Document And Entity Information
Document And Entity Information - shares | 6 Months Ended | |
Jun. 30, 2019 | Jul. 25, 2019 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Jun. 30, 2019 | |
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 $0.000041666 per value | |
Trading Symbol | IOVA | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 123,830,506 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2019 | |
Document Fiscal Period Focus | Q2 | |
Entity Central Index Key | 0001425205 | |
Amendment Flag | false |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Current Assets | ||
Cash and cash equivalents | $ 76,912 | $ 82,152 |
Short-term investments | 327,241 | 386,371 |
Prepaid expenses and other current assets | 6,785 | 6,640 |
Total Current Assets | 410,938 | 475,163 |
Operating lease right-of-use assets | 11,719 | |
Property and equipment, net | 4,472 | 2,683 |
Restricted cash | 5,450 | |
Long-term assets | 3,345 | 2,975 |
Total Assets | 435,924 | 480,821 |
Current Liabilities | ||
Accounts payable | 12,782 | 2,739 |
Accrued expenses | 13,570 | 11,659 |
Operating lease liabilities | 7,484 | |
Total Current Liabilities | 33,836 | 14,398 |
Non-Current Liabilities | ||
Operating lease liabilities | 4,613 | |
Other liabilities | 53 | 230 |
Total Non-Current Liabilities | 4,666 | 230 |
Total Liabilities | 38,502 | 14,628 |
Commitments and contingencies (Note 9) | ||
Stockholders' Equity | ||
Common stock, $0.000041666 par value; 300,000,000 and 150,000,000 shares authorized, 123,820,508 and 123,415,576 shares issued and outstanding as of June 30, 2019 and December 31, 2018, respectively | 5 | 5 |
Additional paid-in capital | 372 | (42) |
Accumulated other comprehensive income (loss) | 854,596 | 838,984 |
Accumulated deficit | (457,557) | (372,760) |
Total Stockholders' Equity | 397,422 | 466,193 |
Total Liabilities and Stockholders' Equity | 435,924 | 480,821 |
Series A Convertible Preferred Stock | ||
Stockholders' Equity | ||
Preferred stock, Value | ||
Series B Convertible Preferred Stock | ||
Stockholders' Equity | ||
Preferred stock, Value | 6 | 6 |
Total Stockholders' Equity | $ 6 | $ 6 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Common Stock, Par or Stated Value Per Share | $ 0.000041666 | $ 0.000041666 |
Common Stock, Shares Authorized | 300,000,000 | 150,000,000 |
Common Stock, Shares, Issued | 123,820,508 | 123,415,576 |
Common Stock, Shares, Outstanding | 123,820,508 | 123,415,576 |
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 | 50,000,000 | 50,000,000 |
Preferred Stock, Shares Issued | 5,854,845 | 5,854,845 |
Preferred Stock, Shares Outstanding | 5,854,845 | 5,854,845 |
Preferred Stock, Liquidation Preference, Value | $ 27,811 | $ 27,811 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Costs and expenses | ||||
Research and development expenses | $ 39,298 | $ 24,551 | $ 70,203 | $ 44,463 |
General and administrative expenses | 10,867 | 6,827 | 19,948 | 13,792 |
Total costs and expenses | 50,165 | 31,378 | 90,151 | 58,255 |
Loss from operations | (50,165) | (31,378) | (90,151) | (58,255) |
Other income | ||||
Interest income, net | 2,614 | 718 | 5,650 | 1,080 |
Net Loss | $ (47,551) | $ (30,660) | $ (84,501) | $ (57,175) |
Net Loss Per Common Share, Basic and Diluted | $ (0.38) | $ (0.34) | $ (0.68) | $ (0.65) |
Weighted Average Common Shares Outstanding, Basic and Diluted | 123,567 | 90,236 | 123,491 | 87,310 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Condensed Consolidated Statements of Comprehensive Loss | ||||
Net Loss | $ (47,551) | $ (30,660) | $ (84,501) | $ (57,175) |
Other comprehensive loss: | ||||
Unrealized gain / (loss) on short-term investments | 234 | (3) | 414 | (3) |
Comprehensive Loss | $ (47,317) | $ (30,663) | $ (84,087) | $ (57,178) |
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, 2017 | $ 7 | $ 3 | $ 394,651 | $ (249,180) | $ 145,481 | ||
Beginning Balance (in Shares) at Dec. 31, 2017 | 1,694 | 7,378,241 | 73,164,914 | ||||
Stock-based compensation expense | 9,326 | 9,326 | |||||
Vesting of restricted shares issued for services (in shares) | 14,546 | ||||||
Tax payments related to shares withheld for vested restricted stock awards | (122) | (122) | |||||
Common stock issued upon exercise of warrants | 4,141 | 4,141 | |||||
Common stock issued upon exercise of warrants (in Shares) | 1,656,510 | ||||||
Common stock issued upon exercise of stock options | 6,828 | 6,828 | |||||
Common stock issued upon exercise of stock options (in shares) | 905,153 | ||||||
Unrealized gain / (loss) on short-term investments | $ (3) | (3) | |||||
Common stock sold in public offering, net of offering costs | 162,093 | 162,093 | |||||
Common stock sold in public offering, net of offering costs (in shares) | 15,000,000 | ||||||
Conversion of convertible preferred stock into common stock | $ (1) | $ 1 | |||||
Conversion of convertible preferred stock into common stock (in Shares) | (1,500) | (1,250,548) | 2,000,549 | ||||
Net loss | (57,175) | (57,175) | |||||
Ending Balance at Jun. 30, 2018 | $ 6 | $ 4 | 576,917 | (3) | (306,355) | 270,569 | |
Ending Balance (in Shares) at Jun. 30, 2018 | 194 | 6,127,692 | 92,741,672 | ||||
Beginning Balance at Mar. 31, 2018 | $ 7 | $ 3 | 568,243 | (275,695) | 292,558 | ||
Beginning Balance (in Shares) at Mar. 31, 2018 | 1,694 | 7,378,241 | 89,605,417 | ||||
Stock-based compensation expense | 5,222 | 5,222 | |||||
Vesting of restricted shares issued for services (in shares) | 7,495 | ||||||
Tax payments related to shares withheld for vested restricted stock awards | (62) | (62) | |||||
Common stock issued upon exercise of warrants | 2,315 | 2,315 | |||||
Common stock issued upon exercise of warrants (in Shares) | 926,129 | ||||||
Common stock issued upon exercise of stock options | 1,198 | 1,198 | |||||
Common stock issued upon exercise of stock options (in shares) | 202,082 | ||||||
Unrealized gain / (loss) on short-term investments | (3) | (3) | |||||
Conversion of convertible preferred stock into common stock | $ (1) | $ 1 | 1 | 1 | |||
Conversion of convertible preferred stock into common stock (in Shares) | (1,500) | (1,250,549) | 2,000,549 | ||||
Net loss | (30,660) | (30,660) | |||||
Ending Balance at Jun. 30, 2018 | $ 6 | $ 4 | 576,917 | (3) | (306,355) | 270,569 | |
Ending Balance (in Shares) at Jun. 30, 2018 | 194 | 6,127,692 | 92,741,672 | ||||
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 | 12,272 | 12,272 | |||||
Vesting of restricted shares issued for services | $ 1 | (1) | |||||
Vesting of restricted shares issued for services (in shares) | 14,532 | ||||||
Tax payments related to shares withheld for vested restricted stock awards | (94) | (94) | |||||
Common stock issued upon exercise of stock options | 3,474 | 3,474 | |||||
Common stock issued upon exercise of stock options (in shares) | 422,900 | ||||||
Unrealized gain / (loss) on short-term investments | 414 | 414 | |||||
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 | (84,501) | (84,501) | |||||
Ending Balance at Jun. 30, 2019 | $ 6 | $ 5 | 854,596 | 372 | (457,557) | 397,422 | |
Ending Balance (in Shares) at Jun. 30, 2019 | 194 | 5,854,845 | 123,820,508 | ||||
Beginning Balance at Mar. 31, 2019 | $ 6 | $ 5 | 844,789 | 138 | (410,006) | 434,932 | |
Beginning Balance (in Shares) at Mar. 31, 2019 | 194 | 5,854,845 | 123,395,113 | ||||
Stock-based compensation expense | 6,426 | 6,426 | |||||
Vesting of restricted shares issued for services | (1) | (1) | |||||
Vesting of restricted shares issued for services (in shares) | 7,495 | ||||||
Tax payments related to shares withheld for vested restricted stock awards | (23) | (23) | |||||
Common stock issued upon exercise of stock options | 3,405 | 3,405 | |||||
Common stock issued upon exercise of stock options (in shares) | 417,900 | ||||||
Unrealized gain / (loss) on short-term investments | 234 | 234 | |||||
Net loss | (47,551) | (47,551) | |||||
Ending Balance at Jun. 30, 2019 | $ 6 | $ 5 | 854,596 | $ 372 | (457,557) | $ 397,422 | |
Ending Balance (in Shares) at Jun. 30, 2019 | 194 | 5,854,845 | 123,820,508 | ||||
Adoption of ASU 2018-07 | $ 296 | $ (296) |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2019 | Jun. 30, 2018 | |
Cash Flows from Operating Activities | ||
Net loss | $ (84,501) | $ (57,175) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 560 | 453 |
Noncash lease expense | 3,031 | |
Loss on disposal of assets | 9 | |
Gain on settlement of dispute | 336 | |
Accretion of discounts on investments | (2,430) | (1) |
Stock-based compensation expense | 12,272 | 9,326 |
Changes in assets and liabilities: | ||
Prepaid expenses, other assets, and long-term assets | (515) | 1,604 |
Operating lease liabilities (Right-of-use assets) | (2,651) | |
Accounts payable | 9,951 | 3,686 |
Accrued expenses and other liabilities | 1,734 | 326 |
Net cash used in operating activities | (62,885) | (41,772) |
Cash Flows from Investing Activities | ||
Maturities of short-term investments | 263,102 | |
Purchase of short-term investments | (201,129) | (30,084) |
Purchase of property and equipment | (2,257) | (440) |
Net cash provided by (used in) investing activities | 59,716 | (30,524) |
Cash Flows from Financing Activities | ||
Tax payments related to shares withheld for vested restricted stock awards | (95) | (122) |
Proceeds from the issuance of common stock upon exercise of warrants | 4,141 | |
Proceeds from the issuance of common stock upon exercise of options | 3,474 | 6,828 |
Proceeds from the issuance of common stock, net | 162,093 | |
Net cash provided by financing activities | 3,379 | 172,940 |
Net increase in cash, cash equivalents, and restricted cash | 210 | 100,644 |
Cash, Cash Equivalents, and Restricted Cash Beginning of Period | 82,152 | 145,373 |
Cash, Cash Equivalents, and Restricted Cash End of Period | 82,362 | 246,017 |
Supplemental disclosure of non-cash investing and financing activities: | ||
Unrealized gain (loss) on short-term investments | 414 | (3) |
Acquisitions of property and equipment included in accounts payable | $ 92 | 278 |
Conversion of convertible preferred stock to common stock | $ 1 |
GENERAL ORGANIZATION AND BUSINE
GENERAL ORGANIZATION AND BUSINESS | 6 Months Ended |
Jun. 30, 2019 | |
