2020 Operating lease costs $ 944 $ 946 $ 1,143 Variable lease costs (1) 310 252 293 Total lease costs $ 1,254 $ 1,198 $ 1,436 (1) Variable lease costs represent non-lease components, such as common area maintenance charges. The undiscounted future non-cancellable lease payments under the New Jersey Lease and the Foster City Lease as of December 31, 2022 were as follows (in thousands): 2023 $ 962 2024 987 2025 1,014 2026 1,040 2027 717 Thereafter 1,050 Total lease payments 5,770 Less: imputed interest ( 1,174 ) Total $ 4,596 |
DEBT
DEBT | 12 Months Ended |
Dec. 31, 2022 | |
Debt Disclosure [Abstract] | |
DEBT | 8. DEBT On September 30, 2020, or the Closing Date, we, Hercules Capital, Inc., or Hercules, and Silicon Valley Bank, or SVB, entered into a term loan facility, or the Term Loan, up to $ 75,000,000 , which was amended in August 2021, or the Original Loan Agreement. On June 30, 2022, or the Effective Date, we entered into a second amendment to the Original Loan Agreement, or as amended, the Loan Agreement. Under the second amendment, the aggregate principal amount available to us increased from $ 75,000,000 to $ 125,000,000 , with such principal being available in a series of tranches, subject to certain terms and conditions. As of December 31, 2022 , a total of $ 50,000,000 has been drawn under the Loan Agreement. Under the second amendment, the $ 75,000,000 in remaining loan principal as of December 31, 2022 can be drawn as follows: (a) the first tranche of $ 20,000,000 is available within the earlier of 30 days of the achievement of certain clinical and financial milestones or September 15, 2023 , subject to the achievement of such milestones; (b) the second tranche of $ 10,000,000 is available from January 1, 2023 until December 15, 2023 , subject to the achievement of certain clinical and regulatory milestones, and satisfaction of certain other requirements; (c) the third tranche of $ 20,000,000 is available from September 15, 2023 until September 15, 2024 , subject to the achievement of certain clinical and regulatory milestones, and satisfaction of certain capitalization requirements; and (d) the final tranche of $ 25,000,000 is available through December 31, 2024 , subject to approval by an investment committee comprised of Hercules and SVB (or its successor, if any). However, on March 10, 2023, the Federal Deposit Insurance Corporation, or FDIC, issued a press release stating that SVB was closed by the California Department of Financial Protection and Innovation, which appointed the FDIC as receiver. Of the remaining term commitments under the Loan Agreement, Hercules and its affiliates hold 65 % and 35 % were held by SVB. As a result of the closure of SVB, we do not know whether and to what extent we would be able to draw down the remaining $ 55.0 million under the Loan Agreement, even if we meet the conditions set forth in the Loan Agreement necessary for additional draw downs, and it is possible that we will not be able to access any additional funding under the Loan Agreement. With the exception of the final tranche, and subject to achievement of the applicable milestones and other requirements with respect to each tranche, draw downs are at our election. Under the second amendment, the maturity date, interest only payment dates, end of term charges, collateral, events of default, representations, warranties and covenants remain consistent with the terms of the Original Loan Agreement, except as follows: • Beginning June 1, 2022 and prior to the regulatory approval for imetelstat, or the potential Regulatory Approval, if any, we are required to maintain a minimum cash balance in an amount equal to the greater of: 50 % of the outstanding principal amount under the Loan Agreement or $ 30,000,000 . • After the potential Regulatory Approval, if any, the minimum cash requirement may be satisfied through one of the following three options, as elected by us: (a) maintaining a cash balance in an amount not less than 40 % of the outstanding principal amount under the Loan Agreement; (b) maintaining a cash balance in an amount not less than 25 % of the outstanding principal amount under the Loan Agreement, if our market cap is or exceeds $ 750,000,000 ; or (c) maintaining six month net product revenues of at least 70 % of net product revenues forecasted by us, should any potential Regulatory Approval for imetelstat be obtained. On the Effective Date of the second amendment, we paid $ 100,000 as a facility charge that we recognized as a debt discount and are amortizing such cost to interest expense over the life of the loan using the effective interest rate method. Additional facility charges applied to future draw downs will be treated similarly. We incurred approximately $ 75,000 in legal fees in connection with the second amendment, which we recognized as debt issuance costs and are amortizing such cost to interest expense over the life of the loan using the effective interest rate method. Future debt issuance costs will be treated similarly. Under the second amendment, if we choose to prepay the principal with respect to any future draw down after the Effective Date, any such prepayment within the first 36 months after the Effective Date will be subject to a prepayment charge equal to 1.5 % of the principal amount prepaid. No prepayment charge will be assessed for any prepayment occurring more than 36 months after the Effective Date. Unchanged from the Original Loan Agreement, the Term Loan matures on October 1, 2024 , or the Loan Maturity Date, and may be extended up to an additional 12 months upon the achievement of certain clinical, regulatory and financial milestones. The Term Loan bears interest at a floating rate per annum equal to the greater of either (i) 9.0% or (ii) 9.0 % plus the prime rate as reported in The Wall Street Journal (7.5% as of December 31, 2022) less 3.25%. The Term Loan provided for an initial interest-only payment period from the Closing Date until November 1, 2022. As of December 31, 2022, the interest-only period expires May 1, 2023. Upon the achievement of certain regulatory and financial milestones, the interest-only period may be extended for another six months until November 1, 2023. Following the expiration of the interest-only period, we will repay the Term Loan in equal monthly amortization payments of principal and interest until the Loan Maturity Date. Upon full repayment of the Term Loan, we are also obligated to pay an end of term charge in an amount equal to 6.55 % of the amount of the Term Loan actually borrowed. Such end of term charge is being accrued to interest expense over the term of the Term Loan using the effective interest rate method. At our option, upon at least five business days’ prior written notice to Hercules, we may prepay all or any portion greater than or equal to $ 5,000,000 of the outstanding loan by paying the entire principal balance (or portion thereof) and all accrued and unpaid interest. Such prepayment is subject to a prepayment charge of 1.5 % of the prepayment amount, if the prepayment is made in any of the first 36 months following the Closing Date for any draw downs prior to the second amendment. Thereafter, any prepayment is not subject to a prepayment charge. The Term Loan is secured by substantially all of Geron’s assets, except our intellectual property, which is the subject of a negative pledge. The Term Loan contains certain representations and warranties, affirmative covenants, negative covenants and conditions that are customarily required for similar financings. We are in compliance with the covenants under the Term Loan as of December 31, 2022. In the event of default (subject, in certain instances, to specified grace periods), the principal, interest and any other monetary obligations on all the then outstanding amounts under the Term Loan may become due and payable immediately. Upon the occurrence of an event of default, a default interest rate of an additional 5 % may be applied to the outstanding principal balance, and Hercules, as the administrative agent, may declare all outstanding obligations immediately due and payable (subject, in certain instances, to specified grace periods) and take such other actions as set forth in the Term Loan. Upon the occurrence of certain bankruptcy and insolvency events, the obligations under the Term Loan would automatically become due and payable. Embedded Derivatives and Debt Discounts The conditional exercisable call option related to the event of default is considered to be an embedded derivative which is required to be bifurcated and accounted for as a separate financial instrument. In the periods presented, the value of the embedded derivative is not material and therefore, no amount has been recognized. If an event of default becomes more probable than is currently estimated, then the embedded derivative could become material in future periods and would be recognized as a separate financial instrument at that time. As of December 31, 2022 , the net carrying value of the Term Loan was $ 51,157,000 , which includes the principal amount of $ 50,000,000 less the net unamortized discounts and debt issuance costs of $ 628,000 plus accrued end of term charge of $ 1,785,000 . The carrying value of the debt approximates the fair value as of December 31, 2022. The debt discounts and debt issuance costs are being amortized to interest expense over the life of loan amounts under Term Loan using the effective interest rate method. Future Minimum Payments The following table presents future minimum payments, including interest and the end of term charge, under the Term Loan as of December 31, 2022 (in thousands): 2023 $ 26,843 2024 34,160 Total 61,003 Less: amount representing interest ( 7,728 ) Less: unamortized debt discount and issuance costs ( 628 ) Less: unamortized end of term charge ( 1,490 ) Less: current portion of debt ( 20,945 ) Noncurrent portion of debt $ 30,212 |
STOCKHOLDERS' EQUITY
STOCKHOLDERS' EQUITY | 12 Months Ended |
Dec. 31, 2022 | |
Stockholders' Equity Note [Abstract] | |
STOCKHOLDERS' EQUITY | 9. STOCKHOLDERS’ EQUITY Authorized Common Stock In May 2021, our stockholders approved an amendment to our Restated Certificate of Incorporation to increase the total number of authorized shares of common stock from 450,000,000 to 675,000,000 shares. Public Offering On April 1, 2022, we completed an underwritten public offering of 53,333,334 shares of our common stock and a pre-funded warrant to purchase 18,095,238 shares of our common stock, or the 2022 pre-funded warrant, together with accompanying warrants to purchase 35,714,286 shares of our common stock, also known as the 2022 stock purchase warrants. The shares of common stock and the 2022 pre-funded warrant were immediately separable from the 2022 stock purchase warrants. All of the securities were issued separately. The combined public offering price of the common stock and accompanying 2022 stock purchase warrants was $ 1.05 per share. The 2022 stock purchase warrants have an exercise price of $ 1.45 per share and are exercisable immediately. The term of the 2022 stock purchase warrants expires on the earlier to occur of (a) the date that is 30 business days following the date on which we first issue a press release disclosing, if applicable, that the United States Food and Drug Administration, or FDA, has accepted for filing a New Drug Application submitted to the FDA for imetelstat in Low or Intermediate-1 risk myelodysplastic syndromes and (b) April 1, 2027. The combined public offering price of the 2022 pre-funded warrant and accompanying 2022 stock purchase warrant was $ 1.049 per share. The 2022 pre-funded warrant has an exercise price of $ 0.001 per share and may be exercised at any time until the 2022 pre-funded warrant is exercised in full. As of December 31, 2022, none of the 2022 pre-funded warrant and 2022 stock purchase warrants have been exercised. The net cash proceeds from this offering were $ 69,916,000 , after deducting the underwriting discount and other offering