Document And Entity Information
Document And Entity Information - shares | 3 Months Ended | |
Mar. 31, 2023 | May 02, 2023 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Mar. 31, 2023 | |
Current Fiscal Year End Date | --12-31 | |
Document Transition Report | false | |
Entity File Number | 001-36860 | |
Entity Registrant Name | IOVANCE BIOTHERAPEUTICS, INC. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 75-3254381 | |
Entity Address, Address Line One | 825 Industrial Road, Suite 400 | |
Entity Address, City or Town | San Carlos | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 94070 | |
City Area Code | 650 | |
Local Phone Number | 260-7120 | |
Title of 12(b) Security | Common Stock, par value $0.000041666 | |
Trading Symbol | IOVA | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 224,448,554 | |
Entity Central Index Key | 0001425205 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q1 | |
Amendment Flag | false |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Current Assets | ||
Cash and cash equivalents | $ 543,484 | $ 231,731 |
Short-term investments | 82,808 | 240,114 |
Prepaid expenses and other assets | 11,489 | 7,271 |
Total Current Assets | 637,781 | 479,116 |
Property and equipment, net | 109,923 | 105,232 |
Operating lease right-of-use assets | 70,431 | 73,015 |
Restricted cash | 6,430 | 6,430 |
Long-term assets | 202 | 189 |
Total Assets | 824,767 | 663,982 |
Current Liabilities | ||
Accounts payable | 31,572 | 26,603 |
Accrued expenses | 43,088 | 52,295 |
Operating lease liabilities | 12,614 | 12,587 |
Total Current Liabilities | 87,274 | 91,485 |
Non-Current Liabilities | ||
Operating lease liabilities - non-current | 69,612 | 71,859 |
Long-term note payable | 1,000 | 1,000 |
Total Non-Current Liabilities | 70,612 | 72,859 |
Total Liabilities | 157,886 | 164,344 |
Commitments and contingencies | ||
Stockholders' Equity | ||
Common stock, $0.000041666 par value; 300,000,000 shares authorized, 224,358,979 and 157,004,742 shares issued and outstanding as of March 31, 2023 and December 31, 2022, respectively | 9 | 8 |
Accumulated other comprehensive loss | (126) | (902) |
Additional paid-in capital | 2,342,703 | 2,068,867 |
Accumulated deficit | (1,675,708) | (1,568,338) |
Total Stockholders' Equity | 666,881 | 499,638 |
Total Liabilities and Stockholders' Equity | 824,767 | 663,982 |
Series A Convertible Preferred Stock | ||
Stockholders' Equity | ||
Preferred stock, Value | 0 | 0 |
Series B Convertible Preferred Stock | ||
Stockholders' Equity | ||
Preferred stock, Value | $ 3 | $ 3 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets - $ / shares | Mar. 31, 2023 | Dec. 31, 2022 |
Common stock, par or stated value per share | $ 0.000041666 | $ 0.000041666 |
Common stock, shares authorized | 300,000,000 | 300,000,000 |
Common Stock, Shares, Issued | 224,358,979 | 187,812,072 |
Common Stock, Shares, Outstanding | 224,358,979 | 187,812,072 |
Series A Convertible Preferred Stock | ||
Preferred stock, par or stated value per share | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 17,000 | 17,000 |
Preferred Stock, Shares Issued | 194 | 194 |
Preferred stock, shares outstanding | 194 | 194 |
Series B Convertible Preferred Stock | ||
Preferred stock, par or stated value per share | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 11,500,000 | 11,500,000 |
Preferred Stock, Shares Issued | 2,842,158 | 2,842,158 |
Preferred stock, shares outstanding | 2,842,158 | 2,842,158 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Costs and expenses | ||
Research and development | $ 82,734 | $ 68,300 |
General and administrative | 28,122 | 23,413 |
Total costs and expenses | 110,856 | 91,713 |
Loss from operations | (110,856) | (91,713) |
Other income | ||
Interest income, net | 3,486 | 106 |
Net Loss | $ (107,370) | $ (91,607) |
Net Loss Per Share of Common Stock, Basic | $ (0.50) | $ (0.58) |
Net Loss Per Share of Common Stock, Diluted | $ (0.50) | $ (0.58) |
Weighted Average Shares of Common Stock Outstanding, Basic | 213,694 | 157,113 |
Weighted Average Shares of Common Stock Outstanding, Diluted | 213,694 | 157,113 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Condensed Consolidated Statements of Comprehensive Loss | ||
Net Loss | $ (107,370) | $ (91,607) |
Other comprehensive loss: | ||
Unrealized gain/(loss) on investments | 776 | (1,742) |
Comprehensive Loss | $ (106,594) | $ (93,349) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Series A Convertible Preferred Stock Preferred Stock | Series B Convertible Preferred Stock Preferred Stock | Common Stock | Additional Paid-In Capital | Accumulated Comprehensive Income | Accumulated Deficit | Total |
Beginning Balance at Dec. 31, 2021 | $ 3 | $ 7 | $ 1,794,695 | $ (601) | $ (1,172,445) | $ 621,659 | |
Beginning Balance (in Shares) at Dec. 31, 2021 | 194 | 2,842,158 | 157,004,742 | ||||
Stock-based compensation expense | 22,265 | 22,265 | |||||
Common stock issued upon exercise of stock options | 1,417 | 1,417 | |||||
Common stock issued upon exercise of stock options (in shares) | 163,579 | ||||||
Unrealized gain/(loss) on investments | (1,742) | (1,742) | |||||
Net loss | (91,607) | (91,607) | |||||
Ending Balance at Mar. 31, 2022 | $ 3 | $ 7 | 1,818,377 | (2,343) | (1,264,052) | 551,992 | |
Ending Balance (in Shares) at Mar. 31, 2022 | 194 | 2,842,158 | 157,168,321 | ||||
Beginning Balance at Dec. 31, 2022 | $ 3 | $ 8 | 2,068,867 | (902) | (1,568,338) | 499,638 | |
Beginning Balance (in Shares) at Dec. 31, 2022 | 194 | 2,842,158 | 187,812,072 | ||||
Stock-based compensation expense | 15,665 | 15,665 | |||||
Vesting of restricted shares issued for services (in shares) | 770,257 | ||||||
Tax payments related to shares retired for vested restricted stock units | (1,929) | (1,929) | |||||
Tax payments related to shares retired for vested restricted stock units (Shares) | (303,576) | ||||||
Common stock sold in public offering, net of offering costs | $ 1 | 260,100 | 260,101 | ||||
Common stock sold in public offering, net of offering costs (in shares) | 36,080,226 | ||||||
Unrealized gain/(loss) on investments | 776 | 776 | |||||
Net loss | (107,370) | (107,370) | |||||
Ending Balance at Mar. 31, 2023 | $ 3 | $ 9 | $ 2,342,703 | $ (126) | $ (1,675,708) | $ 666,881 | |
Ending Balance (in Shares) at Mar. 31, 2023 | 194 | 2,842,158 | 224,358,979 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Cash Flows from Operating Activities | ||
Net loss | $ (107,370) | $ (91,607) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation expense | 15,665 | 22,265 |
Amortization of right of use asset | 2,933 | 3,181 |
Depreciation and amortization | 2,764 | 1,797 |
Accretion of discounts and premiums on investments | (978) | 541 |
Loss on write-off of fixed assets | 0 | 314 |
Changes in assets and liabilities: | ||
Prepaid expenses, other assets and long-term assets | (4,231) | (3,715) |
Operating lease liabilities, net of tenant improvement allowance received | (2,569) | 690 |
Accounts payable | 3,025 | (2,104) |
Accrued expenses and other liabilities | (9,054) | (5,164) |
Net cash used in operating activities | (99,815) | (73,802) |
Cash Flows from Investing Activities | ||
Maturities of investments | 164,383 | 143,508 |
Purchase of investments | (5,323) | (45,552) |
Purchase of property and equipment | (5,664) | (11,440) |
Net cash provided by / (used in) investing activities | 153,396 | 86,516 |
Cash Flows from Financing Activities | ||
Tax payments related to shares withheld for vested restricted stock units | (1,929) | 0 |
Proceeds from the issuance of common stock upon exercise of options | 0 | 1,417 |
Proceeds from the issuance of common stock, net | 260,101 | 0 |
Net cash provided by financing activities | 258,172 | 1,417 |
Net increase in cash, cash equivalents and restricted cash | 311,753 | 14,131 |
Cash, Cash Equivalents and Restricted Cash Beginning of Period | 238,161 | 84,313 |
Cash, Cash Equivalents and Restricted Cash End of Period | 549,914 | 98,444 |
Supplemental disclosure of non-cash investing and financing activities: | ||
Net unrealized loss on investments | 776 | (1,742) |
Acquisition of property and equipment included in accounts payable and accrued expenses | 7,777 | 4,900 |
Lease liabilities arising from obtaining right-of-use asset from lease modifications | $ 349 | $ 7,673 |
GENERAL ORGANIZATION, BUSINESS
GENERAL ORGANIZATION, BUSINESS AND LIQUIDITY | 3 Months Ended |
Mar. 31, 2023 | |
GENERAL ORGANIZATION, BUSINESS AND LIQUIDITY | |
GENERAL ORGANIZATION, BUSINESS AND LIQUIDITY | NOTE 1. GENERAL ORGANIZATION, BUSINESS AND LIQUIDITY General Organization and Business Iovance Biotherapeutics, Inc. (the “Company”) is a clinical-stage biopharmaceutical company pioneering a transformational approach to treating cancer by harnessing the human immune system’s ability to recognize and destroy diverse cancer cells using therapies personalized for each patient. The Company’s mission is to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (“TIL”) therapies for patients with solid tumor cancers. The Company’s autologous TIL therapy platform uses a centralized, scalable, and proprietary 22-day manufacturing process to grow polyclonal T-cells unique to each patient and yields a cryopreserved, individualized therapy. The Company is currently conducting clinical trials to investigate multiple TIL therapies for multiple indications, including its lead product candidate, lifileucel, for advanced, or metastatic or unresectable, melanoma. The Company completed a rolling Biologics License Application (“BLA”) submission to the U.S. Food and Drug Administration (“FDA”) for lifileucel in March 2023. The Company is also pursuing registrational strategies for lifileucel in advanced cervical cancer and for its TIL therapy LN-145 in metastatic non-small cell lung cancer (“NSCLC”). In addition, the Company is investigating next generation approaches to optimize TIL products, manufacturing processes and treatment regimens, including a first-in-human clinical trial of its lead genetically modified TIL therapy, IOV-4001. The Company is also exploring a 16-day manufacturing process, tumor tissue procurement via core biopsy, additional genetically modified TIL therapies including multiple immune checkpoint gene edits and cytokine-tethered TIL therapies, as well as, a novel interleukin-2 (“IL-2”) analog, designated IOV-3001, as potential avenues to improve manufacturing timelines, sample collection and supportive treatments involved in the overall TIL therapy process and treatment regimen. Basis of Presentation of Unaudited Condensed Consolidated Financial Information The accompanying unaudited Condensed Consolidated Financial Statements of the Company for the three months ended March 31, 2023 and 2022 have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information and pursuant to the requirements for reporting on Form 10-Q and Regulation S-X. Accordingly, they do not include all the information and footnotes required by GAAP for audited financial statements. However, such information reflects all adjustments (consisting solely of normal recurring adjustments), which are, in the opinion of management, necessary for the fair presentation of the Company's financial position and results of operations. Results shown for interim periods are not necessarily indicative of the results that may be expected for the year ended December 31, 2023 or for any other period. The Condensed Consolidated Balance Sheet as of December 31, 2022 was derived from the audited consolidated financial statements included in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on February 28, 2023. These interim financial statements should be read in conjunction with that report. Certain prior period amounts reported in the Company’s Condensed Consolidated Financial Statements and accompanying notes have been reclassified to conform to the current period presentation. Liquidity The Company is currently engaged in the development of therapeutics to fight cancer, specifically solid tumors. The Company currently does not have any commercial products and has not yet generated any revenues from its business. With the completion of the rolling BLA for lifileucel for advanced melanoma in March 2023 and the expected completion of the closing of the acquisition of the worldwide rights to Proleukin ® The Company expects to continue to incur significant expenses to support its research and development activities, on-going pre-commercial activities and completion of the construction of tenant improvements for the Iovance Cell Therapy Center (the “ i scientific staff and continuation of pre-commercial activities. Based on the funds the Company has available as of the date these consolidated financial statements are issued, the Company believes that it has sufficient capital to fund its anticipated operating expenses and capital expenditures, and the Proleukin® acquisition, as planned for at least the next twelve months from the date these consolidated financial statements are issued. Concentrations of Risk The Company is subject to credit risk from its portfolio of cash, cash equivalents and investments. Under its investment policy, the Company limits amounts invested in securities by credit rating, maturity, industry group, investment type and issuer, except for securities issued by the U.S. government. The Company does not believe it is exposed to any significant concentrations of credit risk from these financial instruments. The goals of its investment policy are safety and preservation of principal, diversification of risk, and liquidity of investments sufficient to meet cash flow requirements. |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 3 Months Ended |
