Document And Entity Information
Document And Entity Information - shares | 3 Months Ended | |
Mar. 31, 2020 | Apr. 28, 2020 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Mar. 31, 2020 | |
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 | 999 Skyway Road, Suite 150 | |
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 $0.000041666 per share | |
Trading Symbol | IOVA | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 126,861,580 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2020 | |
Document Fiscal Period Focus | Q1 | |
Entity Central Index Key | 0001425205 | |
Amendment Flag | false |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Current Assets | ||
Cash and cash equivalents | $ 52,540 | $ 13,969 |
Short-term investments | 193,112 | 293,112 |
Prepaid expenses and other assets | 10,729 | 9,412 |
Total Current Assets | 256,381 | 316,493 |
Property and equipment, net | 13,607 | 8,536 |
Operating lease right-of-use assets | 9,305 | 10,695 |
Restricted cash | 5,525 | 5,450 |
Long-term assets | 3,480 | 3,481 |
Total Assets | 288,298 | 344,655 |
Current Liabilities | ||
Accounts payable | 10,614 | 15,567 |
Accrued expenses | 22,500 | 16,265 |
Operating lease liabilities - current | 6,431 | 7,252 |
Total Current Liabilities | 39,545 | 39,084 |
Non-Current Liabilities | ||
Operating lease liabilities - noncurrent | 3,088 | 4,248 |
Other liabilities | 2,352 | 2,352 |
Total Non-Current Liabilities | 5,440 | 6,600 |
Total Liabilities | 44,985 | 45,684 |
Commitments and contingencies (Notes 8 and 9) | ||
Stockholders' Equity | ||
Common stock, $0.000041666 par value; 300,000,000 shares authorized, 126,823,156 and 126,411,808 shares issued and outstanding as of March 31, 2020 and December 31, 2019, respectively | 5 | 5 |
Accumulated other comprehensive income | 912 | 220 |
Additional paid-in capital | 882,599 | 869,354 |
Accumulated deficit | (640,207) | (570,612) |
Total Stockholders' Equity | 243,313 | 298,971 |
Total Liabilities and Stockholders' Equity | 288,298 | 344,655 |
Series B Convertible Preferred Stock | ||
Stockholders' Equity | ||
Preferred stock, Value | 4 | 4 |
Total Stockholders' Equity | $ 4 | $ 4 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
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 | 126,823,156 | 126,411,808 |
Common Stock, Shares, Outstanding | 126,823,156 | 126,411,808 |
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 |
Preferred Stock, Liquidation Preference, Value | $ 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 | 3,581,119 | 3,581,119 |
Preferred stock, shares outstanding | 3,581,119 | 3,581,119 |
Preferred Stock, Liquidation Preference, Value | $ 17,010 | $ 17,010 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Costs and expenses | ||
Research and development expenses | $ 56,952 | $ 30,905 |
General and administrative expenses | 13,858 | 9,081 |
Total costs and expenses | 70,810 | 39,986 |
Loss from operations | (70,810) | (39,986) |
Other income | ||
Interest income, net | 1,215 | 3,036 |
Net Loss | $ (69,595) | $ (36,950) |
Net Loss Per Common Share, Basic and Diluted | $ (0.55) | $ (0.30) |
Weighted Average Common Shares Outstanding, Basic and Diluted | 126,568 | 123,415 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Condensed Consolidated Statements of Comprehensive Loss | ||
Net Loss | $ (69,595) | $ (36,950) |
Other comprehensive income: | ||
Unrealized gain on short-term investments | 692 | 180 |
Comprehensive Loss | $ (68,903) | $ (36,770) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Series A Convertible Preferred Stock | Series B Convertible Preferred Stock | Common Stock | Additional Paid-in Capital | Accumulated other Comprehensive Income | Accumulated Deficit | Total |
Beginning Balance at Dec. 31, 2018 | $ 6 | $ 5 | $ 838,984 | $ (42) | $ (372,760) | $ 466,193 | |
Beginning Balance (in Shares) at Dec. 31, 2018 | 194 | 5,854,845 | 123,415,576 | ||||
Stock-based compensation expense | 5,846 | 5,846 | |||||
Vesting of restricted shares issued for services | $ 1 | 1 | |||||
Vesting of restricted shares issued for services (in shares) | 7,037 | ||||||
Tax payments related to shares withheld for vested restricted stock units | (71) | (71) | |||||
Common stock issued upon exercise of stock options | $ 0 | 69 | 69 | ||||
Common stock issued upon exercise of stock options (in shares) | 5,000 | ||||||
Unrealized gain on short-term investments | 180 | 180 | |||||
Cancellation of common shares from settlement of dispute | $ (1) | (335) | (336) | ||||
Cancellation of common shares from settlement of dispute (In Shares) | (32,500) | ||||||
Net loss | (36,950) | (36,950) | |||||
Ending Balance at Mar. 31, 2019 | $ 6 | $ 5 | 844,789 | 138 | (410,006) | 434,932 | |
Ending Balance (in Shares) at Mar. 31, 2019 | 194 | 5,854,845 | 123,395,113 | ||||
Adoption of ASU 2018-07 | 296 | (296) | |||||
Beginning Balance at Dec. 31, 2019 | $ 4 | $ 5 | 869,354 | 220 | (570,612) | 298,971 | |
Beginning Balance (in Shares) at Dec. 31, 2019 | 194 | 3,581,119 | 126,411,808 | ||||
Stock-based compensation expense | 9,412 | 9,412 | |||||
Vesting of restricted shares issued for services (in shares) | 7,273 | ||||||
Tax payments related to shares withheld for vested restricted stock units | (118) | (118) | |||||
Common stock issued upon exercise of stock options | 3,951 | 3,951 | |||||
Common stock issued upon exercise of stock options (in shares) | 404,075 | ||||||
Unrealized gain on short-term investments | 692 | 692 | |||||
Net loss | (69,595) | (69,595) | |||||
Ending Balance at Mar. 31, 2020 | $ 4 | $ 5 | $ 882,599 | $ 912 | $ (640,207) | $ 243,313 | |
Ending Balance (in Shares) at Mar. 31, 2020 | 194 | 3,581,119 | 126,823,156 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Cash Flows from Operating Activities | ||
Net loss | $ (69,595) | $ (36,950) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation expense | 9,412 | 5,846 |
Noncash lease expense | 1,870 | 1,424 |
Amortization of premiums on investments | (50) | (1,232) |
Depreciation and amortization | 252 | 271 |
Gain on settlement of dispute | (336) | |
Changes in assets and liabilities: | ||
Prepaid expenses, other assets, and long-term assets | (1,316) | 1,592 |
Operating lease liabilities (Right-of-use assets) | (2,461) | (942) |
Accounts payable | (7,768) | 4,583 |
Accrued expenses and other liabilities | 4,364 | (3,346) |
Net cash used in operating activities | (65,292) | (29,090) |
Cash Flows from Investing Activities | ||
Maturities of short-term investments | 113,665 | 91,042 |
Purchase of short-term investments | (12,923) | (89,185) |
Purchase of property and equipment | (637) | (824) |
Net cash provided by investing activities | 100,105 | 1,033 |
Cash Flows from Financing Activities | ||
Tax payments related to shares withheld for vested restricted stock awards | (118) | (71) |
Proceeds from the issuance of common stock upon exercise of options | 3,951 | 69 |
Net cash provided by / (used in) financing activities | 3,833 | (2) |
Net increase / (decrease) in cash, cash equivalents and restricted cash | 38,646 | (28,059) |
Cash, Cash Equivalents, and Restricted Cash, Beginning of Period | 19,419 | 82,152 |
Cash, Cash Equivalents, and Restricted Cash, End of Period (Note 2) | 58,065 | 54,093 |
Supplemental disclosure of non-cash investing and financing activities: | ||
Net unrealized gain on short-term investments | 692 | 180 |
Acquisitions of property and equipment included in accounts payable and accrued expenses | $ 4,686 | $ 268 |
GENERAL ORGANIZATION AND BUSINE
GENERAL ORGANIZATION AND BUSINESS | 3 Months Ended |
Mar. 31, 2020 | |
GENERAL ORGANIZATION AND BUSINESS | |
GENERAL ORGANIZATION AND BUSINESS | NOTE 1. GENERAL ORGANIZATION AND BUSINESS Iovance Biotherapeutics, Inc. (the “Company”, “we”, “us” or “our”) is a clinical-stage biopharmaceutical company focused on the development and commercialization of cell therapies as novel cancer immunotherapy products designed to harness the power of a patient’s own immune system to eradicate cancer cells. Tumor infiltrating lymphocyte or TIL therapy is an autologous cell therapy platform technology that was originally developed by the National Cancer Institute (NCI), which conducted initial clinical trials in diseases such as metastatic melanoma and cervical cancer. The Company has developed a new, shorter manufacturing process for TIL therapy known as Generation 2, or Gen 2, which yields a cryopreserved TIL product. This proprietary and scalable manufacturing method is being further investigated in multiple indications. The Company’s lead product candidates include lifileucel for metastatic melanoma and LN-145 for metastatic cervical cancer. In addition to metastatic melanoma and metastatic cervical cancer, it is investigating the effectiveness and safety of TIL therapy and peripheral blood lymphocyte therapy for the treatment of squamous cell carcinoma of the head and neck, non-small cell lung cancer, and chronic lymphocytic leukemia through its sponsored trials, as well as in other oncology indications through collaborations. On June 1, 2017, the Company reincorporated to become a company governed by Delaware corporation laws. Basis of Presentation of Unaudited Condensed Consolidated Financial Information The unaudited condensed consolidated financial statements of the Company for the three months ended March 31, 2020 and 2019 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-K. Accordingly, they do not include all the information and footnotes required by GAAP for complete 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 financial position and the results of operations. Results shown for interim periods are not necessarily indicative of the results to be obtained for a full fiscal year. The balance sheet information as of December 31, 2019, was derived from the audited financial statements included in the Company's financial statements as of and for the year ended December 31, 2019 included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on February 25, 2020. These financial statements should be read in conjunction with that report. 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. The Company currently does not anticipate that it will generate any revenues from the sale or licensing of any of its product candidates during the 12 months from the date these financial statements are issued. The Company has incurred a net loss of $69.6 million for the three months ended March 31, 2020 and used $65.3 million of cash in its operating activities during the three months ended March 31, 2020. As of March 31, 2020, the Company had $251.2 million in cash, cash equivalents, short-term investments, and restricted cash ($52.5 million of cash and cash equivalents, $193.1 million in short-term investments and $5.5 million in restricted cash). The Company expects to continue its research and development activities, increase pre-commercial activities and initiate the construction on the tenant improvements on its new manufacturing facility, which will increase the amount of cash used during 2020 and beyond. Specifically, the Company expects continued spending on its current and planned clinical trials, continued expansion of manufacturing activities, including construction of a manufacturing facility, higher payroll expenses as the Company increases its professional and scientific staff, and continuation of pre-commercial activities. Based on the funds the Company has available as of the date these financial statements are issued, the Company believes that it has sufficient capital to fund its anticipated operating expenses and capital expenditures for at least the next twelve months from the date these financial statements are issued. The Company has latitude as to the timing and amount of expenditures for its commercial-scale production facility under construction in Philadelphia, Pennsylvania. Impact of COVID-19 In December 2019, a novel (new) coronavirus known as SARS-CoV-2 was first detected in Wuhan, Hubei Province, People’s Republic of China, causing outbreaks of the coronavirus disease, known as COVID-19, that has now spread globally. On January 30, 2020 the World Health Organization (WHO) declared COVID-19 a pandemic (the "COVID-19 Pandemic"). The Secretary of Health and Human Services declared a public health emergency on January 31, 2020, under section 319 of the Public Health Service Act (42 U.S.C. 247d), in response to the COVID-19 Pandemic. The full impact of the COVID-19 Pandemic is unknown and rapidly evolving. While the potential economic impact brought by and the duration of the COVID-19 Pandemic may be difficult to assess or predict, the Company believes the COVID-19 Pandemic has resulted in significant disruption of global financial markets, which could in the future negatively affect its liquidity. In addition, a recession or market volatility resulting from the COVID-19 Pandemic could affect the Company’s business. Given the nature and type of the Company’s short-term investments in US government securities, the Company does not believe the COVID-19 Pandemic will have a material impact on the Company's current investment liquidity. Concentrations of Risk The Company is subject to credit risk from its portfolio of cash equivalents and short-term investments. Under its investment policy, the Company limits amounts invested in such 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, in order of priority, are as follows: safety and preservation of principal and 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, 2020 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | NOTE 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Cash, Cash Equivalents, and Short-term 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 short-term investments are classified as “available-for-sale”. The Company includes these investments in current assets and carries them at fair value. Unrealized gains and losses on available-for-sale securities are included in accumulated other comprehensive income. Any impairment losses related to credit losses (if any) are included in an allowance for credit losses with an offsetting entry to net loss. No impairment losses related to credit losses were recognized for the three months ended March 31, 2020 or for the same period in 2019. 