DOCUMENT AND ENTITY INFORMATION
DOCUMENT AND ENTITY INFORMATION - shares | 9 Months Ended | |
Sep. 30, 2023 | Oct. 31, 2023 | |
Cover [Abstract] | ||
Entity Registrant Name | GERON CORP | |
Entity Central Index Key | 0000886744 | |
Document Type | 10-Q | |
Document Period End Date | Sep. 30, 2023 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Common Stock, Shares Outstanding | 543,063,950 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q3 | |
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 BOULEVARD | |
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, $0.001 par value | |
Security Exchange Name | NASDAQ | |
Entity Incorporation, State or Country Code | DE | |
Document Quarterly Report | true | |
Document Transition Report | false |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 30,709 | $ 56,845 |
Restricted cash | 536 | 364 |
Marketable securities | 282,818 | 115,901 |
Interest and other receivables | 14,754 | 3,144 |
Prepaid and other current assets | 6,268 | 3,992 |
Total current assets | 335,085 | 180,246 |
Noncurrent marketable securities | 67,821 | |
Property and equipment, net | 1,231 | 793 |
Operating leases, right-of-use assets | 3,683 | 4,147 |
Deposits and other assets | 5,197 | 5,389 |
Total assets | 413,017 | 190,575 |
Current liabilities: | ||
Accounts payable | 13,684 | 10,190 |
Accrued compensation and benefits | 10,837 | 11,534 |
Operating lease liabilities | 943 | 925 |
Debt | 22,060 | 20,945 |
Accrued liabilities | 41,862 | 33,100 |
Total current liabilities | 89,386 | 76,694 |
Noncurrent operating lease liabilities | 3,179 | 3,671 |
Noncurrent debt | 29,838 | 30,212 |
Commitments and contingencies | ||
Stockholders' equity: | ||
Common stock | 542 | 390 |
Additional paid-in capital | 1,836,818 | 1,493,469 |
Accumulated deficit | (1,545,796) | (1,413,642) |
Accumulated other comprehensive loss | (950) | (219) |
Total stockholders' equity | 290,614 | 79,998 |
Total liabilities and stockholders' equity | $ 413,017 | $ 190,575 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Revenues: | ||||
Royalties | $ 164 | $ 297 | $ 214 | $ 493 |
Operating expenses: | ||||
Research and development | 29,426 | 24,603 | 92,135 | 67,308 |
General and administrative | 18,350 | 15,642 | 47,734 | 29,784 |
Total operating expenses | 47,776 | 40,245 | 139,869 | 97,092 |
Loss from operations | (47,612) | (39,948) | (139,655) | (96,599) |
Interest income | 4,965 | 852 | 13,556 | 1,294 |
Interest expense | (2,066) | (1,817) | (5,991) | (4,877) |
Other income and (expense), net | (92) | (138) | (64) | 916 |
Net loss | $ (44,805) | $ (41,051) | $ (132,154) | $ (99,266) |
Basic net loss per share | $ (0.08) | $ (0.1) | $ (0.23) | $ (0.26) |
Diluted net loss per share | $ (0.08) | $ (0.1) | $ (0.23) | $ (0.26) |
Shares used in computing basic net loss per share | 579,508,305 | 405,237,474 | 562,445,577 | 380,659,049 |
Shares used in computing diluted net loss per share | 579,508,305 | 405,237,474 | 562,445,577 | 380,659,049 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Statement of Comprehensive Income [Abstract] | ||||
Net loss | $ (44,805) | $ (41,051) | $ (132,154) | $ (99,266) |
Net unrealized loss on marketable securities | (11) | 153 | (722) | (468) |
Foreign currency translation adjustments | 6 | 9 | (9) | 21 |
Comprehensive loss | $ (44,810) | $ (40,889) | $ (132,885) | $ (99,713) |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED 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, 2021 | $ 126,416 | $ 324 | $ 1,398,006 | $ (1,271,741) | $ (173) |
Balances (in shares) at Dec. 31, 2021 | 323,731,591 | ||||
Increase (Decrease) in Stockholders' Equity | |||||
Net loss | (30,098) | (30,098) | |||
Other comprehensive income (loss) | (539) | (539) | |||
Foreign currency translation adjustment | 1 | 1 | |||
Stock-based compensation related to issuance of common stock and options in exchange for services | 15 | 15 | |||
Stock-based compensation related to issuance of common stock and options in exchange for services (in shares) | 5,284 | ||||
Stock-based compensation for equity-based awards to employees and directors | 1,692 | 1,692 | |||
Balances at Mar. 31, 2022 | 97,487 | $ 324 | 1,399,713 | (1,301,839) | (711) |
Balances (in shares) at Mar. 31, 2022 | 323,736,875 | ||||
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 | ||||
Increase (Decrease) in Stockholders' Equity | |||||
Net loss | (99,266) | ||||
Foreign currency translation adjustment | 21 | ||||
Balances at Sep. 30, 2022 | 108,172 | $ 382 | 1,479,417 | (1,371,007) | (620) |
Balances (in shares) at Sep. 30, 2022 | 381,214,326 | ||||
Balances at Mar. 31, 2022 | 97,487 | $ 324 | 1,399,713 | (1,301,839) | (711) |
Balances (in shares) at Mar. 31, 2022 | 323,736,875 | ||||
Increase (Decrease) in Stockholders' Equity | |||||
Net loss | (28,117) | (28,117) | |||
Other comprehensive income (loss) | (82) | (82) | |||
Foreign currency translation adjustment | 11 | 11 | |||
Issuance of common stock and pre-funded warrant to purchase common stock in public offering, net of issuance costs | 69,916 | $ 53 | 69,863 | ||
Issuance of common stock and pre-funded warrant to purchase common stock in public offering, net of issuance costs (in shares) | 53,333,334 | ||||
Stock-based compensation related to issuance of common stock and options in exchange for services | 13 | 13 | |||
Stock-based compensation related to issuance of common stock and options in exchange for services (in shares) | 4,637 | ||||
Issuance of common stock under equity plans | 761 | $ 1 | 760 | ||
Issuance of common stock under equity plans (in shares) | 589,913 | ||||
Stock-based compensation for equity-based awards to employees and directors | 2,058 | 2,058 | |||
Balances at Jun. 30, 2022 | 142,047 | $ 378 | 1,472,407 | (1,329,956) | (782) |
Balances (in shares) at Jun. 30, 2022 | 377,664,759 | ||||
Increase (Decrease) in Stockholders' Equity | |||||
Net loss | (41,051) | (41,051) | |||
Other comprehensive income (loss) | 162 | 162 | |||
Foreign currency translation adjustment | 9 | ||||
Issuance of common stock in connection with exercise of warrants | 3,638 | $ 3 | 3,635 | ||
Issuance of common stock in connection exercise of warrants (in shares) | 2,798,003 | ||||
Stock-based compensation related to issuance of common stock and options in exchange for services | 112 | 112 | |||
Stock-based compensation related to issuance of common stock and options in exchange for services (in shares) | 3,071 | ||||
Issuance of common stock under equity plans | 1,201 | $ 1 | 1,200 | ||
Issuance of common stock under equity plans (in shares) | 748,493 | ||||
Stock-based compensation for equity-based awards to employees and directors | 2,063 | 2,063 | |||
Balances at Sep. 30, 2022 | 108,172 | $ 382 | 1,479,417 | (1,371,007) | (620) |
Balances (in shares) at Sep. 30, 2022 | 381,214,326 | ||||
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 | ||||
Increase (Decrease) in Stockholders' Equity | |||||
Net loss | (38,122) | (38,122) | |||
Other comprehensive income (loss) | 75 | 75 | |||
Foreign currency translation adjustment | (16) | (16) | |||
Issuance of common stock and pre-funded warrant to purchase common stock in public offering, net of issuance costs | 213,337 | $ 68 | 213,269 | ||
Issuance of common stock and pre-funded warrant to purchase common stock in public offering, net of issuance costs (in shares) | 68,007,741 | ||||
Issuance of common stock in connection with exercise of warrants | 59,835 | $ 45 | 59,790 | ||
Issuance of common stock in connection exercise of warrants (in shares) | 44,983,193 | ||||
Stock-based compensation related to issuance of common stock and options in exchange for services | 112 | $ 1 | 111 | ||
Stock-based compensation related to issuance of common stock and options in exchange for services (in shares) | 9,360 | ||||
Issuance of common stock under equity plans | 7,875 | $ 5 | 7,870 | ||
Issuance of common stock under equity plans (in shares) | 5,469,028 | ||||
Stock-based compensation for equity-based awards to employees and directors | 2,961 | 2,961 | |||
Balances at Mar. 31, 2023 | 326,055 | $ 509 | 1,777,470 | (1,451,764) | (160) |
Balances (in shares) at Mar. 31, 2023 | 508,731,846 | ||||
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 | ||||
Increase (Decrease) in Stockholders' Equity | |||||
Net loss | (132,154) | ||||
Foreign currency translation adjustment | (9) | ||||
Balances at Sep. 30, 2023 | 290,614 | $ 542 | 1,836,818 | (1,545,796) | (950) |
Balances (in shares) at Sep. 30, 2023 | 542,479,666 | ||||
Balances at Mar. 31, 2023 | 326,055 | $ 509 | 1,777,470 | (1,451,764) | (160) |
Balances (in shares) at Mar. 31, 2023 | 508,731,846 | ||||
Increase (Decrease) in Stockholders' Equity | |||||