Mar. 31, 2023 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | NOTE 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Cash, Cash Equivalents, and Investments The Company’s cash and cash equivalents include short-term investments with original maturities of three months or less when purchased. The Company's investments are classified as “available-for-sale.” The Company includes these investments in current assets or non-current assets in the Condensed Consolidated Balance Sheets based on the length of maturity from the reporting date and carries them at fair value. Unrealized gains and losses on available-for-sale securities are recorded in accumulated other comprehensive loss. Impairment losses related to credit losses (if any) are recorded as an allowance for credit losses with an offsetting entry to Interest income, net. No impairment losses related to credit losses were recognized for the three months ended March 31, 2023 and 2022. The cost of debt securities is adjusted for the amortization of premiums and accretion of discounts to maturity. Such amortization and accretion are included in Interest income, net in the Condensed Consolidated Statements of Operations. Gains and losses on securities sold are recorded based on the specific identification method and are included in Interest income, net in the Condensed Consolidated Statements of Operations. The Company has not incurred any realized gains or losses from sales of securities to date. The Company’s investment policy limits investments to certain types of instruments such as certificates of deposit, money market instruments, obligations issued by the U.S. government and U.S. government agencies as well as corporate debt securities and commercial paper, and places restrictions on maturities and concentration by type and issuer, except for securities issued by the U.S. government. Restricted Cash The Company maintains a required minimum balance in a segregated bank account in connection with its letters of credit for which amounts are restricted as to their use by the Company. Currently, the Company’s letters of credit are primarily comprised of one for the benefit of the landlord for the i The following table provides a reconciliation of cash, cash equivalents, and restricted cash, reported within the Condensed Consolidated Balance Sheets that sum to the total of the same such amounts shown in the Condensed Consolidated Statements of Cash Flows (in thousands): March 31, 2023 2022 Cash and cash equivalents $ 543,484 $ 92,360 Restricted cash 6,430 6,084 Total cash, cash equivalents and restricted cash $ 549,914 $ 98,444 Net Loss per Share Basic net loss per share is computed by dividing the net loss by the weighted average number of common shares outstanding during the period. Diluted net loss per share is computed by dividing the net loss by the sum of the weighted average number of shares of common stock outstanding and the dilutive common stock equivalents outstanding during the period. The Company’s potentially dilutive common stock equivalent shares, which include incremental common shares issuable upon (i) the exercise of outstanding stock options, (ii) purchases though the 2020 Employee Stock Purchase Plan (the “2020 ESPP”), (iii) vesting of restricted stock units, and (iv) conversion of preferred stock, are only included in the calculation of diluted net loss per share when their effect is dilutive. As of March 31, 2023 and 2022, the following outstanding common stock equivalents have been excluded from the calculation of net loss per share because their impact would be anti-dilutive: March 31, 2023 2022 Stock options 19,264,017 14,101,526 Employee Stock Purchase Plan 247,284 86,448 Restricted stock units 3,910,457 3,095,177 Series A Convertible Preferred Stock* 97,000 97,000 Series B Convertible Preferred Stock* 2,842,158 2,842,158 26,360,916 20,222,309 * on an as-converted basis The dilutive effect of potentially dilutive securities would be reflected in diluted earnings per common share by application of the treasury stock method. Under the treasury stock method, an increase in the fair market value of the Company's common stock could result in a greater dilutive effect from potentially dilutive securities. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates. Significant items subject to such estimates and assumptions include assumptions made in the fair value of equity awards and related stock-based compensation, assumptions used in measuring operating right-of-use assets and operating lease liabilities, accounting for potential liabilities, including estimates inherent in accruals related to clinical trials, and the realizability of the Company’s deferred tax assets . Principles of Consolidation The accompanying Condensed Consolidated Financial Statements include the accounts of Iovance Biotherapeutics, Inc. and its wholly-owned subsidiaries, Iovance Biotherapeutics Manufacturing LLC, Iovance Biotherapeutics GmbH, Iovance Biotherapeutics B.V ., Iovance Biotherapeutics UK LTD, and Iovance Biotherapeutics Canada, Inc. All intercompany accounts and transactions have been eliminated. The Condensed Consolidated Financial Statements are presented in U.S. dollars. The functional currency for most of the Company’s foreign subsidiaries is their respective local currency. Leases The Company determines if an arrangement includes a lease at inception and thereafter, if modified. Operating leases are included in its Condensed Consolidated Balance Sheets as Operating lease right-of-use assets and Operating lease liabilities as of March 31, 2023 and December 31, 2022. Operating lease right-of-use assets represent the Company’s right to use an underlying asset for the lease term and operating lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Operating lease right-of-use assets and liabilities are recognized at the lease commencement date or modification date based on the present value of lease payments over the lease term. In determining the net present value of lease payments, the Company uses an estimated incremental borrowing rate that is applicable to the Company based on the information available at the later of the lease commencement or modification date. The operating lease right-of-use assets also include any lease payments made less lease incentives. The Company’s leases may include options to extend or terminate the lease, which is considered in the lease term when it is reasonably certain that the Company will exercise any such options. Lease expense is recognized on a straight-line basis over the expected lease term and recorded in costs and expenses in the Condensed Consolidated Statements of Operations. The Company has elected not to apply the recognition requirements of Accounting Standards Update (“ASU”) No. 2016-02 and No. 2018-10 (together “Topic 842”) for short-term leases. For lease agreements entered into by the Company that include lease and non-lease components, such components are generally accounted for separately. Stock-Based Compensation The Company periodically grants stock options to employees and non-employees as compensation for services rendered. The Company accounts for all stock-based payment awards made to employees, including the employee stock purchase plans, and non-employees in accordance with the authoritative guidance provided by the Financial Accounting Standards Board (“FASB”) where the value of the award is measured on the date of grant and recognized over the vesting period. Forfeitures are recognized in the period in which they occur. The Company accounts for stock option grants to non-employees in a similar manner as stock option grants to employees except for the term used in the grant date fair value, therefore no longer requiring a re-measurement at the then-current fair values at each reporting date until the shares underlying the options have vested. The non-employee awards that contain a performance condition that affects the quantity or other terms of the award are measured based on the outcome that is probable. The fair value of the Company's common stock option grants is estimated using a Black-Scholes option pricing model, which uses certain assumptions related to risk-free interest rates, expected volatility, expected term of the common stock options, and future dividends. The stock-based compensation expense is recorded based upon the value derived from the Black-Scholes option pricing model. The assumptions used in the Black-Scholes option pricing model could affect compensation expense recorded in future periods. The Company issues restricted stock units (“RSUs”) from time to time as part of its equity incentive plans. The Company measures the compensation cost with respect to RSUs issued to employees based upon the estimated fair value of the equity instruments at the date of the grant, which is recognized as an expense over the period during which an employee is required to provide services in exchange for the awards. The fair value of RSUs is based on the closing price of the Company’s common stock on the grant date. In addition to RSUs that have time-based vesting requirements, from time to time the Company may issue RSUs that include certain performance vesting criteria based upon the satisfaction of stated objectives (“PRSUs”). The Company measures the compensation cost with respect to PRSUs issued to employees based upon the estimated fair value of the equity instruments at the date of grant, which is recognized as an expense over the period that achievement is determined to be probable through the stated service period associated with the award. Accrued Research and Development Costs Research and development costs are expensed as incurred. Clinical development costs compose a significant component of research and development costs. The Company has a history of contracting with third parties, including contract research organizations (“CROs”), independent clinical investigators, and contract manufacturing organizations (“CMOs”) that perform various clinical trial activities on the Company’s behalf in connection with the ongoing development of the Company’s product candidates. The financial terms of these contracts are subject to negotiations and may vary from contract to contract and may result in uneven payment flow. The Company accrues and expenses costs for clinical trial activities performed by third parties based upon estimates of work completed to date for each clinical trial in accordance with agreements established with CROs, hospitals, and clinical investigators. Accruals for CROs and CMOs are recorded based on estimates of services received and efforts expended pursuant to agreements established with CROs, CMOs and other outside service providers. The Company determines its estimates through discussions with internal clinical stakeholders and outside service providers as to the progress or stage of completion of clinical trials or services and the contracted fee to be paid for such services. Included in the Company’s clinical development costs are investigator costs, which are costs associated with treatments administered at clinical sites as required under each clinical study protocol. The Company’s estimates for clinical investigator costs and timing of expense recognition will depend on a number of factors that include, but are not limited to, (i) the overall number of patients that enroll in the trial at each individual site, (ii) the length of study enrollment period, (iii) discontinuation and completion rates of patients, (iv) duration of patient safety follow-ups, (v) the number of sites included in the clinical trial, and (vi) the contracted fee of each participating site for patient treatment while on study, which can vary greatly for several reasons including, but not limited to, geographic region, medical center or physician costs, and overhead costs. In addition, the Company’s estimates for per patient trial costs will vary based on a number of factors that include, but are not limited to, the extent of additional treatments that may be administered by investigators as a result of patient health status, recoverability of patient costs through insurance carriers of patients, and unanticipated cost of injuries incurred as a result of the study treatment. The Company accrues for estimated expenses resulting from obligations under investigator site agreements as the timing of payments does not always timely align with the periods over which the treatments are administered by the clinical investigators. These estimates are typically based on contracted amounts, patient visit data, discussions with internal clinical stakeholders and outside service providers, and historical look-back analysis of actual payments made to date. The Company makes judgements and estimates in determining the accrual balance in each reporting period. In the event advance payments are made to a CRO, CMO or other outside service provider, the payments are recorded within prepaid expenses and other current assets in the Condensed Consolidated Balance Sheets and subsequently recognized as research and development expense in the Condensed Consolidated Statements of Operations when the associated services have been performed. As actual costs become known, the Company adjusts its estimates, liabilities and assets. Inputs used in the determination of estimates discussed above may vary from actual, which will result in adjustments to research and development expense in future periods. Changes in these estimates that result in material changes to the Company’s accruals could materially affect its results of operations. The Company’s historical estimates have not been materially different from actual amounts recorded. Segment Reporting The Company operates in one segment, focused on innovating, developing and commercializing therapies using autologous TIL for the treatment of advanced melanoma and other solid tumor cancers. |
CASH EQUIVALENTS, INVESTMENTS A
CASH EQUIVALENTS, INVESTMENTS AND FAIR VALUE MEASUREMENTS | 3 Months Ended |
Mar. 31, 2023 | |
CASH EQUIVALENTS, INVESTMENTS AND FAIR VALUE MEASUREMENTS | |
CASH EQUIVALENTS, INVESTMENTS AND FAIR VALUE MEASUREMENTS | NOTE 3. CASH EQUIVALENTS, INVESTMENTS AND FAIR VALUE MEASUREMENTS The amortized cost and fair value of cash equivalents and investments as of March 31, 2023 and December 31, 2022 were as follows (in thousands): Gross Gross Amortized Unrealized Unrealized As of March 31, 2023 Cost Gains Losses Fair Value U.S. treasury securities $ 45,212 $ — $ (117) $ 45,095 Commercial paper 38,716 — (9) 38,707 Money market funds 284,486 — — 284,486 Total investments $ 368,414 $ — $ (126) $ 368,288 Gross Gross Amortized Unrealized Unrealized As of December 31, 2022 Cost Gains Losses Fair Value U.S. treasury securities $ 118,570 $ — $ (850) $ 117,720 U.S. government agency securities 11,272 — (7) 11,265 Corporate securities 7,230 — — 7,230 Commercial paper 148,299 8 (53) 148,254 Money market funds 88,001 — — 88,001 Total investments $ 373,372 $ 8 $ (910) $ 372,470 The fair value of cash equivalents and investments as of March 31, 2023 and December 31, 2022 are classified as follows in the Company’s Consolidated Balance Sheets (in thousands): March 31, December 31, Classified as: 2023 2022 Cash equivalents $ 285,480 $ 132,356 Short-term investments 82,808 240,114 Total investments $ 368,288 $ 372,470 Cash equivalents in the tables above exclude cash demand deposits of $258.0 Unrealized gains and losses are included in accumulated other comprehensive loss, and as of no unrealized losses on available-for-sale securities have resulted from credit risk. All available-for-sale securities held as of had contractual maturities of less than one year. The amount of unrealized losses on available-for-sale securities that have been in a continuous unrealized loss position for more than 12 months, held as of the periods presented, was immaterial. The Company determined that it has the ability and intent to hold all marketable securities that have been in a continuous loss position for more than 12 months until maturity or recovery. To date, the Company has not recorded any impairment charges on its marketable securities. Recurring Fair Value Measurements As of March 31, 2023 and December 31, 2022, the fair value of the Company’s financial assets that are measured at fair value on a recurring basis, which consist of cash equivalents and short-term and long-term investments classified as available-for-sale securities, are categorized in the table below based upon the lowest level of significant input to the valuations (in thousands): Assets at Fair Value as of March 31, 2023 Level 1 Level 2 Level 3 Total U.S. treasury securities $ 45,095 $ — $ — $ 45,095 Commercial paper — 38,707 — 38,707 Money market funds 284,486 — — 284,486 Total $ 329,581 $ 38,707 $ — $ 368,288 Assets at Fair Value as of December 31, 2022 Level 1 Level 2 Level 3 Total U.S. treasury securities $ 117,720 $ — $ — $ 117,720 U.S. government agency securities — 11,265 — 11,265 Corporate securities — 7,230 — 7,230 Commercial paper — 148,254 — 148,254 Money market funds 88,001 — — 88,001 Total $ 205,721 $ 166,749 $ — $ 372,470 Level 2 assets consist of commercial paper and government agency securities. Level 2 inputs for the valuations are limited to quoted prices for similar assets or liabilities in active markets and inputs other than quoted prices that are observable for the asset. |