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 net interest income 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 net interest income 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 places restrictions on maturities and concentration by type and issuer. Currently the Company invests excess cash only in obligations issued by the U.S. government and U.S. government agencies. The Company maintains a certain minimum balance, currently $5.5 million in a segregated bank account in connection with two letters of credit, one for $5.45 million for the benefit of the landlord for its commercial manufacturing facility used as a security deposit for the lease (See Note 9 - Leases), and a second one for $74,685 for the benefit of a utilities service provider. The total amount is classified as Restricted Cash on the Balance Sheet. The letter of credit will expire on May 28, 2020, however, it will be automatically extended, without written agreement, for one-year periods to May 28 in each succeeding calendar year, through at least 60 days after the lease expiration rate. Further, on the expiration of the seventh year of the lease, and each anniversary date thereafter, the letter of credit may be decreased by $1,000,000, with a minimum security deposit of $1,450,000 maintained through the end of the lease term. The $74,685 letter of credit will expire on February 25, 2021, however, it will be automatically extended, without written agreement, to the expiration date of December 1, 2022. As of March 31, 2020, restricted cash consisted of $5.5 million and this amount has been classified as a non-current asset on the Company’s condensed consolidated balance sheets. 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: March 31, March 31, 2020 2019 Cash and cash equivalents $ 52,540 $ 54,093 Restricted cash (included in non-current assets on the condensed consolidated balance sheets) 5,525 — Total cash, cash equivalents and restricted cash $ 58,065 $ 54,093 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 equivalent shares 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 and warrants (ii) vesting of restricted stock units and restricted stock awards, and (iii) conversion of preferred stock, are only included in the calculation of diluted net loss per share when their effect is dilutive. At March 31, 2020 and 2019, 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, 2020 2019 Stock options 12,136,899 9,274,973 Series A Convertible Preferred Stock* 97,000 97,000 Series B Convertible Preferred Stock* 3,581,119 5,854,845 Restricted stock units 11,458 57,285 15,826,476 15,284,103 * on an as-converted basis The 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. Fair Value Measurements Under Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 820, Fair Value Measurements and Disclosures, fair value is defined as the price at which an asset could be exchanged, or a liability transferred in a transaction between knowledgeable, willing parties in the principal or most advantageous market for the asset or liability. Where available, fair value is based on observable market prices or parameters or derived from such prices or parameters. Where observable prices or parameters are not available, valuation models are applied. Assets and liabilities recorded at fair value in the Company’s financial statements are categorized based upon the level of judgment associated with the inputs used to measure their fair value. Hierarchical levels directly related to the amount of subjectivity associated with the inputs to fair valuation of these assets and liabilities, are as follows: Level 1–These are investments where values are based on unadjusted quoted prices for identical assets in an active market that the Company has the ability to access. Level 2–These are investments where values are based on quoted market prices in markets that are not active or model derived valuations in which all significant inputs are observable in active markets The Company does not have fair valued assets classified under Level 2 as of March 31, 2020 and December 31, 2019. Level 3–These are financial instruments where values are derived from techniques in which one or more significant inputs are unobservable. The Company does not have fair valued assets classified under Level 3 as of March 31, 2020 and December 31, 2019. The Company’s financial instruments consist of cash and cash equivalents and short-term investments, all of which are reported at their respective fair value on its condensed consolidated balance sheets. As of March 31, 2020 and December 31, 2019, financial assets measured at fair value on a recurring basis 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, 2020 Level 1 Level 2 Level 3 Total US treasury securities $ 161,512 $ — $ — $ 161,512 US government agency securities 31,600 — — 31,600 Total $ 193,112 $ — $ — $ 193,112 Assets at Fair Value as of December 31, 2019 Level 1 Level 2 Level 3 Total US treasury securities $ 242,249 $ — $ — $ 242,249 US government agency securities 50,863 — — 50,863 Total $ 293,112 $ — $ — $ 293,112 Use of Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America (“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 revenue and expenses during the reporting period. Actual results could differ from those estimates. Significant estimates include the assumptions made in valuing stock instruments issued for services and used in measuring operating right-of-use assets and operating lease liabilities, valuation of short-term investments, accounting for potential liabilities, and the valuation allowance associated with 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, and Iovance Biotherapeutics GmbH. All intercompany accounts and transactions have been eliminated. The U.S. dollar is the functional currency for all the Company's consolidated operations. Income Taxes The Company accounts for income taxes using the asset and liability method whereby deferred tax assets are recognized for deductible temporary differences, and deferred tax liabilities are recognized for taxable temporary differences. Temporary differences are the differences between the reported amounts of assets and liabilities and their tax bases. Deferred tax assets are reduced by a valuation allowance when, in the opinion of management, it is more likely than not that some portion or all of the deferred tax assets will be realized. Deferred tax assets and liabilities are adjusted for the effects of changes in tax laws and rates on the date of enactment. ASC Topic 740-10-30 clarifies the accounting for uncertainty in income taxes recognized in an enterprise’s financial statements and prescribes a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. ASC Topic 740-10-40 provides guidance on de-recognition, classification, interest and penalties, accounting in interim periods, disclosure, and transition. The Company will classify as income tax expense any interest and penalties. The Company has no material uncertain tax positions for any of the reporting periods presented. On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”) was enacted and signed into law, and GAAP requires recognition of the tax effects of new legislation during the reporting period that includes the enactment date. The CARES Act, among other things, includes changes to the tax provisions that benefits business entities and makes certain technical corrections to the 2017 Tax Cuts and Jobs Act. The tax relief measures for business include a five-year net operating loss (“NOL”) carrybacks, suspension of annual deduction limitation of 80% taxable income from net operating losses generated in a tax year beginning after December 31, 2017, changes in the deductibility of interest, acceleration of alternative minimum tax credit refunds, payroll tax relief, and technical correction to allow accelerated deductions for qualified improvement property. The CARES Act also provides other non-tax benefits to assist those impacted by the pandemic. The Company evaluated the impact of the CARES Act and determined no material tax provision impact for the quarter ended March 31, 2020. Leases The Company determines if an arrangement includes a lease at inception. Operating leases are included in its condensed consolidated balance sheet as Operating lease right-of-use assets and Operating lease liabilities as of March 31, 2020 and December 31, 2019. 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 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 date or the date of adoption of Accounting Standard Update (ASU) No. 2016-02 and ASU No. 2018-10, Leases (together “Topic 842”). 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. The Company has elected not to apply the recognition requirements of Topic 842 for short-term leases. For lease agreements entered into after the adoption of Topic 842 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 in non-capital raising transactions as compensation for services rendered. The Company accounts for stock option grants to employees based on the authoritative guidance provided by the FASB where the value of the award is measured on the date of grant and recognized over the vesting period. Upon the adoption of ASU No. 2018-07, Compensation-Stock Compensation (“Topic 718”), 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 share options have vested. The nonemployee 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 life 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 materially affect compensation expense recorded in future periods. The Company has in the past issued restricted stock units (RSU) and restricted stock awards (RSA) as part of its share-based compensation programs. The Company measures the compensation cost with respect to RSUs and RSAs 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 and RSAs is based on the closing price of the Company’s common stock on the grant date. Total stock-based compensation expense related to all of the Company’s stock-based awards was recorded on the statements of operations as follows (in thousands): Three Months Ended March 31, 2020 2019 Research and development $ 4,318 $ 2,701 General and administrative 5,094 3,145 Total stock-based compensation expense $ 9,412 $ 5,846 Total stock-based compensation expenses broken down based on each individual instrument were as follows (in thousands): Three Months Ended March 31, 2020 2019 Stock option expense $ 9,345 $ 5,779 Restricted stock unit expense 67 67 Total stock-based compensation expense $ 9,412 $ 5,846 Preferred Stock The Company applies the accounting standards for distinguishing liabilities from equity when determining the classification and measurement of its preferred stock. Preferred shares subject to mandatory redemption are classified as liability instruments and are measured at fair value. Conditionally redeemable preferred shares (including preferred shares that feature redemption rights that are either within the control of the holder or subject to redemption upon the occurrence of uncertain events not solely within the Company’s control) are classified as temporary equity. At all other times, preferred shares are classified as stockholders’ equity. Convertible Instruments The Company applies the accounting standards for derivatives and hedging and for distinguishing liabilities from equity when accounting for hybrid contracts that feature conversion options. The accounting standards require companies to bifurcate conversion options from their host instruments and account for them as free-standing derivative financial instruments according to certain criteria. The criteria include circumstances in which (i) the economic characteristics and risks of the embedded derivative instrument are not clearly and closely related to the economic characteristics and risks of the host contract, (ii) the hybrid instrument that embodies both the embedded derivative instrument and the host contract is not re-measured at fair value under otherwise applicable generally accepted accounting principles with changes in fair value reported in earnings as they occur and (iii) a separate instrument with the same terms as the embedded derivative instrument would be considered a derivative instrument. The derivative is subsequently marked to market at each reporting date based on current fair value, with the changes in fair value reported in results of operations. Conversion options that contain variable settlement features such as provisions to adjust the conversion price upon subsequent issuances of equity or equity linked securities at exercise prices more favorable than that featured in the hybrid contract generally result in their bifurcation from the host instrument. The Company also records, when necessary, deemed dividends for the intrinsic value of the conversion options embedded in preferred stock based upon the difference between the fair value of the underlying common stock at the commitment date of the transaction and the effective conversion price embedded in the preferred stock. Recent Accounting Standards Financial Instruments In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses, and also issued subsequent amendments to the initial guidance, ASU 2018-19, ASU 2019-04, ASU 2019-05, and ASU 2019-11 (collectively, Topic 326), to introduce a new impairment model for recognizing credit losses on financial instruments based on an estimate of current expected credit losses (“CECL”). Under Topic 326, an entity is required to estimate CECL on available-for-sale (“AFS”) debt securities only when the fair value is below the amortized cost of the asset and is no longer based on an impairment being “other-than-temporary”. Topic 326 also requires the impairment calculation on an individual security level and requires an entity use present value of cash flows when estimating the CECL. The credit-related losses are required to be recognized through earnings and non-credit related losses are reported in other comprehensive income. In April 2019, the FASB further clarified the scope of Topic 326 and addressed issues related to accrued interest receivable balances, recoveries, variable interest rates and prepayment. Topic 326 will be effective for public entities in fiscal years beginning after December 15, 2019, including interim periods within those fiscal years. The new guidance requires modified retrospective application to all outstanding instruments, with a cumulative effect adjustment recorded to opening retained earnings as of the beginning of the first period in which the guidance becomes effective. The Company adopted this guidance on January 1, 2020, however, the adoption of this new guidance did not have any material impact on its condensed consolidated financial statements. Cloud Computing Arrangements In August 2018, the FASB issued ASU 2018-15, Intangibles-Goodwill and Other-Internal-Use Software (Subtopic 350-40) Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract (ASU 2018-15). The guidance requires a customer in a cloud computing arrangement that is a service contract to follow the internal use software guidance to determine which implementation costs to defer and recognize as an asset. It therefore requires a customer to defer potentially significant implementation costs incurred in a cloud computing arrangement that were often expensed as incurred under the legacy GAAP and recognize them as expense over the term of the hosting arrangement. ASU 2018-15 is effective for fiscal years beginning subsequent to December 15, 2019. The Company adopted this guidance on January 1, 2020. There was no impact on its condensed consolidated balance sheets and statements of operations as of and for the three months ended March 31, 2020, however, the Company believes it will have a material impact on its condensed consolidated balance sheets and statements of operations in 2020 by deferring recognition of costs as it prepares to invest in information technology infrastructure for its commercial manufacturing build-out. Subsequent Event The Company’s management evaluates events that have occurred after the balance sheet date but before the financial statements are issued. Reclassifications Certain amounts within the condensed consolidated statements of cash flows and notes to the financial statements for the prior period have been reclassified to conform with the current period presentation. These reclassifications had no impact on the Company's previously reported financial position or cash flows for any of the periods presented. |