Net loss | (49,227) | (49,227) | |||
Other comprehensive income (loss) | (786) | (786) | |||
Foreign currency translation adjustment | 1 | 1 | |||
Issuance of common stock in connection with exercise of warrants | 17,767 | $ 13 | 17,754 | ||
Issuance of common stock in connection exercise of warrants (in shares) | 12,842,857 | ||||
Stock-based compensation related to issuance of common stock and options in exchange for services | 99 | 99 | |||
Stock-based compensation related to issuance of common stock and options in exchange for services (in shares) | 6,327 | ||||
Issuance of common stock under equity plans | 573 | 573 | |||
Issuance of common stock under equity plans (in shares) | 361,074 | ||||
Stock-based compensation for equity-based awards to employees and directors | 3,945 | 3,945 | |||
Balances at Jun. 30, 2023 | 298,427 | $ 522 | 1,799,841 | (1,500,991) | (945) |
Balances (in shares) at Jun. 30, 2023 | 521,942,104 | ||||
Increase (Decrease) in Stockholders' Equity | |||||
Net loss | (44,805) | (44,805) | |||
Other comprehensive income (loss) | (11) | (11) | |||
Foreign currency translation adjustment | 6 | 6 | |||
Issuance of common stock in connection with exercise of warrants | 28,309 | $ 19 | 28,290 | ||
Issuance of common stock in connection exercise of warrants (in shares) | 19,523,808 | ||||
Stock-based compensation related to issuance of common stock and options in exchange for services | 440 | 440 | |||
Stock-based compensation related to issuance of common stock and options in exchange for services (in shares) | 9,581 | ||||
Issuance of common stock under equity plans | 1,044 | $ 1 | 1,043 | ||
Issuance of common stock under equity plans (in shares) | 1,004,173 | ||||
Stock-based compensation for equity-based awards to employees and directors | 7,204 | 7,204 | |||
Balances at Sep. 30, 2023 | $ 290,614 | $ 542 | $ 1,836,818 | $ (1,545,796) | $ (950) |
Balances (in shares) at Sep. 30, 2023 | 542,479,666 |
CONDENSED CONSOLIDATED STATEM_4
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Jun. 30, 2022 | |
Public Offering of Common Stock and Warrants | ||
Issuance costs | $ 14,507 | $ 5,066 |
CONDENSED CONSOLIDATED STATEM_5
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Cash flows from operating activities: | ||
Net loss | $ (132,154) | $ (99,266) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 328 | 208 |
Accretion and amortization on investments, net | (8,335) | (9) |
Amortization of debt issuance costs/debt discounts | 742 | 1,103 |
Stock-based compensation for services by non-employees | 650 | 140 |
Stock-based compensation for employees and directors | 14,110 | 5,813 |
Amortization of right-of-use assets | 464 | 431 |
Changes in assets and liabilities: | ||
Current and noncurrent assets | (13,694) | (24,506) |
Current and noncurrent liabilities | 11,084 | 23,888 |
Net cash used in operating activities | (126,805) | (92,198) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (766) | (291) |
Purchases of marketable securities | (459,727) | (97,336) |
Proceeds from maturities of marketable securities | 232,602 | 140,706 |
Net cash (used in) provided by investing activities | (227,891) | 43,079 |
Cash flows from financing activities: | ||
Proceeds from issuances of common stock from equity plans | 9,492 | 1,962 |
Proceeds from issuance of common stock from public offering and pre-funded warrant, net of paid issuance costs | 213,337 | 69,916 |
Proceeds from exercise of warrants | 105,912 | 3,638 |
Debt discount and issuance costs for debt financing | (175) | |
Net cash provided by financing activities | 328,741 | 75,341 |
Effect of exchange rates on cash, cash equivalents and restricted cash | (9) | 10 |
Net increase in cash, cash equivalents and restricted cash | (25,964) | 26,232 |
Cash, cash equivalents and restricted cash at the beginning of the period | 57,209 | 35,235 |
Cash, cash equivalents and restricted cash at the end of the period | $ 31,245 | $ 61,467 |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Basis of Presentation The terms “Geron”, the “Company”, “we” and “us” as used in this report refer to Geron Corporation and its wholly-owned subsidiaries, Geron UK Limited, or Geron UK, a United Kingdom company, and Geron Netherlands B.V., or Geron Netherlands, a Netherlands company. Geron UK was incorporated in September 2021, and its operations commenced in January 2022. Geron Netherlands was incorporated in February 2023, and its operations commenced in June 2023. The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by United States, or U.S., generally accepted accounting principles, or GAAP, for complete financial statements. In the opinion of management, all adjustments (consisting only of normal recurring accruals) considered necessary for a fair presentation have been included. Operating results for the three and nine months ended September 30, 2023 are not necessarily indicative of the results that may be expected for the year ending December 31, 2023 or any other period. These unaudited condensed consolidated financial statements and notes should be read in conjunction with the audited financial statements for each of the three years ended December 31, 2022, included in our Annual Report on Form 10-K for the year ended December 31, 2022, or the Form 10-K. The accompanying condensed consolidated balance sheet as of December 31, 2022 has been derived from audited financial statements at that date. Prior Period Reclassification The prior period presentations of other comprehensive loss in the condensed consolidated statements of stockholders' equity and accrued liabilities have been updated to conform to current period presentation. See Note 3 on Accrued Liabilities. Principles of Consolidation The condensed consolidated financial statements include the accounts of Geron Corporation and its wholly-owned subsidiaries, Geron UK and Geron Netherlands. For Geron UK and Geron Netherlands, we have eliminated intercompany accounts and transactions. We prepare the financial statements of Geron UK and Geron Netherlands using the local currency as the functional currency. We translate the assets and liabilities of Geron UK and Geron Netherlands 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 condensed 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 connection with previous public offerings, we issued pre-funded warrants to purchase shares of our common stock. These pre-funded warrants are exercisable immediately at an exercise price of $ 0.001 per share each, and as of September 30, 2023, none of these pre-funded warrants have been exercised. These pre-funded warrants, which represent an aggregate of 51,430,477 shares of common stock, have been included in the computation of basic net loss per share, since their exercise price is negligible and they may be exercised at any time. 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 condensed consolidated statements of operations. Since we incurred a net loss for the three and nine months ended September 30, 2023 and 2022 , the diluted net loss per share calculation excludes potential dilutive securities of 77,651,673 and 174,347,456 , respectively, related to outstanding stock options and warrants as their effect would have been anti-dilutive. Use of Estimates The accompanying condensed consolidated financial statements have been prepared in accordance with 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, 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, 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 condensed consolidated statements of operations. See Note 2 on Fair Value Measurements. 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 condensed 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 condensed 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. 