PROPERTY AND EQUIPMENT, NET
PROPERTY AND EQUIPMENT, NET | 3 Months Ended |
Mar. 31, 2023 | |
PROPERTY AND EQUIPMENT, NET | |
PROPERTY AND EQUIPMENT, NET | NOTE 4. PROPERTY AND EQUIPMENT, NET Property and equipment, net consists of the following (in thousands): March 31, December 31, 2023 2022 Leasehold improvements $ 75,016 $ 74,305 Lab, process, and validation equipment 22,448 22,136 Utility equipment 5,990 5,951 Office furniture and equipment 3,138 2,927 Computer software 6,736 6,736 Computer equipment 695 695 Machinery and equipment 251 82 Construction in progress 15,023 9,118 Total property and equipment, cost 129,297 121,950 Less: Accumulated depreciation and amortization (19,374) (16,718) Property and equipment, net $ 109,923 $ 105,232 Depreciation expense for the three months ended March 31, 2023 and 2022, was $2.8 million, respectively. |
ACCRUED EXPENSES
ACCRUED EXPENSES | 3 Months Ended |
Mar. 31, 2023 | |
ACCRUED EXPENSES | |
ACCRUED EXPENSES | NOTE 5. ACCRUED EXPENSES Accrued expenses consist of the following (in thousands): March 31, December 31, 2023 2022 Accrued payroll and employee related expenses $ 13,904 $ 19,407 Clinical related 10,578 14,812 Manufacturing related 5,004 4,652 Facilities related 6,652 6,510 Legal and related services 2,660 3,015 Other accrued expenses 4,290 3,899 Total accrued expenses $ 43,088 $ 52,295 |
STOCKHOLDERS' EQUITY
STOCKHOLDERS' EQUITY | 3 Months Ended |
Mar. 31, 2023 | |
STOCKHOLDERS' EQUITY | |
STOCKHOLDERS' EQUITY | NOTE 6. STOCKHOLDERS’ EQUITY Common Stock The Company’s certificate of incorporation, as amended, authorizes the issuance of up to 300,000,000 shares of the Company’s common stock, par value $0.000041666. As of March 31, 2023, 224,358,979 shares of the Company’s common stock were issued and outstanding At the Market Offering Program On February 8, 2021, the Company entered into an Open Market Sale Agreement (the “ First Pursuant to the Sales Agreements, Jefferies may sell the Common Shares by any method permitted by law deemed to be an “at the market” offering as defined in Rule 415 of the Securities Act of 1933, as amended. Jefferies will use commercially reasonable efforts consistent with its normal trading and sales practices to sell the Common Shares from time to time, based upon instructions from the Company (including any price or size limits or other customary parameters or conditions the Company may impose). The Company will pay Jefferies a commission of up to 3.0% of the gross sales proceeds of any Common Shares sold through Jefferies under the Sales Agreements. The Company is not obligated to make any sales of Common Shares under the Sales Agreements. The offering of Common Shares pursuant to the Sales Agreements will terminate upon the earlier to occur of (i) the issuance and sale, through Jefferies, of all Common Shares subject to the Sales Agreements and (ii) termination of the Sales Agreements in accordance with its terms. For the three months ended March 31, 2023, the Company received approximately $260.1 million in net proceeds, net of offering costs, through the sale of 36,080,226 shares of its common stock through the Sales Agreements at a weighted average price per share of $7.35. No sales were made pursuant to the Sales Agreements during the three months ended March 31, 2022. Preferred Stock The Company’s certificate of incorporation authorizes the issuance of up to 50,000,000 shares of “blank check” preferred stock. As of March 31, 2023, 17,000 shares were designated as Series A Convertible Preferred Stock (“Series A Convertible Preferred Stock”) and 11,500,000 shares were designated as Series B Convertible Preferred Stock (“Series B Convertible Preferred Stock”). Series A Convertible Preferred Stock A total of 17,000 shares of Series A Convertible Preferred Stock have been authorized for issuance under the Company’s Certificate of Designation of Preferences and Rights of Series A Convertible Preferred Stock. The shares of Series A Convertible Preferred Stock have a stated value of $1,000 per share and are initially convertible into shares of common stock at a price of $2.00 per share, subject to adjustment. Each share of Series A Preferred Stock is initially convertible into 500 shares of common stock. The Series A Convertible Preferred Stock may, at the option of each investor, be converted into fully paid and non-assessable shares of common stock. The holders of shares of Series A Convertible Preferred Stock do not have the right to vote on matters that come before the Company’s stockholders. In the event of any dissolution or winding up of the Company, proceeds shall be paid pari passu among the holders of common stock and preferred stock, pro rata based on the number of shares held by each holder. The Company may not declare, pay, or set aside any dividends on shares of capital stock of the Company (other than dividends on shares of common stock payable in shares of common stock) unless the holders of the Series A Convertible Preferred Stock shall first receive an equal dividend on each outstanding share of Series A Convertible Preferred Stock. No shares of Series A Convertible Preferred Stock were converted into shares of common stock during the three months ended March 31, 2023 or 2022. As of March 31, 2023 and December 31, 2022, 194 shares of Series A Convertible Preferred Stock (that are convertible into 97,000 shares of common stock) remained outstanding. Series B Convertible Preferred Stock A total of 11,500,000 shares of Series B Convertible Preferred Stock are authorized for issuance under the Company’s Series B Certificate of Designation of Rights, Preferences and Privileges of Series B Convertible Preferred Stock. The shares of Series B Convertible Preferred Stock have a stated value of $4.75 per share and are convertible into shares of the Company’s common stock at an initial conversion price of $4.75 per share. Each share of Series B Preferred Stock is initially convertible into 1 share of common stock. The Series B Convertible Preferred Stock may, at the option of each investor, be converted into fully paid and non-assessable shares of common stock. The holders of shares of Series B Convertible Preferred Stock do not have the right to vote on matters that come before the Company's stockholders. In the event of any dissolution or winding up of the Company, proceeds shall be paid pari passu among the holders of common stock and preferred stock, pro rata based on the number of shares held by each holder. Holders of Series B Convertible Preferred Stock are entitled to dividends on an as-if-converted basis in the same form as any dividends actually paid on shares of the Series A Convertible Preferred Stock or the Company’s common stock. So long as any Series B Convertible Preferred Stock remains outstanding, the Company may not redeem, purchase, or otherwise acquire any material amount of the Series A Convertible Preferred Stock or any securities junior to the Series B Convertible Preferred Stock. During the three months ended March 31, 2023 and 2022, no shares of Series B Convertible Preferred Stock were converted into shares of common stock. As of March 31, 2023 and December 31, 2022, 2,842,158 shares of Series B Preferred Stock (that are convertible into 2,842,158 shares of common stock) remained outstanding. Equity Incentive Plans The Company has multiple equity incentive plans under which it grants awards. As of March 31, 2023, there are 61,293 shares available to grant under the 2014 Equity Incentive Plan (the “2014 Plan”). On April 22, 2018, the Company’s board of directors (the “Board”) adopted the Iovance Biotherapeutics, Inc. 2018 Equity Incentive Plan (as amended, the “2018 Plan”), which was approved by the Company’s stockholders in June 2018. The 2018 Plan as approved initially authorized the issuance up to an aggregate of 6,000,000 shares of common stock in the form of incentive (qualified) stock options, non-qualified options, common stock, stock appreciation rights, restricted stock awards, restricted stock units, other stock-based awards, other cash-based awards or any combination of the foregoing. On June 8, 2020, the Company's stockholders approved an amendment to the 2018 Plan to increase the number of shares available for issuance under the 2018 Plan from 6,000,000 to 14,000,000 shares, which became effective immediately. Additionally, on June 10, 2022, the Company’s stockholders approved an amendment to the 2018 Plan to increase the number of shares available for issuance under the 2018 Plan from 14,000,000 to 20,700,000 shares, which became effective immediately. As of March 31, 2023, 545,618 shares of common stock were available for grant under the Company’s 2018 Plan. On September 22, 2021, the Board adopted the Iovance Biotherapeutics, Inc. 2021 Inducement Plan (as amended, the “2021 Inducement Plan”). The 2021 Inducement Plan provides for the grant of non-qualified options, common stock, stock appreciation rights, restricted stock awards, restricted stock units, other stock-based awards, other cash-based awards, or any combination of the foregoing. The 2021 Inducement Plan was recommended for approval by the Compensation Committee of the Board (the “Compensation Committee”), and subsequently approved and adopted by the Board without stockholder approval pursuant to Rule 5635(c)(4) of the rules and regulations of The Nasdaq Stock Market, LLC (the “Nasdaq Listing Rules”). The Board initially reserved 1,000,000 shares of the Company’s common stock for issuance pursuant to equity awards granted under the 2021 Inducement Plan, and the 2021 Inducement Plan is administered by the Compensation Committee. On January 12, 2022, the Compensation Committee approved an amendment to the 2021 Inducement Plan solely to increase the number of shares reserved for issuance under the 2021 Inducement Plan from 1,000,000 shares of the Company’s common stock to 1,750,000 shares of the Company’s common stock without stockholder approval pursuant to Rule 5635(c)(4) of the Nasdaq Listing Rules. On March 13, 2023, the Compensation Committee approved an amendment to the 2021 Inducement Plan solely to increase the number of shares reserved for issuance under the 2021 Inducement Plan from 1,750,000 shares of the Company’s common stock to 2,250,000 shares of the Company’s common stock without stockholder approval pursuant to Rule 5635(c)(4) of the Nasdaq Listing Rules. In accordance with Rule 5635(c)(4) of the Nasdaq Listing Rules, equity awards under the 2021 Inducement Plan may only be made to an employee if such employee is granted such equity awards in connection with his or her commencement of employment with the Company or a subsidiary and such grant is an inducement material to his or her entering into employment with the Company or such subsidiary. In addition, awards under the 2021 Inducement Plan may only be made to employees who have not previously been an employee or member of the Board (or any parent or subsidiary of the Company) or following a bona fide period of non-employment of the employee by the Company (or a parent or subsidiary of the Company). As of March 31, 2023, 111,185 shares of common stock were available for grant under the 2021 Inducement Plan. Stock Options A summary of the stock option activity during the three months ended March 31, 2023, is presented in the following table: Weighted Weighted Average Aggregate Number Average Remaining Intrinsic of Exercise Contract Value Options Price Life Outstanding at December 31, 2022 15,240,197 $ 22.45 Issued 4,293,745 7.10 Exercised — — Expired/Cancelled (269,925) 18.92 Outstanding at March 31, 2023 19,264,017 $ 19.08 7.55 $ 174,200 Ending vested and expected to vest at March 31, 2023 19,264,017 $ 19.08 7.55 $ 174,200 Options exercisable at March 31, 2023 10,777,903 $ 22.85 6.25 $ 174,200 As of March 31, 2023, there was $66.5 The weighted average grant date fair value for employee options granted under the Company’s stock option plans during the three months ended March 31, 2023 and 2022 was $4.94 The aggregate intrinsic value in the table above reflects the total pre-tax intrinsic value (calculated as the difference between the Company’s closing stock price on the last trading day of the quarter ended March 31, 2023 and the exercise price of the options, multiplied by the number of in-the-money stock options) that would have been received by the option holders had all option holders exercised their options on March 31, 2023. The intrinsic value of the Company’s stock options changes based on the closing price of the Company’s common stock. Employee Stock Purchase Plan In June 2020, the Company adopted the 2020 Employee Stock Purchase Plan (as amended, the “ESPP”) upon its approval by the Company’s shareholders at its Annual Stockholders Meeting on June 8, 2020. The Company reserved 500,000 shares of its common stock for issuance under the 2020 ESPP. Under the 2020 ESPP, employees of the Company can purchase shares of its common stock based on a percentage of their compensation subject to certain limits. The purchase price per share is equal to the lower of 85% of the fair market value of its common stock on the offering date or the purchase date with a six-month look-back feature. The 2020 ESPP purchases are settled with common stock from the 2020 ESPP’s previously authorized and available pool of shares. The compensation expense related to the 2020 ESPP for the three months ended March 31, 2023 and 2022 was $0.3 million and $0.2 million, respectively. As of March 31, 2023, 356,849 shares have been issued to date under the 2020 ESPP and there was $0.3 million of unrecognized compensation cost associated with the 2020 ESPP, which is expected to be recognized over the remaining 2.3 months. Restricted Stock Units and Performance Restricted Stock Units In addition to RSUs that have time-based vesting requirements, from time to time the Company may issue RSUs that include certain performance vesting criteria based upon the satisfaction of stated objectives (“PRSUs”). Compensation expense related to PRSUs is based on the grant date fair value of the award and recorded from the period that achievement is determined to be probable through the stated service period associated with the award. Activity for RSUs and PRSUs during the three months ended March 31, 2023 is presented in the following table: Weighted Number Average of Grant Date RSUs and PRSUs Fair Value Outstanding as of December 31, 2022 2,436,764 $ 14.74 Granted 2,267,306 7.12 Vested/Released (770,257) 17.20 Canceled/Forfeited (23,356) 15.49 Outstanding as of March 31, 2023 3,910,457 $ 9.83 Ending vested and expected to vest at March 31, 2023 3,910,457 $ 9.83 As of March 31, 2023, there was $32.7 Stock-Based Compensation Total stock-based compensation expense related to all of the Company’s stock-based awards was recorded on the Condensed Consolidated Statements of Operations as follows (in thousands): Three Months Ended March 31, 2023 2022 Research and development $ 8,859 $ 13,651 General and administrative 6,806 8,614 Total stock-based compensation expense $ 15,665 $ 22,265 Total stock-based compensation expense by type of award was as follows (in thousands): Three Months Ended March 31, 2023 2022 Stock option expense $ 11,702 $ 14,867 Restricted stock expense 3,660 7,162 ESPP expense 303 236 Total stock-based compensation expense $ 15,665 $ 22,265 |