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 novel cancer immunotherapy products designed to harness the power of a patient’s own immune system to eradicate cancer cells. Tumor infiltrating lymphocyte (TIL) therapy is a platform technology that has been licensed from National Cancer Institute (NCI) primarily based on data in metastatic melanoma and advanced cervical cancer. The Company has developed its own proprietary and scalable manufacturing method which is being further investigated in multiple indications. The Company’s lead product candidates include, lifileucel for metastatic melanoma, and LN-145 for advanced cervical cancer. Both product candidates are autologous adoptive cell therapy utilizing TIL, which are T cells derived from patients’ tumors. In addition to metastatic melanoma and advanced cervical cancer, the Company is investigating the effectiveness and safety of TIL therapy for the treatment of squamous cell carcinoma of the head and neck and metastatic non-small cell lung cancer through company sponsored trials, as well as other oncology indications through collaborations. The Company is currently conducting the pivotal cohort of its C-144-01 clinical trial of lifileucel in patients with metastatic melanoma. The Company is also conducting a pivotal trial of LN-145, C-145-04, in patients with advanced cervical cancer. 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 and six months ended June 30, 2019 and 2018 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, 2018 was derived from the audited financial statements included in the Company's financial statements as of and for the year ended December 31, 2018 included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on February 28, 2019. These financial statements should be read in conjunction with that report. Liquidity The Company is currently engaged in the development of therapeutics to treat 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 $84.5 million for the six months ended June 30, 2019 and used $62.9 million of cash in its operating activities during the six months ended June 30, 2019. 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. The net proceeds from the offering, after deducting the underwriting discounts and commissions and other offering expenses payable by the Company, were $162.0 million. In October 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. The net proceeds from the offering, after deducting the underwriting discounts and commissions and other offering expenses payable by the Company, were $236.7 million. As of June 30, 2019, the Company had $404.1 in cash, cash equivalents and short-term investments ($76.9 million of cash and cash equivalents and $327.2 million in short-term investments). The Company expects to further increase its research and development activities, which will increase the amount of cash used during 2019 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, increased research and development activities and initiation of pre-commercial activities. However, the extent and the timing of these expenditures are under the control of the Company. 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 for at least next twelve months from the date these financial statements are issued Concentrations of Risk The Company is subject to credit risk from our 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; liquidity of investments sufficient to meet cash flow requirements; and a competitive after-tax rate of return. |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 6 Months Ended |
Jun. 30, 2019 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | NOTE 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Cash, Cash Equivalents, Restricted Cash, 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 loss. 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 consolidated statements operations. Gains and losses on securities sold are recorded based on the specific identification method and are included in net interest income in the consolidated statement 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. The Company maintains a certain minimum balance, currently $5.5 million in a segregated bank account in connection with a letter of credit for the benefit of the landlord for its commercial manufacturing facility used as a security deposit for the lease (See Note 9 - Leases). This 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. As of June 30, 2019, restricted cash consisted of $5.5 million and this amount has been classified as non-current asset on the Company’s 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 statement of cash flows: June 30, June 30, 2019 2018 Cash $ 76,912 $ 246,017 Restricted cash (included in non-current assets on the consolidated balance sheets) 5,450 — Total cash, cash equivalents and restricted cash $ 82,362 $ 246,017 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 June 30, 2019 and 2018, the following outstanding common stock equivalents have been excluded from the calculation of net loss per share because their impact would be anti-dilutive. June 30, 2019 2018 Stock options 9,205,672 6,837,817 Warrants — 4,644,706 Series A Convertible Preferred Stock* 97,000 97,000 Series B Convertible Preferred Stock* 5,854,845 6,127,692 Restricted stock units 45,828 91,665 15,203,345 17,798,880 * on an as-converted basis The dilutive effect of potentially dilutive securities would be reflected in diluted earnings per common share by application of the treasury stock method. Under the treasury stock method, an increase in the fair market value of the Company's common stock could result in a greater dilutive effect from potentially dilutive securities. 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—Inputs are unadjusted, quoted prices in active markets for identical assets at the reporting date. Active markets are those in which transactions for the asset or liability occur in sufficient frequency and volume to provide pricing information on an ongoing basis. Level 2—Are inputs, other than quoted prices included in Level 1, that are either directly or indirectly observable for the asset or liability through correlation with market data at the reporting date and for the duration of the instrument’s anticipated life. The fair valued assets the Company holds that are generally assessed under Level 2 are corporate bonds and commercial paper. The Company utilizes third party pricing services in developing fair value measurements where fair value is based on valuation methodologies such as models using observable market inputs, including benchmark yields, reported trades, broker/dealer quotes, bids, offers and other reference data. The Company uses quotes from external pricing service providers and other on-line quotation systems to verify the fair value of investments provided by its third-party pricing service providers. The Company reviews independent service auditor’s reports from its third-party pricing service providers particularly regarding the controls over pricing and valuation of financial instruments and ensure that its internal controls address certain control deficiencies, if any, and complementary user entity controls are in place. The Company does not have fair valued assets classified under Level 2 as of June 30, 2019 and December 31, 2018. Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities and which reflect management’s best estimate of what market participants would use in pricing the asset or liability at the reporting date. Consideration is given to the risk inherent in the valuation technique and the risk inherent in the inputs to the model. The Company’s financial instruments consist of cash and cash equivalents, short-term investments, and accounts payable, all of which are reported at their respective fair value on its consolidated balance sheets. The Company does not have fair valued assets classified under Level 3 as of June 30, 2019 and December 31, 2018. As of June 30, 2019 and December 31, 2018, 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 June 30, 2019 Level 1 Level 2 Level 3 Total U.S. treasury securities $ 187,695 $ — $ — $ 187,695 U.S. government agency securities 139,546 — — 139,546 Total $ 327,241 $ — $ — $ 327,241 Assets at Fair Value as of December 31, 2018 Level 1 Level 2 Level 3 Total U.S. treasury securities $ 265,393 $ — $ — $ 265,393 U.S. government agency securities 120,978 — — 120,978 Total $ 386,371 $ — $ — $ 386,371 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 valuation of short-term investments, accounting for potential liabilities, the valuation allowance associated with the Company’s deferred tax assets, the assumptions made in valuing stock instruments issued for services and used in measuring operating lease right-of-use assets and operating lease liabilities. Principles of Consolidation The accompanying consolidated financial statements include the accounts of Iovance Biotherapeutics, Inc. and its wholly-owned subsidiary, 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. 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 June 30, 2019. Operating lease right-of-use assets represent our right to use an underlying asset for the lease term and operating lease liabilities represent our 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 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. Prior period amounts continue to be reported in accordance with our historic accounting under previous lease guidance, Topic 840. See “Recently Adopted Accounting Pronouncements - Leases” below, for more information about the impact of the adoption on Topic 842. Stock-Based Compensation The Company periodically grants stock options to employees and non-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 the similar manner as stock option grants to employees, therefore no longer requiring a remeasurement 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. For non-employee stock option awards, an option term is used in the Black-Scholes option pricing model in lieu of expected life of the common stock options. 