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. The following table summarizes the stock-based compensation expense included in operating expenses on our condensed consolidated statements of operations related to stock options and employee stock purchases for the three and nine months ended September 30, 2023 and 2022, which was allocated as follows: Three Months Ended September 30, Nine Months Ended September 30, (In thousands) 2023 2022 2023 2022 Research and development $ 2,951 $ 932 $ 5,847 $ 2,799 General and administrative 4,253 1,131 8,263 3,014 Stock-based compensation expense included in $ 7,204 $ 2,063 $ 14,110 $ 5,813 As stock-based compensation expense recognized in our condensed consolidated statements of operations for the three and nine months ended September 30, 2023 and 2022 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. We recognized stock-based compensation expense of $ 3.2 million related to performance-based stock options on our condensed consolidated statements of operations for the three and nine months ended September 30, 2023, as we achieved a specified strategic milestone associated with certain performance-based stock options. We have not recognized any additional stock-based compensation expense for any remaining performance-based stock options on our condensed consolidated statements of operations for the three and nine months ended September 30, 2023 and 2022, as achievement of the specified strategic milestones associated with the remaining performance-based stock options was not considered probable at that time. Stock Options We grant service-based and performance-based stock options under our equity plans to employees, non-employee directors and consultants. The service-based vesting period for employee stock options is generally four years from the date of the stock option grant. Performance-based stock options vest upon the achievement of specified strategic milestones. The fair value of service-based stock options granted during the nine months ended September 30, 2023 and 2022 has been estimated at the date of grant using the Black Scholes option-pricing model with the following assumptions: Nine Months Ended September 30, 2023 2022 Dividend yield 0 % 0 % Expected volatility range 81.5 % to 82.1 % 77.7 % to 81.6 % Risk-free interest rate range 3.42 % to 4.62 % 1.69 % to 3.77 % Expected term 6 years 5.5 years Employee Stock Purchase Plan The fair value of employees’ stock purchase rights during the nine months ended September 30, 2023 and 2022 has been estimated using the Black Scholes option-pricing model with the following assumptions: Nine Months Ended September 30, 2023 2022 Dividend yield 0 % 0 % Expected volatility range 79.0 % to 83.2 % 61.4 % to 86.5 % Risk-free interest rate range 4.73 % to 5.40 % 0.40 % to 2.79 % Expected term range 6 months to 12 months 6 months to 12 months Dividend yield is based on historical cash dividend payments and Geron has paid no cash dividends to date. The expected volatility range is based on historical volatilities of our stock, since traded options on Geron common stock do not correspond to option terms and the trading volume of options is limited. The risk-free interest rate range is based on the U.S. Zero Coupon Treasury Strip Yields for the expected term in effect on the date of grant for an award. The expected term of 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’ stock purchase rights is equal to the purchase period. Non-Employee Stock-Based Awards We measure share-based payments to non-employees based on the grant-date fair value of the equity awards. We recognize stock-based compensation expense for the fair value of the vested portion of non-employee stock-based awards on our condensed consolidated statements of operations. Segment Information Our executive management team represents our chief decision maker. We view our operations as a single segment, the development of therapeutic products for oncology. As a result, the financial information disclosed herein materially represents all of the financial information related to our principal operating segment. Recent Accounting Pronouncements New Accounting Pronouncements – Recently Adopted In June 2016, the Financial Accounting Standards Board, or FASB, issued Accounting Standards Update, or ASU, 2016-13, Measurement of Credit Losses on Financial Instruments , or ASU 2016-13. 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 , or ASU 2019-11, which expands the scope of the practical expedient that allows entities to exclude the accrued interest component of amortized cost from various disclosure. We adopted ASU 2016-13 and related updates as of January 1, 2023. Adoption of this new guidance did not have a material impact on our condensed consolidated financial statements. New Accounting Pronouncements – Issued But Not Yet Adopted 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 condensed consolidated 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 condensed consolidated financial statements. |
FAIR VALUE MEASUREMENTS
FAIR VALUE MEASUREMENTS | 9 Months Ended |
Sep. 30, 2023 | |
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 September 30, 2023 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 $ 12,549 $ — $ — $ 12,549 Commercial Paper 3,970 — — 3,970 $ 16,519 $ — $ — $ 16,519 Restricted cash: Money market fund $ 264 $ — $ — $ 264 Certificate of deposit 272 — — 272 $ 536 $ — $ — $ 536 Marketable securities: U.S. Treasury securities - due in 1 to 2 years $ 26,467 $ 1 $ ( 22 ) $ 26,446 Government-sponsored enterprise 94,524 4 ( 293 ) 94,235 Government-sponsored enterprise 10,651 — ( 35 ) 10,616 Commercial paper (due in less than 149,583 1 ( 280 ) 149,304 Corporate notes (due in less than one year) 39,438 2 ( 160 ) 39,280 Corporate notes (due in one to two years) 30,939 1 ( 182 ) 30,758 $ 351,602 $ 9 $ ( 972 ) $ 350,639 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 3,000 — ( 24 ) 2,976 Government-sponsored enterprise securities 9,860 — ( 14 ) 9,846 Commercial paper (due in less than 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 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 September 30, 2023 and December 31, 2022 were as follows: Less Than 12 Months 12 Months or Longer Total Gross Gross Gross Estimated Unrealized Estimated Unrealized Estimated Unrealized (In thousands) Fair Value Losses Fair Value Losses Fair Value Losses As of September 30, 2023: US Treasury Securities (due in less than one year) $ 26,446 $ ( 22 ) $ — $ — $ 26,446 $ ( 22 ) Government-sponsored enterprise 94,523 ( 293 ) — — 94,523 ( 293 ) Government-sponsored enterprise 10,651 ( 35 ) — — 10,651 ( 35 ) Commercial paper (due in less than 149,584 ( 281 ) — — 149,584 ( 281 ) Corporate notes (due in less than 39,438 ( 160 ) — — 39,438 ( 160 ) Corporate notes (due in one to 30,939 ( 181 ) — — 30,939 ( 181 ) $ 351,581 $ ( 972 ) $ — $ — $ 351,581 $ ( 972 ) As of December 31, 2022: U.S. Treasury securities $ 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 (due in less than 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 ) The gross unrealized losses related to U.S. Treasury securities, municipal securities, government-sponsored enterprise securities, commercial paper and corporate notes as of September 30, 2023 and December 31, 2022 were due to changes in interest rates and not credit risk. If an available-for-sale security’s fair value is less than its amortized cost basis, we evaluate whether the decline is the result of a credit loss, in which case an impairment is recorded through an allowance for credit losses. We have not recorded any allowances for credit losses on our available-for-sale securities for the three and nine months ended September 30, 2023 and 2022 as we have not identified any unrealized losses for these securities attributable to credit factors. Our exposure to unrealized losses may increase in the future due to the economic pressures or uncertainties associated with macroeconomic or other global economic conditions, including those resulting from inflation, rising interest rates, prospects of a recession, bank failures and other disruptions to financial systems, civil or political unrest, military conflicts, pandemics or other health crises. Fair Value on a Recurring Basis We categorize financial instruments recorded at fair value on our condensed 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 an 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. Money market funds are categorized as Level 1 within the fair value hierarchy as their fair values are based on quoted prices available in active markets. U.S. Treasury securities, municipal securities, government-sponsored enterprise securities, commercial paper, 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 September 30, 2023 and December 31, 2022 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 September 30, 2023: Money market funds (1)(2) $ 12,813 $ — $ — $ 12,813 Certificate of deposit (2) 272 — — 272 U.S. Treasury securities (3) — 26,446 — 26,446 Government-sponsored enterprise (3)(4) — 104,852 — 104,852 Commercial paper (3) — 153,274 — 153,274 Corporate notes (3)(4) — 70,037 — 70,037 Total $ 13,085 $ 354,609 $ — $ 367,694 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 (2) — 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 (1) Included in cash and cash equivalents on our condensed consolidated balance sheets. (2) Included in restricted cash on our condensed consolidated balance sheets. (3) Included in current portion of marketable securities on our condensed consolidated balance sheets. (4) Included in noncurrent portion of marketable securities on our condensed consolidated balance sheets. |