expenses paid by us, and exclude any future proceeds from the exercise of the 2022 pre-funded warrant and 2022 stock purchase warrants. Upon the issuance of the 2022 pre-funded warrant and 2022 stock purchase warrants, we evaluated the terms of each warrant to determine the appropriate accounting and classification pursuant to FASB Accounting Standards Codification Topic 480, Distinguishing Liabilities from Equity , and FASB Accounting Standards Codification Topic 815, Derivatives and Hedging . Warrants are classified as liabilities when the warrant terms allow settlement of the warrant exercise in cash and classified as equity when the warrant terms only allow settlement in shares of common stock. The terms of the 2022 pre-funded warrant and the 2022 stock purchase warrants include certain provisions related to fundamental transactions and a cashless exercise provision in the event registered shares are not available, and do not include any mandatory redemption provisions. Based on our evaluation, we concluded the 2022 pre-funded warrant and the 2022 stock purchase warrants should be classified as equity with no subsequent remeasurement as long as such warrants continue to be classified as equity. Warrant Exercises For the year ended December 31, 2022, warrants to purchase 11,663,387 shares of our common stock were exercised for net cash proceeds of approximately $ 15,163,000 . The warrants were issued in connection with an underwritten public offering of common stock and a pre-funded warrant, together with accompanying stock purchase warrants in May 2020. As of December 31, 2022, the pre-funded warrant to purchase 8,335,239 shares of our common stock was outstanding and stock purchase warrants to purchase 44,110,079 shares of our common stock associated with the May 2020 public offering remained outstanding. Sales Agreement On September 4, 2020, we entered into an At Market Issuance Sales Agreement, or the 2020 Sales Agreement, with B. Riley Securities, Inc., or B. Riley, 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 as our sales agent. We agreed to pay B. Riley 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 under the 2020 Sales Agreement. In connection with the 2020 Sales Agreement, we terminated the 2018 Sales Agreement. For the year ended December 31, 2021 , we sold an aggregate of 10,571,556 shares of our common stock pursuant to the 2020 Sales Agreement, resulting in net cash proceeds to us of approximately $ 20,385,000 , after deducting sales commissions and other offering expenses paid by us. No shares of our common stock were sold pursuant to the 2020 Sales Agreement for the year ended December 31, 2022. The 2020 Sales Agreement will expire upon the earlier of: (a) the sale of all common stock subject to the 2020 Sales Agreement, or (b) September 4, 2023. Equity Plans 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 stock options or stock purchase rights were made from the 2011 Plan. Stock options granted under the 2011 Plan expire no later than ten years from the date of grant. Stock 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 stock 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. 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 non-employee 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 Equity Incentive 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 Equity Incentive 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. In May 2022, May 2021 and June 2020, our stockholders approved amendments to our 2018 Equity Incentive Plan to increase the total number of shares issuable under such plan by 11,000,000 , 12,500,000 and 5,700,000 shares of our common stock, respectively. Stock options granted under the 2018 Plan expire no later than ten years from the date of grant. Stock 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 a stock 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 stock 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 stock options generally vest over a period of four years from the date of the stock option grant. Performance-based stock 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, stock options may be exercised prior to vesting, subject to our right to repurchase the shares underlying such stock 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 stock option. During 2022 and 2021, we did not repurchase any shares under the 2018 Plan. As of December 31, 2022, we have no shares outstanding subject to repurchase under the 2018 Plan. As of December 31, 2022, our Non‑Employee Director Compensation Policy adopted by our board of directors in March 2014 and amended and restated in February and March 2022 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 a stock option to purchase 200,000 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 stock option to purchase 125,000 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 stock 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 stock 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 our common stock to be used exclusively for grants of inducement awards to individuals who were not previously Geron employees or non-employee directors, other than following a bona fide period of non-employment. As of December 31, 2022, an aggregate total of 21,100,000 shares of common stock have been reserved under the Inducement Plan. 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 our stockholder-approved 2018 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 our common stock has been reserved for the Directors Market Plan. Under the Directors Market Plan, non-employee directors may purchase shares of our 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. For the years ended December 31, 2022, 2021 and 2020, we issued 15,962 , 20,783 , and 17,986 shares of common stock, respectively, from the Directors Market Plan. The weighted average grant date fair value of stock granted during the years ended December 31, 2022, 2021 and 2020 was $ 1.92 , $ 1.38 and $ 1.60 per share, respectively. The total fair value of vested stock grants during 2022, 2021 and 2020 was $ 29,000 , $ 29,000 and $ 29,000 , respectively. Aggregate stock option and award activity for the 2011 Plan, 2018 Plan, 2006 Directors Plan, Inducement Plan and Directors Market Plan is as follows: Outstanding Stock 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, 2021 18,763,393 49,952,409 $ 2.06 Additional shares authorized 16,755,000 — $ — Stock options granted ( 19,747,760 ) 19,747,760 $ 1.37 Awards granted ( 15,962 ) — $ — Stock options exercised — ( 1,181,711 ) $ 1.52 Stock options cancelled/forfeited/expired 2,616,058 ( 2,616,058 ) $ 1.70 Balance at December 31, 2022 18,370,729 65,902,400 (1) $ 1.87 6.56 $ 50,205 Stock options exercisable at 36,085,389 $ 2.17 5.09 $ 22,878 Stock options fully vested and expected 64,539,649 $ 1.88 6.52 $ 48,951 (1) Includes 8,791,750 performance-based stock options granted 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 $ 2.42 per share as of December 31, 2022, which would have been received by the option holders had all the option holders exercised their stock options as of that date. We have not granted any stock options with an exercise price below or greater than the fair market value of our common stock on the date of grant in 2022, 2021, and 2020. As of December 31, 2022, 2021 and 2020 , there were 36,085,389 , 30,459,136 and 25,721,508 exercisable stock options outstanding at weighted average exercise prices per share of $ 2.17 , $ 2.35 and $ 2.54 , respectively. The total pretax intrinsic value of stock options exercised during 2022, 2021, and 2020 was $ 787,000 , $ 93,000 and $ 17,000 , respectively. Cash received from the exercise of stock options in 2022, 2021, and 2020 totaled approximately $ 1,799,000 , $ 556,000 and $ 25,000 , 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. In May 2022, our stockholders approved an amendment to our 2014 Purchase Plan to increase the total number of shares issuable under such plan by 1,000,000 shares of our common stock, for an aggregate total reserve of 2,000,000 shares. As of December 31, 2022 , an aggregate of 868,236 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 our common stock on the employee’s entry date into that offering period or (ii) the fair market value per share of our common stock on the purchase date. If the fair market value per share of our 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 on the consolidated statements of operations for the years ended December 31, 2022, 2021 and 2020 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. In 2022 and 2021, our board of directors awarded 2,741,750 and 550,000 performance-based stock options, respectively, to certain employees. These performance-based stock options are included in the outstanding stock options table above. Performance-based stock options vest only upon achievement of discrete strategic milestones. Stock-based compensation expense for performance-based stock 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 achieved, if ever. None of the performance-based stock options have vested. 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 on our consolidated statements of operations for the years ended December 31, 2022, 2021 and 2020, 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 and employee stock purchases for the years ended December 31, 2022, 2021 and 2020 which was allocated as follows: Year Ended December 31, (In thousands) 2022 2021 2020 Research and development $ 3,720 $ 3,597 $ 2,337 General and administrative 4,281 4,483 4,558 Stock-based compensation expense $ 8,001 $ 8,080 $ 6,895 The fair value of stock options granted in 2022, 2021, and 2020 has been estimated at the date of grant using the Black Scholes option‑pricing model with the following assumptions: Year Ended December 31, 2022 2021 2020 Dividend yield 0 % 0 % 0 % Expected volatility range 0.772 to 0.817 0.775 to 0.783 0.781 to 0.793 Risk-free interest rate range 1.69 % to 4.57 % 0.51 % to 1.30 % 0.31 % to 1.62 % Expected term range 5.5 yrs 5.5 yrs 5.25 yrs The fair value of employee stock purchases in 2022, 2021, and 2020 has been estimated using the Black Scholes option‑pricing model with the following assumptions: Year Ended December 31, 2022 2021 2020 Dividend yield 0 % 0 % 0 % Expected volatility range 0.614 to 0.865 0.507 to 0.707 0.478 to 0.818 Risk-free interest rate range 0.40 % to 2.79 % 0.09 % to 0.16 % 0.16 % to 1.57 % Expected term range 6 - 12 mos 6 - 12 mos 6 - 12 mos Dividend yield is based on historical cash dividend payments and we have paid no cash dividends to date. The expected volatility range is based on historical volatilities of our stock, since traded options on our 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 stock options is derived from actual historical exercise and post‑vesting cancellation data and represents the period of time that stock 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, 2022, 2021 and 2020 was $ 0.92 , $ 1.17 and $ 0.88 per share, respectively. The weighted average estimated fair value of employees’ purchase rights for the years ended December 31, 2022, 2021 and 2020 was $ 0.48 , $ 0.56 and $ 0.62 per share, respectively. As of December 31, 2022 , 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 $ 17,791,000 , which is expected to be recognized over the next 26 months on a weighted‑average basis. Stock‑Based Compensation to Service Providers We grant stock options to consultants from time to time in exchange for services performed for us. In general, the stock options vest over the contractual period of the consulting arrangement. The fair value of stock options held by consultants is recorded as operating expenses over the vesting term of the respective equity awards. With the adoption of Accounting Standards Update 2018-07, Improvements to Nonemployee Share-Based Payment Accounting , or ASU 2018-07, in the first quarter of 2019, the measurement date of stock options granted to consultants was fixed at the grant date. We recorded stock‑based compensation expense of $ 235,000 , $ 62,000 and $ 56,000 for the vested portion of the fair value of stock options held by consultants in 2022, 2021, and 2020, respectively. Common Stock Reserved for Future Issuance Common stock reserved for future issuance as of December 31, 2022 is as follows: Outstanding stock options 65,902,400 Stock options and awards available for grant 18,370,729 Employee stock purchase plan 1,131,764 Warrants outstanding 106,254,842 Total 191,659,735 |