CASH EQUIVALENTS AND SHORT-TERM
CASH EQUIVALENTS AND SHORT-TERM INVESTMENTS | 3 Months Ended |
Mar. 31, 2020 | |
CASH EQUIVALENTS AND SHORT-TERM INVESTMENTS | |
CASH EQUIVALENTS AND SHORT-TERM INVESTMENTS | NOTE 3. CASH EQUIVALENTS AND SHORT-TERM INVESTMENTS Cash equivalents and short-term investments consist of the following (in thousands): March 31, December 31, 2020 2019 Cash equivalents - Money market funds $ 39,924 $ 10,049 Cash equivalents total $ 39,924 $ 10,049 Cash equivalents in the tables above exclude cash demand deposits of $12.6 million and $3.9 million as of March 31, 2020 and December 31, 2019, respectively (in thousands). March 31, December 31, Short-term Investments 2020 2019 US treasury securities $ 161,512 $ 242,249 US government agency securities 31,600 50,863 Short-term investments total $ 193,112 $ 293,112 The cost and fair value of cash equivalents and short-term investments at March 31, 2020 and December 31, 2019 were as follows (in thousands): Gross Gross Accretion Unrealized Unrealized As of March 31, 2020 Cost (Amortization) Gains Losses Fair Value US treasury securities $ 160,708 $ (16) $ 820 $ — $ 161,512 US government agency securities 31,463 45 92 — 31,600 Total $ 192,171 $ 29 $ 912 $ — $ 193,112 Gross Gross Unrealized Unrealized As of December 31, 2019 Cost Accretion Gains Losses Fair Value US treasury securities $ 241,709 $ 364 $ 179 $ (3) $ 242,249 US government agency securities 50,712 107 44 — 50,863 Total $ 292,421 $ 471 $ 223 $ (3) $ 293,112 Upon adoption of Topic 326 on January 1, 2020, the Company is required to assess and estimate CECL on AFS debt securities only when the fair value is below the amortized cost of the asset and is no longer based on an impairment being “other-than-temporary”. The credit-related losses are required to be recognized through the statements of operations and non-credit related losses are reported in other comprehensive income. For the three months ended March 31, 2020, no CECL was recognized in the condensed consolidated statement of operations and all unrealized gains and losses are included in accumulated other comprehensive income. All short-term investments held by the Company as of March 31, 2020 and December 31, 2019 have a maturity of less than one year. |
BALANCE SHEET COMPONENTS
BALANCE SHEET COMPONENTS | 3 Months Ended |
Mar. 31, 2020 | |
BALANCE SHEET COMPONENTS | |
BALANCE SHEET COMPONENTS | NOTE 4. BALANCE SHEET COMPONENTS Accrued liabilities consist of the following (in thousands): March 31, December 31, 2020 2019 Clinical related $ 10,211 $ 4,692 Accrued payroll and employee related expenses 4,118 6,866 Manufacturing related 3,527 2,184 Commercial manufacturing facility related 1,869 17 Legal and related services 1,100 866 Accrued other 1,675 1,640 $ 22,500 $ 16,265 |
STOCKHOLDERS' EQUITY
STOCKHOLDERS' EQUITY | 3 Months Ended |
Mar. 31, 2020 | |
STOCKHOLDERS' EQUITY | |
STOCKHOLDERS' EQUITY | NOTE 5. STOCKHOLDERS’ EQUITY Public Offerings In January 2018, the Company closed an underwritten public offering of 15,000,000 shares of the Company’s common stock at a public offering price of $11.50 per share, before underwriting discounts, which included 1,956,521 shares issued upon the exercise in full by the underwriter of its option to purchase additional shares at the public offering price less the underwriting discount. The gross proceeds from the offering, before deducting the underwriting discounts and commissions and other offering expenses payable by the Company, were $172.5 million, with net proceeds to the Company of $162.0 million. On October 17, 2018, the Company completed an underwritten public offering of 25,300,000 shares of the Company’s common stock at a public offering price of $9.97 per share, before underwriting discounts, which included 3,300,000 shares issued upon the exercise in full by the underwriter of its option to purchase additional shares at the public offering price less the underwriting discount. The gross proceeds from the offering, before deducting the underwriting discounts and commissions and other estimated offering expenses payable by the Company, were $252.2 million, with net proceeds to the Company of $236.7 million. On June 10, 2019, the certificate of incorporation of the Company was amended to increase the number of authorized shares of the Company’s common stock, par value $0.000041666, from 150,000,000 shares to 300,000,000 shares (the “Certificate of Amendment”). The Certificate of Amendment was approved by the Company’s stockholders at the Company’s 2019 Annual Meeting of Stockholders held on June 10, 2019. Preferred Stock The Company’s certificate of incorporation authorizes the issuance of up to 50,000,000 shares of “blank check” preferred stock. At March 31, 2020, 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. 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. The common shares issued were determined on a formula basis of 500 common shares for each share of Series A Convertible Preferred Stock converted. No Shares of Series A Convertible Preferred Stock were converted during the three months ended March 31, 2020 or 2019. At March 31, 2020 and December 31, 2019, 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. 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. No shares of Series B Convertible Preferred Stock were converted during the three months ended March 31, 2020 and 2019. At March 31, 2020 and December 31, 2019, 3,581,119 shares of Series B Preferred Stock (that are convertible into 3,581,119 shares of common stock) remained outstanding. Cancellation of Common Shares On September 30, 2013, Iovance and a third party entered into an agreement under which the Company issued 50,000 shares of unregistered stock in the Company to the third party. On January 16, 2019, the two parties entered into a confidential settlement agreement in connection with a dispute related to their prior relationship and activities. As part of the settlement, the third party returned 32,500 shares of common stock to the Company for cancellation and retained the remaining 17,500 shares. The Company included a gain of $335,000 on cancellation of 32,500 shares in Other income in its condensed consolidated statement of operations. |
STOCK BASED COMPENSATION
STOCK BASED COMPENSATION | 3 Months Ended |
Mar. 31, 2020 | |
STOCK BASED COMPENSATION | |
STOCK BASED COMPENSATION | NOTE 6. STOCK BASED COMPENSATION Stock Plans On October 14, 2011, the Company adopted the 2011 Equity Incentive Plan (the “2011 Plan”). Employees, directors, consultants and advisors of the Company are eligible to participate in the 2011 Plan. The 2011 Plan initially had 180,000 shares of common stock reserved for issuance in the form of incentive stock options, non-qualified options, common stock, and grant appreciation rights. The 2011 Plan was not approved by the Company’s stockholders within the required one-year period following its adoption and, accordingly, no incentive stock options can be granted under that plan. In August 2013, the Company’s Board of Directors and a majority of the Company’s stockholders approved an amendment to increase the number of shares available under the 2011 Plan from 180,000 shares to 1,700,000 shares, and an amendment to increase the number options or other awards that can be granted to any one person during a twelve (12) month period from 50,000 shares to 300,000 shares. The foregoing amendment to the 2011 Plan became effective in September 2013. On August 20, 2014, the Company’s Board of Directors amended the 2011 Plan to increase the number of shares available for issuance upon the exercise of stock options under the 2011 Plan from 1,700,000 to 1,900,000 shares, effective immediately. At March 31, 2020, 151,240 shares were available for future grant under the 2011 Plan. On September 19, 2014, the Company’s Board of Directors adopted the Iovance Biotherapeutics, Inc. 2014 Equity Incentive Plan (the “2014 Plan”). The 2014 Plan was approved by the Company’s stockholders at the Company’s 2014 Annual Meeting of Stockholders held in November 2014. The 2014 Plan, as approved by the stockholders, authorized the issuance up to an aggregate of 2,350,000 shares of the Company’s common stock. On April 10, 2015, the Board amended the 2014 Plan to increase the total number of shares that can be issued under the 2014 Plan to 4,000,000 shares of the Company’s common stock. The increase in shares available for issuance under the 2014 Plan was approved by the Company’s stockholders at the Company’s 2015 Annual Meeting of Stockholders in June 2015. On August 16, 2016, the Company’s stockholders approved an increase in the total number of shares that can be issued under the 2014 Plan to 9,000,000 shares of the Company’s common stock. At March 31, 2020, 89,408 shares were available for grant under the Company’s 2014 Plan. On April 22, 2018, the Board of Directors adopted the Iovance Biotherapeutics, Inc. 2018 Equity Incentive Plan (the “2018 Plan”). The 2018 Plan was approved by the Company’s stockholders at the annual meeting of stockholders held in June 2018. The 2018 Plan as approved by the stockholders authorized the issuance up to an aggregate of 6,000,000 shares of common stock reserved for issuance 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. At March 31, 2020, 336,222 shares of common stock were available for grant under the Company’s 2018 Plan. Restricted Stock Units On June 1, 2016, the Company entered into a restricted stock unit agreement with the Company’s new Chief Executive Officer, Maria Fardis, Ph.D., pursuant to which the Company granted Dr. Fardis 550,000 non-transferrable restricted stock units at fair market value of $5.87 per share as an inducement of employment pursuant to the exception to The Nasdaq Global Market rules that generally require stockholder approval of equity incentive plans. The 550,000 restricted stock units vest in installments as follows: (i) 137,500 restricted stock units vested upon the first anniversary of the effective date of Dr. Fardis’ employment agreement; (ii) 275,000 restricted stock units vest upon the satisfaction of certain clinical trial milestones; and (iii) 137,500 restricted stock units vest in equal monthly installments over the 36 -month period following the first anniversary of the effective date of Dr. Fardis’ employment, provided that Dr. Fardis has been continuously employed with the Company as of such vesting dates. At March 31, 2020, 11,458 restricted stock units remained unvested. Stock-based compensation expense for restricted stock units are measured based on the closing fair market value of the Company’s common stock on the date of grant. The stock-based compensation expenses relating to restricted stock units were $0.1 million and $0.1 million for the three months ended March 31, 2020 and 2019, respectively, recorded as part of general and administrative expenses. As of March 31, 2020, $0.04 million of total unrecognized compensation costs related to non-vested restricted stock units to be recognized over a weighted average period of 0.17 years. Stock Options A summary of the status of stock options at March 31, 2020, and the changes during the three months then ended, is presented in the following table: Weighted Weighted Aggregate Number Average Average Intrinsic of Exercise Remaining Value (in Options Price Contract Life thousands) Outstanding at January 1, 2020 9,494,712 $ 12.00 Granted 3,276,351 24.58 Exercised (404,075) 9.78 Expired/Forfeited (230,089) 12.91 Outstanding at March 31, 2020 12,136,899 $ 15.46 8.37 $ 176,592 Options exercisable at March 31, 2020 5,256,772 $ 10.16 7.14 $ 104,569 The Company recorded stock-based compensation expenses related to stock options of $9.3 million and $5.8 million for the three months ended March 31, 2020 and 2019. As of March 31, 2020, there was $81.1 million of total unrecognized compensation expense related to the options to be recognized over a weighted average period of 2.24 years. 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, 2020 and 2019 was $15.67 and $6.99 per option respectively. The aggregate intrinsic value in the table above reflects the total pre-tax intrinsic value (the difference between the Company’s closing stock price on the last trading day of the three months ended March 31, 2020 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, 2020. The intrinsic value of the Company’s stock options changes based on the closing price of the Company’s common stock. The following table summarizes the assumptions relating to options granted pursuant to the Company’s equity incentive plans for the three months ended March 31, 2020 and 2019: Three Months Ended March 31, Assumptions: 2020 2019 Expected term (years) 6.19 6.06 Expected volatility 69.99% 70.78% Risk-free interest rate 1.83% 2.59% Expected dividend yield 0% 0% Expected Dividend Yield —The Company has never paid dividends and does not expect to pay dividends in the foreseeable future. Risk-Free Interest Rate —The risk-free interest rate was based on the market yield currently available on United States Treasury securities with maturities approximately equal to the option’s expected term. Expected Term —The expected term of the stock option grants was calculated based on historical exercises, cancellations, and forfeitures of stock options and outstanding option shares Expected Volatility —The expected volatility is based on the historical volatility for the Company’s stock over a period equal to the expected terms of the options. Forfeiture Rate —The Company recognizes forfeitures as they occur. Each of the inputs discussed above is subjective and generally requires significant management judgment. |