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 RSU and RSA 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 award. The fair value of restricted stock units 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 Six Months Ended June 30, June 30, 2019 2018 2019 2018 Research and development $ 2,720 $ 2,381 $ 5,421 $ 4,381 General and administrative 3,706 2,841 6,851 4,945 Total stock-based compensation expenses $ 6,426 $ 5,222 $ 12,272 $ 9,326 Total stock-based compensation expenses broken down based on each individual instrument were as follows (in thousands): Three Months Ended Six Months Ended June 30, June 30, 2019 2018 2019 2018 Stock option expenses $ 6,359 $ 5,155 $ 12,138 $ 9,192 Restricted stock award expenses — — — — Restricted stock unit expenses 67 67 134 134 Total stock-based compensation expenses $ 6,426 $ 5,222 $ 12,272 $ 9,326 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 Pronouncements Leases On January 1, 2019, the Company adopted Topic 842, which establishes a new lease accounting method for lessees. The updated guidance requires an entity to recognize assets and liabilities arising from a lease for both financing and operating leases, along with additional qualitative and quantitative disclosures. The Company elected the package of practical expedients requiring no reassessment of whether any expired or existing contracts are or contain leases, the lease classification of any expired or existing leases, or initial direct costs for any existing leases. The standard had a material impact on its consolidated balance sheets by recognizing Operating lease right-of-use assets and Operating lease liabilities for operating leases but did not have an impact on our consolidated statement of operations or cash flows. The adoption of the Topic 842 resulted in recognition of Operating lease right-of-use assets of $10.4 million, $4.9 million of Operating lease liabilities – current, and $5.8 million of Operating lease liabilities – noncurrent as of January 1, 2019, the date of adoption. Improvements to Nonemployee Share-Based Payment Accounting On January 1, 2019, the Company adopted Topic 718, which eliminates the separate accounting method for nonemployee share-based payment awards and generally requires companies to account for share-based payment transactions with nonemployees in the same manner as share-based payment transactions with employees. Under the new guidance, nonemployee share-based payment transactions are measured at the grant-date fair value and are no longer remeasured at the then-current fair values at each reporting date until the share options have vested. The guidance requires a modified-retrospective approach in transition. The Company compared the cumulative amounts that were recorded for its nonemployee share-based payments through December 31, 2018 immediately preceding the date of adoption to the cumulative amounts that should be recognized at the adoption date and recognized a cumulative effect of the transition adjustment of $0.3 million to retained earnings as of the date of adoption, January 1, 2019. Presentation of Stockholders’ Equity In August 2018, the Security Exchange Commission (SEC) adopted the final rule under SEC Release No. 33-10532, “Disclosure Update and Simplification,” amending certain disclosure requirements that were redundant, duplicative, overlapping, outdated or superseded. In addition, the amendments expanded the disclosure requirements on the analysis of stockholders’ equity for interim financial statements. Under the amendments, an analysis of changes in each caption of stockholders’ equity presented in the balance sheet must be provided in a note or separate statement. The Company has included its presentation of changes in stockholders’ equity in this Quarterly Report on Form 10-Q for the three and six months ended June 30, 2019 and 2018. Fair Value Measurements Disclosure In August 2018, the FASB issued ASU No. 2018-13 Fair Value Measurement (Topic 820): Disclosure Framework- Changes to the Disclosure Requirements for Fair Value Measurement, which eliminates disclosure requirement regarding transfers between level 1 and level 2 of the fair value of hierarchy, however, adds disclosure requirements on the range and weighted average used to develop significant unobservable inputs for level 3 fair value measurements. The Company adopted the guidance on January 1, 2019, however, there was no adjustment required to its disclosures as it did not have fair value assets classified under level 2 or 3 as of June 30, 2019 and December 31, 2018. 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, and ASU 2019-05 (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 will require 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 does not believe the adoption of this new guidance will have any material impact on its 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), to help entities evaluate the accounting for fees paid by a customer in a cloud computing arrangement (hosting arrangement) by providing guidance for determining when the arrangement includes a software license. The guidance provided generally means that an intangible asset is recognized for the software license and, to the extent that the payments attributable to the software license are made over time, a liability also is recognized. If a cloud computing arrangement does not include a software license, the entity should account for the arrangement as a service contract. This generally means that the fees associated with the hosting element (service) of the arrangement are expensed as incurred. ASU 2018-15 is effective for fiscal years beginning subsequent to December 15, 2019. The Company is currently assessing the potential impact of adopting ASU 2018-15 on its consolidated financial statements and related disclosures. Reclassifications Certain amounts within the balance sheets 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 | 6 Months Ended |
Jun. 30, 2019 | |
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): June 30, December 31, 2019 2018 Cash equivalents - Money market funds $ 33,250 $ 25,968 Cash equivalents - U.S government securities 9,979 — Cash equivalents total $ 43,229 $ 25,968 Cash equivalents in the tables above exclude cash demand deposits of $33.7 million and $56.2 million as of June 30, 2019 and December 31, 2018, respectively. June 30, December 31, Short-term Investments 2019 2018 U.S. treasury securities $ 187,695 $ 265,393 U.S. government agency securities 139,546 120,978 Short-term investments total $ 327,241 $ 386,371 The cost and fair value of cash equivalents and short-term investments at June 30, 2019 and December 31, 2018 were as follows (in thousands): Gross Gross Unrealized Unrealized As of June 30, 2019 Cost Accretion Gains Losses Fair Value U.S. treasury securities $ 186,540 $ 923 $ 232 $ — $ 187,695 U.S. government agency securities 138,499 907 140 — 139,546 Total $ 325,039 $ 1,830 $ 372 $ — $ 327,241 Gross Gross Unrealized Unrealized As of December 31, 2018 Cost Accretion Gains Losses Fair Value U.S. treasury securities $ 264,619 $ 813 $ 19 $ (58) $ 265,393 U.S. government agency securities 120,653 328 21 (24) 120,978 Total $ 385,272 $ 1,141 $ 40 $ (82) $ 386,371 Unrealized gains and losses are included in accumulated other comprehensive loss. All short-term investments held by the Company as of June 30, 2019 and December 31, 2018 have a maturity of less than one year. |
BALANCE SHEET COMPONENTS
BALANCE SHEET COMPONENTS | 6 Months Ended |
Jun. 30, 2019 | |
BALANCE SHEET COMPONENTS | |
BALANCE SHEET COMPONENTS | NOTE 4. BALANCE SHEET COMPONENTS Accrued expenses consist of the following (in thousands): June 30, December 31, 2019 2018 Accrued payroll and employee related expenses $ 3,944 $ 4,113 Legal and related services 790 825 Clinical related 4,446 3,424 Manufacturing related 3,410 2,684 Accrued other 980 489 Deferred rent - current — 124 $ 13,570 $ 11,659 |
STOCKHOLDERS' EQUITY
STOCKHOLDERS' EQUITY | 6 Months Ended |
Jun. 30, 2019 | |
STOCKHOLDERS' EQUITY | |
STOCKHOLDERS' EQUITY | NOTE 5. STOCKHOLDERS’ EQUITY Public Offerings and Common Stock In September 2017, the Company closed an underwritten public offering of 8,846,154 shares of the Company’s common stock at a public offering price of $6.50 per share, before underwriting discounts, which included 1,153,846 shares issued upon the exercise in full by the underwriters of their option to purchase additional shares at the public offering price less the underwriting discounts. The gross proceeds from the offering, before deducting the underwriting discounts and commissions and other offering expenses payable by the Company, were $57.5 million, with net proceeds to the Company of $53.7 million. 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 June 30, 2019, 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 six months ended June 30, 2019. 1,500 shares of Series A Convertible Preferred Stock were converted into 750,000 shares of common stock during the six months ended June 30, 2018. At June 30, 2019 and 2018, 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 six months ended June 30, 2019. 1,250,549 shares of Series B Convertible Preferred Stock were converted into 1,250,549 shares of common stock during the six months ended June 30, 2018. At June 30, 2019 and 2018, 5,854,845 and 6,127,692 shares of Series B Preferred Stock (that are convertible into 5,854,845 and 6,127,692 shares of common stock) remained outstanding, respectively. Cancellation of Common Shares On September 30, 2013, the Company 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 | 6 Months Ended |
Jun. 30, 2019 | |
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 the 2011 plan, but non-qualified options, common stock and grant appreciation rights can still be granted. 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 of 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. As of June 30, 2019, 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 of Directors 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. As of June 30, 2019, 36,024 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. As of June 30, 2019, 4,029,500 shares were available for grant under the 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 for employment pursuant to Nasdaq Listing Rule 5635(c)(4). 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. As of June 30, 2019, 45,828 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 June 30, 2019 and 2018, respectively, and $0.1 million and $0.1 million for the six months ended June 30, 2019 and 2018, respectively, recorded as part of general and administrative expenses. As of June 30, 2019, $0.3 million of total unrecognized compensation costs related to non-vested restricted stock units to be recognized over a weighted average period of 0.92 years. Stock Options A summary of the status of stock options at June 30, 2019, and the changes during the six 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, 2019 6,889,287 $ 10.25 Granted 3,066,300 12.09 Exercised (422,900) 8.22 Expired/Forfeited (327,015) 12.01 Outstanding at June 30, 2019 9,205,672 $ 10.89 8.31 126,117 Options exercisable at June 30, 2019 3,965,687 $ 9.25 7.33 $ 61,231 The Company recorded stock-based compensation expenses related to options of $6.4 million and $5.2 million for the three months ended June 30, 2019 and 2018, respectively, and $12.1 million and $9.2 million for the six months ended June 30, 2019 and 2018, respectively. As of June 30, 2019, there was $43.8 million of total unrecognized compensation expense related to the options to be recognized over a weighted average period of 2.09 years. The weighted average grant date fair value for employee options granted under the Company’s stock option plans during the six months ended June 30, 2019 and 2018 was $7.98 and $15.26 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 quarter ended June 30, 2019 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 June 30, 2019. 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 six months ended June 30, 2019 and 2018: Six Months Ended June 30, Assumptions: 2019 2018 Expected term (years) 6.06 5.13 – 6.50 Expected volatility 70.78% 167.54% – 200.28% Risk-free interest rate 2.59% 2.27% – 2.97% 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 | 6 Months Ended |