LICENSES AND AGREEMENTS
LICENSES AND AGREEMENTS | 3 Months Ended |
Mar. 31, 2023 | |
LICENSES AND AGREEMENTS | |
LICENSES AND AGREEMENTS | NOTE 7. LICENSES AND AGREEMENTS National Institutes of Health (the “NIH”) and the National Cancer Institute (the “NCI”) Cooperative Research and Development Agreement (the “CRADA”) In August 2011, the Company signed a five-year CRADA with the NCI to work on the development of adoptive cell immunotherapies that are designed to destroy advanced melanoma cells. The CRADA was amended in 2015 and 2016 to, among other things, extend the term of the CRADA through August 2021, include new indications such as the development of TIL therapy for the treatment of patients with bladder, lung, triple-negative breast, and Human Papilloma Virus (“HPV”)-associated cancers, and modify the focus on the development of unmodified TIL as a stand-alone therapy or in combination. The parties have continued the development of improved methods for the generation and selection of TIL with anti-tumor reactivity in metastatic melanoma, bladder, lung, breast, and HPV-associated cancers. In August 2021, the NCI and the Company entered into a third amendment to the CRADA. The third amendment, among other things, extended the term of the CRADA by three years to August 2024. The research plan in this amendment includes the evaluation in clinical trials of strategies for development of more potent TILs, such as selection of CD39/69 double negative cells and the use of certain inhibitors or other reagents in TIL expansion cultures. Pursuant to the terms of the CRADA, as amended, the Company is required to make quarterly payments of $0.5 million to the NCI for support of research activities. To the extent the Company licenses patent rights relating to a TIL-based product candidate, the Company will be responsible for all patent-related expenses and fees, past and future, relating to the TIL-based product candidate. In addition, the Company may be required to supply certain test articles, including TIL, grown and processed under Current Good Manufacturing Practice (“cGMP”) conditions, suitable for use in clinical trials. The extended CRADA has a three-year term expiring in August 2024. The Company or the NCI may unilaterally terminate the CRADA for any reason or for no reason at any time by providing written notice at least 60 days before the desired termination date. The Company recorded costs associated with the CRADA of $0.5 million for each of the three months ended March 31, 2023 and 2022, respectively, as research and development expenses. Patent License Agreement Related to the Development and Manufacture of TIL Therapies The Company entered into an Exclusive Patent License Agreement (the “Patent License Agreement”) with the NIH, an agency of the U.S. Public Health Service within the Department of Health and Human Services, in 2011, as amended in 2015. Pursuant to the Patent License Agreement, as amended, the NIH granted the Company licenses, including exclusive, co-exclusive, and non-exclusive licenses, to certain technologies relating to autologous tumor infiltrating lymphocyte adoptive cell therapy products for the treatment of metastatic melanoma, lung, breast, bladder and HPV-positive cancers. Effective May 6, 2021, the Company entered into an Amended and Restated Patent License Agreement with NIH, which included the grant of additional exclusive, worldwide patent rights in the indications to interleukin-15 and interleukin-21cytokine-tethered TIL technology, and expanded the non-exclusive, worldwide field of use to all cancers. Effective August 1, 2022, the Company entered into a Second Amended and Restated Patent License Agreement with NIH to include additional exclusive, worldwide patent rights to TIL products expressing interleukin-12, expanded rights to TIL selection technologies previously licensed under the Exclusive Patent License Agreement below, and additional non-exclusive, worldwide patent rights to certain technologies for enhancing TIL products. The Second Amended and Restated Patent License Agreement requires the Company to pay royalties based on a percentage of net sales in jurisdictions where patent rights exist, which percentage can fall into a tier that may be less than one percent to mid-single digits depending upon certain factors, including the exclusivity of the rights, and the Company expects lower overall royalty payments as a result. The Company also agreed to potential milestone payments on the achievement of certain clinical, regulatory, and commercial sales milestones for each of the indications and other direct costs incurred by the NIH pursuant to the Second Amended and Restated Patent License Agreement. The Company anticipates making payments that could range from several hundred thousand dollars to the mid-single-digit millions of dollars in conjunction with certain development milestones, the approval of a BLA or its foreign equivalent, or the first U.S. and foreign commercial sales of any of its product candidates covered by the Second Amended and Restated Patent License Agreement. The term of the Second Amended and Restated Patent License Agreement continues until the expiry of the last-to-expire patent rights licensed thereunder, and the agreement contains standard termination provisions. Exclusive Patent License Agreement Related to TIL Selection On February 10, 2015, the Company entered into an exclusive patent license agreement (the “Exclusive Patent License Agreement”) with the NIH under which the Company received an exclusive, worldwide license under a patent related to selected TILs. This license was superseded and replaced by the Second Amended and Restated Patent License Agreement. H. Lee Moffitt Cancer Center Research Collaboration and Clinical Grant Agreements with Moffitt In June 2020, the Company entered into a Sponsored Research Agreement with the H. Lee Moffitt Cancer Center (“Moffitt”), with a term that ends either upon completion of the research thereunder or on July 1, 2022, whichever is sooner. In June 2022, this agreement was extended until June 2023. The Company recorded $0.1 million for the three months ended March 31, 2023 and 2022, respectively, as research and development costs. In December 2016, the Company entered into a clinical grant agreement with Moffitt to support an ongoing clinical trial at Moffitt that combines TIL therapy with nivolumab for the treatment of patients with metastatic melanoma. In June 2017, the Company entered into a second clinical grant agreement with Moffitt to support a new clinical trial at Moffitt that combines TIL therapy with nivolumab for the treatment of patients with non-small cell lung cancer, under which the Company obtained a non-exclusive, royalty-free license to any new Moffitt inventions made in the performance of the agreement. Under both clinical grant agreements with Moffit, the Company has non-exclusive rights to clinical data arising from the respective clinical trials. No expenses were recorded for each of the three months ended March 31, 2023 and 2022, in connection with the research collaboration and clinical grant agreements with Moffitt. Exclusive License Agreements with Moffitt The Company entered into a license agreement with Moffitt (the “First Moffitt License”), effective as of June 28, 2014, under which the Company received a world-wide license to Moffitt’s rights to patent-pending technologies related to methods for improving TIL for adoptive cell therapy using toll-like receptor agonists. Unless earlier terminated, the term of the license extends until the earlier of the expiration of the last issued patent related to the licensed technology or 20 years after the effective date of the license agreement. Pursuant to the First Moffitt License, the Company paid an upfront licensing fee in the amount of $0.1 million which was recorded as research and development expense. In 2022, the Company paid a patent issuance fee that was payable under the First Moffitt License upon the issuance of the first U.S. patent covering the subject technology. In addition, the Company agreed to pay milestone license fees upon completion of specified milestones, customary royalties based on a specified percentage of net sales (which percentage is in the low single digits) and sublicensing payments, as applicable, and annual minimum royalties beginning with the first sale of products based on the licensed technologies, which minimum royalties will be credited against the percentage royalty payments otherwise payable in that year. The Company will also be responsible for all costs associated with the preparation, filing, maintenance and prosecution of the patent applications and patents covered by the First Moffitt License related to the treatment of any cancers in the U.S., Europe, and Japan and in other countries designated by the Company in agreement with Moffitt. No expenses were recorded for the First Moffitt License for each of the three months ended March 31, 2023 and 2022. The Company entered into a second license agreement with Moffitt effective as of May 7, 2018 (the “Second Moffitt License”), under which the Company received a license to Moffitt’s rights to patent-pending technologies related to the use of 4-1BB agonists in conjunction with TIL manufacturing processes and therapies. Pursuant to the Second Moffitt License, the Company paid an upfront licensing fee in the amount of $0.1 million in 2018. An annual license maintenance fee is also payable commencing on the first anniversary of the effective date. The Company agreed to pay an annual commercial use payment for each indication for which a first sale has occurred, which in the aggregate amounts to up to $0.4 million a year. The Company recorded a de minimis amount for the three months ended March 31, 2023 and 2022, respectively, as research and development expenses in connection with this agreement. The Company subsequently exercised an option to exclusively license Moffitt’s rights to patent pending technologies related to the use of tumor digests in conjunction with TIL manufacturing processes and therapies and entered into an amended and restated Second Moffitt License in October 2021 (the “Amended & Restated Second Moffit License”), to include these rights. Pursuant to the Amended & Restated Second Moffitt License, the Company paid an upfront licensing fee in the amount of $0.2 million in 2021, which was recorded as research and development expense. In addition, the Company agreed to pay an annual commercial use payment for each indication for which a first sale has occurred for products relating to the use of 4-1BB antagonists covered by the license and an additional annual commercial use payment for each indication for which a first sale has occurred for products relating to the use of tumor digests covered by the license. The University of Texas M.D. Anderson Cancer Center Strategic Alliance Agreement On April 17, 2017, the Company entered into a Strategic Alliance Agreement (the “SAA”) with The University of Texas M.D. Anderson Cancer Center (“MDACC”) under which the Company and MDACC agreed to conduct clinical and preclinical research studies. The Company agreed in the SAA to provide total funding not to exceed approximately $14.2 million for the performance of the multi-year studies under the SAA, of which approximately $5.3 million has been funded cumulatively through March 31, 2023, and has been recorded as research and development expense. In return, the Company acquired all rights to inventions resulting from the studies and has been granted a non-exclusive, sub-licensable, royalty-free, and perpetual license to specified background intellectual property of MDACC reasonably necessary to exploit, including the commercialization thereof. The Company has also been granted certain rights in clinical data generated by MDACC outside of the clinical trials to be performed under the SAA. The SAA’s term shall continue in effect until the later of the fourth anniversary of the SAA or the completion or termination of the research and receipt by the Company of all deliverables due from MDACC thereunder. No expenses were recorded for the three months ended March 31, 2023 in connection with this agreement. The Company recorded a de minimis amount for the three months ended March 31, 2022, as research and development expenses associated with this agreement. WuXi Advanced Therapies, Inc. First WuXi Manufacturing and Services Agreement In November 2016, the Company entered into a three-year manufacturing and services agreement (the “First WuXi MSA”) with WuXi Advanced Therapies, Inc. (“WuXi”) pursuant to which WuXi agreed to provide manufacturing and other services, which has since been amended and assigned to its subsidiary Iovance Biotherapeutics Manufacturing LLC. Under the First WuXi MSA, the Company entered into multiple statements of work for two cGMP manufacturing suites to be operated by WuXi for the Company. The terms of one of these statements of work expired in December 2022. Second WuXi Manufacturing and Services Agreement In October 2022, the Company’s subsidiary Iovance Biotherapeutics Manufacturing LLC entered into an additional three-year manufacturing and services agreement (the “Second WuXi MSA”) with WuXi and its parent company WuXi Apptec, Co, Ltd pursuant to which WuXi agreed to provide commercial and clinical manufacturing services and related testing services. Under the Second WuXi MSA, the Company entered into a statement of work for the two cGMP manufacturing suites to be operated by WuXi for the Company. Both suites are expected to be capable of being used for the commercial and clinical manufacture of the Company’s products. The Second WuXi MSA and its related statement of work will supersede the statements of work under the First WuXi MSA with respect to commercial and clinical manufacturing and the two manufacturing suites. Certain other statements of work for related services will also be covered by the Second WuXi MSA. The First WuXi MSA will continue to address development services provided by WuXi to the Company. Prior to regulatory approval, or if the Company experiences a material adverse event, the Company may unilaterally terminate the statement of work for commercial and clinical manufacturing under the Second WuXi MSA at any time by providing written notice of at least 120 days. Post regulatory approval, the Company may unilaterally terminate the statement of work for commercial and clinical manufacturing with written notice of 15 month in year 1 of the term, written notice of 9 months in year 2 of the term, and written notice of 6 months in year 3 of the term. If WuXi fails a Pre-Licensing Inspection and does not address any related issues within 90 days of receipt of the FDA response letter, the Company may either terminate the statement of work for commercial and clinical manufacturing under the Second WuXi MSA immediately or shorten the term of this statement of work to June 30, 2024. The Company recorded costs associated with agreements with WuXi of $3.9 million for each of the three months ended March 31, 2023 and 2022, respectively, as research and development expenses. Cellectis S.A. On December 31, 2019, the Company entered into a research collaboration and exclusive worldwide license agreement whereby the Company will license gene-editing technology from Cellectis S.A. (“Cellectis”), a clinical-stage biopharmaceutical company, to develop TIL therapies that have been genetically edited using TALEN ® technology, including a PD-1 inactivated product that the Company refers to as IOV-4001. Financial terms of the license include annual license payments and development, regulatory and sales milestone payments from the Company to Cellectis, as well as royalty payments based on net sales of TALEN®-modified TIL products. The Company recorded costs associated with the license agreement with Cellectis of $0.1 million for each of the three months ended March 31, 2023 and 2022, as research and development expense. Novartis Pharma AG On January 9, 2020, the Company obtained a license from Novartis Pharma AG (“Novartis”) to develop and commercialize an antibody cytokine engrafted protein, which the Company refers to as IOV-3001. Under the agreement, the Company has paid an upfront payment to Novartis and may pay future milestones related to initiation of patient dosing in various phases of clinical development for IOV-3001 and approval of the product in the U.S, EU, and Japan. Novartis is also entitled to low-to-mid single digit percentage royalties from commercial sales of the product. The Company recorded costs associated with the license agreement from Novartis of $10.0 million as research and development expense during for the year ended December 31, 2020. No expenses were recorded for each of the three months ended March 31, 2023 and 2022. |