LICENSES AND AGREEMENTS
LICENSES AND AGREEMENTS | 3 Months Ended |
Mar. 31, 2020 | |
LICENSES AND AGREEMENTS | |
LICENSES AND AGREEMENTS | NOTE 7. LICENSES AND AGREEMENTS National Institutes of Health (NIH) and the National Cancer Institute (NCI) Cooperative Research and Development Agreement (CRADA) In August 2011, the Company signed a five-year CRADA with the NCI to work with Dr. Steven Rosenberg on developing adoptive cell immunotherapies that are designed to destroy metastatic melanoma cells using a patient’s tumor infiltrating lymphocytes. In January 2015, the Company executed an amendment to the CRADA to include four new indications. As amended, in addition to metastatic melanoma, the CRADA included the development of TIL therapy for the treatment of patients with bladder, lung, triple-negative breast, and Human Papilloma Virus (“HPV”)-associated cancers. In August 2016, the NCI and the Company entered into a second amendment to the CRADA. The principal changes effected by the second amendment included (i) extending the term of the CRADA by another five years to August 2021, and (ii) modifying the focus on the development of unmodified TIL as a stand-alone therapy or in combination with U.S. Food and Drug Administration ("FDA") - licensed products and commercially available reagents routinely used for adoptive cell therapy. The parties will continue 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. 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 cGMP conditions, suitable for use in clinical trials, where the Company holds the investigational new drug application for such clinical trial. The extended CRADA has a five-year term expiring in August 2021. 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 the three months ended March 31, 2020 and 2019 as research and development expenses. Patent License Agreement Related to the Development and Manufacture of TIL Effective October 5, 2011, the Company entered into an Exclusive Patent License Agreement (the “Patent License Agreement”) with the NIH, an agency of the United States Public Health Service within the Department of Health and Human Services (NIH), which was subsequently amended on February 9, 2015 and October 2, 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. The Patent License Agreement requires the Company to pay royalties based on a percentage of net sales (which percentage is in the mid-single digits), a percentage of revenues from sublicensing arrangements, and lump sum benchmark royalty payments on the achievement of certain clinical and regulatory milestones for each of the various indications and other direct costs incurred by the NIH pursuant to the agreement. The Company anticipates to pay a milestone payment in conjunction with the submission of Biologics License Application. 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 license to the NIH’s rights to patent-pending technologies related to methods for improving adoptive cell therapy through more potent and efficient production of TIL from melanoma tumors by selecting for T cell populations that express various inhibitory receptors. Unless terminated sooner, the license shall remain in effect until the last licensed patent right expires. Under the Exclusive Patent License Agreement, the Company agreed to pay customary royalties based on a percentage of net sales of a licensed product (which percentage is in the mid-single digits), a percentage of revenues from sublicensing arrangements, and lump sum benchmark payments upon the successful completion of clinical studies involving licensed technologies, the receipt of the first FDA approval or foreign equivalent for a licensed product or process resulting from the licensed technologies, the first commercial sale of a licensed product or process in the United States, and the first commercial sale of a licensed product or process in any foreign country. H. Lee Moffitt Cancer Center Research Collaboration and Clinical Grant Agreements with Moffitt In December 2016, the Company entered into a new three-year Sponsored Research Agreement with H. Lee Moffitt Cancer Center (“Moffitt”). At the same time, 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. The Company recorded research and development costs of $0.2 million and $0.3 million for the three months ended March 31, 2020 and 2019, respectively, 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. A patent issuance fee will also be 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 United States, 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 the three months ended March 31, 2020 and 2019. The Company entered into a 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 will be also payable commencing on the first anniversary of the effective date. In addition, 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 research and development costs of $0.02 million for the Second Moffit License for the three months ended March 31, 2020. No expenses were recorded for the same period in 2019. M.D. Anderson Cancer Center Strategic Alliance Agreement On April 17, 2017, the Company entered into a Strategic Alliance Agreement (the “SAA”) with 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. 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. In May 2017, the Company made a prepayment of $1.4 million under this agreement. In light of the COVID-19 Pandemic, MDACC has temporarily suspended their research programs and decommissioned their research labs, and as a result, enrollment in our MDACC-sponsored studies under the SAA is temporarily paused. The Company recorded $0.2 million and $1.2 million associated with the MDACC SAA for the three months ended March 31, 2020 and 2019, respectively as research and development expenses. WuXi Apptech, Inc. (WuXi) In November 2016, the Company entered into a three-year manufacturing and services agreement (“MSA”) with WuXi AppTech, Inc. (“WuXi”) pursuant to which WuXi agreed to provide manufacturing and other services. Under the agreement, the Company entered into two statements of work for two cGMP manufacturing suites to be established and operated by WuXi for the Company, both of the suites are expected to be capable of being used for the commercial manufacture of its products. The statements of work for each of the suites were amended in 2019. The statements of work for facility include a fixed component to reserve a dedicated suite and a trained work force, and a variable component, mainly materials and testing used during the manufacturing processes. Both statements of work provide for adjustments to the targeted production capacity levels and the corresponding fixed quarterly fees upon written notice from the Company of 30 days and 90 days for the first and second dedicated suites, respectively. The quarterly fixed fees payable for each of the dedicated manufacturing suites ranges from $1.2 million to $2.7 million depending on the production capacity level targeted. The terms of the related statements of work for the first and second dedicated manufacturing suites currently extend to May 2020 and June 2021, respectively. The Company recorded costs associated with agreements with WuXi of $6.7 million and $3.8 million for the three months ended March 31, 2020 and 2019 respectively, as research and development expenses. Cellectis S.A. (Cellectis) On January 12, 2020, the Company announced that it had 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, in order to develop TIL therapies that have been genetically edited. Financial terms of the license include 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 from Cellectis of $0.1 million for the three months ended March 31, 2020 Novartis Pharma AG (Novartis) On January 12, 2020, the Company announced that it had 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 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 expenses for the three months ended March 31, 2020. |
LEGAL PROCEEDINGS
LEGAL PROCEEDINGS | 3 Months Ended |
Mar. 31, 2020 | |
LEGAL PROCEEDINGS | |
LEGAL PROCEEDINGS | NOTE 8. LEGAL PROCEEDINGS Class Action Lawsuit In the Matter of Certain Stock Promotion Leonard DeSilvio v. Lion Biotechnologies, Inc., et al., (Amra Kuc vs. Lion Biotechnologies, Inc., et al., In the Matter of Certain Stock Promotions Kuc Kuc Jay Rabkin v. Lion Biotechnologies, Inc., et al., In the Matter of Certain Stock Promotions dismissing two of plaintiff’s six claims. As a result of mediation, on September 28, 2018, lead plaintiff filed an unopposed motion for settlement.. The court granted preliminary approval to the proposed settlement on November 30, 2018 . A final hearing was held on April 12, 2019 to determine whether the proposed settlement was fair, reasonable, and adequate, and whether the claims should be dismissed. On April 17, 2019, the court approved the final settlement, involving a payment of $3,250,000 by the Company's insurance carrier to a settlement fund, awarded attorney's fees and costs to be paid to plaintiff's counsel from the settlement fund, approved the plan of allocation for settlement class members, and ordered that the claims against us should be dismissed with prejudice. The Company does not expect to incur any costs or expenses in connection with this settlement. Derivative Lawsuits. In the Matter of Certain Stock Promotions In the Matter of Certain Stock Promotions In re Iovance Biotherapeutics, Inc. Stockholder Derivative Litigation Solomon Capital, LLC. Solomon Capital, LLC, Solomon Capital 401(K) Trust, Solomon Sharbat and Shelhav Raff v. Lion Biotechnologies, Inc. was filed by Solomon Capital, LLC, Solomon Capital 401(k) Trust, Solomon Sharbat and Shelhav Raff ("Solomon Plaintiffs") against the Company in the Supreme Court of the State of New York, County of New York (index no. 651881/2016 ). The Solomon Plaintiffs allege that, between June and November 2012, they provided to the Company $0.1 million and that they advanced and paid on behalf of the Company an additional $0.2 million. 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 reverse split of the Company’s common stock effected in March 2013), and (iii) allow the Solomon Plaintiffs to convert the foregoing funds into its securities in the next transaction. The Solomon Plaintiffs allege that they should have been able to convert their advances and payments into shares of the Company’s common stock in the restructuring that took effect in May 2013. Based on the foregoing, the Solomon Plaintiffs allege causes for breach of contract and unjust enrichment and demand judgment against the Company in an unspecified amount exceeding $1.5 million, plus interest. On June 3, 2016, the Company filed an answer and counterclaims in the lawsuit. The Company has asserted counterclaims for fraudulent inducement, fraudulent misrepresentation, fraudulent concealment, breach of fiduciary duty, and breach of contract, alleging principally that the counterclaim defendants misrepresented their qualifications and failed to disclose that Solomon Sharbat was the subject of an investigation by the Financial Industry Regulatory Authority (“FINRA”) that resulted in the loss of his FINRA license. 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 plaintiffs contend entitled them to obtain shares of Company stock. No trial date has been set for the First Solomon Suit. 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 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 United States District Court for the Southern District of New York, where the case has been assigned case no. 1:20-cv-1391. The Company has not yet responded to the complaint in the Second Solomon Suit. 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. Litigation Involving Dr. Steven Fischkoff Steven Fischkoff v. Lion Biotechnologies, Inc. and Maria Fardis The Company intends to vigorously defend against Dr. Fischkoff’s lawsuit and pursue the Company’s counterclaims. Based on the current stage of the litigation, it is not possible to estimate the amount or range of (i) a possible loss that might result from an adverse judgment or settlement of this action, or (ii) the potential recovery that might result from a favorable judgment or a settlement of this action. Other 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. |
LEASES
LEASES | 3 Months Ended |
Mar. 31, 2020 | |
LEASES | |