Jun. 30, 2019 | |
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 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, the Company is currently 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 June 30, 2019 and 2018, and $1.0 million for the six months ended June 30, 2019 and 2018 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, 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. 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 $1.0 million for the three months ended June 30, 2019 and 2018, respectively, and $0.5 million and $1.6 million for the six months ended June 30, 2019 and 2018, 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 and six months ended June 30, 2019 and 2018. 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. The Company continues to develop TIL therapies using 4-1BB agonists in manufacturing in conjunction with M.D. Anderson Cancer Center. 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 $0.1 million for the three and six months ended June 30, 2019 and 2018 as research and development expenses in connection with the Second Moffitt License. PolyBioCept PolyBioCept Exclusive and Co-Exclusive License Agreement On September 14, 2016, the Company entered into an exclusive and co-exclusive license agreement (the “PolyBioCept Agreement”) with PolyBioCept AB, a corporation organized under the laws of Sweden (“PolyBioCept”). Under the PolyBioCept Agreement, the Company received the exclusive right and license to PolyBioCept’s intellectual property to develop, manufacture, market and genetically engineer TIL produced by expansion, selection and enrichment using a proprietary cytokine cocktail. The Company also received a co-exclusive license (with PolyBioCept) to develop, manufacture and market genetically engineered TIL under the same intellectual property. The licenses were for use in all cancers and were worldwide in scope, with the exception that the uses in melanoma were not included for certain countries of the former Soviet Union. On June 13, 2019, the Company terminated the PolyBioCept Agreement. The Company paid PolyBioCept a total of $2.5 million as an up-front exclusive license payment. No expense was recorded for the three and six months ended June 30, 2019 and 2018 in connection with this agreement. The Company believes it does not owe additional amounts to PolyBioCept. 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. The Company recorded $0.4 million and $0.1 million associated with the MDACC SAA for the three months ended June 30, 2019 and 2018, respectively, and $1.6 and $0.1 million for the six months ended June 30, 2019 and 2018, respectively, as research and development expenses. MedImmune In December 2015, the Company entered into a collaboration agreement (the “MedImmune Agreement”) with MedImmune, the global biologics research and development arm of AstraZeneca (“MedImmune”), to conduct clinical and preclinical research immuno-oncology. Under the MedImmune Agreement, the Company funded and sought to conduct at least one clinical trial combining MedImmune’s PD-L1 inhibitor, durvalumab, with TIL for the treatment of patients. MedImmune supplied durvalumab for the clinical trials. On April 3, 2019, the Company and MedImmune announced that the study was closed because of a changing treatment landscape and a lack of enrollment, and the collaboration agreement was terminated as of April 1, 2019. 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, one of the suites is expected to be capable of being used for the commercial manufacture of our products. The statements of work for each facility include a fixed component to reserve a dedicated suite and a variable component, mainly labor and materials used during the manufacturing process. The fee payable under the first statement of work for the use of one of the manufacturing suites during the first year of the agreement, including the fees for the necessary personnel, was $2.5 million. The second statement of work, under which WuXi agreed to establish and operate a second, dedicated suite for a late stage/commercial manufacturing cGMP suite requires the Company to pay approximately $5.9 million during the first year of the agreement. The Company and WuXi have extended the term of the related statements of work until May 2020. The Company recorded costs associated with agreements with WuXi of $6.8 million and $3.3 million for three months ended June 30, 2019 and 2018 respectively, and $10.7 million and $6.0 million for the six months ended June 30, 2019 and 2018, respectively, as research and development expenses. |
LEGAL PROCEEDINGS
LEGAL PROCEEDINGS | 6 Months Ended |
Jun. 30, 2019 | |
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 Derivative Lawsuits. In the Matter of Certain Stock Promotions Company’s current and former officers and directors, and others, as defendants, in the U.S. District Court for the District of Delaware (case no. 1:18-cv-00469). The complaint alleges, among other things, violations of securities law, breach of fiduciary duty, aiding and abetting, waste of corporate assets, and unjust enrichment. The complaint is based on claims arising from the SEC’s investigation in the In the Matter of Certain Stock Promotions Solomon Capital, LLC. Solomon Capital, LLC, Solomon Capital 401(K) Trust, Solomon Sharbat and Shelhav Raff v. Lion Biotechnologies, Inc. The Company intends to vigorously defend the complaint and pursue its counterclaims. Litigation Involving Dr. Steven Fischkoff. Steven Fischkoff v. Lion Biotechnologies, Inc. and Maria Fardis possessing, or using any of the Company’s proprietary materials or trade secrets. On July 5, 2018, the court entered an order dismissing two of Dr. Fischkoff’s claims against the Company and Dr. Fardis. On October 18, 2018, Dr. Fischkoff amended his complaint to assert a new claim for defamation arising from SEC filings in which the Company provided the information about this litigation. 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. In connection with the Company’s reincorporation from Nevada to Delaware in 2017, the Company (as a Delaware corporation) untimely filed a post-effective amendment to adopt a Form S-8 registration statement that the Company filed (as a Nevada corporation) to register the shares underlying the 2011 Plan. Before the Company filed the required post-effective amendment, options to purchase 200,000 shares were exercised under the 2011 Plan. The effect of the delayed post-effective amendment filing on the 200,000 option shares is uncertain, but the issuance and sale of the shares may not have been in compliance with the Form S-8 registration statement. The existence of any liability to the Company, and the amount of any such liability to the Company, as a result of the issuance of the 200,000 shares is uncertain. Accordingly, no accrual for a potential claim has been made by the Company in its financial statements. 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 the Company’s financial position, results of operations or cash flows. |
LEASES
LEASES | 6 Months Ended |
Jun. 30, 2019 | |
LEASES | |
LEASES | NOTE 9. LEASES As described further in “Note 2. Summary of Significant Accounting Policies”, the Company adopted Topic 842 as of January 1, 2019. Prior period amounts have not been adjusted and continue to be reported in accordance with its historic accounting under ASU Topic 840- Leases (Topic 840). 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 has 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. The lease expires in December 2019. The Company has notified the landlord of its intent to renew the lease under the existing terms. 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. 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. Beginning in 2020, the Company will 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 the current lease guidance 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: June 30, 2019 Operating lease right-of-use assets $ 11,719 Operating lease liabilities Current portion included in current liabilities 7,484 long-term portion included in non-current liabilities 4,613 Total Operating lease liabilities $ 12,097 The components of lease expenses, which were included in Total expenses in the Company’s consolidated statement of operations, were as follows: For the Three Months For the Six Months Ended Ended June 30, 2019 June 30, 2019 Operating lease cost $ 1,681 $ 3,275 Variable lease cost 1,045 1,941 Short-term lease cost 18 37 Total lease cost $ 2,744 $ 5,253 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 and six months ended June 30, 2019 was $2.0 million and $3.4 million, respectively, and were included in Net cash used by operating activities in its consolidated statement of cash flows. Upon the adoption of Topic 842 on January 1, 2019, the Company increased noncash balances of operating lease right-of-use assets and operating lease liabilities by $10.4 million and $10.7 million, respectively. The Company additionally increased noncash balance of operating lease right-of-use assets and operating lease liability by $3.3 million for the three months ended June 30, 2019 and $4.3 million as a result of lease modifications and additional lease agreements entered by the Company. As of June 30, 2019, the maturities of the Company’s operating lease liabilities were as follows (in thousands): CMO Facility embedded leases leases Total Remainder of 2019 $ 964 $ 3,352 $ 4,316 2020 1,696 4,818 6,514 2021 577 1,410 1,987 2022 — 131 131 2023 — — — Thereafter — — — Total lease payments $ 3,237 $ 9,711 $ 12,948 Less: Present value adjustment (349) (502) (851) Operating lease liabilities $ 2,888 $ 9,209 $ 12,097 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 or the date of lease modifications. As of June 30, 2019, the weighted average remaining lease term is 1.71 years and the weighted average discount rate used to determine the operating lease liabilities was 8.2%. As of June 30, 2019, we have a finance lease for the commercial manufacturing facility that has not yet commenced. This finance lease will commence in 2020 with a lease term of 20 years. Disclosures related to periods prior to adoption of Topic 842 As required, the following disclosure is provided for periods prior to adoption. Minimum lease commitments as of December 31, 2018 that have initial or remaining lease terms in excess of one year are as follows: CMO Facility embedded leases leases Total 2019 $ 1,373 $ 5,088 $ 6,461 2020 1,223 3,366 4,589 2021 418 994 1,412 2022 — 144 144 2023 — — — Thereafter — — — Total lease payments $ 3,014 $ 9,592 $ 12,606 |
RELATED PARTY TRANSACTIONS