LEASES
LEASES | 3 Months Ended |
Mar. 31, 2023 | |
LEASES | |
LEASES | NOTE 8. LEASES Operating Leases The Company leases corporate office space in California, including 49,918 square feet for its current corporate headquarters’ office space in San Carlos, California, manufacturing, research and development lab facilities and office space in Philadelphia, Pennsylvania, including 136,000 square feet of commercial manufacturing and lab space at the i The Company’s leases have remaining lease terms that range from less than one year to approximately 20 years. Some of the Company’s leases include one or more options to renew with renewal terms that can extend the lease for additional years, or options to terminate the leases, both at the Company’s discretion. The Company’s leases may include options to extend or terminate the lease, which is considered in the lease term when it is reasonably certain that the Company will exercise any such options. Lease expense for minimum lease payments is recognized on a straight-line basis based on the fixed components of a lease arrangement. Variable lease cost is determined based on performance or usage in accordance with the contractual agreements, and not based on an index or rate. Such costs that are not fixed in nature are recognized as incurred. The Company also leases certain furniture and equipment that has a lease term of 12 months or less. Since the lease agreement do not include an option to purchase the underlying asset, the Company elected not to apply the recognition requirements of Topic 842 for short-term leases, however, the lease costs that pertain to the short-term leases are disclosed in the components of lease costs table below. Manufacturing Contracts The Company uses contract manufacturing organizations (collectively the “CMOs” and each a “CMO”) to manufacture and supply TILs for clinical and commercial purposes. The CMO contractual obligations consist of the use of manufacturing facilities and minimum fixed commitment fees, such as personnel, general support fees, and minimum production or material fees. In addition to the minimum fixed commitment fees, the CMO contractual obligations include variable costs such as production and material costs in excess of the minimum quantity specified in each CMO agreement. During the term of each CMO agreement, the Company has access to and control of the use of a dedicated suite in each of the CMOs’ facilities for manufacturing activities. The contracts with CMOs generally contain embedded operating leases based on the fact that the suites are used for the Company’s production are implicitly identified, are used exclusively by the Company during the contractual term of the arrangements, and the CMOs have no substantive contractual rights to substitute the facilities used by the Company. Further, the Company controls the use of the facilities by obtaining all of the economic benefits from the use of the facilities and direct the use of the facilities throughout the period of use. The terms of the CMO contracts include options to terminate the lease with advance notice of five to six months. The termination clauses and extension clauses are included in the calculation of the lease term for each of the CMOs when it is reasonably certain that it will not exercise such options. For contracts with multiple deliverables, Topic 842 requires the Company to first identify a lease deliverable and non-lease deliverable included in the arrangements, and then allocate the fixed contractual consideration to the lease deliverable(s) and the non-lease deliverable(s) on a relative standalone selling price basis to determine the amount of operating lease right-of-use assets and liabilities. The Company identified the use of a dedicated suite as a single lease deliverable, and related labor services as a single non-lease deliverable in each of the CMO arrangements. Judgment is required to determine the relative standalone selling price of each deliverable as the observable standalone selling prices are not readily available. Therefore, management uses estimates and assumptions in determining relative standalone selling price of lease of a suite and labor service using information that includes market and other observable inputs to the extent possible. The balance sheet classification of the Company’s right-of-use asset and lease liabilities was as follows (in thousands): March 31, December 31, 2023 2022 Operating lease right-of-use assets $ 70,431 $ 73,015 Operating lease liabilities Current portion included in current liabilities 12,614 12,587 Long-term portion included in non-current liabilities 69,612 71,859 Total operating lease liabilities $ 82,226 $ 84,446 The following table summarizes components of lease expenses, which were included in Total costs and expenses in the Company’s Condensed Consolidated Statements of Operations, and other information related to its operating leases as follows (in thousands except weighted-average remaining lease terms and discount rates): Three Months Ended March 31, 2023 2022 Operating lease cost $ 4,524 $ 4,555 Variable lease cost 1,694 980 Short-term lease cost 45 42 Total lease cost $ 6,263 $ 5,577 Other information Cash paid for amounts included in the measurement of lease liabilities included in cash flows from operations $ 4,161 $ 3,811 Tenant improvement allowance received for amounts included in the measurement of lease liabilities included in cash flows from operations $ — $ 3,115 Increase in right-of-use assets from lease modifications $ 349 $ 7,673 Weighted-average remaining lease terms (years) 12.90 14.13 Weighted-average discount rates 7.5 % 7.2 % As of March 31, 2023, the maturities of the Company’s operating lease liabilities were as follows (in thousands): CMO Facility embedded Year Ending December 31, leases leases Total Remainder of 2023 $ 6,183 $ 7,888 $ 14,071 2024 8,424 2,181 10,605 2025 8,240 — 8,240 2026 7,989 — 7,989 2027 8,186 — 8,186 Thereafter 83,827 — 83,827 Total lease payments $ 122,849 $ 10,069 $ 132,918 Less: Present value adjustment (50,140) (552) (50,692) Operating lease liabilities $ 72,709 $ 9,517 $ 82,226 |
LEGAL PROCEEDINGS
LEGAL PROCEEDINGS | 3 Months Ended |
Mar. 31, 2023 | |
LEGAL PROCEEDINGS | |
LEGAL PROCEEDINGS | NOTE 9. LEGAL PROCEEDINGS Derivative Lawsuit. 17, 2022, the Court required the parties to take additional steps before it would approve the settlement. The Company, as nominal defendant, and its current directors, as defendants, answered the complaint on February 3, 2023. Solomon Capital, LLC. Solomon Capital, LLC, Solomon Capital 401(K) Trust, Solomon Sharbat and Shelhav Raff v. Lion Biotechnologies, Inc. The complaint further alleges that the Company agreed to (i) provide them with promissory notes totaling $0.2 million, plus interest, (ii) issue a total of 1,110 shares to the Solomon Plaintiffs (after the 1-for-100 In its counterclaims, the Company is seeking damages in an amount exceeding $0.5 million and an order rescinding any and all agreements that the Solomon Plaintiffs contend entitled them to obtain shares of Company stock. On May 12, 2020, the court granted the Company’s motion for summary judgment limiting the Solomon Plaintiffs’ damages for the Equity Claim to less than $0.1 million. The Solomon Plaintiffs filed a notice of appeal of this summary judgment on June 9, 2020. On July 2, 2020, the court granted the Company’s motion to dismiss the First Solomon Suit for want of prosecution. On January 4, 2021, the court granted the Solomon Plaintiffs motion for reconsideration, and reinstituted the case. On January 15, 2021, the Company filed a notice of appeal of the court’s grant of the Solomon Plaintiffs motion for reconsideration. On May 11, 2021, the Appellate Division upheld the court’s grant of the Solomon Plaintiffs’ motion for reconsideration of the dismissal of the First Solomon Suit for want of prosecution. On October 14, 2021, the Appellate Division upheld the court’s grant of the Company’s motion for summary judgment limiting the Solomon Plaintiffs’ damages for the Equity Claim to less than $0.1 million. On September 27, 2019, the Solomon Plaintiffs filed a new lawsuit (through new legal counsel) (“the Second Solomon Suit”) titled Solomon Capital, LLC, Solomon Capital 401(K) Trust, Solomon Sharbat and Shelhav Raff v. Iovance Biotherapeutics, Inc., f/k/a/ Lion Biotechnologies Inc. f/k/a/ Genesis Biopharma Inc., and Manish Singh in the Supreme Court of the State of New York, County of New York (index no. 655668/2019). In the Second Solomon Suit, the Solomon Plaintiffs allege that they are third party beneficiaries of a “finder’s fee agreement” that prior management entered into with a third party unlicensed entity in 2012 in connection with seeking financing, that an agreement or understanding existed between the Company and the plaintiffs that the plaintiffs would be paid fees and commissions (in cash and stock) if they obtained financing for the Company, and that they directly and indirectly introduced investors to the Company who invested in the Company, or were willing to invest in the Company. Finally, the Solomon Plaintiffs allege that they were promised a license to use the Company’s technology in Israel. The plaintiffs claim that the Company breached the foregoing understandings, promises and agreements and, as a result, they are entitled to certain damages. The Solomon Plaintiffs also allege that Manish Singh, the Company’s former Chief Executive Officer, committed fraud and took shares belonging to them. On February 18, 2020, the Company filed a removal petition and removed the Second Solomon Suit to the U.S. District Court for the Southern District of New York, where the case has been assigned case no. 1:20-cv-1391. On May 22, 2020, the Company moved to dismiss the Second Solomon Suit for lack of personal jurisdiction. On March 26, 2021, the Court denied the Company’s motion to dismiss for lack of personal jurisdiction. The Company filed a response to the complaint in the Second Solomon Suit on April 30, 2021. On May 26, 2021, the Company and Singh filed motions for judgment on the pleadings with respect to the second and third claims asserted against the Company and all claims asserted against Singh, respectively, in the Second Solomon Suit. On January 5, 2022, the Court granted the Company’s motions for judgement on the pleadings, dismissing the second and third claims against the Company and dismissing all claims against Singh. On January 4, 2023, the Court granted in part the Company’s motion for sanctions against Plaintiffs for violating Rule 11 of the Federal Rules of Civil Procedure, in a decision and order that dismissed Plaintiffs’ first claim against the Company, denied Plaintiffs’ motion for leave to amend the complaint, and ordered Plaintiffs to pay the Company’s attorneys’ fees incurred in connection with the Rule 11 motion. Following the Court’s decision and order on the Rule 11 motion, only Plaintiffs’ fifth and sixth claims, for unjust enrichment and indemnification, respectively, remain pending against the Company. The Company intends to vigorously defend these complaints and pursue its counterclaims, as applicable. At the current stage of the litigation, in both the First Solomon Suit and the Second Solomon Suit, it is not possible to estimate the amount or range of possible loss that might result from an adverse judgment or a settlement of these matters. The Company may be involved, from time to time, in legal proceedings and claims arising in the ordinary course of its business. Such matters are subject to many uncertainties and outcomes are not predictable with assurance. The Company accrues amounts, to the extent they can be reasonably estimated, that it believes are adequate to address any liabilities related to legal proceedings and other loss contingencies that it believes will result in a probable loss. While there can be no assurances as to the ultimate outcome of any legal proceeding or other loss contingency involving the Company, management does not believe any pending matter will be resolved in a manner that would have a material adverse effect on its financial position, results of operations or cash flows. |
INCOME TAXES
INCOME TAXES | 3 Months Ended |
Mar. 31, 2023 | |
INCOME TAXES | |
INCOME TAXES | NOTE 10. INCOME TAXES The Company did not record income tax expense for the three months ended March 31, 2023 and 2022, respectively as the Company expected to be in a cumulative taxable loss position in 2023 and 2022, and the net deferred tax assets are fully offset by a valuation allowance as it is not more likely than not that the benefit will be realized. As of March 31, 2023, the Company remains in a cumulative book loss position and does not have sufficient positive evidence to realize its net deferred tax assets. As such, the Company continues to maintain a full valuation allowance against its net deferred tax assets. |
PROLEUKIN ACQUISITION
PROLEUKIN ACQUISITION | 3 Months Ended |
Mar. 31, 2023 | |
PROLEUKIN ACQUISITION | |