LEASES | NOTE 9. LEASES Facilities Leases The Company has evaluated the following existing facility leases and determined that, effective upon the adoption of Topic 842, they were all operating leases. Operating lease right-of-use assets and liabilities were recognized as of January 1, 2019 based on the present value of the remaining lease payments over the lease term. As the Company’s leases do not provide an implicit rate, the Company utilized a third party in determining an incremental borrowing rate based on the information available as of the adoption date of Topic 842 to obtain the present value of lease payments. The Company’s lease terms may include options to extend or terminate the lease which are included in the lease term when it is reasonably certain that it will exercise any such options. Lease expense is recognized on a straight-line basis over the expected lease term. The Company elected not to apply the recognition requirements of Topic 842 for short-term leases that have a lease term of 12 months or less. Tampa Lease In December 2014, the Company commenced a five-year non-cancellable operating lease with the University of South Florida Research Foundation for a 5,115 square foot facility located in Tampa, Florida. The facility is part of the University of South Florida research park and is used as the Company’s research and development facilities. The Company had the option to extend the lease term of this facility for an additional five-year period on the same terms and conditions, except that the base rent for the renewal term will be increased in accordance with the applicable consumer price index. In April 2015, the Company amended the original lease agreement to increase the rentable space to 6,043 square feet. In September 2016, the Company further increased the rentable space to 8,673 square feet. The per square foot cost and term of the lease were unchanged, and rent payments are approximately $20,000 per month. In December 2019, the Company entered into an agreement to extend the lease term to December 18, 2024 for approximately $20,500 a month. San Carlos Lease On August 4, 2016, the Company entered into an agreement to lease 8,733 square feet in San Carlos, California. The term of the lease is 54 months subsequent to the commencement date and will expire in April 2021. Monthly lease payments are approximately $38,000. On April 28, 2017, the Company entered into a sublease agreement with Teradata US, Inc., pursuant to which the Company agreed to sublease certain office space located adjacent to the Company’s headquarters for approximately $26,000 per month. The space consists of approximately 11,449 rentable square feet in the building located in San Carlos, California. The sublease for this space expired on October 31, 2018. Monthly lease payments were approximately $26,000. On October 19, 2018, the Company entered into an agreement to lease 12,322 square feet of office space located adjacent to the Company’s headquarters in San Carlos, California. This lease replaces the sublease of 11,449 square feet of office space in the same facility that expired on October 31, 2018. The term of the lease is 30 months subsequent to the commencement date, November 1, 2018, and will expire in April 2021. Monthly lease payments are approximately $59,000, subject to an annual increase of 3%. On June 19, 2019, the Company entered into a first amendment (the “Amended Lease”) to its previously disclosed lease agreement with Hudson Skyway Landing, LLC (the “Lease”) for additional space at its corporate headquarters in San Carlos, California. Under the Amended Lease, the Company will lease an additional 8,110 square feet (the “Expansion Space”), for a total of approximately 20,432 square feet of space on the first floor of the building located at 999 Skyway Road, San Carlos, California, commonly known as Skyway Landing II. The term of the Amended Lease remains the same as that of the Lease and expires on April 30, 2021, unless earlier terminated in accordance with the Amended Lease. The Company’s monthly base rent for the Expansion Space under the Amended Lease will be approximately $39,000 for the first year, and $40,000 for the second year. New York Lease The Company leased office space in New York for a monthly rental of approximately $18,000 a month from January 2017 through July 2017. On June 5, 2017, the Company entered into an agreement whereby the Company will lease office space from August 1, 2017 to July 31, 2018, for approximately $9,000 a month. On April 20, 2018, the Company entered into an agreement to extend the lease term to January 31, 2019 for approximately $7,000 a month. On November 2, 2018, the Company entered into an agreement to extend the lease term to July 31, 2019 for approximately $4,000 a month. On May 1, 2019, the Company entered into an agreement to extend the lease term to January 31, 2020 for approximately $4,000 a month. On October 24, 2019, the Company entered into an agreement to extend the lease term to April 30, 2020 for approximately $4,000 a month. On January 23, 2020, the Company entered into an agreement to extend the lease term to July 31, 2020 for approximately $4,000 a month. Philadelphia Office Lease On May 2, 2019, the Company entered into an agreement to lease approximately 1,500 square feet of office space in Philadelphia, Pennsylvania until July 1, 2019 for a rate of $2,000 a month, and then approximately 4,500 square feet of office space for the remainder of a three-year term at an initial rate of $11,063 per month, subject to annual increases of 2.5%. Commercial Manufacturing Facility Agreement On May 28, 2019, the Company entered into a lease agreement with 300 Rouse Boulevard, LLC (the “Commercial Manufacturing Facility Lease”) for a build-to-suit commercial manufacturing facility, laboratories, and offices located in Philadelphia, Pennsylvania. Under the Commercial Manufacturing Facility Lease, the Company will lease approximately 136,000 rentable square feet of space in a building to be located at 300 Rouse Boulevard, Philadelphia, Pennsylvania (the “Premises”). The commercial manufacturing facility is expected to be constructed in two phases: Phase I-A, the construction of the commercial manufacturing facility, with approximately 66,000 rentable square feet of space; and Phase I-B, the construction of offices and laboratories, with approximately 70,000 rentable square feet of space. The Commercial Manufacturing Facility Lease is for a term of 242 months , commencing on the earlier of (i) the date on which the Company occupies any portion of the Premises for the normal operation of its business or (ii) the date that is the later of (A) one hundred sixty ( 160 ) days after the Phase I-A substantial completion date, currently anticipated to be July 16, 2020, or (B) the Phase I-B Substantial Completion Date (the “Commencement Date”). The Commencement Date shall be extended by one day for each day of landlord delay, net of any tenant delay, as defined in the Lease. The Commercial Manufacturing Facility Lease includes an option to extend the term of the lease, exercisable under certain conditions as described in the Commercial Manufacturing Facility Lease, such that the overall term, when added to the initial term, shall be 359 months , by giving the landlord prior written notice thereof at least 18 months in advance of the expiration date. Beginning on the Commencement Date, the Company’s monthly base rent under the Lease will be approximately $320,000, subject to an annual increase of 2% for the first ten years, and an annual increase of the greater of 2% or 75% of the average ten-year consumer price index. The Company will also be responsible for paying operating expenses, which are expected to be approximately $53,000 per month in 2020. 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. In conjunction with the adoption of Topic 842 on January 1, 2019, the Company reevaluated all of its material contracts it has, to determine whether they contain a lease under Topic 840. An arrangement is considered a lease or contains a lease if an underlying asset is explicitly or implicitly identified and use of the asset is controlled by the customer. Based on this evaluation, the Company concluded that all of its contracts with CMOs contained embedded operating leases because the suites used for its production are implicitly identified, is only used by the Company exclusively 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 an 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. The guidance 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 used 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 Company leases certain furniture and equipment that has a lease term of 12 months or less. Since the commencement date does 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. The balance sheet classification of the Company’s right-of-use asset and lease liabilities was as follows: March 31, 2020 December 31, 2019 Operating lease right-of-use assets $ 9,305 $ 10,695 Operating lease liabilities Current portion included in current liabilities 6,431 7,252 long-term portion included in non-current liabilities 3,088 4,248 Total Operating lease liabilities $ 9,519 $ 11,500 The components of lease expenses, which were included in Total expenses in the Company’s condensed consolidated statement of operations, were as follows: For the Three Months Ended March 31, 2020 2019 Operating lease cost $ 1,636 $ 1,594 Variable lease cost 1,371 896 Short-term lease cost 17 19 Total lease cost $ 3,024 $ 2,509 Variable lease cost is determined based on performance or usage in accordance with the contractual agreements, and not based on an index or rate. Cash paid for amounts included in the measurement of lease liabilities for the three months ended March 31, 2020 and 2019 were $2.2 million and $1.4 million, respectively, and were included in Net cash provided by operating activities in its condensed consolidated statement of cash flows. During the three months ended March 31, 2020 and 2019, the Company increased operating lease right-of-use assets by $0.5 million and $1.0 million, respectively, and operating lease liability by $0.01 million and $1.0 million, respectively, as a result of lease modifications. As of March 31, 2020, the maturities of the Company’s operating lease liabilities were as follows (in thousands): CMO Facility embedded leases leases Total 2020 $ 1,425 $ 3,783 $ 5,208 2021 968 3,155 4,123 2022 342 — 342 2023 269 — 269 2024 253 — 253 Thereafter — — — Total lease payments $ 3,257 $ 6,938 $ 10,195 Less: Present value adjustment (308) (368) (676) Operating lease liabilities $ 2,949 $ 6,570 $ 9,519 Operating lease liabilities are based on the net present value of the remaining lease payments over the remaining lease term. In determining the present value of lease payments, the Company used its incremental borrowing rate based on the information available at the date of adoption of Topic 842. As of March 31, 2020, the weighted average remaining lease term is 1.73 years and the weighted average discount rate used to determine the operating lease liabilities was 7.5%. As of March 31, 2020, the Company has a finance lease for the commercial manufacturing facility that has not yet commenced. This finance lease will commence in December 2020 with a lease term of 20 years. |
RELATED PARTY TRANSACTIONS
RELATED PARTY TRANSACTIONS | 3 Months Ended |
Mar. 31, 2020 | |
RELATED PARTY TRANSACTIONS | |
RELATED PARTY TRANSACTIONS | NOTE 10. RELATED PARTY TRANSACTIONS On September 14, 2017, the Company entered into a three-year consulting agreement with Iain Dukes, D. Phil, the Chairman of the Board of Directors. As compensation for his consulting services, the Company granted Dr. Dukes a stock option to purchase up to 150,000 shares of the Company’s common stock, at an exercise price of $7.30 per share. Under the consulting agreement, Dr. Dukes agreed to provide the Company with services regarding business development opportunities, licensing transactions and technology acquisitions by the Company, and any such strategic initiatives appropriate for the Company that Dr. Dukes may identify. The granted stock options vest in 12 quarterly installments (with 1/12th of the option shares having vested on the date of grant). The vesting of the granted stock options will accelerate, and the entire award will become fully vested upon the closing of a significant licensing transaction, a material product acquisition, a material strategic transaction, or upon a change of control transaction. The Company recognized $0.1 million and $0.1 million in stock-based compensation expense related to this consulting agreement during the three months ended March 31, 2020 and 2019, respectively. In addition, in connection with the adoption of ASC 2018-07, the Company recognized $0.3 million to retained earnings as of January 1, 2019. |
SUMMARY OF SIGNIFICANT ACCOUN_2
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 3 Months Ended |
Mar. 31, 2020 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
Cash, Cash Equivalents, and Short-term Investments | Cash, Cash Equivalents, and Short-term 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 short-term investments are classified as “available-for-sale”. The Company includes these investments in current assets and carries them at fair value. Unrealized gains and losses on available-for-sale securities are included in accumulated other comprehensive income. Any impairment losses related to credit losses (if any) are included in an allowance for credit losses with an offsetting entry to net loss. No impairment losses related to credit losses were recognized for the three months ended March 31, 2020 or for the same period in 2019. 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 net interest income 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 net interest income 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 places restrictions on maturities and concentration by type and issuer. Currently the Company invests excess cash only in obligations issued by the U.S. government and U.S. government agencies. The Company maintains a certain minimum balance, currently $5.5 million in a segregated bank account in connection with two letters of credit, one for $5.45 million for the benefit of the landlord for its commercial manufacturing facility used as a security deposit for the lease (See Note 9 - Leases), and a second one for $74,685 for the benefit of a utilities service provider. The total amount is classified as Restricted Cash on the Balance Sheet. The letter of credit will expire on May 28, 2020, however, it will be automatically extended, without written agreement, for one-year periods to May 28 in each succeeding calendar year, through at least 60 days after the lease expiration rate. Further, on the expiration of the seventh year of the lease, and each anniversary date thereafter, the letter of credit may be decreased by $1,000,000, with a minimum security deposit of $1,450,000 maintained through the end of the lease term. The $74,685 letter of credit will expire on February 25, 2021, however, it will be automatically extended, without written agreement, to the expiration date of December 1, 2022. As of March 31, 2020, restricted cash consisted of $5.5 million and this amount has been classified as a non-current asset on the Company’s condensed consolidated balance sheets. 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: March 31, March 31, 2020 2019 Cash and cash equivalents $ 52,540 $ 54,093 Restricted cash (included in non-current assets on the condensed consolidated balance sheets) 5,525 — Total cash, cash equivalents and restricted cash $ 58,065 $ 54,093 |