RELATED PARTY TRANSACTIONS | 6 Months Ended |
Jun. 30, 2019 | |
RELATED PARTY TRANSACTIONS | |
RELATED PARTY TRANSACTIONS | NOTE 10. RELATED PARTY TRANSACTIONS A former member of the Company’s Board of Directors was an attorney at a law firm, TroyGould PC, that rendered legal services to the Company during the period of his directorship until June 6, 2018, but did not provide legal services to the Company himself during that period. The Company paid TroyGould PC $0.1 million and $0.2 million for the three months ended June 30, 2019 and 2018, respectively, and $0.2 million and $0.3 million for the six months ended June 30, 2019 and 2018, respectively. 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 $0.2 million in stock-based compensation expense related to this consulting agreement during the three months ended June 30, 2019 and 2018, respectively and $0.2 million and $0.6 million for the six months ended June 30, 2019 and 2018, 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) | 6 Months Ended |
Jun. 30, 2019 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
Cash, Cash Equivalents, Restricted Cash, and Short-term Investments | Cash, Cash Equivalents, Restricted Cash, 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 loss. 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 consolidated statements operations. Gains and losses on securities sold are recorded based on the specific identification method and are included in net interest income in the consolidated statement 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. The Company maintains a certain minimum balance, currently $5.5 million in a segregated bank account in connection with a letter of credit for the benefit of the landlord for its commercial manufacturing facility used as a security deposit for the lease (See Note 9 - Leases). This 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. As of June 30, 2019, restricted cash consisted of $5.5 million and this amount has been classified as non-current asset on the Company’s 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 statement of cash flows: June 30, June 30, 2019 2018 Cash $ 76,912 $ 246,017 Restricted cash (included in non-current assets on the consolidated balance sheets) 5,450 — Total cash, cash equivalents and restricted cash $ 82,362 $ 246,017 |
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 June 30, 2019 and 2018, the following outstanding common stock equivalents have been excluded from the calculation of net loss per share because their impact would be anti-dilutive. June 30, 2019 2018 Stock options 9,205,672 6,837,817 Warrants — 4,644,706 Series A Convertible Preferred Stock* 97,000 97,000 Series B Convertible Preferred Stock* 5,854,845 6,127,692 Restricted stock units 45,828 91,665 15,203,345 17,798,880 * on an as-converted basis The dilutive effect of potentially dilutive securities would be reflected in diluted earnings per common share by application of the treasury stock method. Under the treasury stock method, an increase in the fair market value of the Company's common stock could result in a greater dilutive effect from potentially dilutive securities. |
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—Inputs are unadjusted, quoted prices in active markets for identical assets at the reporting date. Active markets are those in which transactions for the asset or liability occur in sufficient frequency and volume to provide pricing information on an ongoing basis. Level 2—Are inputs, other than quoted prices included in Level 1, that are either directly or indirectly observable for the asset or liability through correlation with market data at the reporting date and for the duration of the instrument’s anticipated life. The fair valued assets the Company holds that are generally assessed under Level 2 are corporate bonds and commercial paper. The Company utilizes third party pricing services in developing fair value measurements where fair value is based on valuation methodologies such as models using observable market inputs, including benchmark yields, reported trades, broker/dealer quotes, bids, offers and other reference data. The Company uses quotes from external pricing service providers and other on-line quotation systems to verify the fair value of investments provided by its third-party pricing service providers. The Company reviews independent service auditor’s reports from its third-party pricing service providers particularly regarding the controls over pricing and valuation of financial instruments and ensure that its internal controls address certain control deficiencies, if any, and complementary user entity controls are in place. The Company does not have fair valued assets classified under Level 2 as of June 30, 2019 and December 31, 2018. Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities and which reflect management’s best estimate of what market participants would use in pricing the asset or liability at the reporting date. Consideration is given to the risk inherent in the valuation technique and the risk inherent in the inputs to the model. The Company’s financial instruments consist of cash and cash equivalents, short-term investments, and accounts payable, all of which are reported at their respective fair value on its consolidated balance sheets. The Company does not have fair valued assets classified under Level 3 as of June 30, 2019 and December 31, 2018. As of June 30, 2019 and December 31, 2018, 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 June 30, 2019 Level 1 Level 2 Level 3 Total U.S. treasury securities $ 187,695 $ — $ — $ 187,695 U.S. government agency securities 139,546 — — 139,546 Total $ 327,241 $ — $ — $ 327,241 Assets at Fair Value as of December 31, 2018 Level 1 Level 2 Level 3 Total U.S. treasury securities $ 265,393 $ — $ — $ 265,393 U.S. government agency securities 120,978 — — 120,978 Total $ 386,371 $ — $ — $ 386,371 |
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 valuation of short-term investments, accounting for potential liabilities, the valuation allowance associated with the Company’s deferred tax assets, the assumptions made in valuing stock instruments issued for services and used in measuring operating lease right-of-use assets and operating lease liabilities. |
Principles of Consolidation | Principles of Consolidation The accompanying consolidated financial statements include the accounts of Iovance Biotherapeutics, Inc. and its wholly-owned subsidiary, 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. |
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 June 30, 2019. Operating lease right-of-use assets represent our right to use an underlying asset for the lease term and operating lease liabilities represent our 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 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. Prior period amounts continue to be reported in accordance with our historic accounting under previous lease guidance, Topic 840. See “Recently Adopted Accounting Pronouncements - Leases” below, for more information about the impact of the adoption on Topic 842. |
Stock-Based Compensation | Stock-Based Compensation The Company periodically grants stock options to employees and non-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 the similar manner as stock option grants to employees, therefore no longer requiring a remeasurement 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. For non-employee stock option awards, an option term is used in the Black-Scholes option pricing model in lieu of expected life of the common stock options. 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 RSU and RSA 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 award. The fair value of restricted stock units 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 Six Months Ended June 30, June 30, 2019 2018 2019 2018 Research and development $ 2,720 $ 2,381 $ 5,421 $ 4,381 General and administrative 3,706 2,841 6,851 4,945 Total stock-based compensation expenses $ 6,426 $ 5,222 $ 12,272 $ 9,326 Total stock-based compensation expenses broken down based on each individual instrument were as follows (in thousands): Three Months Ended Six Months Ended June 30, June 30, 2019 2018 2019 2018 Stock option expenses $ 6,359 $ 5,155 $ 12,138 $ 9,192 Restricted stock award expenses — — — — Restricted stock unit expenses 67 67 134 134 Total stock-based compensation expenses $ 6,426 $ 5,222 $ 12,272 $ 9,326 |
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 Pronouncements | Recent Accounting Pronouncements Leases On January 1, 2019, the Company adopted Topic 842, which establishes a new lease accounting method for lessees. The updated guidance requires an entity to recognize assets and liabilities arising from a lease for both financing and operating leases, along with additional qualitative and quantitative disclosures. The Company elected the package of practical expedients requiring no reassessment of whether any expired or existing contracts are or contain leases, the lease classification of any expired or existing leases, or initial direct costs for any existing leases. The standard had a material impact on its consolidated balance sheets by recognizing Operating lease right-of-use assets and Operating lease liabilities for operating leases but did not have an impact on our consolidated statement of operations or cash flows. The adoption of the Topic 842 resulted in recognition of Operating lease right-of-use assets of $10.4 million, $4.9 million of Operating lease liabilities – current, and $5.8 million of Operating lease liabilities – noncurrent as of January 1, 2019, the date of adoption. Improvements to Nonemployee Share-Based Payment Accounting On January 1, 2019, the Company adopted Topic 718, which eliminates the separate accounting method for nonemployee share-based payment awards and generally requires companies to account for share-based payment transactions with nonemployees in the same manner as share-based payment transactions with employees. Under the new guidance, nonemployee share-based payment transactions are measured at the grant-date fair value and are no longer remeasured at the then-current fair values at each reporting date until the share options have vested. The guidance requires a modified-retrospective approach in transition. The Company compared the cumulative amounts that were recorded for its nonemployee share-based payments through December 31, 2018 immediately preceding the date of adoption to the cumulative amounts that should be recognized at the adoption date and recognized a cumulative effect of the transition adjustment of $0.3 million to retained earnings as of the date of adoption, January 1, 2019. Presentation of Stockholders’ Equity In August 2018, the Security Exchange Commission (SEC) adopted the final rule under SEC Release No. 33-10532, “Disclosure Update and Simplification,” amending certain disclosure requirements that were redundant, duplicative, overlapping, outdated or superseded. In addition, the amendments expanded the disclosure requirements on the analysis of stockholders’ equity for interim financial statements. Under the amendments, an analysis of changes in each caption of stockholders’ equity presented in the balance sheet must be provided in a note or separate statement. The Company has included its presentation of changes in stockholders’ equity in this Quarterly Report on Form 10-Q for the three and six months ended June 30, 2019 and 2018. Fair Value Measurements Disclosure In August 2018, the FASB issued ASU No. 2018-13 Fair Value Measurement (Topic 820): Disclosure Framework- Changes to the Disclosure Requirements for Fair Value Measurement, which eliminates disclosure requirement regarding transfers between level 1 and level 2 of the fair value of hierarchy, however, adds disclosure requirements on the range and weighted average used to develop significant unobservable inputs for level 3 fair value measurements. The Company adopted the guidance on January 1, 2019, however, there was no adjustment required to its disclosures as it did not have fair value assets classified under level 2 or 3 as of June 30, 2019 and December 31, 2018. 