PROLEUKIN ACQUISITION | NOTE 11. PROLEUKIN ® ACQUISITION Pursuant to the Option Agreement entered into on January 23, 2023 (the “Option Agreement”) between the Company and Clinigen Holdings Limited, Clinigen Healthcare Limited and Clinigen, Inc. (collectively, “Clinigen”), the Company will acquire worldwide rights to Proleukin® (aldesleukin) (the “Product”), an interleukin-2 (“IL-2”) product used to promote T-cell activity following TIL infusion. Material terms of the Option Agreement include an upfront payment of £167.7 million, or approximately $200 million, a £41.7 million, or approximately $50 million, milestone payment upon first approval of lifileucel in advanced melanoma, and deferred consideration based on double-digit rates on global net sales of the Product payable from the Company to Clinigen following the completion of the transaction for the applicable deferred consideration term. Subject to the terms and conditions of the Option Agreement, the Company will purchase (i) all issued and outstanding shares of Clinigen SP Limited (the “Target”), (ii) the business of the Target and Clinigen comprising the manufacturing, supply, commercialization and the generation of income from the Product rights and the undertaking of an active role in the development, maintenance and exploitation of those rights (the “Operations”), and (iii) certain specified assets identified in the Option Agreement. The Option Agreement is subject to customary termination provisions, and the Company would be required to pay to Clinigen a reverse termination fee (less certain transaction fees and expenses incurred by the Company) upon certain events as described in the Option Agreement. The closing of the transaction is subject to required regulatory approvals and clearances and other customary closing conditions. |
SUMMARY OF SIGNIFICANT ACCOUN_2
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 3 Months Ended |
Mar. 31, 2023 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
Cash, Cash Equivalents, and Investments | Cash, Cash Equivalents, and Investments The Company’s cash and cash equivalents include short-term investments with original maturities of three months or less when purchased. The Company's investments are classified as “available-for-sale.” The Company includes these investments in current assets or non-current assets in the Condensed Consolidated Balance Sheets based on the length of maturity from the reporting date and carries them at fair value. Unrealized gains and losses on available-for-sale securities are recorded in accumulated other comprehensive loss. Impairment losses related to credit losses (if any) are recorded as an allowance for credit losses with an offsetting entry to Interest income, net. No impairment losses related to credit losses were recognized for the three months ended March 31, 2023 and 2022. The cost of debt securities is adjusted for the amortization of premiums and accretion of discounts to maturity. Such amortization and accretion are included in Interest income, net in the Condensed Consolidated Statements of Operations. Gains and losses on securities sold are recorded based on the specific identification method and are included in Interest income, net in the Condensed Consolidated Statements of Operations. The Company has not incurred any realized gains or losses from sales of securities to date. The Company’s investment policy limits investments to certain types of instruments such as certificates of deposit, money market instruments, obligations issued by the U.S. government and U.S. government agencies as well as corporate debt securities and commercial paper, and places restrictions on maturities and concentration by type and issuer, except for securities issued by the U.S. government. |
Restricted Cash | Restricted Cash The Company maintains a required minimum balance in a segregated bank account in connection with its letters of credit for which amounts are restricted as to their use by the Company. Currently, the Company’s letters of credit are primarily comprised of one for the benefit of the landlord for the i The following table provides a reconciliation of cash, cash equivalents, and restricted cash, reported within the Condensed Consolidated Balance Sheets that sum to the total of the same such amounts shown in the Condensed Consolidated Statements of Cash Flows (in thousands): March 31, 2023 2022 Cash and cash equivalents $ 543,484 $ 92,360 Restricted cash 6,430 6,084 Total cash, cash equivalents and restricted cash $ 549,914 $ 98,444 |
Net Loss per Share | Net Loss per Share Basic net loss per share is computed by dividing the net loss by the weighted average number of common shares outstanding during the period. Diluted net loss per share is computed by dividing the net loss by the sum of the weighted average number of shares of common stock outstanding and the dilutive common stock equivalents outstanding during the period. The Company’s potentially dilutive common stock equivalent shares, which include incremental common shares issuable upon (i) the exercise of outstanding stock options, (ii) purchases though the 2020 Employee Stock Purchase Plan (the “2020 ESPP”), (iii) vesting of restricted stock units, and (iv) conversion of preferred stock, are only included in the calculation of diluted net loss per share when their effect is dilutive. As of March 31, 2023 and 2022, the following outstanding common stock equivalents have been excluded from the calculation of net loss per share because their impact would be anti-dilutive: March 31, 2023 2022 Stock options 19,264,017 14,101,526 Employee Stock Purchase Plan 247,284 86,448 Restricted stock units 3,910,457 3,095,177 Series A Convertible Preferred Stock* 97,000 97,000 Series B Convertible Preferred Stock* 2,842,158 2,842,158 26,360,916 20,222,309 * on an as-converted basis The dilutive effect of potentially dilutive securities would be reflected in diluted earnings per common share by application of the treasury stock method. Under the treasury stock method, an increase in the fair market value of the Company's common stock could result in a greater dilutive effect from potentially dilutive securities. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates. Significant items subject to such estimates and assumptions include assumptions made in the fair value of equity awards and related stock-based compensation, assumptions used in measuring operating right-of-use assets and operating lease liabilities, accounting for potential liabilities, including estimates inherent in accruals related to clinical trials, and the realizability of the Company’s deferred tax assets . |
Principles of Consolidation | Principles of Consolidation The accompanying Condensed Consolidated Financial Statements include the accounts of Iovance Biotherapeutics, Inc. and its wholly-owned subsidiaries, Iovance Biotherapeutics Manufacturing LLC, Iovance Biotherapeutics GmbH, Iovance Biotherapeutics B.V ., Iovance Biotherapeutics UK LTD, and Iovance Biotherapeutics Canada, Inc. All intercompany accounts and transactions have been eliminated. The Condensed Consolidated Financial Statements are presented in U.S. dollars. The functional currency for most of the Company’s foreign subsidiaries is their respective local currency. |
Leases | Leases The Company determines if an arrangement includes a lease at inception and thereafter, if modified. Operating leases are included in its Condensed Consolidated Balance Sheets as Operating lease right-of-use assets and Operating lease liabilities as of March 31, 2023 and December 31, 2022. Operating lease right-of-use assets represent the Company’s right to use an underlying asset for the lease term and operating lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Operating lease right-of-use assets and liabilities are recognized at the lease commencement date or modification date based on the present value of lease payments over the lease term. In determining the net present value of lease payments, the Company uses an estimated incremental borrowing rate that is applicable to the Company based on the information available at the later of the lease commencement or modification date. The operating lease right-of-use assets also include any lease payments made less lease incentives. The Company’s leases may include options to extend or terminate the lease, which is considered in the lease term when it is reasonably certain that the Company will exercise any such options. Lease expense is recognized on a straight-line basis over the expected lease term and recorded in costs and expenses in the Condensed Consolidated Statements of Operations. The Company has elected not to apply the recognition requirements of Accounting Standards Update (“ASU”) No. 2016-02 and No. 2018-10 (together “Topic 842”) for short-term leases. For lease agreements entered into by the Company that include lease and non-lease components, such components are generally accounted for separately. |
Stock-Based Compensation | Stock-Based Compensation The Company periodically grants stock options to employees and non-employees as compensation for services rendered. The Company accounts for all stock-based payment awards made to employees, including the employee stock purchase plans, and non-employees in accordance with the authoritative guidance provided by the Financial Accounting Standards Board (“FASB”) where the value of the award is measured on the date of grant and recognized over the vesting period. Forfeitures are recognized in the period in which they occur. The Company accounts for stock option grants to non-employees in a similar manner as stock option grants to employees except for the term used in the grant date fair value, therefore no longer requiring a re-measurement at the then-current fair values at each reporting date until the shares underlying the options have vested. The non-employee awards that contain a performance condition that affects the quantity or other terms of the award are measured based on the outcome that is probable. The fair value of the Company's common stock option grants is estimated using a Black-Scholes option pricing model, which uses certain assumptions related to risk-free interest rates, expected volatility, expected term of the common stock options, and future dividends. The stock-based compensation expense is recorded based upon the value derived from the Black-Scholes option pricing model. The assumptions used in the Black-Scholes option pricing model could affect compensation expense recorded in future periods. The Company issues restricted stock units (“RSUs”) from time to time as part of its equity incentive plans. The Company measures the compensation cost with respect to RSUs issued to employees based upon the estimated fair value of the equity instruments at the date of the grant, which is recognized as an expense over the period during which an employee is required to provide services in exchange for the awards. The fair value of RSUs is based on the closing price of the Company’s common stock on the grant date. In addition to RSUs that have time-based vesting requirements, from time to time the Company may issue RSUs that include certain performance vesting criteria based upon the satisfaction of stated objectives (“PRSUs”). The Company measures the compensation cost with respect to PRSUs issued to employees based upon the estimated fair value of the equity instruments at the date of grant, which is recognized as an expense over the period that achievement is determined to be probable through the stated service period associated with the award. |
Accrued Research and Development Costs | Accrued Research and Development Costs Research and development costs are expensed as incurred. Clinical development costs compose a significant component of research and development costs. The Company has a history of contracting with third parties, including contract research organizations (“CROs”), independent clinical investigators, and contract manufacturing organizations (“CMOs”) that perform various clinical trial activities on the Company’s behalf in connection with the ongoing development of the Company’s product candidates. The financial terms of these contracts are subject to negotiations and may vary from contract to contract and may result in uneven payment flow. The Company accrues and expenses costs for clinical trial activities performed by third parties based upon estimates of work completed to date for each clinical trial in accordance with agreements established with CROs, hospitals, and clinical investigators. Accruals for CROs and CMOs are recorded based on estimates of services received and efforts expended pursuant to agreements established with CROs, CMOs and other outside service providers. The Company determines its estimates through discussions with internal clinical stakeholders and outside service providers as to the progress or stage of completion of clinical trials or services and the contracted fee to be paid for such services. Included in the Company’s clinical development costs are investigator costs, which are costs associated with treatments administered at clinical sites as required under each clinical study protocol. The Company’s estimates for clinical investigator costs and timing of expense recognition will depend on a number of factors that include, but are not limited to, (i) the overall number of patients that enroll in the trial at each individual site, (ii) the length of study enrollment period, (iii) discontinuation and completion rates of patients, (iv) duration of patient safety follow-ups, (v) the number of sites included in the clinical trial, and (vi) the contracted fee of each participating site for patient treatment while on study, which can vary greatly for several reasons including, but not limited to, geographic region, medical center or physician costs, and overhead costs. In addition, the Company’s estimates for per patient trial costs will vary based on a number of factors that include, but are not limited to, the extent of additional treatments that may be administered by investigators as a result of patient health status, recoverability of patient costs through insurance carriers of patients, and unanticipated cost of injuries incurred as a result of the study treatment. The Company accrues for estimated expenses resulting from obligations under investigator site agreements as the timing of payments does not always timely align with the periods over which the treatments are administered by the clinical investigators. These estimates are typically based on contracted amounts, patient visit data, discussions with internal clinical stakeholders and outside service providers, and historical look-back analysis of actual payments made to date. The Company makes judgements and estimates in determining the accrual balance in each reporting period. In the event advance payments are made to a CRO, CMO or other outside service provider, the payments are recorded within prepaid expenses and other current assets in the Condensed Consolidated Balance Sheets and subsequently recognized as research and development expense in the Condensed Consolidated Statements of Operations when the associated services have been performed. As actual costs become known, the Company adjusts its estimates, liabilities and assets. Inputs used in the determination of estimates discussed above may vary from actual, which will result in adjustments to research and development expense in future periods. Changes in these estimates that result in material changes to the Company’s accruals could materially affect its results of operations. The Company’s historical estimates have not been materially different from actual amounts recorded. |