Loss per Share | 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 equivalent shares 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 and warrants (ii) vesting of restricted stock units and restricted stock awards, and (iii) conversion of preferred stock, are only included in the calculation of diluted net loss per share when their effect is dilutive. At March 31, 2020 and 2019, 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, 2020 2019 Stock options 12,136,899 9,274,973 Series A Convertible Preferred Stock* 97,000 97,000 Series B Convertible Preferred Stock* 3,581,119 5,854,845 Restricted stock units 11,458 57,285 15,826,476 15,284,103 * on an as-converted basis The 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. |
Fair Value Measurements | Fair Value Measurements Under Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 820, Fair Value Measurements and Disclosures, fair value is defined as the price at which an asset could be exchanged, or a liability transferred in a transaction between knowledgeable, willing parties in the principal or most advantageous market for the asset or liability. Where available, fair value is based on observable market prices or parameters or derived from such prices or parameters. Where observable prices or parameters are not available, valuation models are applied. Assets and liabilities recorded at fair value in the Company’s financial statements are categorized based upon the level of judgment associated with the inputs used to measure their fair value. Hierarchical levels directly related to the amount of subjectivity associated with the inputs to fair valuation of these assets and liabilities, are as follows: Level 1–These are investments where values are based on unadjusted quoted prices for identical assets in an active market that the Company has the ability to access. Level 2–These are investments where values are based on quoted market prices in markets that are not active or model derived valuations in which all significant inputs are observable in active markets The Company does not have fair valued assets classified under Level 2 as of March 31, 2020 and December 31, 2019. Level 3–These are financial instruments where values are derived from techniques in which one or more significant inputs are unobservable. The Company does not have fair valued assets classified under Level 3 as of March 31, 2020 and December 31, 2019. The Company’s financial instruments consist of cash and cash equivalents and short-term investments, all of which are reported at their respective fair value on its condensed consolidated balance sheets. As of March 31, 2020 and December 31, 2019, financial assets measured at fair value on a recurring basis 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, 2020 Level 1 Level 2 Level 3 Total US treasury securities $ 161,512 $ — $ — $ 161,512 US government agency securities 31,600 — — 31,600 Total $ 193,112 $ — $ — $ 193,112 Assets at Fair Value as of December 31, 2019 Level 1 Level 2 Level 3 Total US treasury securities $ 242,249 $ — $ — $ 242,249 US government agency securities 50,863 — — 50,863 Total $ 293,112 $ — $ — $ 293,112 |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America (“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 revenue and expenses during the reporting period. Actual results could differ from those estimates. Significant estimates include the assumptions made in valuing stock instruments issued for services and used in measuring operating right-of-use assets and operating lease liabilities, valuation of short-term investments, accounting for potential liabilities, and the valuation allowance associated with 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, and Iovance Biotherapeutics GmbH. All intercompany accounts and transactions have been eliminated. The U.S. dollar is the functional currency for all the Company's consolidated operations. |
Income Taxes | Income Taxes The Company accounts for income taxes using the asset and liability method whereby deferred tax assets are recognized for deductible temporary differences, and deferred tax liabilities are recognized for taxable temporary differences. Temporary differences are the differences between the reported amounts of assets and liabilities and their tax bases. Deferred tax assets are reduced by a valuation allowance when, in the opinion of management, it is more likely than not that some portion or all of the deferred tax assets will be realized. Deferred tax assets and liabilities are adjusted for the effects of changes in tax laws and rates on the date of enactment. ASC Topic 740-10-30 clarifies the accounting for uncertainty in income taxes recognized in an enterprise’s financial statements and prescribes a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. ASC Topic 740-10-40 provides guidance on de-recognition, classification, interest and penalties, accounting in interim periods, disclosure, and transition. The Company will classify as income tax expense any interest and penalties. The Company has no material uncertain tax positions for any of the reporting periods presented. On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”) was enacted and signed into law, and GAAP requires recognition of the tax effects of new legislation during the reporting period that includes the enactment date. The CARES Act, among other things, includes changes to the tax provisions that benefits business entities and makes certain technical corrections to the 2017 Tax Cuts and Jobs Act. The tax relief measures for business include a five-year net operating loss (“NOL”) carrybacks, suspension of annual deduction limitation of 80% taxable income from net operating losses generated in a tax year beginning after December 31, 2017, changes in the deductibility of interest, acceleration of alternative minimum tax credit refunds, payroll tax relief, and technical correction to allow accelerated deductions for qualified improvement property. The CARES Act also provides other non-tax benefits to assist those impacted by the pandemic. The Company evaluated the impact of the CARES Act and determined no material tax provision impact for the quarter ended March 31, 2020. |
Leases | Leases The Company determines if an arrangement includes a lease at inception. Operating leases are included in its condensed consolidated balance sheet as Operating lease right-of-use assets and Operating lease liabilities as of March 31, 2020 and December 31, 2019. 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 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 date or the date of adoption of Accounting Standard Update (ASU) No. 2016-02 and ASU No. 2018-10, Leases (together “Topic 842”). 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. The Company has elected not to apply the recognition requirements of Topic 842 for short-term leases. For lease agreements entered into after the adoption of Topic 842 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 in non-capital raising transactions as compensation for services rendered. The Company accounts for stock option grants to employees based on the authoritative guidance provided by the FASB where the value of the award is measured on the date of grant and recognized over the vesting period. Upon the adoption of ASU No. 2018-07, Compensation-Stock Compensation (“Topic 718”), 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 share options have vested. The nonemployee 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 life 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 materially affect compensation expense recorded in future periods. The Company has in the past issued restricted stock units (RSU) and restricted stock awards (RSA) as part of its share-based compensation programs. The Company measures the compensation cost with respect to RSUs and RSAs 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 and RSAs is based on the closing price of the Company’s common stock on the grant date. Total stock-based compensation expense related to all of the Company’s stock-based awards was recorded on the statements of operations as follows (in thousands): Three Months Ended March 31, 2020 2019 Research and development $ 4,318 $ 2,701 General and administrative 5,094 3,145 Total stock-based compensation expense $ 9,412 $ 5,846 Total stock-based compensation expenses broken down based on each individual instrument were as follows (in thousands): Three Months Ended March 31, 2020 2019 Stock option expense $ 9,345 $ 5,779 Restricted stock unit expense 67 67 Total stock-based compensation expense $ 9,412 $ 5,846 |
Preferred Stock | Preferred Stock The Company applies the accounting standards for distinguishing liabilities from equity when determining the classification and measurement of its preferred stock. Preferred shares subject to mandatory redemption are classified as liability instruments and are measured at fair value. Conditionally redeemable preferred shares (including preferred shares that feature redemption rights that are either within the control of the holder or subject to redemption upon the occurrence of uncertain events not solely within the Company’s control) are classified as temporary equity. At all other times, preferred shares are classified as stockholders’ equity. |
Convertible Instruments | Convertible Instruments The Company applies the accounting standards for derivatives and hedging and for distinguishing liabilities from equity when accounting for hybrid contracts that feature conversion options. The accounting standards require companies to bifurcate conversion options from their host instruments and account for them as free-standing derivative financial instruments according to certain criteria. The criteria include circumstances in which (i) the economic characteristics and risks of the embedded derivative instrument are not clearly and closely related to the economic characteristics and risks of the host contract, (ii) the hybrid instrument that embodies both the embedded derivative instrument and the host contract is not re-measured at fair value under otherwise applicable generally accepted accounting principles with changes in fair value reported in earnings as they occur and (iii) a separate instrument with the same terms as the embedded derivative instrument would be considered a derivative instrument. The derivative is subsequently marked to market at each reporting date based on current fair value, with the changes in fair value reported in results of operations. Conversion options that contain variable settlement features such as provisions to adjust the conversion price upon subsequent issuances of equity or equity linked securities at exercise prices more favorable than that featured in the hybrid contract generally result in their bifurcation from the host instrument. The Company also records, when necessary, deemed dividends for the intrinsic value of the conversion options embedded in preferred stock based upon the difference between the fair value of the underlying common stock at the commitment date of the transaction and the effective conversion price embedded in the preferred stock. |
Recent Accounting Standards | Recent Accounting Standards Financial Instruments In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses, and also issued subsequent amendments to the initial guidance, ASU 2018-19, ASU 2019-04, ASU 2019-05, and ASU 2019-11 (collectively, Topic 326), to introduce a new impairment model for recognizing credit losses on financial instruments based on an estimate of current expected credit losses (“CECL”). Under Topic 326, an entity is required to estimate CECL on available-for-sale (“AFS”) debt securities only when the fair value is below the amortized cost of the asset and is no longer based on an impairment being “other-than-temporary”. Topic 326 also requires the impairment calculation on an individual security level and requires an entity use present value of cash flows when estimating the CECL. The credit-related losses are required to be recognized through earnings and non-credit related losses are reported in other comprehensive income. In April 2019, the FASB further clarified the scope of Topic 326 and addressed issues related to accrued interest receivable balances, recoveries, variable interest rates and prepayment. Topic 326 will be effective for public entities in fiscal years beginning after December 15, 2019, including interim periods within those fiscal years. The new guidance requires modified retrospective application to all outstanding instruments, with a cumulative effect adjustment recorded to opening retained earnings as of the beginning of the first period in which the guidance becomes effective. The Company adopted this guidance on January 1, 2020, however, the adoption of this new guidance did not have any material impact on its condensed consolidated financial statements. Cloud Computing Arrangements In August 2018, the FASB issued ASU 2018-15, Intangibles-Goodwill and Other-Internal-Use Software (Subtopic 350-40) Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract (ASU 2018-15). The guidance requires a customer in a cloud computing arrangement that is a service contract to follow the internal use software guidance to determine which implementation costs to defer and recognize as an asset. It therefore requires a customer to defer potentially significant implementation costs incurred in a cloud computing arrangement that were often expensed as incurred under the legacy GAAP and recognize them as expense over the term of the hosting arrangement. ASU 2018-15 is effective for fiscal years beginning subsequent to December 15, 2019. The Company adopted this guidance on January 1, 2020. There was no impact on its condensed consolidated balance sheets and statements of operations as of and for the three months ended March 31, 2020, however, the Company believes it will have a material impact on its condensed consolidated balance sheets and statements of operations in 2020 by deferring recognition of costs as it prepares to invest in information technology infrastructure for its commercial manufacturing build-out. |