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, and ASU 2019-05 (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 will require 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 does not believe the adoption of this new guidance will have any material impact on its 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), to help entities evaluate the accounting for fees paid by a customer in a cloud computing arrangement (hosting arrangement) by providing guidance for determining when the arrangement includes a software license. The guidance provided generally means that an intangible asset is recognized for the software license and, to the extent that the payments attributable to the software license are made over time, a liability also is recognized. If a cloud computing arrangement does not include a software license, the entity should account for the arrangement as a service contract. This generally means that the fees associated with the hosting element (service) of the arrangement are expensed as incurred. ASU 2018-15 is effective for fiscal years beginning subsequent to December 15, 2019. The Company is currently assessing the potential impact of adopting ASU 2018-15 on its consolidated financial statements and related disclosures. |
Reclassifications | Reclassifications Certain amounts within the balance sheets 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) | 6 Months Ended |
Jun. 30, 2019 | |
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 statement of cash flows: June 30, June 30, 2019 2018 Cash $ 76,912 $ 246,017 Restricted cash (included in non-current assets on the consolidated balance sheets) 5,450 — Total cash, cash equivalents and restricted cash $ 82,362 $ 246,017 |
Schedule of Antidilutive securities excluded from computation of earnings per share | At June 30, 2019 and 2018, the following outstanding common stock equivalents have been excluded from the calculation of net loss per share because their impact would be anti-dilutive. June 30, 2019 2018 Stock options 9,205,672 6,837,817 Warrants — 4,644,706 Series A Convertible Preferred Stock* 97,000 97,000 Series B Convertible Preferred Stock* 5,854,845 6,127,692 Restricted stock units 45,828 91,665 15,203,345 17,798,880 * on an as-converted basis |
Schedule of assets measured at fair value | As of June 30, 2019 and December 31, 2018, 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 June 30, 2019 Level 1 Level 2 Level 3 Total U.S. treasury securities $ 187,695 $ — $ — $ 187,695 U.S. government agency securities 139,546 — — 139,546 Total $ 327,241 $ — $ — $ 327,241 Assets at Fair Value as of December 31, 2018 Level 1 Level 2 Level 3 Total U.S. treasury securities $ 265,393 $ — $ — $ 265,393 U.S. government agency securities 120,978 — — 120,978 Total $ 386,371 $ — $ — $ 386,371 |
Schedule of stock-based compensation | 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 Six Months Ended June 30, June 30, 2019 2018 2019 2018 Research and development $ 2,720 $ 2,381 $ 5,421 $ 4,381 General and administrative 3,706 2,841 6,851 4,945 Total stock-based compensation expenses $ 6,426 $ 5,222 $ 12,272 $ 9,326 |
Schedule of compensation cost for share-based payment arrangements, allocation of share-based compensation costs by plan | Total stock-based compensation expenses broken down based on each individual instrument were as follows (in thousands): Three Months Ended Six Months Ended June 30, June 30, 2019 2018 2019 2018 Stock option expenses $ 6,359 $ 5,155 $ 12,138 $ 9,192 Restricted stock award expenses — — — — Restricted stock unit expenses 67 67 134 134 Total stock-based compensation expenses $ 6,426 $ 5,222 $ 12,272 $ 9,326 |
CASH EQUIVALENTS AND SHORT-TE_2
CASH EQUIVALENTS AND SHORT-TERM INVESTMENTS (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
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): June 30, December 31, 2019 2018 Cash equivalents - Money market funds $ 33,250 $ 25,968 Cash equivalents - U.S government securities 9,979 — Cash equivalents total $ 43,229 $ 25,968 Cash equivalents in the tables above exclude cash demand deposits of $33.7 million and $56.2 million as of June 30, 2019 and December 31, 2018, respectively. June 30, December 31, Short-term Investments 2019 2018 U.S. treasury securities $ 187,695 $ 265,393 U.S. government agency securities 139,546 120,978 Short-term investments total $ 327,241 $ 386,371 |
Schedule of cost and fair value of cash equivalents and short-term investments | The cost and fair value of cash equivalents and short-term investments at June 30, 2019 and December 31, 2018 were as follows (in thousands): Gross Gross Unrealized Unrealized As of June 30, 2019 Cost Accretion Gains Losses Fair Value U.S. treasury securities $ 186,540 $ 923 $ 232 $ — $ 187,695 U.S. government agency securities 138,499 907 140 — 139,546 Total $ 325,039 $ 1,830 $ 372 $ — $ 327,241 Gross Gross Unrealized Unrealized As of December 31, 2018 Cost Accretion Gains Losses Fair Value U.S. treasury securities $ 264,619 $ 813 $ 19 $ (58) $ 265,393 U.S. government agency securities 120,653 328 21 (24) 120,978 Total $ 385,272 $ 1,141 $ 40 $ (82) $ 386,371 |
BALANCE SHEET COMPONENTS (Table
BALANCE SHEET COMPONENTS (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
BALANCE SHEET COMPONENTS | |
Schedule of accrued liabilities | Accrued expenses consist of the following (in thousands): June 30, December 31, 2019 2018 Accrued payroll and employee related expenses $ 3,944 $ 4,113 Legal and related services 790 825 Clinical related 4,446 3,424 Manufacturing related 3,410 2,684 Accrued other 980 489 Deferred rent - current — 124 $ 13,570 $ 11,659 |
STOCK BASED COMPENSATION (Table
STOCK BASED COMPENSATION (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
STOCK BASED COMPENSATION | |
Schedule of status of stock options | A summary of the status of stock options at June 30, 2019, and the changes during the six 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, 2019 6,889,287 $ 10.25 Granted 3,066,300 12.09 Exercised (422,900) 8.22 Expired/Forfeited (327,015) 12.01 Outstanding at June 30, 2019 9,205,672 $ 10.89 8.31 126,117 Options exercisable at June 30, 2019 3,965,687 $ 9.25 7.33 $ 61,231 |
Schedule of share-based payment award, stock options, valuation assumptions | The following table summarizes the assumptions relating to options granted pursuant to the Company’s equity incentive plans for the six months ended June 30, 2019 and 2018: Six Months Ended June 30, Assumptions: 2019 2018 Expected term (years) 6.06 5.13 – 6.50 Expected volatility 70.78% 167.54% – 200.28% Risk-free interest rate 2.59% 2.27% – 2.97% Expected dividend yield 0% 0% |
LEASES (Tables)
LEASES (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
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: June 30, 2019 Operating lease right-of-use assets $ 11,719 Operating lease liabilities Current portion included in current liabilities 7,484 long-term portion included in non-current liabilities 4,613 Total Operating lease liabilities $ 12,097 |
Schedule of components of lease expenses | The components of lease expenses, which were included in Total expenses in the Company’s consolidated statement of operations, were as follows: For the Three Months For the Six Months Ended Ended June 30, 2019 June 30, 2019 Operating lease cost $ 1,681 $ 3,275 Variable lease cost 1,045 1,941 Short-term lease cost 18 37 Total lease cost $ 2,744 $ 5,253 |
Schedule of maturities of the Company's operating lease liabilities | As of June 30, 2019, the maturities of the Company’s operating lease liabilities were as follows (in thousands): CMO Facility embedded leases leases Total Remainder of 2019 $ 964 $ 3,352 $ 4,316 2020 1,696 4,818 6,514 2021 577 1,410 1,987 2022 — 131 131 2023 — — — Thereafter — — — Total lease payments $ 3,237 $ 9,711 $ 12,948 Less: Present value adjustment (349) (502) (851) Operating lease liabilities $ 2,888 $ 9,209 $ 12,097 |
Schedule of minimum lease commitments | As required, the following disclosure is provided for periods prior to adoption. Minimum lease commitments as of December 31, 2018 that have initial or remaining lease terms in excess of one year are as follows: CMO Facility embedded leases leases Total 2019 $ 1,373 $ 5,088 $ 6,461 2020 1,223 3,366 4,589 2021 418 994 1,412 2022 — 144 144 2023 — — — Thereafter — — — Total lease payments $ 3,014 $ 9,592 $ 12,606 |
GENERAL ORGANIZATION AND BUSI_2
GENERAL ORGANIZATION AND BUSINESS (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||||||
Oct. 17, 2018 | Jan. 31, 2018 | Sep. 30, 2017 | Sep. 30, 2013 | Jun. 30, 2019 | Jan. 16, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | Dec. 31, 2018 | |
Net Loss | $ (47,551) | $ (30,660) | $ (84,501) | $ (57,175) | ||||||
Net cash used in operating activities | (62,885) | (41,772) | ||||||||
Common stock sold in public offering, net of offering costs (in shares) | 25,300,000 | 50,000 | 17,500 | |||||||
Share price (in dollars per share) | $ 9.97 | |||||||||
Proceeds from the issuance of common stock, net | $ 236,700 | 162,093 | ||||||||
cash, cash equivalents and short-term investments | 404,100 | 404,100 | ||||||||
Cash and cash equivalents | 76,912 | $ 246,017 | 76,912 | $ 246,017 | $ 82,152 | |||||
Short-term investments | $ 327,200 | $ 327,200 | ||||||||
IPO | ||||||||||
Common stock sold in public offering, net of offering costs (in shares) | 15,000,000 | 8,846,154 | ||||||||
Share price (in dollars per share) | $ 11.50 | $ 6.50 | ||||||||