INCOME TAXES
INCOME TAXES | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
INCOME TAXES | 10. INCOME TAXES The following table reconciles the federal statutory tax rate to the effective income tax rate from continuing operations: 2022 2021 2020 Tax at statutory rate 21.0 % 21.0 % 21.0 % State income tax, net of federal benefit 6.8 9.0 6.9 Federal and state tax credits 4.9 5.7 5.3 Stock-based compensation ( 0.8 ) ( 1.2 ) ( 0.5 ) Net operating loss not benefitted ( 4.3 ) ( 5.4 ) ( 6.9 ) Other ( 0.1 ) ( 0.2 ) ( 0.3 ) Change in valuation allowance ( 27.5 ) ( 28.9 ) ( 25.5 ) Effective tax rate 0.0 % 0.0 % 0.0 % 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, 2022 2021 (In thousands) Net operating loss carryforwards $ 254,500 $ 241,300 Federal and state tax credits 56,700 49,600 Capitalized research and development 21,800 6,900 Stock-based compensation 10,800 10,200 Operating lease liabilities 1,300 1,400 Other 5,600 2,600 Total deferred tax assets 350,700 312,000 Less: valuation allowance ( 349,600 ) ( 310,700 ) Net deferred tax assets 1,100 1,300 Operating leases, right-of-use assets ( 1,100 ) ( 1,300 ) Total deferred tax liabilities ( 1,100 ) ( 1,300 ) Total 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 $ 38,900,000 and $ 33,500,000 for the years ended December 31, 2022 and 2021, respectively. As of December 31, 2022 , we had domestic federal net operating loss carryforwards of approximately $ 993,100,000 . Of this, $ 685,300,000 will expire at various dates beginning in 2023 through 2037 and the remaining will carryforward indefinitely under the new tax laws, but is subject to an 80% taxable income limitation for tax years beginning after 2020. As of December 31, 2022 , we had state net operating loss carryforwards of approximately $ 658,400,000 expiring at various dates beginning in 2028 through 2041, if not utilized. We also had federal tax credit carryforwards of approximately $ 62,700,000 expiring at various dates beginning in 2023 through 2042, if not utilized. Our state tax credit carryforwards of approximately $ 20,900,000 carry forward indefinitely. Utilization of net operating loss and tax credit carryforwards may be subject to an annual limitation due to ownership change limitations provided by the Internal Revenue Code and similar state provisions. Annual limitations may result in expiration of net operating loss and tax credit carryforwards before some or all of such amounts have been utilized. The impact of any limitations that may be imposed due to such ownership changes has not yet been determined. In March and December 2020, in response to the COVID-19 pandemic, the Coronavirus Aid, Relief and Economic Security Act, or the CARES Act, and the Consolidated Appropriations Act, 2021 were passed into law and provide additional economic stimulus to address the impact of the COVID-19 pandemic, including among other items, several U.S. income tax provisions related to, among other things, net operating loss carrybacks, alternative minimum tax credits, modifications to interest expense limitations, and an option to defer payroll tax payments for a limited period. In 2021, we assessed our eligibility to claim a refund of employer taxes available under the Employee Retention Credit provisions of the CARES Act. For the years ended December 31, 2022 and 2021, we calculated eligible credits of approximately $ 483,000 and $ 1,152,000 , respectively, provided by the CARES Act, which have been recognized as offsets to salaries costs in operating expenses in 2022 and 2021, respectively. As of December 31, 2022, the aggregate eligible credit amount has been accrued as a receivable on our consolidated balance sheets. 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, 2022 , we had approximately $ 23,700,000 of unrecognized tax benefits, none of which would currently affect our effective tax rate if recognized due to our net 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, 2021 $ 21,300 Decrease related to prior year tax positions — Increase related to current year tax positions 2,400 Balance as of December 31, 2022 $ 23,700 If applicable, we would classify interest and penalties related to uncertain tax positions in income tax expense. Through December 31, 2022, 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, 2023. 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. |
CONSOLIDATED STATEMENTS OF CA_2
CONSOLIDATED STATEMENTS OF CASH FLOWS DATA | 12 Months Ended |
Dec. 31, 2022 | |
Supplemental Cash Flow Elements [Abstract] | |
CONSOLIDATED STATEMENTS OF CASH FLOWS DATA | 11. CONSOLIDATED STATEMENTS OF CASH FLOWS DATA Year Ended December 31, 2022 2021 2020 (In thousands) Supplemental operating and investing activities: Net unrealized loss on $ ( 68 ) $ ( 251 ) $ ( 54 ) Reclassification between prepaid and other ( 5 ) — — Operating lease assets obtained in — — 3,575 Interest paid $ 5,154 $ 2,704 $ 388 |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 12 Months Ended |
Dec. 31, 2022 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENTS | 12. SUBSEQUENT EVENTS Public Offering On January 10, 2023, we completed an underwritten public offering of 68,007,741 shares of our common stock and a pre-funded warrant to purchase 25,000,000 shares of our common stock, or the 2023 pre-funded warrant. The net cash proceeds from this offering are approximately $ 213,300,000 , after deducting the underwriting discount and other offering expenses paid by us, and excludes any future proceeds from the exercise of the 2023 pre-funded warrant, which has not been exercised. Warrant Exercises From January 1, 2023 through March 9, 2023, we have received $ 46,716,000 in cash proceeds from the exercise of the 2020 purchase warrants, representing 35,935,577 shares of our common stock. From January 1, 2023 through March 9, 2023, we have received $ 13,119,000 in cash proceeds from the exercise of the 2022 purchase warrants, representing 9,047,617 shares of our common stock. |
ORGANIZATION AND SUMMARY OF S_2
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Principles of Consolidation | Principles of Consolidation The consolidated financial statements include the accounts of Geron and our wholly-owned subsidiary, Geron UK Limited, or Geron UK, a United Kingdom company. Geron UK was incorporated in September 2021, and its operations commenced in January 2022. We have eliminated intercompany accounts and transactions. We prepare the financial statements of Geron UK using the local currency as the functional currency. We translate the assets and liabilities of Geron UK at rates of exchange at the balance sheet date and translate income and expense items at average monthly rates of exchange. The resultant translation adjustments are included in accumulated other comprehensive income (loss), a separate component of stockholders’ equity, on our consolidated balance sheets. |
Net Loss Per Share | Net Loss Per Share Basic net income (loss) per share is calculated by dividing net income (loss) by the weighted-average number of shares of common stock outstanding for the periods presented without consideration of potential common shares. In April 2022, we entered into an underwriting agreement in connection with a public offering of our common stock, pursuant to which we issued a pre-funded warrant to purchase 18,095,238 shares of our common stock, also known as the 2022 pre-funded warrant, together with accompanying warrants to purchase shares of our common stock. In May 2020, we entered into an underwriting agreement in connection with a public offering of our common stock, pursuant to which we issued a pre-funded warrant to purchase 8,335,239 shares of our common stock, or the 2020 pre-funded warrant, together with accompanying warrants to purchase shares of our common stock. The 2022 pre-funded warrant and 2020 pre-funded warrant each are exercisable immediately at an exercise price of $ 0.001 per share. We included the 2022 pre-funded warrant and 2020 pre-funded warrant in the computation of basic net loss per share, as applicable, since their exercise price is negligible, and they may be exercised at any time. See Note 9 on Stockholders' Equity for further discussion of the April 2022 public offering. Diluted net income per share would be calculated by adjusting the weighted-average number of shares of common stock outstanding for the dilutive effect of additional shares of common stock that would have been outstanding if potentially dilutive securities had been issued, as determined using the treasury-stock method. Potential dilutive securities consist of outstanding stock options and warrants to purchase our common stock. Diluted net loss per share excludes potential dilutive securities for all periods presented as their effect would be anti-dilutive. Accordingly, basic and diluted net loss per share is the same for all periods presented in the accompanying consolidated statements of operations. Since we incurred a net loss for 2022, 2021, and 2020 , the diluted net loss per share calculation excludes potential dilutive securities of 145,726,765 , 105,725,875 and 101,881,391 shares, respectively, related to outstanding stock options and warrants as their effect would have been anti-dilutive. |
Use of Estimates | Use of Estimates The accompanying consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States, or U.S. GAAP. The preparation of financial statements in conformity with U.S. 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, operating leases, right-of-use assets, lease liabilities, 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. Treasury securities, municipal securities, 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 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 income on our consolidated 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 income. We have not recorded any other‑than‑temporary impairment charges on our available‑for‑sale securities for the years ended December 31, 2022, 2021 and 2020. See Note 2 on Fair Value Measurements. Equity Investments We measure our investment in equity securities at fair value at each reporting date. Changes in fair value resulting from observable price changes are included in change in fair value of equity investment and changes in fair value resulting from foreign currency translation are included in other expense on our consolidated statements of operations. |
Leases | Leases At the inception of an arrangement, we determine whether the arrangement is or contains a lease based on the unique facts and circumstances present. Operating leases are included in operating leases, right-of-use assets and lease liabilities on our consolidated balance sheets. Right-of-use assets represent our right to use an underlying asset for the lease term and lease liabilities represent our obligation to make lease payments arising from the lease. Operating lease liabilities and their corresponding right-of-use assets are recorded based on the present value of remaining lease payments over the expected lease term. The present value of remaining lease payments within the 12 months following the balance sheet date are classified as current lease liabilities. The present value of lease payments not within the 12 months following the balance sheet date are classified as noncurrent lease liabilities. The interest rate implicit in lease contracts is typically not readily determinable. As such, to calculate the net present value of lease payments, we apply our incremental borrowing rate, which is the estimated rate to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment as of the lease commencement date. We may adjust the right-of-use assets for certain adjustments, such as initial direct costs paid or incentives received. In addition, we include any options to extend or terminate the lease in the expected lease term when it is reasonably certain that we will exercise any such option. Lease expense is recognized on a straight-line basis over the expected lease term. For lease agreements entered into after January 1, 2019 that include lease and non-lease components, such components are generally accounted for separately. We have also elected not to recognize on our consolidated balance sheets leases with terms of one year or less. |