Subsequent Event | Subsequent Event The Company’s management evaluates events that have occurred after the balance sheet date but before the financial statements are issued. |
Reclassifications | Reclassifications Certain amounts within the condensed consolidated statements of cash flows and notes to the financial statements for the prior period have been reclassified to conform with the current period presentation. These reclassifications had no impact on the Company's previously reported financial position or cash flows for any of the periods presented. |
SUMMARY OF SIGNIFICANT ACCOUN_3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
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: March 31, March 31, 2020 2019 Cash and cash equivalents $ 52,540 $ 54,093 Restricted cash (included in non-current assets on the condensed consolidated balance sheets) 5,525 — Total cash, cash equivalents and restricted cash $ 58,065 $ 54,093 |
Schedule of Antidilutive securities excluded from computation of earnings per share | March 31, 2020 2019 Stock options 12,136,899 9,274,973 Series A Convertible Preferred Stock* 97,000 97,000 Series B Convertible Preferred Stock* 3,581,119 5,854,845 Restricted stock units 11,458 57,285 15,826,476 15,284,103 * on an as-converted basis |
Schedule of assets measured at fair value | Assets at Fair Value as of March 31, 2020 Level 1 Level 2 Level 3 Total US treasury securities $ 161,512 $ — $ — $ 161,512 US government agency securities 31,600 — — 31,600 Total $ 193,112 $ — $ — $ 193,112 Assets at Fair Value as of December 31, 2019 Level 1 Level 2 Level 3 Total US treasury securities $ 242,249 $ — $ — $ 242,249 US government agency securities 50,863 — — 50,863 Total $ 293,112 $ — $ — $ 293,112 |
Schedule of stock-based compensation | Three Months Ended March 31, 2020 2019 Research and development $ 4,318 $ 2,701 General and administrative 5,094 3,145 Total stock-based compensation expense $ 9,412 $ 5,846 |
Schedule of compensation cost for share-based payment arrangements, allocation of share-based compensation costs by plan | Three Months Ended March 31, 2020 2019 Stock option expense $ 9,345 $ 5,779 Restricted stock unit expense 67 67 Total stock-based compensation expense $ 9,412 $ 5,846 |
CASH EQUIVALENTS AND SHORT-TE_2
CASH EQUIVALENTS AND SHORT-TERM INVESTMENTS (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
CASH EQUIVALENTS AND SHORT-TERM INVESTMENTS | |
Schedule of cash, money market funds and short-term investments | Cash equivalents and short-term investments consist of the following (in thousands): March 31, December 31, 2020 2019 Cash equivalents - Money market funds $ 39,924 $ 10,049 Cash equivalents total $ 39,924 $ 10,049 |
Schedule of cost and fair value of cash equivalents and short-term investments | Cash equivalents in the tables above exclude cash demand deposits of $12.6 million and $3.9 million as of March 31, 2020 and December 31, 2019, respectively (in thousands). March 31, December 31, Short-term Investments 2020 2019 US treasury securities $ 161,512 $ 242,249 US government agency securities 31,600 50,863 Short-term investments total $ 193,112 $ 293,112 The cost and fair value of cash equivalents and short-term investments at March 31, 2020 and December 31, 2019 were as follows (in thousands): Gross Gross Accretion Unrealized Unrealized As of March 31, 2020 Cost (Amortization) Gains Losses Fair Value US treasury securities $ 160,708 $ (16) $ 820 $ — $ 161,512 US government agency securities 31,463 45 92 — 31,600 Total $ 192,171 $ 29 $ 912 $ — $ 193,112 Gross Gross Unrealized Unrealized As of December 31, 2019 Cost Accretion Gains Losses Fair Value US treasury securities $ 241,709 $ 364 $ 179 $ (3) $ 242,249 US government agency securities 50,712 107 44 — 50,863 Total $ 292,421 $ 471 $ 223 $ (3) $ 293,112 |
BALANCE SHEET COMPONENTS (Table
BALANCE SHEET COMPONENTS (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
BALANCE SHEET COMPONENTS | |
Schedule of accrued liabilities | March 31, December 31, 2020 2019 Clinical related $ 10,211 $ 4,692 Accrued payroll and employee related expenses 4,118 6,866 Manufacturing related 3,527 2,184 Commercial manufacturing facility related 1,869 17 Legal and related services 1,100 866 Accrued other 1,675 1,640 $ 22,500 $ 16,265 |
STOCK BASED COMPENSATION (Table
STOCK BASED COMPENSATION (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
STOCK BASED COMPENSATION | |
Schedule of status of stock options | Weighted Weighted Aggregate Number Average Average Intrinsic of Exercise Remaining Value (in Options Price Contract Life thousands) Outstanding at January 1, 2020 9,494,712 $ 12.00 Granted 3,276,351 24.58 Exercised (404,075) 9.78 Expired/Forfeited (230,089) 12.91 Outstanding at March 31, 2020 12,136,899 $ 15.46 8.37 $ 176,592 Options exercisable at March 31, 2020 5,256,772 $ 10.16 7.14 $ 104,569 |
Schedule of share-based payment award, stock options, valuation assumptions | Three Months Ended March 31, Assumptions: 2020 2019 Expected term (years) 6.19 6.06 Expected volatility 69.99% 70.78% Risk-free interest rate 1.83% 2.59% Expected dividend yield 0% 0% |
LEASES (Tables)
LEASES (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
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: March 31, 2020 December 31, 2019 Operating lease right-of-use assets $ 9,305 $ 10,695 Operating lease liabilities Current portion included in current liabilities 6,431 7,252 long-term portion included in non-current liabilities 3,088 4,248 Total Operating lease liabilities $ 9,519 $ 11,500 |
Schedule of components of lease expenses | The components of lease expenses, which were included in Total expenses in the Company’s condensed consolidated statement of operations, were as follows: For the Three Months Ended March 31, 2020 2019 Operating lease cost $ 1,636 $ 1,594 Variable lease cost 1,371 896 Short-term lease cost 17 19 Total lease cost $ 3,024 $ 2,509 |
Schedule of maturities of the Company's operating lease liabilities | As of March 31, 2020, the maturities of the Company’s operating lease liabilities were as follows (in thousands): CMO Facility embedded leases leases Total 2020 $ 1,425 $ 3,783 $ 5,208 2021 968 3,155 4,123 2022 342 — 342 2023 269 — 269 2024 253 — 253 Thereafter — — — Total lease payments $ 3,257 $ 6,938 $ 10,195 Less: Present value adjustment (308) (368) (676) Operating lease liabilities $ 2,949 $ 6,570 $ 9,519 |
GENERAL ORGANIZATION AND BUSI_2
GENERAL ORGANIZATION AND BUSINESS (Details) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2020 | Mar. 31, 2019 | Dec. 31, 2019 | |
GENERAL ORGANIZATION AND BUSINESS | |||
Net Loss | $ 69,595 | $ 36,950 | |
Net cash used in operating activities | 65,292 | 29,090 | |
Cash, cash equivalents and short-term investments | 251,200 | ||
cash equivalents, short-term investments, and restricted cash | 52,500 | ||
Cash and cash equivalents | 52,540 | $ 54,093 | $ 13,969 |
Short-term investments | 193,112 | 293,112 | |
Restricted cash | $ 5,525 | $ 5,450 |
SUMMARY OF SIGNIFICANT ACCOUN_4
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Cash, Cash equivalents and Restricted Cash (Details) - USD ($) | Mar. 31, 2020 | Dec. 31, 2019 | Mar. 31, 2019 | Dec. 31, 2018 |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | ||||
Security deposit | $ 5,500,000 | |||
Security deposit for the benefit of the landlord for its commercial manufacturing facility | 5,450,000 | |||
Security deposit for the benefit of utilities service provider | 74,685,000 | |||
Letter of credit | 1,000,000 | |||
Cash and cash equivalents | 52,540,000 | $ 13,969,000 | $ 54,093,000 | |
Restricted cash (included in non-current assets on the condensed consolidated balance sheets) | 5,525,000 | 5,450,000 | ||
Total cash, cash equivalents and restricted cash | 58,065,000 | $ 19,419,000 | $ 54,093,000 | $ 82,152,000 |
Minimum | ||||
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | ||||
Security deposit | $ 1,450,000 |
SUMMARY OF SIGNIFICANT ACCOUN_5
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Loss per share (Details) - shares | 3 Months Ended | ||
Mar. 31, 2020 | Mar. 31, 2019 | ||
Antidilutive securities excluded from calculation of net loss per share | 15,826,476 | 15,284,103 | |
Stock option | |||
Antidilutive securities excluded from calculation of net loss per share | 12,136,899 | 9,274,973 | |
Restricted stock units | |||
Antidilutive securities excluded from calculation of net loss per share | 11,458 | 57,285 | |
Series A Convertible Preferred Stock | |||
Antidilutive securities excluded from calculation of net loss per share | [1] | 97,000 | 97,000 |
Series B Convertible Preferred Stock | |||
Antidilutive securities excluded from calculation of net loss per share | [1] | 3,581,119 | 5,854,845 |
[1] | on an as-converted basis |
SUMMARY OF SIGNIFICANT ACCOUN_6
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Fair value (Details) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Total | $ 193,112 | $ 293,112 |
US treasury securities | ||
Total | 161,512 | 242,249 |
US government agency securities | ||
Total | 31,600 | 50,863 |
Level 1 | ||
Total | 193,112 | 293,112 |
Level 1 | US treasury securities | ||
Total | 161,512 | 242,249 |
Level 1 | US government agency securities | ||
Total | $ 31,600 | $ 50,863 |
SUMMARY OF SIGNIFICANT ACCOUN_7
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Stock-based compensation expense (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Total stock-based compensation expenses | $ 9,412 | $ 5,846 |
Research and development | ||
Total stock-based compensation expenses | 4,318 | 2,701 |
General and administrative | ||
Total stock-based compensation expenses | $ 5,094 | $ 3,145 |
SUMMARY OF SIGNIFICANT ACCOUN_8
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Stock-based compensation by instrument (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Total stock-based compensation expenses | $ 9,412 | $ 5,846 |
Stock option | ||
Total stock-based compensation expenses | 9,345 | 5,779 |
Restricted stock units | ||
Total stock-based compensation expenses | $ 67 | $ 67 |
CASH EQUIVALENTS AND SHORT-TE_3
CASH EQUIVALENTS AND SHORT-TERM INVESTMENTS (Details) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Cash equivalents total | $ 39,924 | $ 10,049 |
Money Market Funds | ||
Cash equivalents total | 39,924 | 10,049 |
Demand Deposits | ||
Cash equivalents total | $ 12,600 | $ 3,900 |
CASH EQUIVALENTS AND SHORT-TE_4
CASH EQUIVALENTS AND SHORT-TERM INVESTMENTS - Short-term investments (Details) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Short-term Investments | $ 193,112 | $ 293,112 |
Available-for-sale Securities, Current | 193,112 | 293,112 |
US treasury securities | ||
Available-for-sale Securities, Current | 161,512 | 242,249 |
US government agency securities | ||
Available-for-sale Securities, Current | $ 31,600 | $ 50,863 |
CASH EQUIVALENTS AND SHORT-TE_5
CASH EQUIVALENTS AND SHORT-TERM INVESTMENTS - Cost and fair value (Details) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Cost | $ 192,171 | $ 292,421 |
Accretion (Amortization) | 29 | 471 |
Gross Unrealized Gains | 912 | 223 |
Gross Unrealized Losses | (3) | |
Fair Value | 193,112 | 293,112 |
US treasury securities | ||
Cost | 160,708 | 241,709 |
Accretion (Amortization) | (16) | 364 |
Gross Unrealized Gains | 820 | 179 |
Gross Unrealized Losses | (3) | |
Fair Value | 161,512 | 242,249 |
US government agency securities | ||
Cost | 31,463 | 50,712 |
Accretion (Amortization) | 45 | 107 |
Gross Unrealized Gains | 92 | 44 |
Fair Value | $ 31,600 | $ 50,863 |
BALANCE SHEET COMPONENTS (Detai
BALANCE SHEET COMPONENTS (Details) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
BALANCE SHEET COMPONENTS | ||
Clinical related | $ 10,211 | $ 4,692 |
Accrued payroll and employee related expenses | 4,118 | 6,866 |
Manufacturing related | 3,527 | 2,184 |
Commercial manufacturing facility related | 1,869 | 17 |
Legal and related services | 1,100 | 866 |
Accrued other | 1,675 | 1,640 |
Accrued liabilities | $ 22,500 | $ 16,265 |
STOCKHOLDERS' EQUITY (Details)
STOCKHOLDERS' EQUITY (Details) - USD ($) $ / shares in Units, $ in Thousands | Jan. 16, 2019 | Oct. 17, 2018 | Sep. 30, 2013 | Jan. 31, 2018 | Mar. 31, 2020 | Mar. 31, 2019 | Dec. 31, 2019 | Jun. 10, 2019 | Jun. 09, 2019 |
Common Stock | |||||||||
Common stock sold in public offering, net of offering costs (in shares) | 25,300,000 | 50,000 | |||||||
Share price (in dollars per share) | $ 9.97 | ||||||||
Stock repurchased (in shares) | 32,500 | ||||||||
Common stock, par or stated value per share | $ 0.000041666 | $ 0.000041666 | $ 0.000041666 | ||||||
Common stock, shares authorized | 300,000,000 | 300,000,000 | 300,000,000 | 150,000,000 | |||||
Other Income | |||||||||
Common Stock | |||||||||
Proceeds from cancellation of shares sold | $ 335,000 | ||||||||
Underwriter | |||||||||
Common Stock | |||||||||
Common stock sold in public offering, net of offering costs (in shares) | 3,300,000 | ||||||||
IPO | |||||||||
Common Stock | |||||||||
Common stock sold in public offering, net of offering costs (in shares) | 15,000,000 | ||||||||
Share price (in dollars per share) | $ 11.50 | ||||||||
Proceeds from the issuance of common stock, net | $ 236,700 | $ 162,000 | |||||||
IPO | Underwriter | |||||||||
Common Stock | |||||||||
Common stock sold in public offering, net of offering costs (in shares) | 1,956,521 | ||||||||
Proceeds from the issuance of common stock, net | $ 252,200 | $ 172,500 | |||||||
Series A Convertible Preferred Stock | |||||||||
Common Stock | |||||||||
Preferred stock, shares authorized | 17,000 | ||||||||
Preferred stock, shares outstanding | 194 | 194 | |||||||
Conversion of stock, shares issued | 500 | ||||||||
Conversion of Stock, shares converted | 0 | 0 | |||||||
Series A Convertible Preferred Stock | Common Stock | |||||||||
Common Stock | |||||||||
Conversion of Stock, shares converted | 97,000 | 97,000 | |||||||
Series A Convertible Preferred Stock | Private Placement | |||||||||
Common Stock | |||||||||
Sale of stock, price per share | $ 2 | ||||||||
Preferred stock, par or stated value per share | $ 1,000 | ||||||||
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 | |||||||
Convertible price per shares | $ 4.75 | ||||||||
