Document And Entity Information
Document And Entity Information - shares | 9 Months Ended | |
Sep. 30, 2018 | Oct. 31, 2018 | |
Document Information [Line Items] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2018 | |
Document Fiscal Year Focus | 2,018 | |
Document Fiscal Period Focus | Q3 | |
Entity Registrant Name | IOVANCE BIOTHERAPEUTICS, INC. | |
Entity Central Index Key | 1,425,205 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Accelerated Filer | |
Trading Symbol | IOVA | |
Entity Common Stock, Shares Outstanding | 123,169,528 | |
Entity Emerging Growth Company | false | |
Entity Small Business | false |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2018 | Dec. 31, 2017 |
Current Assets | ||
Cash and cash equivalents | $ 80,738 | $ 145,373 |
Short-term investments | 179,262 | 0 |
Prepaid expenses and other assets | 5,863 | 3,917 |
Total Current Assets | 265,863 | 149,290 |
Property and equipment, net | 2,640 | 2,450 |
Long-term assets | 2,331 | 3,633 |
Total Assets | 270,834 | 155,373 |
Current Liabilities | ||
Accounts payable | 6,014 | 1,232 |
Accrued expenses | 10,660 | 8,660 |
Total Current Liabilities | 16,674 | 9,892 |
Commitments and contingencies (Note 9) | ||
Stockholders' Equity | ||
Common stock, $0.000041666 par value; 150,000,000 shares authorized, 97,425,721 and 73,164,914 shares issued and outstanding as of September 30, 2018 and December 31, 2017, respectively | 4 | 3 |
Accumulated other comprehensive loss | (120) | 0 |
Additional paid-in capital | 594,455 | 394,651 |
Accumulated deficit | (340,185) | (249,180) |
Total Stockholders' Equity | 254,160 | 145,481 |
Total Liabilities and Stockholders' Equity | 270,834 | 155,373 |
Series A Convertible Preferred stock [Member] | ||
Stockholders' Equity | ||
Preferred stock, Value | 0 | 0 |
Series B Convertible Preferred stock [Member] | ||
Stockholders' Equity | ||
Preferred stock, Value | $ 6 | $ 7 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - USD ($) $ in Thousands | Sep. 30, 2018 | Dec. 31, 2017 |
Common Stock, Par or Stated Value Per Share | $ 0.000041666 | $ 0.000041666 |
Common Stock, Shares Authorized | 150,000,000 | 150,000,000 |
Common Stock, Shares, Issued | 97,425,721 | 73,164,914 |
Common Stock, Shares, Outstanding | 97,425,721 | 73,164,914 |
Series A Convertible Preferred Stock [Member] | ||
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 | 1,694 |
Preferred Stock, Shares Outstanding | 194 | 1,694 |
Preferred Stock, Redemption Amount | $ 194 | $ 194 |
Series B Convertible Preferred Stock [Member] | ||
Preferred Stock, Par or Stated Value Per Share | $ 0.001 | $ 0.001 |
Preferred Stock, Shares Authorized | 11,500,000 | 11,500,000 |
Preferred Stock, Shares Issued | 5,854,845 | 7,378,241 |
Preferred Stock, Shares Outstanding | 5,854,845 | 7,378,241 |
Preferred Stock, Redemption Amount | $ 27,811 | $ 27,811 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Revenues | $ 0 | $ 0 | $ 0 | $ 0 |
Costs and expenses | ||||
Research and development expenses | 27,947 | 16,679 | 72,410 | 50,919 |
General and administrative expenses | 7,113 | 5,664 | 20,905 | 15,887 |
Total costs and expenses | 35,060 | 22,343 | 93,315 | 66,806 |
Loss from operations | (35,060) | (22,343) | (93,315) | (66,806) |
Other income | ||||
Interest income, net | 1,230 | 194 | 2,310 | 596 |
Net Loss | $ (33,830) | $ (22,149) | $ (91,005) | $ (66,210) |
Net Loss Per Common Share, Basic and Diluted | $ (0.36) | $ (0.35) | $ (1.01) | $ (1.06) |
Weighted Average Common Shares Outstanding, Basic and Diluted | 95,077 | 63,332 | 89,927 | 62,697 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Net Loss | $ (33,830) | $ (22,149) | $ (91,005) | $ (66,210) |
Other comprehensive loss: | ||||
Unrealized loss on short-term investments | (117) | 0 | (120) | (29) |
Comprehensive Loss | $ (33,947) | $ (22,149) | $ (91,125) | $ (66,239) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2018 | Sep. 30, 2017 | |
Cash Flows from Operating Activities | ||
Net loss | $ (91,005) | $ (66,210) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 704 | 710 |
Loss on disposal of assets | 9 | 0 |
Accretion and amortization of discounts and premiums on investments | (388) | 19 |
Stock-based compensation expense | 14,842 | 9,208 |
Changes in assets and liabilities: | ||
Prepaid expenses and other assets | (644) | (4,953) |
Accounts payable | 4,782 | 2,148 |
Accrued expenses | 2,000 | 1,333 |
Net cash used in operating activities | (69,700) | (57,745) |
Cash Flows from Investing Activities | ||
Maturities of short-term investments | 0 | 59,705 |
Purchase of short-term investments | (178,994) | 0 |
Purchase of property and equipment | (903) | (1,086) |
Net cash (used in) provided by investing activities | (179,897) | 58,619 |
Cash Flows from Financing Activities | ||
Tax payments related to shares withheld for vested restricted stock awards | (181) | (1,203) |
Proceeds from the issuance of common stock upon exercise of warrants | 14,684 | 388 |
Proceeds from the issuance of common stock upon exercise of options | 8,366 | 2,554 |
Proceeds from the issuance of common stock, net | 162,093 | 54,050 |
Net cash provided by financing activities | 184,962 | 55,789 |
Net (decrease) / increase in cash and cash equivalents | (64,635) | 56,663 |
Cash and Cash Equivalents, Beginning of Period | 145,373 | 106,717 |
Cash and Cash Equivalents, End of Period | 80,738 | 163,380 |
Supplemental disclosure of non-cash investing and financing activities: | ||
Unrealized loss on short-term investments | (120) | (29) |
Acquisitions of property and equipment included in accounts payable | 0 | (155) |
Offering costs under accounts payable and accrued expenses | 0 | 235 |
Conversion of convertible preferred stock to common stock | $ 1 | $ 0 |