Debt Issuance Costs and Debt Discounts | Debt Issuance Costs and Debt Discounts Debt issuance costs include legal fees, accounting fees, and other direct costs incurred in connection with the execution of our debt financing. Debt discounts represent costs paid to the lenders. Debt issuance costs and debt discounts are deducted from the carrying amount of the debt liability and are amortized to interest expense over the term of the related debt using the effective interest method. |
Revenue Recognition | Revenue Recognition We recognize revenue in accordance with the provisions of Accounting Standards Codification Topic 606, Revenue from Contracts with Customers, or Topic 606. In determining the appropriate amount and timing of revenue to be recognized under this guidance, we perform the following five steps: (i) identify the contract(s) with our customer; (ii) identify the promised goods or services in the agreement and determine whether they are performance obligations, including whether they are distinct in the context of the agreement; (iii) measure the transaction price, including the constraint on variable consideration; (iv) allocate the transaction price to the performance obligations based on stand-alone selling prices; and (v) recognize revenue when (or as) we satisfy each performance obligation. 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 Agreements In connection with the divestiture of Geron’s human embryonic stem cell assets, including intellectual property and proprietary technology, to Lineage Cell Therapeutics, Inc. (formerly BioTime, Inc. which acquired Asterias Biotherapeutics, Inc.) in 2013, we are entitled to receive royalties on sales of certain research or commercial products utilizing Geron’s divested intellectual property. 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 date, 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. For example, 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 date, we assess the probability of achievement of each milestone under any 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 date, we estimate the sales incurred by each licensee during the reporting period based on historical experience and accrue the associated royalty amount. |
Restricted Cash | Restricted Cash Restricted cash consists of funds maintained in separate money market or certificate of deposit accounts for credit card purchases. |
Research and Development Expenses | Research and Development Expenses Research and development expenses currently consist of expenses incurred in developing and testing imetelstat and research related to potential next generation telomerase inhibitors. These expenses include, but are not limited to, payroll and personnel expense, lab supplies, non-clinical studies, clinical trials, including support for investigator-led 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 and research-related overhead. Our current imetelstat clinical trials are being supported by contract research organizations, or CROs, and other vendors. We accrue expenses for clinical trial activities performed by CROs based upon the estimated amount of work completed on each trial. For clinical trial expenses and related expenses associated with the conduct of clinical trials, the significant factors used in estimating accruals include the number of patients enrolled, the number of active clinical sites, and the duration for which the patients have been enrolled in the trial. We monitor patient enrollment levels and related activities to the extent possible through internal reviews, review of contractual terms and correspondence with CROs. We base our estimates on the best information available at the time. However, additional information may become available to us which will allow us to make a more accurate estimate in future periods. In that 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 can be granted to employees, non-employee directors and consultants. We also have an employee stock purchase plan for all eligible employees. We recognize stock-based compensation expense based on grant-date fair values of service-based stock options 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 the assessment of probability of the performance condition changes, the impact of the change in estimate would be recognized in the period of the change. The determination of grant-date fair values for our service-based and performance-based stock options and employee stock purchases using the Black Scholes option pricing model is affected by our stock price as well as assumptions regarding a number of complex and subjective variables. The grant-date fair value for service-based restricted stock awards is determined using the fair value of our common stock on the date of grant. We evaluate whether an adjustment to the assumptions of fair value of our common stock and historical volatility are required if observed prices of our common stock materially differ from historical information. We measure share-based payments to non-employees based on the grant-date fair value of the equity awards to be issued. We recognize stock-based compensation expense for the fair value of the vested portion of non-employee stock-based awards on our consolidated statements of operations. For additional information, see Note 9 on Stockholders’ Equity. |
Accumulated Other Comprehensive Gain (Loss) | Accumulated Other Comprehensive Gain (Loss) Accumulated other comprehensive gain (loss) includes certain changes in stockholders’ equity which are excluded from net income (loss). Accumulated other comprehensive loss on our consolidated balance sheets as of December 31, 2022 and 2021 , respectively, is comprised of net unrealized losses on marketable securities and cumulative translation adjustments. |
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, federal and state tax 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. |
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 – Issued But Not Yet Adopted In June 2016, the FASB issued ASU 2016-13, Measurement of Credit Losses on Financial Instruments , or ASU 2016-13. The main objective of ASU 2016-13 is to provide financial statement users with more decision-useful information about an entity's expected credit losses on financial instruments and other commitments to extend credit at each reporting date. To achieve this objective, the amendments in this update replace the incurred loss impairment methodology currently used today with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to develop credit loss estimates. Subsequent to issuing ASU 2016-13, the FASB issued ASU 2018-19, Codification Improvements to Topic 326, Financial Instruments – Credit Losses , or ASU 2018-19, for the purpose of clarifying certain aspects of ASU 2016-13. In May 2019, the FASB issued ASU 2019-05, Financial Instruments – Credit Losses (Topic 326): Targeted Transition Relief , or ASU 2019-05, to provide entities with more flexibility in applying the fair value option on adoption of the credit impairment standard. In November 2019, the FASB issued ASU 2019-11, Codification Improvements to Topic 326, Financial Instruments – Credit Losses , which expands the scope of the practical expedient that allows entities to exclude the accrued interest component of amortized cost from various disclosure. Entities that elect to apply the practical expedient must disclose the total amount of accrued interest that they exclude from their disclosures of amortized cost. ASU 2018-19, ASU 2019-05 and ASU 2019-11 have the same effective date and transition requirements as ASU 2016-13. ASU 2016-13 will be effective for fiscal years beginning after December 15, 2022, using a modified retrospective approach, for smaller reporting companies. Early adoption is permitted. We plan to adopt ASU 2016-13 and related updates as of January 1, 2023. We do not expect the adoption of this standard to have a material impact on our financial statements. In August 2020, the FASB issued ASU 2020-06, Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity , or ASU 2020-06. The key elements of ASU 2020-06 aim to reduce unnecessary complexity in GAAP for certain financial instruments with characteristics of liabilities and equity. In addressing the complexity, the FASB focused on amending the guidance on convertible instruments and the guidance on the derivatives scope exception for contracts in an entity’s own equity. For convertible instruments, the FASB decided to reduce the number of accounting models for convertible debt instruments and convertible preferred stock. For contracts in an entity’s own equity, the FASB observed that the application of the derivatives scope exception guidance results in accounting for some contracts as derivatives while accounting for economically similar contracts as equity. The FASB also decided to improve and amend the related earnings per share guidance. ASU 2020-06 is effective for fiscal years beginning after December 15, 2021, and interim periods within those fiscal years for public business entities that are not smaller reporting companies. For all other entities, ASU 2020-06 is effective for fiscal years beginning after December 15, 2023, and interim periods within those fiscal years. We plan to adopt ASU 2020-06 as of January 1, 2024. We do not expect the adoption of this standard to have a material impact on our financial statements. Other recent accounting pronouncements issued by the FASB did not or are not believed by management to have a material impact on our financial statements. |
FAIR VALUE MEASUREMENTS (Tables
FAIR VALUE MEASUREMENTS (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
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, 2022 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 $ 39,771 $ — $ — $ 39,771 $ 39,771 $ — $ — $ 39,771 Restricted cash: Money market fund $ 93 $ — $ — $ 93 Certificate of deposit 271 — — 271 $ 364 $ — $ — $ 364 Marketable securities: U.S. Treasury securities (due in $ 12,983 $ — $ ( 62 ) $ 12,921 Municipal securities (due in less than one year) 3,000 — ( 24 ) 2,976 Government-sponsored enterprise securities 9,860 — ( 14 ) 9,846 Commercial paper (due in less than one year) 64,285 6 ( 92 ) 64,199 Corporate notes (due in less than one year) 26,014 — ( 55 ) 25,959 $ 116,142 $ 6 $ ( 247 ) $ 115,901 Cash equivalents, restricted cash and marketable securities by security type at December 31, 2021 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 $ 24,207 $ — $ — $ 24,207 Commercial paper 7,499 — — 7,499 $ 31,706 $ — $ — $ 31,706 Restricted cash: Money market fund $ 93 $ — $ — $ 93 Certificate of deposit 271 — — 271 $ 364 $ — $ — $ 364 Marketable securities: U.S. Treasury securities (due in $ 15,585 $ — $ ( 18 ) $ 15,567 U.S. Treasury securities (due in 1,524 — ( 3 ) 1,521 Municipal securities (due in 3,000 — ( 15 ) 2,985 Government-sponsored enterprise securities 12,500 — ( 7 ) 12,493 Commercial paper (due in less than one year) 84,398 2 ( 38 ) 84,362 Corporate notes (due in less than one year) 36,444 2 ( 17 ) 36,429 Corporate notes (due in one to two years) 24,224 — ( 79 ) 24,145 $ 177,675 $ 4 $ ( 177 ) $ 177,502 |