ACCRUED LIABILITIES
ACCRUED LIABILITIES | 9 Months Ended |
Sep. 30, 2023 | |
Payables and Accruals [Abstract] | |
ACCRUED LIABILITIES | 3. ACCRUED LIABILITIES Accrued liabilities consisted of the following as o f September 30, 2023 and December 31, 2022: SEPTEMBER 30, DECEMBER 31, (In thousands) 2023 2022 CRO and clinical trial costs $ 18,271 $ 17,040 Manufacturing activities 13,066 5,321 Legal settlements 7,000 8,350 Professional legal and accounting fees 718 1,318 Interest payable 594 561 Other 2,213 510 $ 41,862 $ 33,100 |
DEBT
DEBT | 9 Months Ended |
Sep. 30, 2023 | |
Debt Disclosure [Abstract] | |
DEBT | 4. DEBT On September 30, 2020, we, Hercules Capital, Inc., or Hercules, and Silicon Valley Bank, a Division of First-Citizens Bank & Trust Company (successor by purchase to the Federal Deposit Insurance Corporation as receiver for Silicon Valley Bridge Bank, N.A. (as successor to Silicon Valley Bank)), or SVB, entered into a term loan facility, or the Original Loan Agreement, consisting of up to $ 75,000,000 aggregate principal amount available to us, as amended in August 2021. 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 September 30, 2023, a total of $ 50,000,000 has been drawn under the Loan Agreement. As of September 30, 2023 , $ 55,000,000 remains as committed principal that can be drawn as follows: (a) one 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; (b) a second 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 (c) a final tranche of $ 25,000,000 is available through December 31, 2024 , subject to approval by an investment committee comprised of Hercules and SVB. 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 Loan Agreement, 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. Under the Loan Agreement, 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. We are in compliance with the covenants under the Loan Agreement as of September 30, 2023. The interest-only payment period was extended from April 2023 to April 2024 upon the achievement of positive top-line results from the IMerge Phase 3 clinical trial in January 2023. As of September 30, 2023 , the net carrying value of the debt under the Loan Agreement was $ 51,898,000 , which includes the principal amount of $ 50,000,000 less net unamortized debt discounts and issuance costs of $ 408,000 plus accrued end of term charge of $ 2,306,000 . The carrying value of the debt approximates the fair value as of September 30, 2023. The debt discounts and debt issuance costs are being amortized to interest expense over the life of the outstanding loan amounts using the effective interest rate method. The following table presents future minimum payments, including interest and the end of term charge, under the Loan Agreement as of September 30, 2023 (in thousands): Remainder of 2023 $ 1,801 2024 39,362 2025 20,056 Total 61,219 Less: amount representing interest ( 7,944 ) Less: unamortized debt discount and issuance costs ( 408 ) Less: unaccrued end of term charge ( 969 ) Less: current portion of debt ( 22,060 ) Noncurrent portion of debt $ 29,838 |
CONTINGENCIES AND UNCERTAINTIES
CONTINGENCIES AND UNCERTAINTIES | 9 Months Ended |
Sep. 30, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
CONTINGENCIES AND UNCERTAINTIES | 5. CONTINGENCIES AND UNCERTAINTIES 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. On September 2, 2022 , the parties agreed to a settlement and entered into a Stipulation and Agreement of Settlement, or the Stipulation, which was subject to Court approval. 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 insurance coverage and, at our election, $ 7,000,000 in either shares of our common stock and/or cash which was payable after final approval of the settlement by the Court. On October 13, 2022, the Court preliminarily approved the parties’ settlement, and the Court granted final approval of the settlement on September 28, 2023 and final judgment was entered on October 3, 2023. As of September 30, 2023 and December 31, 2022, our portion of the settlement amount of $ 7,000,000 has been included in accrued liabilities on our condensed consolidated balance sheets. The settlement amount was paid in the first week of October 2023. Between April 23, 2020 and June 8, 2021, seven shareholder derivative actions were filed in a number of courts, naming as defendants certain of our current officers and certain current and former members of our board. On May 17, 2023, the Delaware Court of Chancery approved a settlement of the derivative case pending before it, and the case was dismissed with prejudice. Subsequently, each of the remaining derivative cases were dismissed with prejudice as well. 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, the District of Delaware, and the Chancery Court, the parties agreed to a cash settlement of $ 1,350,000 which was accrued on our consolidated balance sheet as of December 31, 2022. In the second quarter of 2023, our insurance carriers paid $ 525,000 in cash, and we paid $ 825,000 in cash, for an aggregate total payment of $ 1,350,000 . Any other future lawsuits are subject to inherent uncertainties, and the actual defense and disposition costs will depend upon many unknown factors. The outcome of any other future lawsuits is necessarily uncertain. We could be forced to expend significant resources in the defense against any other future 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. 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 any future lawsuit. Such amounts could be material to our condensed consolidated financial statements if we do not prevail in the defense against any future lawsuits, or even if we do prevail. We have not established any reserve for any potential liability relating to any future lawsuits. 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: (x) a severance payment upon a Change of Control Triggering Event and Separation from Service and (y) 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 Severanc e Plan. As of September 30, 2023, 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, Political and Health Conditions Our business is subject to various risks and uncertainties, including risks and uncertainties associated with macroeconomic or other global economic conditions, including those resulting from inflation, rising interest rates, prospects of a recession, bank failures and other disruptions to financial systems, civil or political unrest, military conflicts, pandemics or other health crises and supply chain and resource issues. Occurrences of such events have caused and may cause in the future and unpredictable impacts on global societies, economies, financial markets and business practices. Specifically for our business, such risks and uncertainties have adversely affected and may continue to adversely affect our ability to: • continue to develop imetelstat or advance imetelstat to subsequent clinical trials, including receiving regulatory approval for or to commercialize imetelstat, on a timely basis or at all; • conduct and complete current imetelstat clinical trials on a timely basis or at all; • establish sales, marketing and distribution capabilities, or obtain coverage and adequate third-party payor reimbursement, to successfully commercialize imetelstat, if regulatory approval is obtained; • open clinical sites or recruit, enroll and retain patients in current or future clinical trials of imetelstat; • manufacture and supply imetelstat in adequate quantities that meet specifications that may be approved or required by regulatory authorities and on timelines necessary for current and potential future clinical trials and potential commercial uses; • execute on our business strategy and/or our operations by our employees without any restrictions; and • obtain additional capital to continue the development of imetelstat in current and any potential future clinical trials of imetelstat, and establish potential future imetelstat commercialization efforts. The extent to which macroeconomic or other global economic conditions, including those resulting from inflation, rising interest rates, prospects of a recession, bank failures and other disruptions to financial systems, civil or political unrest, military conflicts, pandemics or other health crises and supply chain and resource issues, 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. 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. |
STOCKHOLDERS' EQUITY
STOCKHOLDERS' EQUITY | 9 Months Ended |
Sep. 30, 2023 | |
Stockholders' Equity Note [Abstract] | |