Segment Reporting | Segment Reporting The Company operates in one segment, focused on innovating, developing and commercializing therapies using autologous TIL for the treatment of advanced melanoma and other solid tumor cancers. |
SUMMARY OF SIGNIFICANT ACCOUN_3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
Schedule of cash and cash equivalents and restricted cash | The following table provides a reconciliation of cash, cash equivalents, and restricted cash, reported within the Condensed Consolidated Balance Sheets that sum to the total of the same such amounts shown in the Condensed Consolidated Statements of Cash Flows (in thousands): March 31, 2023 2022 Cash and cash equivalents $ 543,484 $ 92,360 Restricted cash 6,430 6,084 Total cash, cash equivalents and restricted cash $ 549,914 $ 98,444 |
Schedule of Antidilutive securities excluded from computation of earnings per share | March 31, 2023 2022 Stock options 19,264,017 14,101,526 Employee Stock Purchase Plan 247,284 86,448 Restricted stock units 3,910,457 3,095,177 Series A Convertible Preferred Stock* 97,000 97,000 Series B Convertible Preferred Stock* 2,842,158 2,842,158 26,360,916 20,222,309 * on an as-converted basis |
CASH EQUIVALENTS, INVESTMENTS_2
CASH EQUIVALENTS, INVESTMENTS AND FAIR VALUE MEASUREMENTS (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
CASH EQUIVALENTS, INVESTMENTS AND FAIR VALUE MEASUREMENTS | |
Schedule of cost and fair value of cash equivalents and short-term investments | The amortized cost and fair value of cash equivalents and investments as of March 31, 2023 and December 31, 2022 were as follows (in thousands): Gross Gross Amortized Unrealized Unrealized As of March 31, 2023 Cost Gains Losses Fair Value U.S. treasury securities $ 45,212 $ — $ (117) $ 45,095 Commercial paper 38,716 — (9) 38,707 Money market funds 284,486 — — 284,486 Total investments $ 368,414 $ — $ (126) $ 368,288 Gross Gross Amortized Unrealized Unrealized As of December 31, 2022 Cost Gains Losses Fair Value U.S. treasury securities $ 118,570 $ — $ (850) $ 117,720 U.S. government agency securities 11,272 — (7) 11,265 Corporate securities 7,230 — — 7,230 Commercial paper 148,299 8 (53) 148,254 Money market funds 88,001 — — 88,001 Total investments $ 373,372 $ 8 $ (910) $ 372,470 |
Schedule of available-for-sale debt securities | The fair value of cash equivalents and investments as of March 31, 2023 and December 31, 2022 are classified as follows in the Company’s Consolidated Balance Sheets (in thousands): March 31, December 31, Classified as: 2023 2022 Cash equivalents $ 285,480 $ 132,356 Short-term investments 82,808 240,114 Total investments $ 368,288 $ 372,470 |
Schedule of fair value of the company's financial assets | As of March 31, 2023 and December 31, 2022, the fair value of the Company’s financial assets that are measured at fair value on a recurring basis, which consist of cash equivalents and short-term and long-term investments classified as available-for-sale securities, are categorized in the table below based upon the lowest level of significant input to the valuations (in thousands): Assets at Fair Value as of March 31, 2023 Level 1 Level 2 Level 3 Total U.S. treasury securities $ 45,095 $ — $ — $ 45,095 Commercial paper — 38,707 — 38,707 Money market funds 284,486 — — 284,486 Total $ 329,581 $ 38,707 $ — $ 368,288 Assets at Fair Value as of December 31, 2022 Level 1 Level 2 Level 3 Total U.S. treasury securities $ 117,720 $ — $ — $ 117,720 U.S. government agency securities — 11,265 — 11,265 Corporate securities — 7,230 — 7,230 Commercial paper — 148,254 — 148,254 Money market funds 88,001 — — 88,001 Total $ 205,721 $ 166,749 $ — $ 372,470 |
PROPERTY AND EQUIPMENT, NET (Ta
PROPERTY AND EQUIPMENT, NET (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
PROPERTY AND EQUIPMENT, NET | |
Schedule of Property and equipment | Property and equipment, net consists of the following (in thousands): March 31, December 31, 2023 2022 Leasehold improvements $ 75,016 $ 74,305 Lab, process, and validation equipment 22,448 22,136 Utility equipment 5,990 5,951 Office furniture and equipment 3,138 2,927 Computer software 6,736 6,736 Computer equipment 695 695 Machinery and equipment 251 82 Construction in progress 15,023 9,118 Total property and equipment, cost 129,297 121,950 Less: Accumulated depreciation and amortization (19,374) (16,718) Property and equipment, net $ 109,923 $ 105,232 |
ACCRUED EXPENSES (Tables)
ACCRUED EXPENSES (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
ACCRUED EXPENSES | |
Schedule of accrued expenses | Accrued expenses consist of the following (in thousands): March 31, December 31, 2023 2022 Accrued payroll and employee related expenses $ 13,904 $ 19,407 Clinical related 10,578 14,812 Manufacturing related 5,004 4,652 Facilities related 6,652 6,510 Legal and related services 2,660 3,015 Other accrued expenses 4,290 3,899 Total accrued expenses $ 43,088 $ 52,295 |
STOCKHOLDERS' EQUITY (Tables)
STOCKHOLDERS' EQUITY (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
STOCKHOLDERS' EQUITY | |
Schedule of status of stock options | Weighted Weighted Average Aggregate Number Average Remaining Intrinsic of Exercise Contract Value Options Price Life Outstanding at December 31, 2022 15,240,197 $ 22.45 Issued 4,293,745 7.10 Exercised — — Expired/Cancelled (269,925) 18.92 Outstanding at March 31, 2023 19,264,017 $ 19.08 7.55 $ 174,200 Ending vested and expected to vest at March 31, 2023 19,264,017 $ 19.08 7.55 $ 174,200 Options exercisable at March 31, 2023 10,777,903 $ 22.85 6.25 $ 174,200 |
Schedule of summary of RSU activity including PRSUs | Weighted Number Average of Grant Date RSUs and PRSUs Fair Value Outstanding as of December 31, 2022 2,436,764 $ 14.74 Granted 2,267,306 7.12 Vested/Released (770,257) 17.20 Canceled/Forfeited (23,356) 15.49 Outstanding as of March 31, 2023 3,910,457 $ 9.83 Ending vested and expected to vest at March 31, 2023 3,910,457 $ 9.83 |
Schedule of stock-based compensation | Three Months Ended March 31, 2023 2022 Research and development $ 8,859 $ 13,651 General and administrative 6,806 8,614 Total stock-based compensation expense $ 15,665 $ 22,265 |
Schedule of stock-based compensation by type of award | Three Months Ended March 31, 2023 2022 Stock option expense $ 11,702 $ 14,867 Restricted stock expense 3,660 7,162 ESPP expense 303 236 Total stock-based compensation expense $ 15,665 $ 22,265 |
LEASES (Tables)
LEASES (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
LEASES | |
Schedule of balance sheet classification of the Company's right-of-use asset and lease liabilities | The balance sheet classification of the Company’s right-of-use asset and lease liabilities was as follows (in thousands): March 31, December 31, 2023 2022 Operating lease right-of-use assets $ 70,431 $ 73,015 Operating lease liabilities Current portion included in current liabilities 12,614 12,587 Long-term portion included in non-current liabilities 69,612 71,859 Total operating lease liabilities $ 82,226 $ 84,446 |
Schedule of components of lease expenses | The following table summarizes components of lease expenses, which were included in Total costs and expenses in the Company’s Condensed Consolidated Statements of Operations, and other information related to its operating leases as follows (in thousands except weighted-average remaining lease terms and discount rates): Three Months Ended March 31, 2023 2022 Operating lease cost $ 4,524 $ 4,555 Variable lease cost 1,694 980 Short-term lease cost 45 42 Total lease cost $ 6,263 $ 5,577 Other information Cash paid for amounts included in the measurement of lease liabilities included in cash flows from operations $ 4,161 $ 3,811 Tenant improvement allowance received for amounts included in the measurement of lease liabilities included in cash flows from operations $ — $ 3,115 Increase in right-of-use assets from lease modifications $ 349 $ 7,673 Weighted-average remaining lease terms (years) 12.90 14.13 Weighted-average discount rates 7.5 % 7.2 % |
Schedule of minimum lease commitments | As of March 31, 2023, the maturities of the Company’s operating lease liabilities were as follows (in thousands): CMO Facility embedded Year Ending December 31, leases leases Total Remainder of 2023 $ 6,183 $ 7,888 $ 14,071 2024 8,424 2,181 10,605 2025 8,240 — 8,240 2026 7,989 — 7,989 2027 8,186 — 8,186 Thereafter 83,827 — 83,827 Total lease payments $ 122,849 $ 10,069 $ 132,918 Less: Present value adjustment (50,140) (552) (50,692) Operating lease liabilities $ 72,709 $ 9,517 $ 82,226 |
GENERAL ORGANIZATION, BUSINES_2
GENERAL ORGANIZATION, BUSINESS AND LIQUIDITY (Details) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | |
GENERAL ORGANIZATION, BUSINESS AND LIQUIDITY | |||
Net loss | $ (107,370) | $ (91,607) | |
Net cash used in operating activities | (99,815) | (73,802) | |
Cash equivalents, short-term investments, and restricted cash | 632,700 | ||
Cash and cash equivalents | 543,484 | 92,360 | $ 231,731 |
Short-term investments | 82,808 | 240,114 | |
Restricted cash | $ 6,430 | $ 6,084 | $ 6,430 |
SUMMARY OF SIGNIFICANT ACCOUN_4
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Cash, Cash equivalents and Restricted Cash (Details) - USD ($) $ in Thousands | 3 Months Ended | |||
Mar. 31, 2023 | Dec. 31, 2022 | Mar. 31, 2022 | Dec. 31, 2021 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | ||||
Restricted security deposit | $ 5,450 | |||
Cash and cash equivalents | 543,484 | $ 231,731 | $ 92,360 | |
Restricted cash | 6,430 | 6,430 | 6,084 | |
Total cash, cash equivalents and restricted cash | 549,914 | $ 238,161 | $ 98,444 | $ 84,313 |
Commercial manufacturing facility | ||||
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | ||||
Security deposit | 5,450 | |||
Decrease in letters of credit | 1,000 | |||
Commercial manufacturing facility | Minimum | ||||
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | ||||
Security deposit | 1,500 | |||
Headquarters lease | ||||
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | ||||
Security deposit | $ 600 |
SUMMARY OF SIGNIFICANT ACCOUN_5
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Net Loss per Share (Details) - shares | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Antidilutive securities excluded from calculation of net loss per share | 26,360,916 | 20,222,309 |
Stock options | ||
Antidilutive securities excluded from calculation of net loss per share | 19,264,017 | 14,101,526 |
Employee Stock Purchase Plan | ||
Antidilutive securities excluded from calculation of net loss per share | 247,284 | 86,448 |
Restricted stock units | ||
Antidilutive securities excluded from calculation of net loss per share | 3,910,457 | 3,095,177 |
Series A Convertible Preferred Stock | ||
Antidilutive securities excluded from calculation of net loss per share | 97,000 | 97,000 |
Series B Convertible Preferred Stock | ||
Antidilutive securities excluded from calculation of net loss per share | 2,842,158 | 2,842,158 |
SUMMARY OF SIGNIFICANT ACCOUN_6
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Additional information (Details) | 3 Months Ended |
Mar. 31, 2023 segment | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
Number of operating segments | 1 |
CASH EQUIVALENTS, INVESTMENTS_3
CASH EQUIVALENTS, INVESTMENTS AND FAIR VALUE MEASUREMENTS - Cost and fair value (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Amortized Cost | $ 368,414 | $ 373,372 |
Gross Unrealized Gains | 8 | |
Gross Unrealized Losses | (126) | (910) |
Fair Value | 368,288 | 372,470 |
U.S. treasury securities | ||
Amortized Cost | 45,212 | 118,570 |
Gross Unrealized Losses | (117) | (850) |
Fair Value | 45,095 | 117,720 |
U.S. government agency securities | ||
Amortized Cost | 11,272 | |
Gross Unrealized Losses | (7) | |
Fair Value | 11,265 | |
Corporate securities | ||
Amortized Cost | 7,230 | |
Fair Value | 7,230 | |
Commercial paper | ||
Amortized Cost | 38,716 | 148,299 |
Gross Unrealized Gains | 8 | |
Gross Unrealized Losses | (9) | (53) |
Fair Value | 38,707 | 148,254 |
Money market funds | ||
Amortized Cost | 284,486 | 88,001 |
Fair Value | $ 284,486 | $ 88,001 |
CASH EQUIVALENTS, INVESTMENTS_4
CASH EQUIVALENTS, INVESTMENTS AND FAIR VALUE MEASUREMENTS - Available for sale debt securities (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Cash and Cash Equivalents [Line Items] | ||
Short-term investments | $ 82,808 | $ 240,114 |
Total investments | 368,288 | 372,470 |
Money market funds | ||
Cash and Cash Equivalents [Line Items] | ||
Cash equivalents | $ 285,480 | $ 132,356 |
CASH EQUIVALENTS, INVESTMENTS_5
CASH EQUIVALENTS, INVESTMENTS AND FAIR VALUE MEASUREMENTS - Narrative (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2023 | Dec. 31, 2022 | |
Unrealized losses on available-for-sale | $ 0 | $ 0 |
Money market funds | ||
Cash equivalents total | 285,480 | 132,356 |
Demand Deposits | ||
Cash equivalents total | $ 258,000 | $ 99,400 |
CASH EQUIVALENTS, INVESTMENTS_6
CASH EQUIVALENTS, INVESTMENTS AND FAIR VALUE MEASUREMENTS - Fair value of company's financial assets (Details) - Recurring - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Total | $ 368,288 | $ 372,470 |
U.S. treasury securities | ||
Total | 45,095 | 117,720 |
U.S. government agency securities | ||
Total | 11,265 | |
Corporate securities | ||
Total | 7,230 | |
Commercial paper | ||
Total | 38,707 | 148,254 |
Money market funds | ||
Total | 284,486 | 88,001 |
Level 1 | ||
Total | 329,581 | 205,721 |
Level 1 | U.S. treasury securities | ||
Total | 45,095 | 117,720 |
Level 1 | Money market funds | ||
Total | 284,486 | 88,001 |
Level 2 | ||
Total | 38,707 | 166,749 |
Level 2 | U.S. government agency securities | ||
Total | 11,265 | |
Level 2 | Corporate securities | ||
Total | 7,230 | |
Level 2 | Commercial paper | ||
Total | $ 38,707 | $ 148,254 |
PROPERTY AND EQUIPMENT, NET - (
PROPERTY AND EQUIPMENT, NET - (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Property, Plant and Equipment [Line Items] | ||
Total property and equipment, cost | $ 129,297 | $ 121,950 |
Less: Accumulated depreciation and amortization | (19,374) | (16,718) |
Property and equipment, net | 109,923 | 105,232 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment, cost | 75,016 | 74,305 |
Lab, process, and validation equipment | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment, cost | 22,448 | 22,136 |
Utility equipment | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment, cost | 5,990 | 5,951 |
Office furniture and equipment | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment, cost | 3,138 | 2,927 |
Computer software | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment, cost | 6,736 | 6,736 |
Computer equipment | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment, cost | 695 | 695 |
Machinery and equipment | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment, cost | 251 | 82 |
Construction in progress | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment, cost | $ 15,023 | $ 9,118 |
PROPERTY AND EQUIPMENT, NET - O
PROPERTY AND EQUIPMENT, NET - Other information (Details) - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