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, 2022 and 2021 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, 2022: U.S. Treasury $ 11,424 $ ( 57 ) $ 1,497 $ ( 5 ) $ 12,921 $ ( 62 ) Municipal securities — — 2,976 ( 24 ) 2,976 ( 24 ) Government-sponsored 9,845 ( 14 ) — — 9,845 ( 14 ) Commercial paper 52,454 ( 92 ) — — 52,454 ( 92 ) Corporate notes (due in 1,998 ( 2 ) 23,962 ( 53 ) 25,960 ( 55 ) $ 75,721 $ ( 165 ) $ 28,435 $ ( 82 ) $ 104,156 $ ( 247 ) As of December 31, 2021: U.S. Treasury $ 15,567 $ ( 18 ) $ — $ — $ 15,567 $ ( 18 ) U.S. Treasury 1,521 ( 3 ) — — 1,521 ( 3 ) Municipal securities 2,985 ( 15 ) — — 2,985 ( 15 ) Government-sponsored 1,500 — 4,993 ( 7 ) 6,493 ( 7 ) Commercial paper 66,872 ( 38 ) — — 66,872 ( 38 ) Corporate notes (due in 16,001 ( 17 ) — — 16,001 ( 17 ) Corporate notes (due in 24,145 ( 79 ) — — 24,145 ( 79 ) $ 128,591 $ ( 170 ) $ 4,993 $ ( 7 ) $ 133,584 $ ( 177 ) |
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, 2022 and 2021 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, 2022: Money market funds (1)(2) $ 39,864 $ — $ — $ 39,864 Certificate of deposit (2) 271 — — 271 U.S. Treasury securities (3) — 12,921 — 12,921 Municipal securities (3) — 2,976 — 2,976 Government-sponsored enterprise securities (3) — 9,846 — 9,846 Commercial paper (3) — 64,199 — 64,199 Corporate notes (3) — 25,959 — 25,959 Total $ 40,135 $ 115,901 $ — $ 156,036 As of December 31, 2021: Money market funds (1) $ 24,207 $ — $ — $ 24,207 U.S. Treasury securities (3)(4) — 17,088 — 17,088 Municipal securities (4) — 2,985 — 2,985 Government-sponsored enterprise securities (3) — 12,493 — 12,493 Commercial paper (1)(3) — 91,861 — 91,861 Corporate notes (3)(4) — 60,574 — 60,574 Total $ 24,207 $ 185,001 $ — $ 209,208 (1) Included in cash and cash equivalents on our consolidated balance sheets. (2) Included in restricted cash on our consolidated balance sheets. (3) Included in current portion of marketable securities on our consolidated balance sheets. (4) Included in noncurrent portion of marketable securities on our consolidated balance sheets. |
PROPERTY AND EQUIPMENT (Tables)
PROPERTY AND EQUIPMENT (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
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) 2022 2021 Furniture and computer equipment $ 1,554 $ 1,171 Leasehold improvements 135 129 1,689 1,300 Less accumulated depreciation and amortization ( 896 ) ( 650 ) $ 793 $ 650 |
ACCRUED LIABILITIES (Tables)
ACCRUED LIABILITIES (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Payables and Accruals [Abstract] | |
Schedule of accrued liabilities | December 31, (In thousands) 2022 2021 CRO and clinical trial costs $ 17,040 $ 22,804 Manufacturing activities 5,321 4,123 Professional legal and accounting fees 9,668 2,030 Interest payable 561 336 Other 510 541 $ 33,100 $ 29,834 |
OPERATING LEASES (Tables)
OPERATING LEASES (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Leases [Abstract] | |
Components of lease costs | The components of lease costs included in operating expenses on our consolidated statements of operations for the New Jersey Lease, the Foster City Lease and a lease from a former location in Menlo Park, California, were as follows: Year Ended December 31, (In thousands) 2022 2021 2020 Operating lease costs $ 944 $ 946 $ 1,143 Variable lease costs (1) 310 252 293 Total lease costs $ 1,254 $ 1,198 $ 1,436 (1) Variable lease costs represent non-lease components, such as common area maintenance charges. |
Undiscounted future non-cancellable lease payments | The undiscounted future non-cancellable lease payments under the New Jersey Lease and the Foster City Lease as of December 31, 2022 were as follows (in thousands): 2023 $ 962 2024 987 2025 1,014 2026 1,040 2027 717 Thereafter 1,050 Total lease payments 5,770 Less: imputed interest ( 1,174 ) Total $ 4,596 |
DEBT (Tables)
DEBT (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Debt Disclosure [Abstract] | |
Future Minimum Payments Under Term Loan Facility | The following table presents future minimum payments, including interest and the end of term charge, under the Term Loan as of December 31, 2022 (in thousands): 2023 $ 26,843 2024 34,160 Total 61,003 Less: amount representing interest ( 7,728 ) Less: unamortized debt discount and issuance costs ( 628 ) Less: unamortized end of term charge ( 1,490 ) Less: current portion of debt ( 20,945 ) Noncurrent portion of debt $ 30,212 |
STOCKHOLDERS' EQUITY (Tables)
STOCKHOLDERS' EQUITY (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Stockholders' Equity Note [Abstract] | |
Schedule of aggregate stock option and award activity | Aggregate stock option and award activity for the 2011 Plan, 2018 Plan, 2006 Directors Plan, Inducement Plan and Directors Market Plan is as follows: Outstanding Stock 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, 2021 18,763,393 49,952,409 $ 2.06 Additional shares authorized 16,755,000 — $ — Stock options granted ( 19,747,760 ) 19,747,760 $ 1.37 Awards granted ( 15,962 ) — $ — Stock options exercised — ( 1,181,711 ) $ 1.52 Stock options cancelled/forfeited/expired 2,616,058 ( 2,616,058 ) $ 1.70 Balance at December 31, 2022 18,370,729 65,902,400 (1) $ 1.87 6.56 $ 50,205 Stock options exercisable at 36,085,389 $ 2.17 5.09 $ 22,878 Stock options fully vested and expected 64,539,649 $ 1.88 6.52 $ 48,951 (1) Includes 8,791,750 performance-based stock options granted that have not achieved certain strategic milestones. |
Summary of allocation of stock-based compensation expense related to share-based payment awards | 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 on our consolidated statements of operations for the years ended December 31, 2022, 2021 and 2020, 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 and employee stock purchases for the years ended December 31, 2022, 2021 and 2020 which was allocated as follows: Year Ended December 31, (In thousands) 2022 2021 2020 Research and development $ 3,720 $ 3,597 $ 2,337 General and administrative 4,281 4,483 4,558 Stock-based compensation expense $ 8,001 $ 8,080 $ 6,895 |
Schedule of assumptions used to estimate the fair value of stock options granted | The fair value of stock options granted in 2022, 2021, and 2020 has been estimated at the date of grant using the Black Scholes option‑pricing model with the following assumptions: Year Ended December 31, 2022 2021 2020 Dividend yield 0 % 0 % 0 % Expected volatility range 0.772 to 0.817 0.775 to 0.783 0.781 to 0.793 Risk-free interest rate range 1.69 % to 4.57 % 0.51 % to 1.30 % 0.31 % to 1.62 % Expected term range 5.5 yrs 5.5 yrs 5.25 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 2022, 2021, and 2020 has been estimated using the Black Scholes option‑pricing model with the following assumptions: Year Ended December 31, 2022 2021 2020 Dividend yield 0 % 0 % 0 % Expected volatility range 0.614 to 0.865 0.507 to 0.707 0.478 to 0.818 Risk-free interest rate range 0.40 % to 2.79 % 0.09 % to 0.16 % 0.16 % to 1.57 % 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, 2022 is as follows: Outstanding stock options 65,902,400 Stock options and awards available for grant 18,370,729 Employee stock purchase plan 1,131,764 Warrants outstanding 106,254,842 Total 191,659,735 |
INCOME TAXES (Tables)
INCOME TAXES (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Schedule reconciles the federal statutory tax rate to the effective income tax rate from continuing operations | The following table reconciles the federal statutory tax rate to the effective income tax rate from continuing operations: 2022 2021 2020 Tax at statutory rate 21.0 % 21.0 % 21.0 % State income tax, net of federal benefit 6.8 9.0 6.9 Federal and state tax credits 4.9 5.7 5.3 Stock-based compensation ( 0.8 ) ( 1.2 ) ( 0.5 ) Net operating loss not benefitted ( 4.3 ) ( 5.4 ) ( 6.9 ) Other ( 0.1 ) ( 0.2 ) ( 0.3 ) Change in valuation allowance ( 27.5 ) ( 28.9 ) ( 25.5 ) Effective tax rate 0.0 % 0.0 % 0.0 % |
Schedule of significant components of the entity's deferred tax assets | Significant components of our deferred tax assets are as follows: December 31, 2022 2021 (In thousands) Net operating loss carryforwards $ 254,500 $ 241,300 Federal and state tax credits 56,700 49,600 Capitalized research and development 21,800 6,900 Stock-based compensation 10,800 10,200 Operating lease liabilities 1,300 1,400 Other 5,600 2,600 Total deferred tax assets 350,700 312,000 Less: valuation allowance ( 349,600 ) ( 310,700 ) Net deferred tax assets 1,100 1,300 Operating leases, right-of-use assets ( 1,100 ) ( 1,300 ) Total deferred tax liabilities ( 1,100 ) ( 1,300 ) Total 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, 2021 $ 21,300 Decrease related to prior year tax positions — Increase related to current year tax positions 2,400 Balance as of December 31, 2022 $ 23,700 |
CONSOLIDATED STATEMENTS OF CA_3
CONSOLIDATED STATEMENTS OF CASH FLOWS DATA (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Supplemental Cash Flow Elements [Abstract] | |
Supplemental schedule of non-cash operating and investing activities | Year Ended December 31, 2022 2021 2020 (In thousands) Supplemental operating and investing activities: Net unrealized loss on $ ( 68 ) $ ( 251 ) $ ( 54 ) Reclassification between prepaid and other ( 5 ) — — Operating lease assets obtained in — — 3,575 Interest paid $ 5,154 $ 2,704 $ 388 |
ORGANIZATION AND SUMMARY OF S_3
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - NET LOSS PER SHARE (Detail) - Pre-Funded Warrants - Public Offering of Common Stock and Warrants - $ / shares | Apr. 01, 2022 | May 27, 2020 |
Warrants to purchase common stock, shares | 18,095,238 | 8,335,239 |
Warrants exercise price | $ 0.001 | $ 0.001 |
ORGANIZATION AND SUMMARY OF S_4
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - NET LOSS PER SHARE (Detail1) - shares | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
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) | 145,726,765 | 105,725,875 | 101,881,391 |
ORGANIZATION AND SUMMARY OF S_5
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - USEFUL LIVES OF ASSETS (Details) | 12 Months Ended |
Dec. 31, 2022 | |
Depreciation [Abstract] | |
Estimated useful lives of assets | 4 years |
FAIR VALUE MEASUREMENTS - SECUR
FAIR VALUE MEASUREMENTS - SECURITY TYPE (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Included in cash and cash equivalents: | ||
Amortized Cost | $ 39,771 | $ 31,706 |
Estimated Fair Value | 39,771 | 31,706 |
Restricted cash: | ||
Amortized Cost | 364 | 364 |
Estimated Fair Value | 364 | 364 |
Marketable securities: | ||
Amortized Cost | 116,142 | 177,675 |
Gross Unrealized Gains | 6 | 4 |
Gross Unrealized Losses | (247) | (177) |
Estimated Fair Value | 115,901 | 177,502 |
Money market funds | ||
Included in cash and cash equivalents: | ||
Amortized Cost | 39,771 | 24,207 |
Estimated Fair Value | 39,771 | 24,207 |
Restricted cash: | ||
Amortized Cost | 93 | 93 |
Estimated Fair Value | 93 | 93 |
Commercial paper | ||
Included in cash and cash equivalents: | ||
Amortized Cost | 7,499 | |
Estimated Fair Value | 7,499 | |
Certificate of deposit | ||
Restricted cash: | ||
Amortized Cost | 271 | 271 |
Estimated Fair Value | 271 | 271 |
U.S. Treasury securities (due in less than one year) | ||
Marketable securities: | ||
Amortized Cost | 12,983 | 15,585 |
Gross Unrealized Losses | (62) | (18) |
Estimated Fair Value | 12,921 | 15,567 |
U.S. Treasury securities (due in one to two years) | ||
Marketable securities: | ||
Amortized Cost | 1,524 | |
Gross Unrealized Losses | (3) | |
Estimated Fair Value | 1,521 | |
Municipal securities (due in less than one year) | ||
Marketable securities: | ||
Amortized Cost | 3,000 | |
Gross Unrealized Losses | (24) | |
Estimated Fair Value | 2,976 | |
Municipal securities (due in one to two years) | ||
Marketable securities: | ||
Amortized Cost | 3,000 | |
Gross Unrealized Losses | (15) | |
Estimated Fair Value | 2,985 | |
Government-sponsored enterprise securities (due in less than one year) | ||
Marketable securities: | ||
Amortized Cost | 9,860 | 12,500 |
Gross Unrealized Losses | (14) | (7) |
Estimated Fair Value | 9,846 | 12,493 |
Commercial paper (due in less than one year) | ||
Marketable securities: | ||