STOCKHOLDERS' EQUITY | 6. STOCKHOLDERS’ EQUITY Public Offering On January 10, 2023 we completed the January 2023 offering consisting of 68,007,741 shares of our common stock and the 2023 pre-funded warrant. All of the securities were issued separately. The public offering price of the common stock was $ 2.45 per share. The public offering price of the 2023 pre-funded warrant was $ 2.449 per share. The 2023 pre- funded warrant has an exercise price of $ 0.001 per share and may be exercised at any time until the 2023 pre-funded warrant is exercised in full. As of September 30, 2023 , none of the 2023 pre-funded warrant has been exercised. The net cash proceeds from this offering were $ 213,337,000 , after deducting the underwriting discount and other offering expenses paid by us, and exclude any future proceeds from the exercise of the 2023 pre-funded warrant. Upon the issuance of the 2023 pre-funded warrant, 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 2023 pre-funded warrant 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 2023 pre-funded warrant should be classified as equity with no subsequent remeasurement as long as such warrant continue to be classified as equity. Warrant Exercises In the first quarter of 2023, warrants to purchase 44,983,194 shares of Geron common stock were exercised for net cash proceeds of approximately $ 59,835,000 . In the second quarter of 2023, warrants to purchase 12,842,857 shares of Geron common stock were exercised for net cash proceeds of approximately $ 17,767,000 . In the third quarter of 2023, warrants to purchase 19,523,808 shares of Geron common stock were exercised for net cash and receivables of approximately $ 28,309,522 . The warrants were issued in connection with underwritten public offerings of common stock and pre-funded warrants, together with accompanying stock purchase warrants in May 2020 and April 2022. As of September 30, 2023, the following warrants remained outstanding: • pre-funded warrants with an exercise price of $ 0.001 per share to purchase 51,430,477 shares of our common stock; and • stock purchase warrants with an exercise price of $ 1.30 per share to purchase 2,474,503 shares of our common stock related to the public offering of our common stock in May 2020. 2023 At Market Issuance Sales Agreement On November 1, 2023, we entered into an At Market Issuance Sales Agreement, or the 2023 Sales Agreement with B. Riley Securities, Inc., or B. Riley Securities, pursuant to which we may issue and sell shares of our common stock having an aggregate offering price of up to $ 100 million from time to time through B. Riley Securities as the sales agent. The issuance and sale of common stock under the 2023 Sales Agreement will be pursuant our effective shelf registration statement on Form S-3 filed with the United States Securities and Exchange Commission, or the SEC, on January 4, 2023. B. Riley Securities may sell the common stock by any method that is deemed an “at the market offering” as defined in Rule 415 promulgated under the Securities Act of 1933, as amended. Subject to the terms and conditions of the 2023 Sales Agreement, B. Riley Securities will use commercially reasonable efforts consistent with its normal trading and sales practices to sell our common stock from time to time, based upon our instructions (including any price, time or size limits or other customary parameters or conditions we impose). We are not obligated to make any sales of common stock under the 2023 Sales Agreement. We will pay B. Riley Securities 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 Securities under the 2023 Sales Agreement. We have also provided B. Riley Securities with customary indemnification rights. Unless earlier terminated as provided below, the 2023 Sales Agreement will automatically terminate upon earlier of (i) the sale of all common stock subject to the 2023 Sales Agreement or (ii) termination of the 2023 Sales Agreement in accordance with its terms. |
SUMMARY OF SIGNIFICANT ACCOUN_2
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The terms “Geron”, the “Company”, “we” and “us” as used in this report refer to Geron Corporation and its wholly-owned subsidiaries, Geron UK Limited, or Geron UK, a United Kingdom company, and Geron Netherlands B.V., or Geron Netherlands, a Netherlands company. Geron UK was incorporated in September 2021, and its operations commenced in January 2022. Geron Netherlands was incorporated in February 2023, and its operations commenced in June 2023. The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by United States, or U.S., generally accepted accounting principles, or GAAP, for complete financial statements. In the opinion of management, all adjustments (consisting only of normal recurring accruals) considered necessary for a fair presentation have been included. Operating results for the three and nine months ended September 30, 2023 are not necessarily indicative of the results that may be expected for the year ending December 31, 2023 or any other period. These unaudited condensed consolidated financial statements and notes should be read in conjunction with the audited financial statements for each of the three years ended December 31, 2022, included in our Annual Report on Form 10-K for the year ended December 31, 2022, or the Form 10-K. The accompanying condensed consolidated balance sheet as of December 31, 2022 has been derived from audited financial statements at that date. |
Prior Period Reclassification | Prior Period Reclassification The prior period presentations of other comprehensive loss in the condensed consolidated statements of stockholders' equity and accrued liabilities have been updated to conform to current period presentation. See Note 3 on Accrued Liabilities. |
Principles of Consolidation | Principles of Consolidation The condensed consolidated financial statements include the accounts of Geron Corporation and its wholly-owned subsidiaries, Geron UK and Geron Netherlands. For Geron UK and Geron Netherlands, we have eliminated intercompany accounts and transactions. We prepare the financial statements of Geron UK and Geron Netherlands using the local currency as the functional currency. We translate the assets and liabilities of Geron UK and Geron Netherlands 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 condensed 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 connection with previous public offerings, we issued pre-funded warrants to purchase shares of our common stock. These pre-funded warrants are exercisable immediately at an exercise price of $ 0.001 per share each, and as of September 30, 2023, none of these pre-funded warrants have been exercised. These pre-funded warrants, which represent an aggregate of 51,430,477 shares of common stock, have been included in the computation of basic net loss per share, since their exercise price is negligible and they may be exercised at any time. 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 condensed consolidated statements of operations. Since we incurred a net loss for the three and nine months ended September 30, 2023 and 2022 , the diluted net loss per share calculation excludes potential dilutive securities of 77,651,673 and 174,347,456 , respectively, related to outstanding stock options and warrants as their effect would have been anti-dilutive. |
Use of Estimates | Use of Estimates The accompanying condensed consolidated financial statements have been prepared in accordance with 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, 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, 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 condensed consolidated statements of operations. See Note 2 on Fair Value Measurements. |