PROPERTY AND EQUIPMENT, NET | ||
Depreciation | $ 2.8 | $ 1.8 |
ACCRUED EXPENSES (Details)
ACCRUED EXPENSES (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
ACCRUED EXPENSES | ||
Accrued payroll and employee related expenses | $ 13,904 | $ 19,407 |
Clinical related | 10,578 | 14,812 |
Manufacturing related | 5,004 | 4,652 |
Facilities related | 6,652 | 6,510 |
Legal and related services | 2,660 | 3,015 |
Other accrued expenses | 4,290 | 3,899 |
Total accrued expenses | $ 43,088 | $ 52,295 |
STOCKHOLDERS' EQUITY (Details)
STOCKHOLDERS' EQUITY (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |||||||||||
Feb. 08, 2021 | Jun. 08, 2020 | Mar. 31, 2023 | Mar. 31, 2022 | Mar. 13, 2023 | Mar. 12, 2023 | Dec. 31, 2022 | Jun. 10, 2022 | Jan. 12, 2022 | Jan. 11, 2022 | Sep. 22, 2021 | Apr. 22, 2018 | |
Common Stock | ||||||||||||
Common stock, shares authorized | 300,000,000 | 300,000,000 | ||||||||||
Common stock, par or stated value per share | $ 0.000041666 | $ 0.000041666 | ||||||||||
Common stock, shares issued | 224,358,979 | 187,812,072 | ||||||||||
Common stock, shares outstanding | 224,358,979 | 187,812,072 | ||||||||||
Proceeds from the issuance of common stock, net | $ 260,101 | $ 0 | ||||||||||
Weighted average grant date fair value, options granted | $ 4.94 | $ 8.81 | ||||||||||
Common Stock | ||||||||||||
Common Stock | ||||||||||||
Common stock issued, net of offering costs (in shares) | 36,080,226 | |||||||||||
At the Market Offering Program | ||||||||||||
Common Stock | ||||||||||||
Maximum amount of shares to be issued | $ 350,000 | |||||||||||
Maximum percentage of commission | 3% | |||||||||||
Common stock issued, net of offering costs (in shares) | 36,080,226 | 0 | ||||||||||
Proceeds from the issuance of common stock, net | $ 260,100 | |||||||||||
Weighted average price | $ 7.35 | |||||||||||
Second Sales Agreement | ||||||||||||
Common Stock | ||||||||||||
Maximum amount of shares to be issued | $ 500,000 | |||||||||||
Series A Convertible Preferred Stock | ||||||||||||
Common Stock | ||||||||||||
Preferred stock, shares authorized | 17,000 | 17,000 | ||||||||||
Preferred stock, par or stated value per share | $ 0.001 | $ 0.001 | ||||||||||
Conversion of Stock, shares converted | 0 | 0 | ||||||||||
Conversion of stock, shares issued | 500 | |||||||||||
Preferred stock, shares outstanding | 194 | 194 | ||||||||||
Series A Convertible Preferred Stock | Common Stock | ||||||||||||
Common Stock | ||||||||||||
Common stock available in conversion, shares | 97,000 | 97,000 | ||||||||||
Series A Convertible Preferred Stock | Private Placement | ||||||||||||
Common Stock | ||||||||||||
Preferred stock, par or stated value per share | $ 1,000 | |||||||||||
Convertible price per share | $ 2 | |||||||||||
Series B Convertible Preferred Stock | ||||||||||||
Common Stock | ||||||||||||
Preferred stock, shares authorized | 11,500,000 | 11,500,000 | ||||||||||
Preferred stock, par or stated value per share | $ 0.001 | $ 0.001 | ||||||||||
Conversion of stock, shares issued | 1 | |||||||||||
Preferred stock, shares outstanding | 2,842,158 | 2,842,158 | ||||||||||
Series B Convertible Preferred Stock | Issuance Of Common Stock Upon Conversion Of Preferred Stock | ||||||||||||
Common Stock | ||||||||||||
Conversion of stock, shares issued | 0 | 0 | ||||||||||
Series B Convertible Preferred Stock | Common Stock | ||||||||||||
Common Stock | ||||||||||||
Preferred stock, shares outstanding | 2,842,158 | 2,842,158 | ||||||||||
Series B Convertible Preferred Stock | IPO | ||||||||||||
Common Stock | ||||||||||||
Preferred stock, par or stated value per share | $ 4.75 | |||||||||||
Convertible price per share | $ 4.75 | |||||||||||
Blank check | ||||||||||||
Common Stock | ||||||||||||
Preferred stock, shares authorized | 50,000,000 | |||||||||||
Stock options | ||||||||||||
Common Stock | ||||||||||||
Unrecognized compensation cost | $ 66,500 | |||||||||||
Unrecognized compensation cost recognition period | 2 years 2 months 12 days | |||||||||||
RSUs and PRSUs | ||||||||||||
Common Stock | ||||||||||||
Unrecognized compensation cost | $ 37,000 | |||||||||||
Unrecognized compensation cost recognition period | 2 years 3 months 3 days | |||||||||||
Unrecognized compensation cost | $ 32,700 | |||||||||||
Aggregate intrinsic value of outstanding non-vested RSUs & PRSUs | $ 23,900 | 51,500 | ||||||||||
Vested | 770,257 | |||||||||||
Granted | 2,267,306 | |||||||||||
2014 Equity Incentive Plan | ||||||||||||
Common Stock | ||||||||||||
Number of shares available | 61,293 | |||||||||||
The 2018 Plan | ||||||||||||
Common Stock | ||||||||||||
Number of shares available | 545,618 | |||||||||||
Shares authorized | 14,000,000 | 6,000,000 | ||||||||||
Common Stock, Capital Shares Reserved for Future Issuance | 20,700,000 | |||||||||||
2020 ESPP | ||||||||||||
Common Stock | ||||||||||||
Common stock issued, net of offering costs (in shares) | 356,849 | |||||||||||
Shares authorized | 500,000 | |||||||||||
Percentage of purchase price | 85% | |||||||||||
Stock-based compensation expense | $ 300 | $ 200 | ||||||||||
Unrecognized compensation cost | $ 300 | |||||||||||
Unrecognized compensation cost recognition period | 2 months 9 days | |||||||||||
2021 Inducement Plan | ||||||||||||
Common Stock | ||||||||||||
Number of shares available | 111,185 | |||||||||||
Shares authorized | 2,250,000 | 1,750,000 | 1,750,000 | 1,000,000 | 1,000,000 |
STOCKHOLDERS' EQUITY - Stock Op
STOCKHOLDERS' EQUITY - Stock Options (Details) - Stock options $ / shares in Units, $ in Thousands | 3 Months Ended |
Mar. 31, 2023 USD ($) $ / shares shares | |
Number of Options | |
Outstanding, beginning balance | shares | 15,240,197 |
Issued | shares | 4,293,745 |
Expired/Cancelled | shares | (269,925) |
Outstanding, ending balance | shares | 19,264,017 |
Ending vested and expected to vest | shares | 19,264,017 |
Options exercisable | shares | 10,777,903 |
Weighted Average Exercise Price | |
Outstanding, beginning balance | $ / shares | $ 22.45 |
Issued | $ / shares | 7.10 |
Expired/Cancelled | $ / shares | 18.92 |
Outstanding, ending balance | $ / shares | 19.08 |
Ending vested and expected to vest | $ / shares | 19.08 |
Options exercisable | $ / shares | $ 22.85 |
Weighted Average Remaining Contractual Life | |
Options outstanding, remaining term | 7 years 6 months 18 days |
Ending vested and expected to vest, remaining term | 7 years 6 months 18 days |
Options exercisable, remaining term | 6 years 3 months |
Aggregate Intrinsic Value | |
Option at ending balance | $ | $ 174,200 |
Ending vested and expected to vest | $ | 174,200 |
Option exercisable | $ | $ 174,200 |
STOCKHOLDERS' EQUITY - Restrict
STOCKHOLDERS' EQUITY - Restricted Stock Units and Performance Restricted Stock Units (Details) - RSUs and PRSUs | 3 Months Ended |
Mar. 31, 2023 $ / shares shares | |
Number of Shares | |
Outstanding, Beginning Balance | shares | 2,436,764 |
Granted | shares | 2,267,306 |
Vested/Released | shares | (770,257) |
Canceled/forfeited | shares | (23,356) |
Outstanding, Ending balance | shares | 3,910,457 |
Ending vested and expected to vest | shares | 3,910,457 |
Weighted Average Grant Date Fair Value | |
Weighted Average Grant Date Fair Value, Beginning Balance | $ / shares | $ 14.74 |
Weighted Average Grant Date Fair Value, Granted | $ / shares | 7.12 |
Weighted Average Grant Date Fair Value, Vested/Released | $ / shares | 17.20 |
Weighted Average Grant Date Fair Value, Canceled/forfeited | $ / shares | 15.49 |
Weighted Average Grant Date Fair Value, Ending Balance | $ / shares | 9.83 |
Weighted Average Grant Date Fair Value, Ending vested and expected to vest | $ / shares | $ 9.83 |
STOCKHOLDERS' EQUITY - Stock ba
STOCKHOLDERS' EQUITY - Stock based expense (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Total stock-based compensation expenses | $ 15,665 | $ 22,265 |
Research and development | ||
Total stock-based compensation expenses | 8,859 | 13,651 |
General and administrative | ||
Total stock-based compensation expenses | $ 6,806 | $ 8,614 |
STOCKHOLDERS' EQUITY - Stock-ba
STOCKHOLDERS' EQUITY - Stock-based compensation by instrument (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Total stock-based compensation expenses | $ 15,665 | $ 22,265 |
Stock options | ||
Total stock-based compensation expenses | 11,702 | 14,867 |
Restricted stock units | ||
Total stock-based compensation expenses | 3,660 | 7,162 |
2020 ESPP | ||
Total stock-based compensation expenses | $ 303 | $ 236 |
LICENSES AND AGREEMENTS (Detail
LICENSES AND AGREEMENTS (Details) $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||||||||
May 07, 2018 USD ($) | Apr. 17, 2017 USD ($) | Jun. 28, 2014 USD ($) | Oct. 31, 2022 item | Aug. 31, 2021 USD ($) | Nov. 30, 2016 item | Aug. 31, 2011 | Mar. 31, 2023 USD ($) | Mar. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | Dec. 31, 2020 USD ($) | |
Research and development | $ 82,734 | $ 68,300 | |||||||||
Strategic Alliance Agreement | |||||||||||
Research and development | 0 | ||||||||||
Maximum | Strategic Alliance Agreement | |||||||||||
Research and development arrangement, contract to perform for others, costs incurred, gross | $ 14,200 | ||||||||||
Sponsored research agreement | |||||||||||
Research and development | 100 | 100 | |||||||||
First WuXi Manufacturing and Services Agreement | |||||||||||
Agreement term | 3 years | ||||||||||
Number Of Statements Of Work | item | 1 | ||||||||||
Number Of Suites Under The Agreement | item | 2 | ||||||||||
Second WuXi Manufacturing and Services Agreement | |||||||||||
Agreement term | 3 years | ||||||||||
Number Of Suites Under The Agreement | item | 2 | ||||||||||
Termination notice period | 120 days | ||||||||||
Period to address issues within receipt of FDA response letter in collaboration arrangement | 90 days | ||||||||||
Research and development | Strategic Alliance Agreement | |||||||||||
Research and development arrangement, contract to perform for others, costs incurred, gross | 5,300 | ||||||||||
Cooperative Research and Development Agreement | |||||||||||
Agreement term | 3 years | 5 years | |||||||||
Research and development | $ 500 | 500 | 500 | ||||||||
Notification Period To Terminate Agreement | 60 days | ||||||||||
Research Collaboration And Clinical Grant Agreements With Moffitt | |||||||||||
Research and development | 0 | 0 | |||||||||
Moffitt License Agreement One | |||||||||||
Agreement term | 20 years | ||||||||||
Research and development | 0 | 0 | |||||||||
Moffitt License Agreement One | Research and development | |||||||||||
Payments for upfront licensing fee | $ 100 | ||||||||||
Moffitt License Agreement Two | |||||||||||
Payments for upfront licensing fee | $ 100 | ||||||||||
Additional milestone payable | 400 | ||||||||||
Moffitt License Agreement Two, Amended and Restated | |||||||||||
Payments for upfront licensing fee | $ 200 | ||||||||||
WuXi Apptech, Inc - Manufacturing and Services Agreement | |||||||||||
Research and development | 3,900 | 3,900 | |||||||||
Cellectis S.A | |||||||||||
Research and development | 100 | 100 | |||||||||
Novartis Pharma AG - License Agreement | |||||||||||
Research and development | $ 0 | $ 0 | $ 10,000 |
LEASES - Additional information
LEASES - Additional information (Details) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2023 USD ($) ft² | Mar. 31, 2022 USD ($) | Dec. 31, 2022 USD ($) | |
Option to extend | true | ||
Monthly lease payments | $ 132,918 | ||
First year | 10,605 | ||
Second year | 8,240 | ||
Monthly lease payments | 4,161 | $ 3,811 | |
Operating lease liabilities | 82,226 | $ 84,446 | |
Operating lease right-of-use assets | $ 70,431 | $ 73,015 | |
Tenant improvement allowance reimbursed | $ 3,115 | ||
Minimum | |||
Term of contract in years | 1 year | ||
Maximum | |||
Term of contract in years | 20 years | ||
Office Space | Minimum | |||
Term of contract in years | 12 months | ||
Office Space | Philadelphia, Pennsylvania | |||
Area of land | ft² | 136,000 | ||
Furniture and equipment | Maximum | |||
Term of contract in years | 12 months | ||
Facility leases | |||
Monthly lease payments | $ 122,849 | ||
First year | 8,424 | ||
Second year | 8,240 | ||
Operating lease liabilities | $ 72,709 | ||
New Headquarters Lease | Office Space | San Carlos, California | |||
Area of land | ft² | 49,918 |
LEASES - Right-of-use asset and
LEASES - Right-of-use asset and lease liabilities (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
LEASES | ||
Operating lease right-of-use assets | $ 70,431 | $ 73,015 |
Operating lease liabilities | ||
Current portion included in current liabilities | 12,614 | 12,587 |
Long-term portion included in non-current liabilities | 69,612 | 71,859 |
Total operating lease liabilities | $ 82,226 | $ 84,446 |
LEASES - Components of lease ex
LEASES - Components of lease expenses (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
LEASES | ||
Operating lease cost | $ 4,524 | $ 4,555 |
Variable lease cost | 1,694 | 980 |
Short-term lease cost | 45 | 42 |
Total lease cost | 6,263 | 5,577 |
Cash paid for amounts included in the measurement of lease liabilities included in cash flows from operations | 4,161 | 3,811 |
Tenant improvement allowance received for amounts included in the measurement of lease liabilities included in cash flows from operations | 3,115 | |
Increase in right-of-use assets from lease modifications | $ 349 | $ 7,673 |
Weighted-average remaining lease terms (years) | 12 years 10 months 24 days | 14 years 1 month 17 days |
Weighted-average discount rates | 7.50% | 7.20% |
LEASES - Maturities of the Comp
LEASES - Maturities of the Company's operating lease liabilities (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Remainder of 2023 | $ 14,071 | |
2024 | 10,605 | |
2025 | 8,240 | |
2026 | 7,989 | |
2027 | 8,186 | |
Thereafter | 83,827 | |
Total lease payments | 132,918 | |
Less: Present value adjustment | (50,692) | |
Operating lease liabilities | 82,226 | $ 84,446 |
Facility leases | ||
Remainder of 2023 | 6,183 | |
2024 | 8,424 | |
2025 | 8,240 | |
2026 | 7,989 | |
2027 | 8,186 | |
Thereafter | 83,827 | |
Total lease payments | 122,849 | |
Less: Present value adjustment | (50,140) | |
Operating lease liabilities | 72,709 | |
CMO embedded leases | ||
Remainder of 2023 | 7,888 | |
2024 | 2,181 | |
Total lease payments | 10,069 | |
Less: Present value adjustment | (552) | |
Operating lease liabilities | $ 9,517 |
LEGAL PROCEEDINGS (Details)
LEGAL PROCEEDINGS (Details) | 1 Months Ended | ||||
Oct. 14, 2021 USD ($) | May 12, 2020 USD ($) | Apr. 08, 2016 USD ($) | Nov. 30, 2012 USD ($) | Jun. 30, 2012 USD ($) | |
Damages claimed | $ 500,000 | ||||
Solomon Capital LLC Litigation | |||||
Proceeds from lawsuit filed | $ 200,000 | $ 100,000 | |||
Face amount | $ 200,000 | ||||
Debt instrument, convertible, number of equity instruments | 1,110 | ||||
Estimate of possible loss | $ 1,500,000 | ||||
Reverse split ratio | 0.01 | ||||
Maximum | |||||
Equity claim | $ 100,000 | $ 100,000 |
PROLEUKIN ACQUISITION (Details)
PROLEUKIN ACQUISITION (Details) - Jan. 23, 2023 - Option Agreement - Clinigen Healthcare Limited and Clinigen, Inc [Member] £ in Millions, $ in Millions | GBP (£) | USD ($) |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Collaboration Agreement, Upfront Payments | £ 167.7 | $ 200 |
Milestone Payable on Approval | £ 41.7 | $ 50 |