Amortized Cost | 64,285 | 84,398 |
Gross Unrealized Gains | 6 | 2 |
Gross Unrealized Losses | (92) | (38) |
Estimated Fair Value | 64,199 | 84,362 |
Corporate notes (due in less than one year) | ||
Marketable securities: | ||
Amortized Cost | 26,014 | 36,444 |
Gross Unrealized Gains | 2 | |
Gross Unrealized Losses | (55) | (17) |
Estimated Fair Value | $ 25,959 | 36,429 |
Corporate notes (due in one to two years) | ||
Marketable securities: | ||
Amortized Cost | 24,224 | |
Gross Unrealized Losses | (79) | |
Estimated Fair Value | $ 24,145 |
FAIR VALUE MEASUREMENTS - SEC_2
FAIR VALUE MEASUREMENTS - SECURITIES WITH UNREALIZED LOSSES (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Schedule Of Available For Sale Securities [Line Items] | ||
Less Than 12 Months - Estimated Fair Value | $ 75,721 | $ 128,591 |
Less Than 12 Months - Gross Unrealized Losses | (165) | (170) |
12 Months or Greater - Estimated Fair Value | 28,435 | 4,993 |
12 Months or Greater - Gross Unrealized Losses | (82) | (7) |
Total - Estimated Fair Value | 104,156 | 133,584 |
Total - Gross Unrealized Losses | (247) | (177) |
U.S. Treasury securities (due in less than one year) | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Less Than 12 Months - Estimated Fair Value | 11,424 | 15,567 |
Less Than 12 Months - Gross Unrealized Losses | (57) | (18) |
12 Months or Greater - Estimated Fair Value | 1,497 | |
12 Months or Greater - Gross Unrealized Losses | (5) | |
Total - Estimated Fair Value | 12,921 | 15,567 |
Total - Gross Unrealized Losses | (62) | (18) |
U.S. Treasury securities (due in one to two years) | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Less Than 12 Months - Estimated Fair Value | 1,521 | |
Less Than 12 Months - Gross Unrealized Losses | (3) | |
Total - Estimated Fair Value | 1,521 | |
Total - Gross Unrealized Losses | (3) | |
Municipal securities (due in less than a year) | ||
Schedule Of Available For Sale Securities [Line Items] | ||
12 Months or Greater - Estimated Fair Value | 2,976 | |
12 Months or Greater - Gross Unrealized Losses | (24) | |
Total - Estimated Fair Value | 2,976 | |
Total - Gross Unrealized Losses | (24) | |
Municipal securities (due in one to two years) | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Less Than 12 Months - Estimated Fair Value | 2,985 | |
Less Than 12 Months - Gross Unrealized Losses | (15) | |
Total - Estimated Fair Value | 2,985 | |
Total - Gross Unrealized Losses | (15) | |
Government-sponsored enterprise securities (due in less than one year) | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Less Than 12 Months - Estimated Fair Value | 9,845 | 1,500 |
Less Than 12 Months - Gross Unrealized Losses | (14) | |
12 Months or Greater - Estimated Fair Value | 4,993 | |
12 Months or Greater - Gross Unrealized Losses | (7) | |
Total - Estimated Fair Value | 9,845 | 6,493 |
Total - Gross Unrealized Losses | (14) | (7) |
Commercial paper (due in less than one year) | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Less Than 12 Months - Estimated Fair Value | 52,454 | 66,872 |
Less Than 12 Months - Gross Unrealized Losses | (92) | (38) |
Total - Estimated Fair Value | 52,454 | 66,872 |
Total - Gross Unrealized Losses | (92) | (38) |
Corporate notes (due in less than one year) | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Less Than 12 Months - Estimated Fair Value | 1,998 | 16,001 |
Less Than 12 Months - Gross Unrealized Losses | (2) | (17) |
12 Months or Greater - Estimated Fair Value | 23,962 | |
12 Months or Greater - Gross Unrealized Losses | (53) | |
Total - Estimated Fair Value | 25,960 | 16,001 |
Total - Gross Unrealized Losses | $ (55) | (17) |
Corporate notes (due in one to two years) | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Less Than 12 Months - Estimated Fair Value | 24,145 | |
Less Than 12 Months - Gross Unrealized Losses | (79) | |
Total - Estimated Fair Value | 24,145 | |
Total - Gross Unrealized Losses | $ (79) |
FAIR VALUE MEASUREMENTS - RECUR
FAIR VALUE MEASUREMENTS - RECURRING BASIS (Details) - Recurring basis - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Fair Value on a Recurring Basis | ||
Total | $ 156,036 | $ 209,208 |
Money market funds | ||
Fair Value on a Recurring Basis | ||
Total | 39,864 | 24,207 |
Certificate of deposit | ||
Fair Value on a Recurring Basis | ||
Total | 271 | |
U.S. Treasury securities | ||
Fair Value on a Recurring Basis | ||
Total | 12,921 | 17,088 |
Municipal securities | ||
Fair Value on a Recurring Basis | ||
Total | 2,976 | 2,985 |
Government-sponsored enterprise securities | ||
Fair Value on a Recurring Basis | ||
Total | 9,846 | 12,493 |
Commercial paper | ||
Fair Value on a Recurring Basis | ||
Total | 64,199 | 91,861 |
Corporate notes | ||
Fair Value on a Recurring Basis | ||
Total | 25,959 | 60,574 |
Level 1 | ||
Fair Value on a Recurring Basis | ||
Total | 40,135 | 24,207 |
Level 1 | Money market funds | ||
Fair Value on a Recurring Basis | ||
Total | 39,864 | 24,207 |
Level 1 | Certificate of deposit | ||
Fair Value on a Recurring Basis | ||
Total | 271 | |
Level 2 | ||
Fair Value on a Recurring Basis | ||
Total | 115,901 | 185,001 |
Level 2 | U.S. Treasury securities | ||
Fair Value on a Recurring Basis | ||
Total | 12,921 | 17,088 |
Level 2 | Municipal securities | ||
Fair Value on a Recurring Basis | ||
Total | 2,976 | 2,985 |
Level 2 | Government-sponsored enterprise securities | ||
Fair Value on a Recurring Basis | ||
Total | 9,846 | 12,493 |
Level 2 | Commercial paper | ||
Fair Value on a Recurring Basis | ||
Total | 64,199 | 91,861 |
Level 2 | Corporate notes | ||
Fair Value on a Recurring Basis | ||
Total | $ 25,959 | $ 60,574 |
FAIR VALUE MEASUREMENTS - EQUIT
FAIR VALUE MEASUREMENTS - EQUITY INVESTMENT (Details) - USD ($) | 3 Months Ended | ||
Aug. 03, 2020 | Mar. 31, 2021 | Dec. 31, 2007 | |
Equity Investments [Line Item] | |||
Number of shares owned | 35,990,825 | 0 | 13,842,625 |
Business Combination Cost Of Acquired Entity Equity Interests Issued And Issuable Fair Value Method | we received 13 BARD1 shares for every five shares of Sienna ordinary shares, resulting in our ownership of 35,990,825 shares of BARD1. | ||
Realized investment gains (losses) | $ 1,233,000 | ||
Maximum | |||
Equity Investments [Line Item] | |||
Cost method investments ownership percentage | 20% | ||
Equity investment | |||
Equity Investments [Line Item] | |||
Cost method investments cost basis | $ 0 |
FAIR VALUE MEASUREMENTS - CREDI
FAIR VALUE MEASUREMENTS - CREDIT RISK (Details) | Dec. 31, 2022 Institution |
Credit Risk | |
Number of financial institutions | 5 |
PROPERTY AND EQUIPMENT (Details
PROPERTY AND EQUIPMENT (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | $ 1,689 | $ 1,300 |
Less accumulated depreciation and amortization | (896) | (650) |
Property and equipment, net | 793 | 650 |
Furniture and computer equipment | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 1,554 | 1,171 |
Leasehold improvements | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | $ 135 | $ 129 |
ACCRUED LIABILITIES (Details)
ACCRUED LIABILITIES (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Payables and Accruals [Abstract] | ||
CRO and clinical trial costs | $ 17,040 | $ 22,804 |
Manufacturing activities | 5,321 | 4,123 |
Professional legal and accounting fees | 9,668 | 2,030 |
Interest payable | 561 | 336 |
Other | 510 | 541 |
Accrued liabilities | $ 33,100 | $ 29,834 |
COMMITMENTS AND CONTINGENCIES -
COMMITMENTS AND CONTINGENCIES - Litigation Settlement (Details) - Insurance Claims - USD ($) | 12 Months Ended | ||
Dec. 21, 2022 | Sep. 02, 2022 | Dec. 31, 2022 | |
Class Action Stipulation | |||
Loss Contingencies [Line Items] | |||
Settlement agreement date | September 2, 2022 | ||
Litigation settlement, amount | $ 24,000,000 | ||
Settlement to be paid by insurers | 17,000,000 | ||
Settlement to be paid in cash or shares as elected by company | $ 7,000,000 | ||
Litigation settlement amount, Accrued liabilities recognized | $ 7,000,000 | ||
Settlement amount, General and administrative expense recognized | 7,000,000 | ||
Derivative Stipulation | |||
Loss Contingencies [Line Items] | |||
Settlement agreement date | December 21, 2022 | ||
Litigation settlement, amount | $ 1,350,000 | ||
Settlement to be paid by insurers | 525,000 | ||
Litigation settlement amount, Accrued liabilities recognized | 1,350,000 | ||
Settlement amount, Interest and other receivable recognized | 525,000 | ||
Settlement amount, General and administrative expense recognized | $ 825,000 | ||
Settlement amount to be paid | $ 825,000 |
COMMITMENTS AND CONTINGENCIES_2
COMMITMENTS AND CONTINGENCIES - Severance Plan (Details) | 12 Months Ended |
Dec. 31, 2022 | |
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 | 3 months |
Maximum | |
Severance Plan | |
Period of base salary to be considered for severance payments | 18 months |
OPERATING LEASES (Details)
OPERATING LEASES (Details) - USD ($) | Mar. 10, 2020 | Oct. 01, 2019 | Apr. 30, 2019 | Dec. 31, 2022 | Dec. 31, 2021 | Oct. 31, 2019 |
Lessee Lease Description [Line Items] | ||||||
Operating Lease, Right-of-Use Asset | $ 4,147,000 | $ 4,727,000 | ||||
New Jersey Office Space Lease | ||||||
Lessee Lease Description [Line Items] | ||||||
Operating Lease, Percentage of Discount Rate | 8% | |||||
Operating Lease, Right-of-Use Asset | $ 2,356,000 | |||||
Operating Lease, Liability | $ 2,356,000 | |||||
Operating lease, initial term | 11 years | 11 years | ||||
Operating lease term, option to extend additional period | 5 years | |||||
Operating lease term, option to terminate lease | one-time option to terminate the New Jersey Lease without cause as of the 103rd month anniversary of the commencement date of the lease | |||||
Operating lease, rent abatement period | 7 months | |||||
Operating lease,remaining lease term | 7 years 9 months 18 days | |||||
Foster City Office Space Lease | ||||||
Lessee Lease Description [Line Items] | ||||||
Operating Lease, Percentage of Discount Rate | 7% | |||||
Operating Lease, Right-of-Use Asset | $ 3,426,000 | |||||
Operating Lease, Liability | $ 3,426,000 | |||||
Operating lease, initial term | 87 months | 87 months | ||||
Operating lease term, option to extend additional period | 5 years | |||||
Operating lease, rent abatement period | 3 months | |||||
Operating lease,remaining lease term | 4 years 6 months |
OPERATING LEASES - COMPONENTS O
OPERATING LEASES - COMPONENTS OF LEASE COSTS (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Lease Cost | |||
Operating lease costs | $ 944 | $ 946 | $ 1,143 |
Variable lease costs | 310 | 252 | 293 |
Total lease costs | $ 1,254 | $ 1,198 | $ 1,436 |
OPERATING LEASES - UNDISCOUNTED
OPERATING LEASES - UNDISCOUNTED FUTURE NON-CANCELLABLE LEASE PAYMENTS (Details) - New Jersey Lease And Foster City Lease $ in Thousands | Dec. 31, 2022 USD ($) |
Operating Lease Liabilities, Payments Due | |
2023 | $ 962 |
2024 | 987 |
2025 | 1,014 |
2026 | 1,040 |
2027 | 717 |
Thereafter | 1,050 |
Total lease payments | 5,770 |
Less: imputed interest | (1,174) |
Operating Lease, Liability | $ 4,596 |
DEBT - Additional Information (
DEBT - Additional Information (Details) - USD ($) | 9 Months Ended | 12 Months Ended | |||
Jun. 30, 2022 | Jun. 01, 2022 | Sep. 30, 2020 | Dec. 31, 2022 | Mar. 10, 2023 | |
Hercules and Silicon Valley Bank [Member] | |||||
Debt Instrument [Line Items] | |||||
Maximum borrowing capacity under term loan | $ 125,000,000 | $ 75,000,000 | |||
Principal amount outstanding under term loan | $ 50,000,000 | ||||
Description of maturity date terms for term loan | the Term Loan matures on October 1, 2024, or the Loan Maturity Date, and may be extended up to an additional 12 months upon the achievement of certain clinical, regulatory and financial milestones. | ||||
Term loan interest rate description | The Term Loan bears interest at a floating rate per annum equal to the greater of either (i) 9.0% or (ii) 9.0% plus the prime rate as reported in The Wall Street Journal (7.5% as of December 31, 2022) less 3.25%. | ||||
Term loan maturity date | Oct. 01, 2024 | ||||