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 condensed 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 condensed 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. 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. The following table summarizes the stock-based compensation expense included in operating expenses on our condensed consolidated statements of operations related to stock options and employee stock purchases for the three and nine months ended September 30, 2023 and 2022, which was allocated as follows: Three Months Ended September 30, Nine Months Ended September 30, (In thousands) 2023 2022 2023 2022 Research and development $ 2,951 $ 932 $ 5,847 $ 2,799 General and administrative 4,253 1,131 8,263 3,014 Stock-based compensation expense included in $ 7,204 $ 2,063 $ 14,110 $ 5,813 As stock-based compensation expense recognized in our condensed consolidated statements of operations for the three and nine months ended September 30, 2023 and 2022 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. We recognized stock-based compensation expense of $ 3.2 million related to performance-based stock options on our condensed consolidated statements of operations for the three and nine months ended September 30, 2023, as we achieved a specified strategic milestone associated with certain performance-based stock options. We have not recognized any additional stock-based compensation expense for any remaining performance-based stock options on our condensed consolidated statements of operations for the three and nine months ended September 30, 2023 and 2022, as achievement of the specified strategic milestones associated with the remaining performance-based stock options was not considered probable at that time. Stock Options We grant service-based and performance-based stock options under our equity plans to employees, non-employee directors and consultants. The service-based vesting period for employee stock options is generally four years from the date of the stock option grant. Performance-based stock options vest upon the achievement of specified strategic milestones. The fair value of service-based stock options granted during the nine months ended September 30, 2023 and 2022 has been estimated at the date of grant using the Black Scholes option-pricing model with the following assumptions: Nine Months Ended September 30, 2023 2022 Dividend yield 0 % 0 % Expected volatility range 81.5 % to 82.1 % 77.7 % to 81.6 % Risk-free interest rate range 3.42 % to 4.62 % 1.69 % to 3.77 % Expected term 6 years 5.5 years Employee Stock Purchase Plan The fair value of employees’ stock purchase rights during the nine months ended September 30, 2023 and 2022 has been estimated using the Black Scholes option-pricing model with the following assumptions: Nine Months Ended September 30, 2023 2022 Dividend yield 0 % 0 % Expected volatility range 79.0 % to 83.2 % 61.4 % to 86.5 % Risk-free interest rate range 4.73 % to 5.40 % 0.40 % to 2.79 % Expected term range 6 months to 12 months 6 months to 12 months Dividend yield is based on historical cash dividend payments and Geron has paid no cash dividends to date. The expected volatility range is based on historical volatilities of our stock, since traded options on Geron common stock do not correspond to option terms and the trading volume of options is limited. The risk-free interest rate range is based on the U.S. Zero Coupon Treasury Strip Yields for the expected term in effect on the date of grant for an award. The expected term of 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’ stock purchase rights is equal to the purchase period. Non-Employee Stock-Based Awards We measure share-based payments to non-employees based on the grant-date fair value of the equity awards. We recognize stock-based compensation expense for the fair value of the vested portion of non-employee stock-based awards on our condensed consolidated statements of operations. |
Segment Information | Segment Information Our executive management team represents our chief decision maker. We view our operations as a single segment, the development of therapeutic products for oncology. As a result, the financial information disclosed herein materially represents all of the financial information related to our principal operating segment. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements New Accounting Pronouncements – Recently Adopted In June 2016, the Financial Accounting Standards Board, or FASB, issued Accounting Standards Update, or ASU, 2016-13, Measurement of Credit Losses on Financial Instruments , or ASU 2016-13. 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 , or ASU 2019-11, which expands the scope of the practical expedient that allows entities to exclude the accrued interest component of amortized cost from various disclosure. We adopted ASU 2016-13 and related updates as of January 1, 2023. Adoption of this new guidance did not have a material impact on our condensed consolidated financial statements. New Accounting Pronouncements – Issued But Not Yet Adopted 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 condensed consolidated 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 condensed consolidated financial statements. |
SUMMARY OF SIGNIFICANT ACCOUN_3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Summary of allocation of stock-based compensation expense included in operating expenses on condensed consolidated statements of operations related to share-based payment awards | The following table summarizes the stock-based compensation expense included in operating expenses on our condensed consolidated statements of operations related to stock options and employee stock purchases for the three and nine months ended September 30, 2023 and 2022, which was allocated as follows: Three Months Ended September 30, Nine Months Ended September 30, (In thousands) 2023 2022 2023 2022 Research and development $ 2,951 $ 932 $ 5,847 $ 2,799 General and administrative 4,253 1,131 8,263 3,014 Stock-based compensation expense included in $ 7,204 $ 2,063 $ 14,110 $ 5,813 |
Schedule of assumptions used to estimate the fair value of service-based stock options granted | The fair value of service-based stock options granted during the nine months ended September 30, 2023 and 2022 has been estimated at the date of grant using the Black Scholes option-pricing model with the following assumptions: Nine Months Ended September 30, 2023 2022 Dividend yield 0 % 0 % Expected volatility range 81.5 % to 82.1 % 77.7 % to 81.6 % Risk-free interest rate range 3.42 % to 4.62 % 1.69 % to 3.77 % Expected term 6 years 5.5 years |
Schedule of assumptions used to estimate the fair value of employee stock purchases under the purchase plan | The fair value of employees’ stock purchase rights during the nine months ended September 30, 2023 and 2022 has been estimated using the Black Scholes option-pricing model with the following assumptions: Nine Months Ended September 30, 2023 2022 Dividend yield 0 % 0 % Expected volatility range 79.0 % to 83.2 % 61.4 % to 86.5 % Risk-free interest rate range 4.73 % to 5.40 % 0.40 % to 2.79 % Expected term range 6 months to 12 months 6 months to 12 months |
FAIR VALUE MEASUREMENTS (Tables
FAIR VALUE MEASUREMENTS (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
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 September 30, 2023 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 $ 12,549 $ — $ — $ 12,549 Commercial Paper 3,970 — — 3,970 $ 16,519 $ — $ — $ 16,519 Restricted cash: Money market fund $ 264 $ — $ — $ 264 Certificate of deposit 272 — — 272 $ 536 $ — $ — $ 536 Marketable securities: U.S. Treasury securities - due in 1 to 2 years $ 26,467 $ 1 $ ( 22 ) $ 26,446 Government-sponsored enterprise 94,524 4 ( 293 ) 94,235 Government-sponsored enterprise 10,651 — ( 35 ) 10,616 Commercial paper (due in less than 149,583 1 ( 280 ) 149,304 Corporate notes (due in less than one year) 39,438 2 ( 160 ) 39,280 Corporate notes (due in one to two years) 30,939 1 ( 182 ) 30,758 $ 351,602 $ 9 $ ( 972 ) $ 350,639 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 3,000 — ( 24 ) 2,976 Government-sponsored enterprise securities 9,860 — ( 14 ) 9,846 Commercial paper (due in less than 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 |
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 September 30, 2023 and December 31, 2022 were as follows: Less Than 12 Months 12 Months or Longer Total Gross Gross Gross Estimated Unrealized Estimated Unrealized Estimated Unrealized (In thousands) Fair Value Losses Fair Value Losses Fair Value Losses As of September 30, 2023: US Treasury Securities (due in less than one year) $ 26,446 $ ( 22 ) $ — $ — $ 26,446 $ ( 22 ) Government-sponsored enterprise 94,523 ( 293 ) — — 94,523 ( 293 ) Government-sponsored enterprise 10,651 ( 35 ) — — 10,651 ( 35 ) Commercial paper (due in less than 149,584 ( 281 ) — — 149,584 ( 281 ) Corporate notes (due in less than 39,438 ( 160 ) — — 39,438 ( 160 ) Corporate notes (due in one to 30,939 ( 181 ) — — 30,939 ( 181 ) $ 351,581 $ ( 972 ) $ — $ — $ 351,581 $ ( 972 ) As of December 31, 2022: U.S. Treasury securities $ 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 (due in less than 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 ) |