Preferred stock, shares outstanding | 3,581,119 | 3,581,119 | |||||||
Conversion of Stock, shares converted | 0 | 0 | |||||||
Series B Convertible Preferred Stock | Common Stock | |||||||||
Common Stock | |||||||||
Conversion of Stock, shares converted | 3,581,119 | 3,581,119 | |||||||
Series B Convertible Preferred Stock | IPO | |||||||||
Common Stock | |||||||||
Preferred stock, shares authorized | 11,500,000 | ||||||||
Preferred stock, par or stated value per share | $ 4.75 | ||||||||
Blank check | |||||||||
Common Stock | |||||||||
Preferred stock, shares authorized | 50,000,000 |
STOCK BASED COMPENSATION - Stoc
STOCK BASED COMPENSATION - Stock Options (Details) - Stock option - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2020 | Dec. 31, 2019 | |
Number of Options | ||
Granted | 3,276,351 | 9,494,712 |
Exercised | (404,075) | |
Expired/Forfeited | (230,089) | |
Outstanding, ending balance | 12,136,899 | |
Options exercisable, number | 5,256,772 | |
Weighted Average Exercise Price | ||
Granted | $ 24.58 | $ 12 |
Exercised | 9.78 | |
Expired/Forfeited | 12.91 | |
Outstanding, ending balance | 15.46 | |
Options exercisable, exercise price | $ 10.16 | |
Weighted Average Remaining Contractual Life | ||
Options outstanding, remaining term | 8 years 4 months 13 days | |
Options exercisable, remaining term | 7 years 1 month 20 days | |
Aggregate Intrinsic Value | ||
Outstanding, end of period | $ 176,592 | |
Exercisable | $ 104,569 |
STOCK BASED COMPENSATION - Assu
STOCK BASED COMPENSATION - Assumptions (Details) | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
STOCK BASED COMPENSATION | ||
Expected term (years) | 6 years 2 months 8 days | 6 years 21 days |
Expected volatility | 69.99% | 70.78% |
Risk-free interest rate | 1.83% | 2.59% |
Expected dividend yield | 0.00% | 0.00% |
STOCK BASED COMPENSATION - Addi
STOCK BASED COMPENSATION - Additional information (Details) - USD ($) $ / shares in Units, $ in Thousands | Jun. 01, 2016 | Aug. 31, 2013 | Jul. 31, 2013 | Mar. 31, 2020 | Mar. 31, 2019 | Apr. 22, 2018 | Aug. 16, 2016 | Apr. 10, 2015 | Nov. 30, 2014 | Aug. 20, 2014 | Aug. 19, 2014 | Oct. 14, 2011 |
STOCK BASED COMPENSATION | ||||||||||||
Vested | (137,500) | |||||||||||
Weighted average grant date fair value, options granted | $ 15.67 | $ 6.99 | ||||||||||
Unvested shares | 11,458 | |||||||||||
Share-based Compensation | $ 9,412 | $ 5,846 | ||||||||||
Restricted Common Stock | ||||||||||||
STOCK BASED COMPENSATION | ||||||||||||
Stock-based compensation expense | 100 | 100 | ||||||||||
Restricted stock units | ||||||||||||
STOCK BASED COMPENSATION | ||||||||||||
Unrecognized compensation cost | $ 40 | |||||||||||
Unrecognized compensation cost recognition period | 2 months 1 day | |||||||||||
Restricted stock units | Chief Executive Officer | ||||||||||||
STOCK BASED COMPENSATION | ||||||||||||
Granted | 550,000 | |||||||||||
Granted | $ 5.87 | |||||||||||
Stock option | ||||||||||||
STOCK BASED COMPENSATION | ||||||||||||
Stock-based compensation expense | $ 9,300 | $ 5,800 | ||||||||||
Total unrecognized compensation expense | $ 81,100 | |||||||||||
Unrecognized compensation cost recognition period | 2 years 2 months 26 days | |||||||||||
First Anniversary | Restricted stock units | ||||||||||||
STOCK BASED COMPENSATION | ||||||||||||
Vested | (137,500) | |||||||||||
Vesting period | 36 months | |||||||||||
Satisfaction Of Clinical Trial Milestones | Restricted stock units | ||||||||||||
STOCK BASED COMPENSATION | ||||||||||||
Vested | (275,000) | |||||||||||
2011 Equity Incentive Plan | ||||||||||||
STOCK BASED COMPENSATION | ||||||||||||
Number of shares available | 151,240 | |||||||||||
Common stock, capital shares reserved for future issuance | 1,700,000 | 1,900,000 | 1,700,000 | 180,000 | ||||||||
Maximum award per person per year (in shares) | 300,000 | 50,000 | ||||||||||
2011 Equity Incentive Plan | Minimum | ||||||||||||
STOCK BASED COMPENSATION | ||||||||||||
Number of shares available | 180,000 | |||||||||||
2014 Equity Incentive Plan | ||||||||||||
STOCK BASED COMPENSATION | ||||||||||||
Shares authorized | 4,000,000 | 2,350,000 | ||||||||||
Number of shares available | 89,408 | |||||||||||
2014 Equity Incentive Plan | Maximum | ||||||||||||
STOCK BASED COMPENSATION | ||||||||||||
Shares authorized | 9,000,000 | |||||||||||
The 2018 Plan | ||||||||||||
STOCK BASED COMPENSATION | ||||||||||||
Shares authorized | 6,000,000 | |||||||||||
Number of shares available | 336,222 |
LICENSES AND AGREEMENTS (Detail
LICENSES AND AGREEMENTS (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||||
Apr. 17, 2017 | Nov. 30, 2016 | Aug. 31, 2011 | Mar. 31, 2020 | Mar. 31, 2019 | Dec. 31, 2019 | May 31, 2017 | |
Research and development expenses | $ 56,952 | $ 30,905 | |||||
Research and Development Arrangement | |||||||
Prepaid expense, current | $ 1,400 | ||||||
Research Collaboration And Clinical Grant Agreement | |||||||
Research and development expenses | 200 | 300 | |||||
Research Collaboration And Clinical Grant Agreements With Moffitt | |||||||
Research and development expenses | 200 | $ 1,200 | |||||
Maximum | Research and Development Arrangement | |||||||
Research and development arrangement, contract to perform for others, costs incurred, gross | $ 14,200 | ||||||
National Cancer Institute | |||||||
Research and development expenses | $ 500 | ||||||
Moffitt License Agreement | |||||||
Agreement term | 20 years | ||||||
Novartis Pharma AG - License Agreement [Member] | |||||||
Research and development expenses | $ 10,000 | ||||||
Cooperative Research and Development Agreement | |||||||
Research and development expenses | 500 | ||||||
Agreement term | 5 years | ||||||
WuXi Apptech, Inc - Manufacturing and Services Agreement | |||||||
Research and development expenses | 6,700 | $ 3,800 | |||||
WuXi Apptech, Inc - Manufacturing and Services Agreement | Manufacturing Suites | |||||||
Manufacturing and services agreement, amount payable | $ 1,200 | ||||||
WuXi Apptech, Inc - Manufacturing and Services Agreement | Commercial Manufacturing cGMP Suite | |||||||
Manufacturing and services agreement, amount payable | $ 2,700 | ||||||
Moffitt License Agreement Two | |||||||
Research and development expenses | 20 | ||||||
Payments for upfront licensing fee | 100 | ||||||
Additional milestone payable | 400 | ||||||
Moffitt License Agreement One | |||||||
Payments for upfront licensing fee | 100 | ||||||
Research Collaboration And Clinical Grant Agreements With Moffitt | |||||||
Research and development expenses | $ 1,200 | ||||||
Cellectis S.A | |||||||
Research and development expenses | $ 100 |
LEGAL PROCEEDINGS (Details)
LEGAL PROCEEDINGS (Details) | Apr. 17, 2019USD ($) | Jun. 13, 2017USD ($)shares | Apr. 08, 2016USD ($) | Nov. 30, 2012USD ($) | Jun. 30, 2012USD ($) | Mar. 31, 2020shares |
Damages claimed | $ 500,000 | |||||
Class Action Lawsuit | ||||||
Settlement amount | $ 3,250,000 | |||||
Twenty Eleven Equity Incentive Plan | ||||||
Common stock issued upon exercise of stock options (in shares) | shares | 200,000 | |||||
Steven Fischkoff | ||||||
Granted | shares | 150,000 | |||||
Severance pay and retention bonus | $ 300,000 | |||||
Minimum | ||||||
Estimate of possible loss | $ 1,500,000 | |||||
Solomon Capital, LLC | ||||||
Proceeds from related party debt | $ 100,000 | $ 200,000 | ||||
Debt instrument, convertible, number of equity instruments | 1,110 | |||||
Solomon Capital, LLC | Commercial Paper | ||||||
Face amount | $ 200,000 |
LEASES - Company's right-of-use
LEASES - Company's right-of-use asset and lease liabilities (Details) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
LEASES | ||
Operating lease right-of-use assets | $ 9,305 | $ 10,695 |
Operating lease liabilities | ||
Current portion included in current liabilities | 6,431 | 7,252 |
Long-term portion included in non-current liabilities | 3,088 | 4,248 |
Total Operating lease liabilities | $ 9,519 | $ 11,500 |
LEASES - components of lease ex
LEASES - components of lease expenses (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
LEASES | ||
Operating lease cost | $ 1,636 | $ 1,594 |
Variable lease cost | 1,371 | 896 |
Short-term lease cost | 17 | 19 |
Total lease cost | $ 3,024 | $ 2,509 |
LEASES - maturities of the Comp
LEASES - maturities of the Company's operating lease liabilities (Details) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
2020 | $ 5,208 | |
2021 | 4,123 | |
2022 | 342 | |
2023 | 269 | |
2024 | 253 | |
Total lease payments | 10,195 | |
Less: Present value adjustment | (676) | |
Operating lease liabilities | 9,519 | $ 11,500 |
Facility leases | ||
2020 | 1,425 | |
2021 | 968 | |
2022 | 342 | |
2023 | 269 | |
2024 | 253 | |
Total lease payments | 3,257 | |
Less: Present value adjustment | (308) | |
Operating lease liabilities | 2,949 | |
CMO embedded leases | ||
2020 | 3,783 | |
2021 | 3,155 | |
Total lease payments | 6,938 | |
Less: Present value adjustment | (368) | |
Operating lease liabilities | $ 6,570 |
LEASES - Additional information
LEASES - Additional information (Details) | Jun. 19, 2019USD ($)ft² | May 28, 2019USD ($)ft²item | Oct. 19, 2018USD ($)ft² | Jul. 31, 2017USD ($) | Sep. 30, 2016USD ($)ft² | Aug. 04, 2016USD ($)ft² | Dec. 31, 2014ft² | Mar. 31, 2020USD ($) | Mar. 31, 2019USD ($) | Jul. 31, 2020USD ($) | Jun. 30, 2020USD ($) | Jan. 31, 2020USD ($) | Jul. 31, 2019USD ($) | Jan. 31, 2019USD ($) | Dec. 31, 2019USD ($) | May 02, 2019USD ($)ft² | Oct. 31, 2018ft² | Jul. 31, 2018USD ($) | Apr. 28, 2017USD ($)ft² | Apr. 30, 2015ft² |
Option to extend | option to extend | |||||||||||||||||||
Monthly lease payments | $ 10,195,000 | |||||||||||||||||||
First year | 5,208,000 | |||||||||||||||||||
Second year | 4,123,000 | |||||||||||||||||||
Lease Expiration Term | 30 months | |||||||||||||||||||
Monthly lease payments | $ 59,000 | 2,200,000 | $ 1,400,000 | |||||||||||||||||
Operating lease liabilities | 9,519,000 | $ 11,500,000 | ||||||||||||||||||
Operating lease right-of-use assets | 9,305,000 | 10,695,000 | ||||||||||||||||||
Operating Leases of Lessee, Contingent Rentals, Basis Spread on Variable Rate | 3.00% | |||||||||||||||||||
Increase in operating lease right-of-use assets | 500,000 | 1,000,000 | ||||||||||||||||||
Increase in operating lease liability | $ 10,000 | $ 1,000,000 | ||||||||||||||||||
Weighted average remaining lease term (in years) | 1 year 8 months 23 days | |||||||||||||||||||
Weighted average discount rate (as a percent) | 7.50% | |||||||||||||||||||
Finance lease term for not yet commenced (in years) | 20 years | |||||||||||||||||||
Tampa Lease | ||||||||||||||||||||
Term of contract (in years) | 5 years | |||||||||||||||||||
Option to extend | option to extend | |||||||||||||||||||
Renewal term (in months) | 5 years | |||||||||||||||||||
Monthly lease payments | $ 20,500 | |||||||||||||||||||
Rent expense | $ 20,000 | |||||||||||||||||||
Area of Land | ft² | 8,673 | 5,115 | 6,043 | |||||||||||||||||
New York Lease | ||||||||||||||||||||
Rent expense | $ 4,000 | $ 4,000 | $ 4,000 | $ 4,000 | ||||||||||||||||
New York Lease | Office Space | ||||||||||||||||||||
Monthly lease payments | $ 9,000 | |||||||||||||||||||
Operating Leases, Rent Expense, Minimum Rentals | $ 18,000 | |||||||||||||||||||
Rent expense | $ 7,000 | |||||||||||||||||||
Teradata US, Inc | ||||||||||||||||||||
Area of Land | ft² | 11,449 | |||||||||||||||||||
San Carlos Lease | ||||||||||||||||||||
Additional space of lease | ft² | 8,110 | |||||||||||||||||||
First year | $ 39,000 | |||||||||||||||||||
Second year | $ 40,000 | |||||||||||||||||||
San Carlos Lease | Land | ||||||||||||||||||||
Monthly lease payments | $ 38,000 | $ 26,000 | ||||||||||||||||||
Lease Expiration Term | 54 months | |||||||||||||||||||
Area of Land | ft² | 12,322 | 8,733 | 11,449 | |||||||||||||||||
San Carlos Lease | Office Space | ||||||||||||||||||||
Area of Land | ft² | 20,432 | |||||||||||||||||||
Philadelphia Office Lease for first year | Office Space | ||||||||||||||||||||
Monthly lease payments | $ 2,000 | |||||||||||||||||||
Area of Land | ft² | 1,500 | |||||||||||||||||||
Philadelphia Office Lease for next three Years | ||||||||||||||||||||
Operating Leases of Lessee, Contingent Rentals, Basis Spread on Variable Rate | 2.50% | |||||||||||||||||||
Philadelphia Office Lease for next three Years | Office Space | ||||||||||||||||||||
Term of contract (in years) | 3 years | |||||||||||||||||||
Monthly lease payments | $ 11,063 | |||||||||||||||||||
Area of Land | ft² | 4,500 | |||||||||||||||||||
Commercial Manufacturing Facility Agreement | ||||||||||||||||||||
Term of contract (in years) | 242 months | |||||||||||||||||||
Renewal term (in months) | 359 months | |||||||||||||||||||
Monthly lease payments | $ 320,000 | |||||||||||||||||||
Number of phases | item | 2 | |||||||||||||||||||
Prior written notice period (in months) | 18 months | |||||||||||||||||||
Minimum annual increase in basis spread on variable rate (as a percent) | 2.00% | |||||||||||||||||||
Maximum annual increase in basis spread on variable rate (as a percent) | 75.00% | |||||||||||||||||||
Operating expenses | $ 53,000 | |||||||||||||||||||
Operating Leases of Lessee, Contingent Rentals, Basis Spread on Variable Rate | 2.00% | |||||||||||||||||||
Commercial Manufacturing Facility Agreement | Office Space | ||||||||||||||||||||
Area of Land | ft² | 136,000 | |||||||||||||||||||
Commercial Manufacturing Facility Agreement for Phase I-A | ||||||||||||||||||||
Term of Phase I-A | 160 days | |||||||||||||||||||
Commercial Manufacturing Facility Agreement for Phase I-A | Office Space | ||||||||||||||||||||
Area of Land | ft² | 66,000 | |||||||||||||||||||
Commercial Manufacturing Facility Agreement for Phase I-B | Office Space | ||||||||||||||||||||
Area of Land | ft² | 70,000 |
RELATED PARTY TRANSACTIONS (Det
RELATED PARTY TRANSACTIONS (Details Textual) - USD ($) $ / shares in Units, $ in Thousands | Sep. 14, 2017 | Sep. 14, 2017 | Mar. 31, 2020 | Mar. 31, 2019 | Dec. 31, 2019 | Jan. 01, 2019 |
Term of consulting agreement (in years) | 3 years | |||||
Terms of award | The granted stock options vest in 12 quarterly installments (with 1/12th of the option shares having vested on the date of grant). | |||||
Stock-based compensation expense | $ 9,412 | $ 5,846 | ||||
Retained earnings | (640,207) | $ (570,612) | $ 300 | |||
Consulting Agreement | ||||||
Stock-based compensation expense | $ 100 | $ 100 | ||||
Board of Directors Chairman | ||||||
Shares authorized | 150,000 | 150,000 | ||||
Granted | $ 7.30 |