Percentage added to prime rate for debt instrument interest rate | 9% | ||||
Interest only period payment term description | the interest-only period expires May 1, 2023. Upon the achievement of certain regulatory and financial milestones, the interest-only period may be extended for another six months until November 1, 2023. | ||||
End of term charge for loan, percentage | 6.55% | ||||
Minimum amount of prepayment allowed under debt instrument | $ 5,000,000 | ||||
Description of term loan payment terms | At our option, upon at least five business days’ prior written notice to Hercules, we may prepay all or any portion greater than or equal to $5,000,000 of the outstanding loan by paying the entire principal balance (or portion thereof) and all accrued and unpaid interest. Such prepayment is subject to a prepayment charge of 1.5% of the prepayment amount, if the prepayment is made in any of the first 36 months following the Closing Date for any draw downs prior to the second amendment. Thereafter, any prepayment is not subject to a prepayment charge. | ||||
Additional percentage of interest on past due amounts | 5% | ||||
Carrying value of term loan, net | $ 51,157,000 | ||||
Unamortized debt discount and issuance costs | 628,000 | ||||
Accrued end of term charge | 1,785,000 | ||||
Hercules and Silicon Valley Bank [Member] | Second Amendment [Member] | |||||
Debt Instrument [Line Items] | |||||
Available remaining loan principal under second amendment | $ 75,000,000 | ||||
Prepayment charge (as a percentage) | 1.50% | ||||
Description of term loan payment terms | Under the second amendment, if we choose to prepay the principal with respect to any future draw down after the Effective Date, any such prepayment within the first 36 months after the Effective Date will be subject to a prepayment charge equal to 1.5% of the principal amount prepaid. No prepayment charge will be assessed for any prepayment occurring more than 36 months after the Effective Date. | ||||
Minimum cash balance as a percentage of loan amount outstanding | 50% | ||||
Debt covenant minimum cash balance | $ 30,000,000 | ||||
Debt discount under second amendment | $ 100,000 | ||||
Debt issuance costs | 75,000 | ||||
Charge for prepayment occurring 36 months after effective date | 0 | ||||
Hercules and Silicon Valley Bank [Member] | Second Amendment [Member] | Subsequent Event [Member] | |||||
Debt Instrument [Line Items] | |||||
Available remaining loan principal under second amendment | $ 55,000,000 | ||||
Hercules and Silicon Valley Bank [Member] | Tranche One [Member] | Second Amendment [Member] | |||||
Debt Instrument [Line Items] | |||||
Maximum borrowing capacity under term loan | $ 20,000,000 | ||||
Expiration date to borrow under a tranche for a debt instrument, description | earlier of 30 days of the achievement of certain clinical and financial milestones or September 15, 2023 | ||||
Hercules and Silicon Valley Bank [Member] | Tranche Two [Member] | Second Amendment [Member] | |||||
Debt Instrument [Line Items] | |||||
Maximum borrowing capacity under term loan | $ 10,000,000 | ||||
Start date to borrow under a tranche for a debt instrument | Jan. 01, 2023 | ||||
Expiration date to borrow under a tranche for a debt instrument | Dec. 15, 2023 | ||||
Hercules and Silicon Valley Bank [Member] | Tranche Three [Member] | Second Amendment [Member] | |||||
Debt Instrument [Line Items] | |||||
Maximum borrowing capacity under term loan | $ 20,000,000 | ||||
Start date to borrow under a tranche for a debt instrument | Sep. 15, 2023 | ||||
Expiration date to borrow under a tranche for a debt instrument | Sep. 15, 2024 | ||||
Hercules and Silicon Valley Bank [Member] | Tranche Four [Member] | Second Amendment [Member] | |||||
Debt Instrument [Line Items] | |||||
Maximum borrowing capacity under term loan | $ 25,000,000 | ||||
Expiration date to borrow under a tranche for a debt instrument | Dec. 31, 2024 | ||||
Hercules and Silicon Valley Bank [Member] | Option one min cash debt covenant [Member] | Second Amendment [Member] | |||||
Debt Instrument [Line Items] | |||||
Minimum cash balance as a percentage of loan amount outstanding | 40% | ||||
Hercules and Silicon Valley Bank [Member] | Option Two Min Cash Debt Covenant [Member] | Second Amendment [Member] | |||||
Debt Instrument [Line Items] | |||||
Minimum cash balance as a percentage of loan amount outstanding | 25% | ||||
Minimum market capitalization requirement for option | $ 750,000,000 | ||||
Hercules and Silicon Valley Bank [Member] | Option three min cash debt covenant [Member] | Second Amendment [Member] | |||||
Debt Instrument [Line Items] | |||||
Minimum cash balance requirement to be met as a percentage of six-month product revenue against forecast | 70% | ||||
Minimum percentage of net product revenues maintenance period | 6 months | ||||
Hercules [Member] | Second Amendment [Member] | Subsequent Event [Member] | |||||
Debt Instrument [Line Items] | |||||
Percentage of remaining term commitments held under loan agreement | 65% | ||||
Silicon Valley Bank [Member] | Second Amendment [Member] | Subsequent Event [Member] | |||||
Debt Instrument [Line Items] | |||||
Percentage of remaining term commitments held under loan agreement | 35% |
DEBT - Schedule of Future Minim
DEBT - Schedule of Future Minimum Payments Under Term Loan Facility (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Debt Disclosure [Abstract] | ||
2023 | $ 26,843 | |
2024 | 34,160 | |
Total | 61,003 | |
Less: amount representing interest | (7,728) | |
Less: unamortized debt discount and issuance costs | (628) | |
Less: unamortized end of term charge | (1,490) | |
Less: current portion of debt | (20,945) | |
Noncurrent portion of debt | $ 30,212 | $ 49,830 |
STOCKHOLDERS' EQUITY - AUTHORIZ
STOCKHOLDERS' EQUITY - AUTHORIZED COMMON STOCK (Details) - shares | Dec. 31, 2022 | Dec. 31, 2021 | May 12, 2021 | May 11, 2021 |
Stockholders' Equity Note [Abstract] | ||||
Common stock, shares authorized | 675,000,000 | 675,000,000 | 675,000,000 | 450,000,000 |
STOCKHOLDERS' EQUITY - PUBLIC O
STOCKHOLDERS' EQUITY - PUBLIC OFFERING (Details) - 2022 Underwritten Public Offering | Apr. 01, 2022 USD ($) $ / shares shares |
Public Offering [Line Items] | |
Combined public offering price per share of common stock and accompanying stock purchase warrants | $ 1.05 |
Issuance of common stock in connection with public offering | shares | 53,333,334 |
Net proceeds from public offering after deducting underwriting discount and other offering expenses | $ | $ 69,916,000 |
2022 Pre-Funded Warrant | |
Public Offering [Line Items] | |
Warrants to purchase common stock, exercise price | $ 0.001 |
Warrants to purchase common stock, shares | shares | 18,095,238 |
Combined public offering price per share of pre-funded warrants and accompanying stock purchase warrants | $ 1.049 |
2022 Stock Purchase Warrants | |
Public Offering [Line Items] | |
Warrants to purchase common stock, exercise price | $ 1.45 |
Warrants to purchase common stock, shares | shares | 35,714,286 |
STOCKHOLDERS' EQUITY - WARRANT
STOCKHOLDERS' EQUITY - WARRANT EXERCISES (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Class of Warrant or Right [Line Items] | |||
Proceeds from exercise of warrants | $ 15,163 | $ 2,479 | $ 16 |
2020 Public Offering of Common Stock and Warrants | 2020 Pre-Funded Warrant | |||
Class of Warrant or Right [Line Items] | |||
Warrants to purchase common stock, shares | 8,335,239 | ||
Underwritten Public Offering | 2020 Stock Purchase Warrant | |||
Class of Warrant or Right [Line Items] | |||
Warrants to purchase common stock exercised, shares | 11,663,387 | ||
Proceeds from exercise of warrants | $ 15,163,000 | ||
Warrants to purchase common stock, shares | 44,110,079 |
STOCKHOLDERS' EQUITY - SALES AG
STOCKHOLDERS' EQUITY - SALES AGREEMENTS (Details) - USD ($) | 12 Months Ended | |||
Sep. 04, 2020 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
At Market Issuance Sales Agreements [Line Items] | ||||
Issuance of common stock in connection with at market offering, net of issuance costs | $ 20,385,000 | $ 4,075,000 | ||
2020 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% | |||
Issuance of common stock in connection with at market offering, net of issuance costs (in shares) | 0 | 10,571,556 | ||
Issuance of common stock in connection with at market offering, net of issuance costs | $ 20,385,000 |
STOCKHOLDERS' EQUITY - EQUITY P
STOCKHOLDERS' EQUITY - EQUITY PLANS (Details) - USD ($) | 1 Months Ended | 12 Months Ended | |||||||
May 31, 2022 | May 31, 2021 | Jun. 30, 2020 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2018 | Oct. 31, 2018 | May 15, 2018 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Common stock, shares reserved for future issuance (in shares) | 191,659,735 | ||||||||
Aggregate Intrinsic Value - Options Outstanding | |||||||||
Closing stock price (in dollars per share) | $ 2.42 | ||||||||
Total pretax intrinsic value of stock options exercised (in dollars) | $ 787,000 | $ 93,000 | $ 17,000 | ||||||
Cash received from exercise of stock options (in dollars) | $ 1,799,000 | $ 556,000 | $ 25,000 | ||||||
Number of Shares - Options Outstanding | |||||||||
Stock options exercisable at the end of the period (in shares) | 36,085,389 | 30,459,136 | 25,721,508 | ||||||
Weighted Average Exercise Price Per Share - Options Outstanding | |||||||||
Stock options exercisable at the end of the period (in dollars per share) | $ 2.17 | $ 2.35 | $ 2.54 | ||||||
2011 Plan | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Vesting period of stock options | 4 years | ||||||||
2011 Plan | Maximum | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Expiration term of stock options from date of grant | 10 years | ||||||||
2018 Plan | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Vesting period of stock options | 4 years | ||||||||
Common stock, shares reserved for future issuance (in shares) | 10,000,000 | ||||||||
Minimum percentage of ownership required for granting stock options at least 110% of fair market value of common stock | 10% | ||||||||
Minimum exercise price as a percentage of fair market value for employees having more than 10 % outstanding common stock | 110% | ||||||||
Maximum expiration term of stock options granted to employees having more than 10 % outstanding common stock | 5 years | ||||||||
Common stock, increase in shares reserved for future issuance (in shares) | 11,000,000 | 12,500,000 | 5,700,000 | ||||||
2018 Plan | First Director Option | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Vesting period of stock options | 3 years | ||||||||
Stock options to be granted to purchase shares upon appointment (shares) | 200,000 | ||||||||
2018 Plan | Subsequent Director Option | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Stock options to be granted to purchase shares (in shares) | 125,000 | ||||||||
2018 Plan | Maximum | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Expiration term of stock options from date of grant | 10 years | ||||||||
2006 Directors Plan | First Director Option | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Vesting period of stock options | 3 years | ||||||||
2006 Directors Plan | Subsequent Director Option | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Vesting period of stock options | 1 year | ||||||||
2006 Directors Plan | Maximum | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Expiration term of stock options from date of grant | 10 years | ||||||||
2018 Inducement Award Plan | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Common stock, shares reserved for future issuance (in shares) | 21,100,000 | 3,000,000 | |||||||
Directors Market Value Stock Purchase Plan | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Common stock, shares reserved for future issuance (in shares) | 1,000,000 | ||||||||
Directors Market Value Stock Purchase Plan | Restricted stock awards | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Shares issued (in shares) | 15,962 | 20,783 | 17,986 | ||||||