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 September 30, 2023 and December 31, 2022 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 September 30, 2023: Money market funds (1)(2) $ 12,813 $ — $ — $ 12,813 Certificate of deposit (2) 272 — — 272 U.S. Treasury securities (3) — 26,446 — 26,446 Government-sponsored enterprise (3)(4) — 104,852 — 104,852 Commercial paper (3) — 153,274 — 153,274 Corporate notes (3)(4) — 70,037 — 70,037 Total $ 13,085 $ 354,609 $ — $ 367,694 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 (2) — 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 (1) Included in cash and cash equivalents on our condensed consolidated balance sheets. (2) Included in restricted cash on our condensed consolidated balance sheets. (3) Included in current portion of marketable securities on our condensed consolidated balance sheets. (4) Included in noncurrent portion of marketable securities on our condensed consolidated balance sheets. |
ACCRUED LIABILITIES (Tables)
ACCRUED LIABILITIES (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Payables and Accruals [Abstract] | |
Schedule of accrued liabilities | Accrued liabilities consisted of the following as o f September 30, 2023 and December 31, 2022: SEPTEMBER 30, DECEMBER 31, (In thousands) 2023 2022 CRO and clinical trial costs $ 18,271 $ 17,040 Manufacturing activities 13,066 5,321 Legal settlements 7,000 8,350 Professional legal and accounting fees 718 1,318 Interest payable 594 561 Other 2,213 510 $ 41,862 $ 33,100 |
DEBT (Tables)
DEBT (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Debt Disclosure [Abstract] | |
Future Minimum Payments Under Loan Agreement | The following table presents future minimum payments, including interest and the end of term charge, under the Loan Agreement as of September 30, 2023 (in thousands): Remainder of 2023 $ 1,801 2024 39,362 2025 20,056 Total 61,219 Less: amount representing interest ( 7,944 ) Less: unamortized debt discount and issuance costs ( 408 ) Less: unaccrued end of term charge ( 969 ) Less: current portion of debt ( 22,060 ) Noncurrent portion of debt $ 29,838 |
SUMMARY OF SIGNIFICANT ACCOUN_4
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - NET LOSS PER SHARE (Details) - Pre-Funded Warrants | Sep. 30, 2023 $ / shares shares |
Warrant exercise price | $ 0.001 |
Public Offering of Common Stock and Warrants | |
Warrant to purchase common stock, shares | shares | 51,430,477 |
Warrant exercise price | $ 0.001 |
SUMMARY OF SIGNIFICANT ACCOUN_5
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - ANTI-DILUTIVE SHARES (Details) - shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
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) | 77,651,673 | 174,347,456 | 77,651,673 | 174,347,456 |
SUMMARY OF SIGNIFICANT ACCOUN_6
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - USEFUL LIVES OF ASSETS (Details) | Sep. 30, 2023 |
Depreciation [Abstract] | |
Estimated useful lives of assets | 4 years |
SUMMARY OF SIGNIFICANT ACCOUN_7
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - STOCK BASED COMPENSATION (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Stock-Based Compensation Expense | ||||
Stock-based compensation expense included in operating expenses | $ 7,204 | $ 2,063 | $ 14,110 | $ 5,813 |
Stock Options | ||||
Stock-Based Compensation Expense | ||||
Stock-based compensation expense included in operating expenses | 3,200 | 3,200 | ||
Research and development | ||||
Stock-Based Compensation Expense | ||||
Stock-based compensation expense included in operating expenses | 2,951 | 932 | 5,847 | 2,799 |
General and administrative | ||||
Stock-Based Compensation Expense | ||||
Stock-based compensation expense included in operating expenses | $ 4,253 | $ 1,131 | $ 8,263 | $ 3,014 |
SUMMARY OF SIGNIFICANT ACCOUN_8
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - STOCK OPTIONS AND EMPLOYEE STOCK PURCHASE PLAN (Details) | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Stock Options | ||
Stock-Based Compensation | ||
Vesting period of awards | 4 years | |
Assumptions used to estimate fair value of awards | ||
Dividend yield (as a percent) | 0% | 0% |
Expected volatility range, minimum (as a percent) | 81.50% | 77.70% |
Expected volatility range, maximum (as a percent) | 82.10% | 81.60% |
Risk-free interest rate range, minimum (as a percent) | 3.42% | 1.69% |
Risk-free interest rate range, maximum (as a percent) | 4.62% | 3.77% |
Expected term | 6 years | 5 years 6 months |
Employee Stock Purchase Plan | ||
Assumptions used to estimate fair value of awards | ||
Dividend yield (as a percent) | 0% | 0% |
Expected volatility range, minimum (as a percent) | 79% | 61.40% |
Expected volatility range, maximum (as a percent) | 83.20% | 86.50% |
Risk-free interest rate range, minimum (as a percent) | 4.73% | 0.40% |
Risk-free interest rate range, maximum (as a percent) | 5.40% | 2.79% |
Employee Stock Purchase Plan | Minimum | ||
Assumptions used to estimate fair value of awards | ||
Expected term | 6 months | 6 months |
Employee Stock Purchase Plan | Maximum | ||
Assumptions used to estimate fair value of awards | ||
Expected term | 12 months | 12 months |
FAIR VALUE MEASUREMENTS - SECUR
FAIR VALUE MEASUREMENTS - SECURITY TYPE (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Included in cash and cash equivalents: | ||
Amortized Cost | $ 16,519 | $ 39,771 |
Estimated Fair Value | 16,519 | 39,771 |
Restricted cash: | ||
Amortized Cost | 536 | 364 |
Estimated Fair Value | 364 | |
Marketable securities: | ||
Amortized Cost | 351,602 | 116,142 |
Gross Unrealized Gains | 9 | 6 |
Gross Unrealized Losses | (972) | (247) |
Estimated Fair Value | 350,639 | 115,901 |
Money market funds | ||
Included in cash and cash equivalents: | ||
Amortized Cost | 12,549 | 39,771 |
Estimated Fair Value | 12,549 | 39,771 |
Restricted cash: | ||
Amortized Cost | 264 | 93 |
Estimated Fair Value | 264 | 93 |
Commercial paper | ||
Included in cash and cash equivalents: | ||
Amortized Cost | 3,970 | |
Estimated Fair Value | 3,970 | |
Certificate of deposit | ||
Restricted cash: | ||
Amortized Cost | 272 | 271 |
Estimated Fair Value | 272 | 271 |
U.S. Treasury securities (due in less than one year) | ||
Marketable securities: | ||
Amortized Cost | 12,983 | |
Gross Unrealized Losses | (62) | |
Estimated Fair Value | 12,921 | |
U.S. Treasury securities - due in 1 to 2 years | ||
Marketable securities: | ||
Amortized Cost | 26,467 | |
Gross Unrealized Gains | 1 | |
Gross Unrealized Losses | (22) | |
Estimated Fair Value | 26,446 | |
Municipal securities (due in less than one year) | ||
Marketable securities: | ||
Amortized Cost | 3,000 | |
Gross Unrealized Losses | (24) | |
Estimated Fair Value | 2,976 | |
Government-sponsored enterprise securities (due in less than one year) | ||
Marketable securities: | ||
Amortized Cost | 94,524 | 9,860 |
Gross Unrealized Gains | 4 | |
Gross Unrealized Losses | (293) | (14) |
Estimated Fair Value | 94,235 | 9,846 |
Government-sponsored enterprise securities (due in one to two years) | ||
Marketable securities: | ||
Amortized Cost | 10,651 | |
Gross Unrealized Losses | (35) | |
Estimated Fair Value | 10,616 | |
Commercial paper (due in less than one year) | ||
Marketable securities: | ||
Amortized Cost | 149,583 | 64,285 |
Gross Unrealized Gains | 1 | 6 |
Gross Unrealized Losses | (280) | (92) |
Estimated Fair Value | 149,304 | 64,199 |
Corporate notes (due in less than one year) | ||
Marketable securities: | ||
Amortized Cost | 39,438 | 26,014 |
Gross Unrealized Gains | 2 | |
Gross Unrealized Losses | (160) | (55) |
Estimated Fair Value | 39,280 | $ 25,959 |
Corporate notes (due in one to two years) | ||
Marketable securities: | ||
Amortized Cost | 30,939 | |
Gross Unrealized Gains | 1 | |
Gross Unrealized Losses | (182) | |
Estimated Fair Value | $ 30,758 |
FAIR VALUE MEASUREMENTS - SEC_2
FAIR VALUE MEASUREMENTS - SECURITIES WITH UNREALIZED LOSSES (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Schedule Of Available For Sale Securities [Line Items] | ||
Less Than 12 Months - Estimated Fair Value | $ 351,581 | $ 75,721 |
Less Than 12 Months - Gross Unrealized Losses | (972) | (165) |
12 Months or Longer - Estimated Fair Value | 28,435 | |
12 Months or Longer - Gross Unrealized Losses | (82) | |
Total - Estimated Fair Value | 351,581 | 104,156 |
Total - Gross Unrealized Losses | (972) | (247) |
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 | 26,446 | 11,424 |
Less Than 12 Months - Gross Unrealized Losses | (22) | (57) |
12 Months or Longer - Estimated Fair Value | 1,497 | |
12 Months or Longer - Gross Unrealized Losses | (5) | |
Total - Estimated Fair Value | 26,446 | 12,921 |
Total - Gross Unrealized Losses | (22) | (62) |
Municipal securities (due in less than one year) | ||
Schedule Of Available For Sale Securities [Line Items] | ||
12 Months or Longer - Estimated Fair Value | 2,976 | |
12 Months or Longer - Gross Unrealized Losses | (24) | |
Total - Estimated Fair Value | 2,976 | |
Total - Gross Unrealized Losses | (24) | |