Proceeds from the issuance of common stock, net | $ 162,000 | $ 53,700 | ||||||||
Common Stock | ||||||||||
Common stock sold in public offering, net of offering costs (in shares) | 25,300,000 | 15,000,000 |
SUMMARY OF SIGNIFICANT ACCOUN_4
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Cash, Cash equivalents and Restricted Cash (Details) - USD ($) | Jun. 30, 2019 | Dec. 31, 2018 | Jun. 30, 2018 | Dec. 31, 2017 |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | ||||
Letter of credit | $ 1,000,000 | |||
Security deposit | 5,500,000 | |||
Cash | 76,912,000 | $ 82,152,000 | $ 246,017,000 | |
Restricted cash (included in non-current assets on the consolidated balance sheets) | 5,450,000 | |||
Total cash, cash equivalents and restricted cash | 82,362,000 | $ 82,152,000 | $ 246,017,000 | $ 145,373,000 |
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 | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | ||
Antidilutive securities excluded from calculation of net loss per share | 15,203,345 | 17,798,880 | |
Stock option expenses | |||
Antidilutive securities excluded from calculation of net loss per share | 9,205,672 | 6,837,817 | |
Warrant | |||
Antidilutive securities excluded from calculation of net loss per share | 4,644,706 | ||
Restricted stock units | |||
Antidilutive securities excluded from calculation of net loss per share | 45,828 | 91,665 | |
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] | 5,854,845 | 6,127,692 |
[1] | on an as-converted basis |
SUMMARY OF SIGNIFICANT ACCOUN_6
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Fair value (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Total | $ 327,241 | $ 386,371 |
U.S. treasury securities | ||
Total | 187,695 | 265,393 |
U.S. government agency securities | ||
Total | 139,546 | 120,978 |
Level 1 | ||
Total | 327,241 | 386,371 |
Level 1 | U.S. treasury securities | ||
Total | 187,695 | 265,393 |
Level 1 | U.S. government agency securities | ||
Total | $ 139,546 | $ 120,978 |
SUMMARY OF SIGNIFICANT ACCOUN_7
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Stock-based compensation expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Total stock-based compensation expenses | $ 6,426 | $ 5,222 | $ 12,272 | $ 9,326 |
Research and development | ||||
Total stock-based compensation expenses | 2,720 | 2,381 | 5,421 | 4,381 |
General and administrative | ||||
Total stock-based compensation expenses | $ 3,706 | $ 2,841 | $ 6,851 | $ 4,945 |
SUMMARY OF SIGNIFICANT ACCOUN_8
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Stock-based compensation by instrument (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Total stock-based compensation expenses | $ 6,426 | $ 5,222 | $ 12,272 | $ 9,326 |
Stock option expenses | ||||
Total stock-based compensation expenses | 6,359 | 5,155 | 12,138 | 9,192 |
Restricted stock units | ||||
Total stock-based compensation expenses | $ 67 | $ 67 | $ 134 | $ 134 |
SUMMARY OF SIGNIFICANT ACCOUN_9
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Textual) - USD ($) $ in Thousands | Jun. 30, 2019 | Jan. 01, 2019 |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | ||
Operating lease right-of-use assets | $ 11,719 | $ 10,400 |
Operating lease liabilities - current | 7,484 | 4,900 |
Operating lease liabilities - noncurrent | $ 4,613 | 5,800 |
Adoption of ASU 2018-07 | $ 300 |
CASH EQUIVALENTS AND SHORT-TE_3
CASH EQUIVALENTS AND SHORT-TERM INVESTMENTS (Details) - USD ($) $ in Thousands | 6 Months Ended | 12 Months Ended | |
Jun. 30, 2019 | Dec. 31, 2018 | Jun. 30, 2018 | |
Cash equivalent total | $ 43,229 | $ 25,968 | |
Cash equivalents total | 76,912 | 82,152 | $ 246,017 |
Demand Deposits | |||
Cash equivalents total | 33,700 | 56,200 | |
Money Market Funds | |||
Cash equivalent total | 33,250 | $ 25,968 | |
U.S government securities | |||
Cash equivalent total | $ 9,979 |
CASH EQUIVALENTS AND SHORT-TE_4
CASH EQUIVALENTS AND SHORT-TERM INVESTMENTS - Short-term investments (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Short-term investments total | $ 327,241 | $ 386,371 |
U.S. treasury securities | ||
Short-term investments total | 187,695 | 265,393 |
U.S. government agency securities | ||
Short-term investments total | $ 139,546 | $ 120,978 |
CASH EQUIVALENTS AND SHORT-TE_5
CASH EQUIVALENTS AND SHORT-TERM INVESTMENTS - Cost and fair value (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Cost | $ 325,039 | $ 385,272 |
Accretion | 1,830 | 1,141 |
Gross Unrealized Gains | 372 | 40 |
Gross Unrealized Losses | (82) | |
Fair Value | 327,241 | 386,371 |
U.S. treasury securities | ||
Cost | 186,540 | 264,619 |
Accretion | 923 | 813 |
Gross Unrealized Gains | 232 | 19 |
Gross Unrealized Losses | (58) | |
Fair Value | 187,695 | 265,393 |
U.S. government agency securities | ||
Cost | 138,499 | 120,653 |
Accretion | 907 | 328 |
Gross Unrealized Gains | 140 | 21 |
Gross Unrealized Losses | (24) | |
Fair Value | $ 139,546 | $ 120,978 |
BALANCE SHEET COMPONENTS - Accr
BALANCE SHEET COMPONENTS - Accrued liabilities (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
BALANCE SHEET COMPONENTS | ||
Accrued payroll and employee related expenses | $ 3,944 | $ 4,113 |
Legal and related services | 790 | 825 |
Clinical related | 4,446 | 3,424 |
Manufacturing related | 3,410 | 2,684 |
Accrued other | 980 | 489 |
Deferred rent - current | 124 | |
Accrued liabilities | $ 13,570 | $ 11,659 |
STOCKHOLDERS' EQUITY (Details)
STOCKHOLDERS' EQUITY (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||||||||
Jan. 16, 2019 | Oct. 17, 2018 | Jan. 31, 2018 | Sep. 30, 2017 | Sep. 30, 2013 | Jan. 16, 2019 | Jun. 30, 2019 | Jun. 30, 2018 | Jun. 10, 2019 | Jun. 09, 2019 | Dec. 31, 2018 | |
Class of Stock [Line Items] | |||||||||||
Common stock sold in public offering, net of offering costs (in shares) | 25,300,000 | 50,000 | 17,500 | ||||||||
Share price (in dollars per share) | $ 9.97 | ||||||||||
Stock repurchased (in shares) | 32,500 | ||||||||||
Proceeds from the issuance of common stock, net | $ 236,700,000 | $ 162,093,000 | |||||||||
Common stock, par or stated value per share | $ 0.000041666 | $ 0.000041666 | $ 0.000041666 | ||||||||
Common stock, shares authorized | 300,000,000 | 300,000,000 | 150,000,000 | 150,000,000 | |||||||
Other Income | |||||||||||
Class of Stock [Line Items] | |||||||||||
Proceeds from the issuance of common stock, net | $ 335,000 | ||||||||||
Underwriter | |||||||||||
Class of Stock [Line Items] | |||||||||||
Common stock sold in public offering, net of offering costs (in shares) | 3,300,000 | ||||||||||
Gross proceeds from issuance of common stock | $ 252,200,000 | ||||||||||
Common Stock | |||||||||||
Class of Stock [Line Items] | |||||||||||
Common stock sold in public offering, net of offering costs (in shares) | 25,300,000 | 15,000,000 | |||||||||
Conversion of stock, shares issued | 5,854,845 | 6,127,692 | |||||||||
IPO | |||||||||||
Class of Stock [Line Items] | |||||||||||
Common stock sold in public offering, net of offering costs (in shares) | 15,000,000 | 8,846,154 | |||||||||
Share price (in dollars per share) | $ 11.50 | $ 6.50 | |||||||||
Proceeds from the issuance of common stock, net | $ 162,000,000 | $ 53,700,000 | |||||||||
IPO | Underwriter | |||||||||||
Class of Stock [Line Items] | |||||||||||
Common stock sold in public offering, net of offering costs (in shares) | 1,956,521 | 1,153,846 | |||||||||
Proceeds from the issuance of common stock, net | $ 172,500,000 | $ 57,500,000 | |||||||||
Series A Convertible Preferred Stock | |||||||||||
Class of Stock [Line Items] | |||||||||||
Preferred stock, shares authorized | 17,000 | ||||||||||
Preferred stock, shares outstanding | 194 | 194 | |||||||||
Conversion of stock, shares issued | 500 | ||||||||||
Conversion of Stock, shares converted | 0 | 1,500 | |||||||||
Series A Convertible Preferred Stock | Common Stock | |||||||||||
Class of Stock [Line Items] | |||||||||||
Conversion of stock, shares issued | 750,000 | ||||||||||
Conversion of Stock, shares converted | 97,000 | 97,000 | |||||||||
Series A Convertible Preferred Stock | Private Placement | |||||||||||
Class of Stock [Line Items] | |||||||||||
Sale of stock, price per share | $ 2 | ||||||||||
Preferred stock, par or stated value per share | $ 1,000 | ||||||||||
Series B Convertible Preferred Stock | |||||||||||
Class of Stock [Line Items] | |||||||||||
Preferred stock, shares authorized | 50,000,000 | 50,000,000 | |||||||||
Preferred stock, par or stated value per share | $ 0.001 | $ 0.001 | |||||||||
Convertible price per shares | $ 4.75 | ||||||||||
Preferred stock, shares outstanding | 5,854,845 | 6,127,692 | 5,854,845 | ||||||||
Conversion of stock, shares issued | 1,250,549 | ||||||||||
Conversion of Stock, shares converted | 0 | 1,250,549 | |||||||||
Series B Convertible Preferred Stock | IPO | |||||||||||
Class of Stock [Line Items] | |||||||||||
Preferred stock, shares authorized | 11,500,000 | ||||||||||
Preferred stock, par or stated value per share | $ 4.75 | ||||||||||
Blank check | |||||||||||
Class of Stock [Line Items] | |||||||||||
Preferred stock, shares authorized | 50,000,000 |
STOCK BASED COMPENSATION - Stoc
STOCK BASED COMPENSATION - Stock Options (Details) - Stock option expenses - USD ($) $ / shares in Units, $ in Thousands | 6 Months Ended |
Jun. 30, 2019 | |
Number of Options | |
Outstanding, beginning balance | 6,889,287 |
Issued | 3,066,300 |
Exercised | (422,900) |
Expired/Forfeited | (327,015) |
Outstanding, ending balance | 9,205,672 |
Options exercisable, number | 3,965,687 |
Weighted Average Exercise Price | |
Outstanding, beginning balance | $ 10.25 |
Exercise price (in dollars per share) | 12.09 |
Exercised | 8.22 |
Expired/Forfeited | 12.01 |
Outstanding, ending balance | 10.89 |
Options exercisable, exercise price | $ 9.25 |
Weighted Average Remaining Contractual Life | |
Options outstanding, remaining term | 8 years 3 months 21 days |
Options exercisable, remaining term | 7 years 3 months 29 days |
Aggregate Intrinsic Value | |
Outstanding, end of period | $ 126,117 |
Exercisable | $ 61,231 |
STOCK BASED COMPENSATION - Assu
STOCK BASED COMPENSATION - Assumptions (Details) | 6 Months Ended | |
Jun. 30, 2019 | Jun. 30, 2018 | |
Expected term (years) | 6 years 21 days | |
Expected volatility | 70.78% | |
Risk-free interest rate | 2.59% | |
Expected dividend yield | 0.00% | 0.00% |
Maximum | ||
Expected term (years) | 6 years 6 months | |
Expected volatility | 200.28% | |
Risk-free interest rate | 2.97% | |
Minimum | ||
Expected term (years) | 5 years 1 month 17 days | |
Expected volatility | 167.54% | |
Risk-free interest rate | 2.27% |
STOCK BASED COMPENSATION (Detai
STOCK BASED COMPENSATION (Details Textual) - USD ($) $ / shares in Units, $ in Thousands | Jun. 02, 2016 | Aug. 31, 2013 | Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | Aug. 31, 2018 | Apr. 22, 2018 | Apr. 16, 2016 | Apr. 10, 2015 | Sep. 19, 2014 | Aug. 20, 2014 | Oct. 14, 2011 |