Weighted average grant date fair value (in dollars per share) | $ 1.92 | $ 1.38 | $ 1.60 | ||||||
Total fair value of restricted stock that vested | $ 29,000 | $ 29,000 | $ 29,000 |
STOCKHOLDERS' EQUITY - EQUITY_2
STOCKHOLDERS' EQUITY - EQUITY PLANS - SCHEDULE OF AGGREGATE STOCK OPTION AND AWARD ACTIVITY (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Shares Available For Grant | |||
Balance at the beginning of the period (in shares) | 18,763,393 | ||
Additional shares authorized (in shares) | 16,755,000 | ||
Stock options granted (in shares) | (19,747,760) | ||
Awards granted (in shares) | (15,962) | ||
Stock options cancelled/forfeited/expired (in shares) | 2,616,058 | ||
Balance at the end of the period (in shares) | 18,370,729 | 18,763,393 | |
Number of Shares - Options Outstanding | |||
Balance at the beginning of the period (in shares) | 49,952,409 | ||
Stock options granted (in shares) | 19,747,760 | ||
Stock options exercised (in shares) | (1,181,711) | ||
Stock options cancelled/forfeited/expired (in shares) | (2,616,058) | ||
Balance at the end of the period (in shares) | 65,902,400 | 49,952,409 | |
Stock options exercisable at the end of the period (in shares) | 36,085,389 | 30,459,136 | 25,721,508 |
Stock options fully vested and expected to vest at the end of the period (in shares) | 64,539,649 | ||
Weighted Average Exercise Price Per Share - Options Outstanding | |||
Balance at the beginning of the period (in dollars per share) | $ 2.06 | ||
Stock options granted (in dollars per share) | 1.37 | ||
Stock options exercised (in dollars per share) | 1.52 | ||
Stock options cancelled/forfeited/expired (in dollars per share) | 1.70 | ||
Balance at the end of the period (in dollars per share) | 1.87 | $ 2.06 | |
Stock options exercisable at the end of the period (in dollars per share) | 2.17 | $ 2.35 | $ 2.54 |
Stock options fully vested and expected to vest at the end of the period (in dollars per share) | $ 1.88 | ||
Weight Average Remaining Contractual Life (in years) - Options Outstanding | |||
Balance at the end of the period | 6 years 6 months 21 days | ||
Stock options exercisable at the end of the period | 5 years 1 month 2 days | ||
Stock options fully vested and expected to vest at the end of the period | 6 years 6 months 7 days | ||
Aggregate Intrinsic Value - Options Outstanding | |||
Balance at the end of the period (in dollars) | $ 50,205 | ||
Stock options exercisable at the end of the period (in dollars) | 22,878 | ||
Stock options fully vested and expected to vest at the end of the period (in dollars) | $ 48,951 |
STOCKHOLDERS' EQUITY - EQUITY_3
STOCKHOLDERS' EQUITY - EQUITY PLANS - SCHEDULE OF AGGREGATE STOCK OPTION AND AWARD ACTIVITY (Parenthetical) (Details) - shares | Dec. 31, 2022 | Dec. 31, 2021 |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Stock options outstanding (in shares) | 65,902,400 | 49,952,409 |
Performance-Based Stock Options | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Stock options outstanding (in shares) | 8,791,750 |
STOCKHOLDERS' EQUITY - EMPLOYEE
STOCKHOLDERS' EQUITY - EMPLOYEE STOCK PURCHASE PLAN (Details) | 1 Months Ended | 12 Months Ended |
May 31, 2022 shares | Dec. 31, 2022 Item shares | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Common stock, shares reserved for future issuance (in shares) | 191,659,735 | |
Employee Stock Purchase Plan | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Aggregate shares issued under plan | 868,236 | |
Common stock, increase in shares reserved for future issuance (in shares) | 1,000,000 | |
Common stock, shares reserved for future issuance (in shares) | 2,000,000 | |
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% | |
Percentage applied to common stock market value in calculating purchase price under purchase plan | 85% | |
Duration of the new offering period | 12 months |
STOCKHOLDERS' EQUITY - PERFORMA
STOCKHOLDERS' EQUITY - PERFORMANCE BASED STOCK OPTIONS (Details) - shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Stock options granted (in shares) | 19,747,760 | |
Performance-Based Stock Options | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Stock options granted (in shares) | 2,741,750 | 550,000 |
STOCKHOLDERS' EQUITY - STOCK-BA
STOCKHOLDERS' EQUITY - STOCK-BASED COMPENSATION EXPENSE FOR EMPLOYEES AND DIRECTORS (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Stock-Based Compensation Expense | |||
Stock-based compensation expense included in operating expenses | $ 8,001 | $ 8,080 | $ 6,895 |
Research and development | |||
Stock-Based Compensation Expense | |||
Stock-based compensation expense included in operating expenses | 3,720 | 3,597 | 2,337 |
General and administrative | |||
Stock-Based Compensation Expense | |||
Stock-based compensation expense included in operating expenses | $ 4,281 | $ 4,483 | $ 4,558 |
STOCKHOLDERS' EQUITY - PRICING
STOCKHOLDERS' EQUITY - PRICING MODEL ASSUMPTIONS (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Compensation cost related to unvested stock awards not yet recognized | |||
Compensation cost not yet recognized, net of estimated forfeitures (in dollars) | $ 17,791,000 | ||
Period for recognition of compensation cost on weighted average basis | 26 months | ||
Stock Options | |||
Assumptions used to estimate fair value of awards | |||
Dividend yield (as a percent) | 0% | 0% | 0% |
Expected volatility range, minimum (as a percent) | 77.20% | 77.50% | 78.10% |
Expected volatility range, maximum (as a percent) | 81.70% | 78.30% | 79.30% |
Risk-free interest rate range, minimum (as a percent) | 1.69% | 0.51% | 0.31% |
Risk-free interest rate range, maximum (as a percent) | 4.57% | 1.30% | 1.62% |
Expected term range | 5 years 6 months | 5 years 6 months | 5 years 3 months |
Additional disclosures | |||
Weighted average estimated fair value of employee stock options granted (in dollars per share) | $ 0.92 | $ 1.17 | $ 0.88 |
Employee Stock Purchase Plan | |||
Assumptions used to estimate fair value of awards | |||
Dividend yield (as a percent) | 0% | 0% | 0% |
Expected volatility range, minimum (as a percent) | 61.40% | 50.70% | 47.80% |
Expected volatility range, maximum (as a percent) | 86.50% | 70.70% | 81.80% |
Risk-free interest rate range, minimum (as a percent) | 0.40% | 0.09% | 0.16% |
Risk-free interest rate range, maximum (as a percent) | 2.79% | 0.16% | 1.57% |
Additional disclosures | |||
Weighted average estimated fair value of other than employee stock options granted (in dollars per share) | $ 0.48 | $ 0.56 | $ 0.62 |
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 - STOCK-_2
STOCKHOLDERS' EQUITY - STOCK-BASED COMPENSATION TO SERVICE PROVIDERS (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Stock-Based Compensation to Service Providers | |||
Stock-based compensation for services by non-employees | $ 264,000 | $ 91,000 | $ 85,000 |
Consultants | Stock Options | |||
Stock-Based Compensation to Service Providers | |||
Stock-based compensation for services by non-employees | $ 235,000 | $ 62,000 | $ 56,000 |
STOCKHOLDERS' EQUITY - COMMON S
STOCKHOLDERS' EQUITY - COMMON STOCK RESERVED FOR FUTURE ISSUANCE (Details) - shares | Dec. 31, 2022 | Dec. 31, 2021 |
STOCKHOLDERS' EQUITY | ||
Stock options outstanding (in shares) | 65,902,400 | 49,952,409 |
Stock options and awards available for grant (in shares) | 18,370,729 | 18,763,393 |
Warrants outstanding (in shares) | 106,254,842 | |
Common stock reserved for future issuance (in shares) | 191,659,735 | |
Employee stock purchase | ||
STOCKHOLDERS' EQUITY | ||
Common stock reserved for future issuance (in shares) | 1,131,764 |
INCOME TAXES - EFFECTIVE INCOME
INCOME TAXES - EFFECTIVE INCOME TAX RATE (Details) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Effective Income Tax Rate Continuing Operations Tax Rate Reconciliation [Abstract] | |||
Tax at statutory rate | 21% | 21% | 21% |
State income tax, net of federal benefit | 6.80% | 9% | 6.90% |
Federal and state tax credits | 4.90% | 5.70% | 5.30% |
Stock-based compensation | (0.80%) | (1.20%) | (0.50%) |
Net operating loss not benefitted | (4.30%) | (5.40%) | (6.90%) |
Other | (0.10%) | (0.20%) | (0.30%) |
Change in valuation allowance | (27.50%) | (28.90%) | (25.50%) |
Effective tax rate | 0% | 0% | 0% |
INCOME TAXES - DEFERRED TAXES (
INCOME TAXES - DEFERRED TAXES (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Significant components of deferred tax assets | ||
Net operating loss carryforwards | $ 254,500,000 | $ 241,300,000 |
Federal and state tax credits | 56,700,000 | 49,600,000 |
Capitalized research and development | 21,800,000 | 6,900,000 |
Stock-based compensation | 10,800,000 | 10,200,000 |
Operating lease liabilities | 1,300,000 | 1,400,000 |
Other | 5,600,000 | 2,600,000 |
Total deferred tax assets | 350,700,000 | 312,000,000 |
Less: valuation allowance | (349,600,000) | (310,700,000) |
Net deferred tax assets | 1,100,000 | 1,300,000 |
Operating leases, right-of-use assets | (1,100,000) | (1,300,000) |
Total deferred tax liabilities | (1,100,000) | (1,300,000) |
Valuation allowance | ||
Increase (decrease) in valuation allowance | $ 38,900,000 | $ 33,500,000 |
INCOME TAXES - OPERATING LOSS C
INCOME TAXES - OPERATING LOSS CARRYFORWARDS (Details) | Dec. 31, 2022 USD ($) |
Federal | |
Operating Loss Carryforwards [Line Items] | |
Net operating loss carryforwards | $ 993,100,000 |
Net operating loss carryforwards, expire beginning 2023 through 2037 | 685,300,000 |
State | |
Operating Loss Carryforwards [Line Items] | |
Net operating loss carryforwards | $ 658,400,000 |
INCOME TAXES - TAX CREDIT CARRY
INCOME TAXES - TAX CREDIT CARRYFORWARDS (Details) | Dec. 31, 2022 USD ($) |
Federal | |
Tax Credit Carryforward [Line Items] | |
Tax credit carryforwards | $ 62,700,000 |
State | |
Tax Credit Carryforward [Line Items] | |
Tax credit carryforwards | $ 20,900,000 |
INCOME TAXES - CARES ACT IMPACT
INCOME TAXES - CARES ACT IMPACT (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
C A R E S Act Impact [Abstract] | ||
Employee retention credit, CARES Act | $ 483,000 | $ 1,152,000 |
INCOME TAXES - UNRECOGNIZED TAX
INCOME TAXES - UNRECOGNIZED TAX BENEFITS (Details) | 12 Months Ended |
Dec. 31, 2022 USD ($) | |
Unrecognized tax benefits | |
Unrecognized tax benefits, if recognized would impact effective tax rate | $ 23,700,000 |
Balance at the beginning of the period | 21,300,000 |
Increase related to current year tax positions | 2,400,000 |
Balance at the end of the period | $ 23,700,000 |
CONSOLIDATED STATEMENTS OF CA_4
CONSOLIDATED STATEMENTS OF CASH FLOWS DATA - Supplemental Investing Activities (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Supplemental operating and investing activities: | |||
Net unrealized loss on marketable securities | $ (68) | $ (251) | $ (54) |
Reclassification between prepaid and other current assets and deposits and other assets | (5) | ||
Operating lease assets obtained in exchange for operating lease liabilities | 3,575 | ||
Cash paid for interest | $ 5,154 | $ 2,704 | $ 388 |
SUBSEQUENT EVENTS - Additional
SUBSEQUENT EVENTS - Additional Information (Details) - USD ($) | 2 Months Ended | 12 Months Ended | |||
Jan. 10, 2023 | Mar. 09, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Subsequent Event [Line Items] | |||||
Proceeds from exercise of warrants | $ 15,163,000 | $ 2,479,000 | $ 16,000 | ||
Subsequent Event | 2023 Underwritten Public Offering | |||||
Subsequent Event [Line Items] | |||||
Issuance of common stock in connection with public offering | 68,007,741 | ||||
Warrants to purchase common stock, shares | 25,000,000 | ||||
Net proceeds from public offering after deducting underwriting discount and other offering expenses | $ 213,300,000 | ||||
Subsequent Event | 2020 Purchase Warrants | |||||
Subsequent Event [Line Items] | |||||
Warrants to purchase common stock exercised, shares | 35,935,577 | ||||
Proceeds from exercise of warrants | $ 46,716,000 | ||||
Subsequent Event | 2022 Purchase Warrants | |||||
Subsequent Event [Line Items] | |||||
Warrants to purchase common stock exercised, shares | 9,047,617 | ||||
Proceeds from exercise of warrants | $ 13,119,000 |