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 | 94,523 | 9,845 |
Less Than 12 Months - Gross Unrealized Losses | (293) | (14) |
Total - Estimated Fair Value | 94,523 | 9,845 |
Total - Gross Unrealized Losses | (293) | (14) |
Government-sponsored enterprise securities (due in one to two years) | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Less Than 12 Months - Estimated Fair Value | 10,651 | |
Less Than 12 Months - Gross Unrealized Losses | (35) | |
Total - Estimated Fair Value | 10,651 | |
Total - Gross Unrealized Losses | (35) | |
Commercial paper (due in less than one year) | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Less Than 12 Months - Estimated Fair Value | 149,584 | 52,454 |
Less Than 12 Months - Gross Unrealized Losses | (281) | (92) |
Total - Estimated Fair Value | 149,584 | 52,454 |
Total - Gross Unrealized Losses | (281) | (92) |
Corporate notes (due in less than one year) | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Less Than 12 Months - Estimated Fair Value | 39,438 | 1,998 |
Less Than 12 Months - Gross Unrealized Losses | (160) | (2) |
12 Months or Longer - Estimated Fair Value | 23,962 | |
12 Months or Longer - Gross Unrealized Losses | (53) | |
Total - Estimated Fair Value | 39,438 | 25,960 |
Total - Gross Unrealized Losses | (160) | $ (55) |
Corporate notes (due in one to two years) | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Less Than 12 Months - Estimated Fair Value | 30,939 | |
Less Than 12 Months - Gross Unrealized Losses | (181) | |
Total - Estimated Fair Value | 30,939 | |
Total - Gross Unrealized Losses | $ (181) |
FAIR VALUE MEASUREMENTS - RECUR
FAIR VALUE MEASUREMENTS - RECURRING BASIS (Details) - Recurring basis - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Fair Value on a Recurring Basis | ||
Total | $ 367,694 | $ 156,036 |
Money market funds | ||
Fair Value on a Recurring Basis | ||
Total | 12,813 | 39,864 |
Certificate of deposit | ||
Fair Value on a Recurring Basis | ||
Total | 272 | 271 |
U.S. Treasury securities | ||
Fair Value on a Recurring Basis | ||
Total | 26,446 | 12,921 |
Municipal securities | ||
Fair Value on a Recurring Basis | ||
Total | 2,976 | |
Government-sponsored enterprise securities | ||
Fair Value on a Recurring Basis | ||
Total | 104,852 | 9,846 |
Commercial paper | ||
Fair Value on a Recurring Basis | ||
Total | 153,274 | 64,199 |
Corporate notes | ||
Fair Value on a Recurring Basis | ||
Total | 70,037 | 25,959 |
Level 1 | ||
Fair Value on a Recurring Basis | ||
Total | 13,085 | 40,135 |
Level 1 | Money market funds | ||
Fair Value on a Recurring Basis | ||
Total | 12,813 | 39,864 |
Level 1 | Certificate of deposit | ||
Fair Value on a Recurring Basis | ||
Total | 272 | 271 |
Level 2 | ||
Fair Value on a Recurring Basis | ||
Total | 354,609 | 115,901 |
Level 2 | U.S. Treasury securities | ||
Fair Value on a Recurring Basis | ||
Total | 26,446 | 12,921 |
Level 2 | Municipal securities | ||
Fair Value on a Recurring Basis | ||
Total | 2,976 | |
Level 2 | Government-sponsored enterprise securities | ||
Fair Value on a Recurring Basis | ||
Total | 104,852 | 9,846 |
Level 2 | Commercial paper | ||
Fair Value on a Recurring Basis | ||
Total | 153,274 | 64,199 |
Level 2 | Corporate notes | ||
Fair Value on a Recurring Basis | ||
Total | $ 70,037 | $ 25,959 |
ACCRUED LIABILITIES (Details)
ACCRUED LIABILITIES (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Payables and Accruals [Abstract] | ||
CRO and clinical trial costs | $ 18,271 | $ 17,040 |
Manufacturing activities | 13,066 | 5,321 |
Legal settlements | 7,000 | 8,350 |
Professional legal and accounting fees | 718 | 1,318 |
Interest payable | 594 | 561 |
Other | 2,213 | 510 |
Accrued liabilities | $ 41,862 | $ 33,100 |
DEBT - Additional Information (
DEBT - Additional Information (Details) - Hercules and Silicon Valley Bank [Member] - USD ($) | Jun. 30, 2022 | Jun. 01, 2022 | Sep. 30, 2023 | Sep. 30, 2020 |
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 | |||
Available remaining loan committed principal | 55,000,000 | |||
Carrying value of term loan, net | 51,898,000 | |||
Unamortized debt discount and issuance costs | 408,000 | |||
Accrued end of term charge | $ 2,306,000 | |||
Prepayment charge (as a percentage) | 1.50% | |||
Charge for prepayment occurring 36 months after effective date | $ 0 | |||
Description of term loan payment terms | Under the Loan Agreement, 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 | |||
Tranche One [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 | |||
Tranche Two [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 | |||
Tranche Three [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 | |||
Option One Min Cash Debt Covenant [Member] | ||||
Debt Instrument [Line Items] | ||||
Minimum cash balance as a percentage of loan amount outstanding | 40% | |||
Option Two Min Cash Debt Covenant [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 | |||
Option Three Min Cash Debt Covenant [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 |
DEBT - Future Minimum Payments
DEBT - Future Minimum Payments Under Loan Agreement (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Debt Disclosure [Abstract] | ||
Remainder of 2023 | $ 1,801 | |
2024 | 39,362 | |
2025 | 20,056 | |
Total | 61,219 | |
Less: amount representing interest | (7,944) | |
Less: unamortized debt discounts and issuance costs | (408) | |
Less: unaccrued end of term charge | (969) | |
Less: current portion of debt | (22,060) | |
Noncurrent portion of debt | $ 29,838 | $ 30,212 |
CONTINGENCIES AND UNCERTAINTI_2
CONTINGENCIES AND UNCERTAINTIES - Litigation Settlement (Details) - Insurance Claims - USD ($) | 3 Months Ended | ||||
Dec. 21, 2022 | Sep. 02, 2022 | Jun. 30, 2023 | Sep. 30, 2023 | Dec. 31, 2022 | |
Class Action Stipulation | |||||
Loss Contingencies [Line Items] | |||||
Settlement agreement date | September 2, 2022 | ||||
Litigation settlement, amount | $ 24,000,000 | ||||
Litigation settlement amount, Accrued liabilities recognized | $ 7,000,000 | $ 7,000,000 | |||
Settlement paid in cash by insurers | 17,000,000 | ||||
Settlement to be paid in cash or shares as elected by company | $ 7,000,000 | ||||
Derivative Stipulation | |||||
Loss Contingencies [Line Items] | |||||
Litigation settlement, amount | $ 1,350,000 | ||||
Litigation settlement amount, Accrued liabilities recognized | $ 1,350,000 | ||||
Settlement paid in cash by insurers | $ 525,000 | ||||
Settlement paid in cash by company | $ 825,000 |
CONTINGENCIES AND UNCERTAINTI_3
CONTINGENCIES AND UNCERTAINTIES - Severance Plan (Details) | 9 Months Ended |
Sep. 30, 2023 | |
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 |
STOCKHOLDERS' EQUITY - PUBLIC O
STOCKHOLDERS' EQUITY - PUBLIC OFFERING (Details) - 2023 Public Offering | Jan. 10, 2023 USD ($) $ / shares shares |
Public Offering [Line Items] | |
Issuance of common stock in connection with public offering (in shares) | shares | 68,007,741 |
Net cash proceeds from public offering after deducting underwriting discount and other offering expenses | $ | $ 213,337,000 |
Common Stock | |
Public Offering [Line Items] | |
Public offering price of common stock per share | $ 2.45 |
2023 Pre-funded Warrant | |
Public Offering [Line Items] | |
Public offering price per share | 2.449 |
Warrant exercise price | $ 0.001 |
STOCKHOLDERS' EQUITY - WARRANT
STOCKHOLDERS' EQUITY - WARRANT EXERCISES (Details) - USD ($) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Sep. 30, 2023 | Sep. 30, 2022 | |
Class of Warrant or Right [Line Items] | |||||
Proceeds from exercise of warrants | $ 105,912,000 | $ 3,638,000 | |||
Pre-Funded Warrants | |||||
Class of Warrant or Right [Line Items] | |||||
Warrant exercise price | $ 0.001 | $ 0.001 | |||
Common stock outstanding warrants to purchase | 51,430,477 | 51,430,477 | |||
2020 Public Offering of Common Stock and Warrants | Stock Purchase Warrants | |||||
Class of Warrant or Right [Line Items] | |||||
Warrant exercise price | $ 1.3 | $ 1.3 | |||
Common stock outstanding warrants to purchase | 2,474,503 | 2,474,503 | |||
Underwritten Public Offering | Stock Purchase Warrants | |||||
Class of Warrant or Right [Line Items] | |||||
Warrants to purchase common stock exercised, shares | 19,523,808 | 12,842,857 | 44,983,194 | 19,523,808 | |
Proceeds from exercise of warrants | $ 28,309,522 | $ 17,767,000 | $ 59,835,000 |
STOCKHOLDERS' EQUITY - 2023 At
STOCKHOLDERS' EQUITY - 2023 At Market Issuance Sales Agreement (Details) - 2023 Sales Agreement - Subsequent Event | Nov. 01, 2023 USD ($) |
At Market Issuance Sales Agreements [Line Items] | |
Aggregate offering price of common stock | $ 100,000,000 |
Maximum commission rate (as a percent) | 3% |