STOCK BASED COMPENSATION | |||||||||||||
Stock-based compensation expense | $ 100 | $ 100 | |||||||||||
Total unrecognized compensation expense | $ 43,800 | $ 43,800 | |||||||||||
Unrecognized compensation cost recognition period | 2 years 1 month 2 days | ||||||||||||
Vested | (137,500) | ||||||||||||
Weighted average grant date fair value, options granted | $ 7.98 | $ 15.26 | |||||||||||
Compensation Arrangement by Share-based payment award, description | an amendment to increase the number of 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. | ||||||||||||
Unvested shares | 45,828 | 45,828 | |||||||||||
Share-based Compensation | $ 12,272 | $ 9,326 | |||||||||||
Restricted Common Stock | |||||||||||||
STOCK BASED COMPENSATION | |||||||||||||
Stock-based compensation expense | $ 100 | $ 100 | |||||||||||
Restricted stock units | |||||||||||||
STOCK BASED COMPENSATION | |||||||||||||
Stock-based compensation expense | $ 300 | ||||||||||||
Unrecognized compensation cost recognition period | 11 months 1 day | ||||||||||||
Restricted stock units | Chief Executive Officer | |||||||||||||
STOCK BASED COMPENSATION | |||||||||||||
Granted | 550,000 | ||||||||||||
Granted | $ 5.87 | ||||||||||||
Stock option expenses | |||||||||||||
STOCK BASED COMPENSATION | |||||||||||||
Stock-based compensation expense | $ 6,400 | $ 5,200 | $ 12,100 | $ 9,200 | |||||||||
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 | 151,240 | |||||||||||
Common stock, capital shares reserved for future issuance | 1,700,000 | 1,700,000 | 1,900,000 | 180,000 | |||||||||
2011 Equity Incentive Plan | Minimum | |||||||||||||
STOCK BASED COMPENSATION | |||||||||||||
Number of shares available | 180,000 | 180,000 | |||||||||||
Equity Incentive Plan | |||||||||||||
STOCK BASED COMPENSATION | |||||||||||||
Shares authorized | 4,000,000 | 2,350,000 | |||||||||||
Number of shares available | 36,024 | 36,024 | |||||||||||
Equity Incentive Plan | Maximum | |||||||||||||
STOCK BASED COMPENSATION | |||||||||||||
Shares authorized | 9,000,000 | ||||||||||||
Twenty Eighteen Equity Incentive Plan | |||||||||||||
STOCK BASED COMPENSATION | |||||||||||||
Shares authorized | 6,000,000 | ||||||||||||
Number of shares available | 4,029,500 | 4,029,500 |
LICENSES AND AGREEMENTS (Detail
LICENSES AND AGREEMENTS (Details) - USD ($) $ in Thousands | Sep. 14, 2016 | Apr. 17, 2017 | Nov. 30, 2016 | Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | May 31, 2017 |
Research and development expenses | $ 39,298 | $ 24,551 | $ 70,203 | $ 44,463 | ||||
Research and Development Arrangement | ||||||||
Prepaid expense, current | $ 1,400 | |||||||
Research Collaboration And Clinical Grant Agreement | ||||||||
Research and development expenses | 200 | 1,000 | 500 | 1,600 | ||||
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 | |||||||
Cooperative Research and Development Agreement | ||||||||
Research and development expenses | 500 | 500 | $ 1,000 | 1,000 | ||||
Agreement term | 5 years | |||||||
PolyBioCept, AB - Exclusive and Co-Exclusive License Agreement | ||||||||
Payment for upfront exclusive license | $ 2,500 | |||||||
WuXi Apptech, Inc - Manufacturing and Services Agreement | ||||||||
Research and development expenses | 6,800 | 3,300 | $ 10,700 | 6,000 | ||||
WuXi Apptech, Inc - Manufacturing and Services Agreement | Manufacturing Suites | ||||||||
Manufacturing and services agreement, amount payable | $ 2,500 | |||||||
WuXi Apptech, Inc - Manufacturing and Services Agreement | Commercial Manufacturing cGMP Suite | ||||||||
Manufacturing and services agreement, amount payable | $ 5,900 | |||||||
Moffitt License Agreement Two | ||||||||
Research and development expenses | 100 | 100 | 100 | 100 | ||||
Payments for upfront licensing fee | 100 | |||||||
Additional milestone payable | 400 | 400 | ||||||
Moffitt License Agreement One | ||||||||
Payments for upfront licensing fee | 100 | |||||||
Research Collaboration And Clinical Grant Agreements With Moffitt | ||||||||
Research and development expenses | $ 400 | $ 100 | $ 1,600 | $ 100 |
LEGAL PROCEEDINGS (Details)
LEGAL PROCEEDINGS (Details) | Apr. 17, 2019USD ($) | Jun. 13, 2017USD ($)shares | Jun. 03, 2016USD ($) | Nov. 30, 2012USD ($) | Jun. 30, 2012USD ($) | Jun. 30, 2016shares | Jun. 30, 2019shares | Apr. 08, 2016USD ($) |
Damages claimed | $ 500,000 | |||||||
Common stock registered for resale | shares | 128,500 | |||||||
Number of share options or share units exercised during the current period. | shares | 128,500 | |||||||
Class Action Suits Alleging Violation Of Federal Securities Laws | ||||||||
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 | ||||||||
Issued | shares | 150,000 | |||||||
Severance pay and retention bonus | $ 300,000 | |||||||
Warrant | ||||||||
Shares sold under ineffective registration | shares | 128,500 | |||||||
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 | 111,425 | |||||||
Solomon Capital, LLC | Commercial Paper | ||||||||
Face amount | $ 200,000 |
LEASES (Details)
LEASES (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Jan. 01, 2019 |
LEASES | ||
Operating lease right-of-use assets | $ 11,719 | $ 10,400 |
Operating lease liabilities | ||
Current portion included in current liabilities | 7,484 | 4,900 |
long-term portion included in non-current liabilities | 4,613 | 5,800 |
Total Operating lease liabilities | $ 12,097 | $ 10,700 |
LEASES (Details 1)
LEASES (Details 1) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended |
Jun. 30, 2019 | Jun. 30, 2019 | |
LEASES | ||
Operating lease cost | $ 1,681 | $ 3,275 |
Variable lease cost | 1,045 | 1,941 |
Short-term lease cost | 18 | 37 |
Total lease cost | $ 2,744 | $ 5,253 |
LEASES (Details 2)
LEASES (Details 2) - USD ($) $ in Thousands | Jun. 30, 2019 | Jan. 01, 2019 |
Remainder of 2019 | $ 4,316 | |
2020 | 6,514 | |
2021 | 1,987 | |
2022 | 131 | |
Total lease payments | 12,948 | |
Less: Present value adjustment | (851) | |
Operating lease liabilities | 12,097 | $ 10,700 |
Facility leases | ||
Remainder of 2019 | 964 | |
2020 | 1,696 | |
2021 | 577 | |
Total lease payments | 3,237 | |
Less: Present value adjustment | (349) | |
Operating lease liabilities | 2,888 | |
CMO embedded leases | ||
Remainder of 2019 | 3,352 | |
2020 | 4,818 | |
2021 | 1,410 | |
2022 | 131 | |
Total lease payments | 9,711 | |
Less: Present value adjustment | (502) | |
Operating lease liabilities | $ 9,209 |
LEASES (Details 3)
LEASES (Details 3) | Jun. 30, 2019USD ($) |
2019 | $ 6,461,000 |
2020 | 4,589,000 |
2021 | 1,412 |
2022 | 144 |
Total lease payments | 12,606 |
Facility leases | |
2019 | 1,373,000 |
2020 | 1,223,000 |
2021 | 418 |
Total lease payments | 3,014 |
CMO embedded leases | |
2019 | 5,088,000 |
2020 | 3,366,000 |
2021 | 994 |
2022 | 144 |
Total lease payments | $ 9,592 |
LEASES (Details Textual)
LEASES (Details Textual) | Jun. 19, 2019USD ($)ft² | May 28, 2019USD ($)ft²item | May 01, 2019USD ($) | Nov. 02, 2018USD ($) | Oct. 19, 2018USD ($)ft² | Jul. 31, 2017USD ($) | Sep. 30, 2016USD ($)ft² | Aug. 04, 2016USD ($)ft² | Dec. 31, 2014ft² | Jun. 30, 2019USD ($) | Jun. 30, 2019USD ($) | Apr. 20, 2019USD ($) | May 02, 2019USD ($)ft² | Jan. 01, 2019USD ($) | Oct. 31, 2018ft² | Jun. 05, 2017USD ($) | Apr. 28, 2017USD ($)ft² | Apr. 30, 2015ft² |
Option to extend | option to extend | |||||||||||||||||
Lease expiration term (in months) | 30 months | |||||||||||||||||
Monthly lease payments | $ 12,948,000 | $ 12,948,000 | ||||||||||||||||
Basis spread on operating lease (as a percent) | 3.00% | |||||||||||||||||
First year | 4,316,000 | 4,316,000 | ||||||||||||||||
Second year | 6,514,000 | 6,514,000 | ||||||||||||||||
Monthly lease payments | $ 59,000 | 2,000,000 | 3,400,000 | |||||||||||||||
Operating lease liabilities | 12,097,000 | 12,097,000 | $ 10,700,000 | |||||||||||||||
Operating lease right-of-use assets | $ 11,719,000 | 11,719,000 | $ 10,400,000 | |||||||||||||||
Increase in operating lease liability | 4,300,000 | |||||||||||||||||
Increase in operating lease right-of-use assets | $ 3,300,000 | |||||||||||||||||
Weighted average remaining lease term (in years) | 1 year 8 months 15 days | 1 year 8 months 15 days | ||||||||||||||||
Weighted average discount rate (as a percent) | 8.20% | 8.20% | ||||||||||||||||
Finance lease term for not yet commenced (in years) | 20 years | 20 years | ||||||||||||||||
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 | ||||||||||||||||||
Area of land | ft² | 12,322 | 8,733 | 11,449 | |||||||||||||||
Lease expiration term (in months) | 54 months | |||||||||||||||||
Monthly lease payments | $ 38,000 | $ 26,000 | ||||||||||||||||
San Carlos Lease | Office Space | ||||||||||||||||||
Area of land | ft² | 20,432 | |||||||||||||||||
New York Lease | ||||||||||||||||||
Rent expense | $ 4,000 | $ 4,000 | ||||||||||||||||
New York Lease | Office Space | ||||||||||||||||||
Monthly lease payments | $ 9,000 | |||||||||||||||||
Monthly rental expenses | $ 18,000 | |||||||||||||||||
Rent expense | $ 7,000 | |||||||||||||||||
Tampa Lease | ||||||||||||||||||
Term of contract (in years) | 5 years | |||||||||||||||||
Area of land | ft² | 8,673 | 5,115 | 6,043 | |||||||||||||||
Option to extend | option to extend | |||||||||||||||||
Renewal term (in months) | 5 years | |||||||||||||||||
Rent expense | $ 20,000 | |||||||||||||||||
Philadelphia Office Lease for first year | Office Space | ||||||||||||||||||
Area of land | ft² | 1,500 | |||||||||||||||||
Monthly lease payments | $ 2,000 | |||||||||||||||||
Philadelphia Office Lease for next three Years | ||||||||||||||||||
Basis spread on operating lease (as a percent) | 2.50% | |||||||||||||||||
Philadelphia Office Lease for next three Years | Office Space | ||||||||||||||||||
Area of land | ft² | 4,500 | |||||||||||||||||
Monthly lease payments | $ 11,063 | |||||||||||||||||
Commercial Manufacturing Facility Agreement | ||||||||||||||||||
Term of contract (in years) | 242 months | |||||||||||||||||
Renewal term (in months) | 359 months | |||||||||||||||||
Monthly lease payments | $ 320,000 | |||||||||||||||||
Basis spread on operating lease (as a percent) | 2.00% | |||||||||||||||||
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 | |||||||||||||||||
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 | Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | Jan. 01, 2019 | Dec. 31, 2018 |
Payments for legal services | $ 100 | $ 200 | $ 200 | $ 300 | ||||
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 | 12,272 | 9,326 | ||||||
Retained earnings | (457,557) | (457,557) | $ 300 | $ (372,760) | ||||
Consulting Agreement | ||||||||
Stock-based compensation expense | $ 100 | $ 200 | $ 200 | $ 600 | ||||
Board of Directors Chairman | ||||||||
Shares authorized | 150,000 | 150,000 | ||||||
Exercise price (in dollars per share) | $ 7.30 |