GENERAL ORGANIZATION AND BUSINE
GENERAL ORGANIZATION AND BUSINESS | 9 Months Ended |
Sep. 30, 2018 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
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. Our lead product candidate, lifileucel (LN-144) for metastatic melanoma, is an autologous adoptive cell therapy utilizing tumor-infiltrating lymphocytes, or TIL, which are T cells derived from patients’ tumors. TIL therapy is a platform technology that has already been studied for the treatment of metastatic melanoma and metastatic cervical cancer by the National Cancer Institute, or NCI. We are investigating the effectiveness and safety of TIL therapy for the treatment of metastatic melanoma, squamous cell carcinoma of the head and neck, cervical carcinoma, and metastatic non-small cell lung cancer, as well as other oncology indications. 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 nine months ended September 30, 2018 and 2017 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, 2017, was derived from the audited financial statements included in the Company's financial statements as of and for the year ended December 31, 2017 included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on March 12, 2018. These financial statements should be read in conjunction with that report. Liquidity The Company is currently engaged in the development of therapeutics to fight cancer, specifically solid tumors. The Company currently does not have any commercial products and has not yet generated any revenues from its business. The Company currently does not anticipate that it will generate any revenues from the sale or licensing of any of its product candidates during the 12 months from the date these financial statements are issued. The Company has incurred a net loss of $91.0 million for the nine months ended September 30, 2018 and used $69.7 million of cash in our operating activities during the nine months ended September 30, 2018. 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 estimated offering expenses payable by the Company, were $172.5 million, with net proceeds to the Company of approximately $162.0 million. For the nine months ended September 30, 2018, the Company received $23.1 million from the exercise of stock options and warrants to purchase common stock. As of September 30, 2018, we had $80.7 million of cash and cash equivalents and $179.3 million in short-term investments. 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, are $252.2 million, with estimated net proceeds to the Company of approximately $236.6 million. The Company expects to further increase its research and development activities, which will increase the amount of cash used during the remainder of 2018 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. 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 the next twelve months from the date that these financial statements are issued. Concentrations of Risk We are subject to credit risk from our portfolio of cash equivalents and short-term investments. Under our investment policy, we limit amounts invested in such securities by credit rating, maturity, industry group, investment type and issuer, except for securities issued by the U.S. government. We are not exposed to any significant concentrations of credit risk from these financial instruments. The goals of our 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 | 9 Months Ended |
Sep. 30, 2018 | |
Accounting Policies [Abstract] | |
SUMMARY OF SIGNIFICANT ACCOUNTING PRACTICES | NOTE 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Cash, Cash Equivalents, and Short-term Investments The Company’s cash and cash equivalents include short-term investments with original maturities of three months or less when purchased. The Company's short-term investments are classified as “available-for-sale”. The Company includes these investments in current assets and carries them at fair value. Unrealized gains and losses on available-for-sale securities are included in accumulated other comprehensive 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 interest expense and income. Gains and losses on securities sold are recorded based on the specific identification method and are included in interest income in the condensed consolidated statement of operations. We have not incurred any realized gains or losses from sales of securities to date. 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 September 30, 2018 and 2017, the following outstanding common stock equivalents have been excluded from the calculation of net loss per share because their impact would be anti-dilutive. September 30, 2018 2017 Stock options 6,912,932 6,706,964 Warrants 427,800 6,411,216 Series A Convertible Preferred Stock* 97,000 847,000 Series B Convertible Preferred Stock* 5,854,845 7,946,673 Restricted stock awards - 834 Restricted stock units 80,200 126,041 13,372,777 22,038,728 * on an as-converted basis The dilutive effect of potentially dilutive securities is 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 can 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 our 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 we held are generally assessed under Level 2 were corporate bonds and commercial paper. We utilize 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. We use quotes from external pricing service providers and other on-line quotation systems to verify the fair value of investments provided by our third-party pricing service providers. We review independent auditor’s reports from our third-party pricing service providers particularly regarding the controls over pricing and valuation of financial instruments and ensure that our 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 September 30, 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 does not have fair valued assets classified under Level 3 as of September 30, 2018. As of September 30, 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 September 30, 2018 Level 1 Level 2 Level 3 Total US treasury securities $ 149,600 $ - $ - $ 149,600 US government agency securities 29,662 - - 29,662 Total $ 179,262 $ - $ - $ 179,262 As of December 31, 2017, the Company had no financial assets measured at fair value on a recurring basis. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. Actual results could differ from those estimates. Significant estimates include valuation of short-term investments, the useful lives of property and equipment, accounting for potential liabilities, the valuation allowance associated with the Company’s deferred tax assets, and the assumptions made in valuing stock instruments issued for services. Principles of Consolidation The accompanying condensed 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 in consolidation. The U.S. dollar is the functional currency for all the Company's consolidated operations. 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. The Company accounts for stock option grants to non-employees in accordance with the authoritative guidance of the FASB where the value of the stock compensation is determined based upon the measurement date at either a) the date at which a performance commitment is reached, or b) at the date at which the necessary performance to earn the equity instruments is complete. Non-employee stock-based compensation charges generally are amortized over the vesting period on a straight-line basis. In certain circumstances where there are no future performance requirements by the non-employee, option grants are immediately vested and the total stock-based compensation charge is recorded in the period of the measurement date. 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. Compensation expense is recorded based upon the value derived from the Black-Scholes option pricing model and based on actual experience. 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 shares of its common stock for share-based compensation programs. The Company measures the compensation cost with respect to restricted shares issued to employees based upon the estimated fair value of the equity instruments at the date of the grant and is recognized as expense over the period 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 expenses related to all our stock-based awards were recorded on the statements of operations as follows (in thousands): Three Months Ended Nine Months Ended 2018 2017 2018 2017 Research and development $ 2,255 $ 881 $ 6,636 $ 3,873 General and administrative 3,261 1,738 8,206 5,335 Total stock-based compensation expenses $ 5,516 $ 2,619 $ 14,842 $ 9,208 Total stock-based compensation expenses broken down based on each individual instrument were as follows (in thousands): Three Months Ended Nine Months Ended 2018 2017 2018 2017 Stock option expenses $ 5,448 $ 2,562 $ 14,640 $ 8,193 Restricted stock award expenses - 6 - 33 Restricted stock unit expenses 68 51 202 982 Total stock-based compensation expenses $ 5,516 $ 2,619 $ 14,842 $ 9,208 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 per certain criteria. The criteria includes circumstances in which (i) the economic characteristics and risks of the embedded derivative instrument are not clearly and closely related to the economic characteristics and risks of the host contract, (ii) the hybrid instrument that embodies both the embedded derivative instrument and the host contract is not re-measured at fair value under otherwise applicable generally accepted accounting principles with changes in fair value reported in earnings as they occur and (iii) a separate instrument with the same terms as the embedded derivative instrument would be considered a derivative instrument. The derivative is subsequently marked to market at each reporting date based on current fair value, with the changes in fair value reported in results of operations. Conversion options that contain variable settlement features such as provisions to adjust the conversion price upon subsequent issuances of equity or equity linked securities at exercise prices more favorable than that featured in the hybrid contract generally result in their bifurcation from the host instrument. The Company also records, when necessary, deemed dividends for the intrinsic value of the conversion options embedded in preferred stock based upon the difference between the fair value of the underlying common stock at the commitment date of the transaction and the effective conversion price embedded in the preferred stock. Recent Accounting Standards Not Yet Adopted In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842), which establishes a new lease accounting model 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. In June 2018, the FASB issued ASU No. 2018-10, Codification Improvements to Topic 842, Leases, which further clarifies how to apply certain aspects of the new lease standard. Both of the guidance are effective for fiscal years, and interim periods within those years, beginning after December 15, 2018, with early adoption permitted. The Company plans to adopt this ASU on January 1, 2019. The Company is currently evaluating the impact of the adoption of this standard on its financial statements. However, the Company expects the adoption of this accounting guidance to result in an increase in lease assets and a corresponding increase in lease liabilities on its balance sheets. In June 2018, the FASB issued ASU No. 2018-07, Compensation- Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting, which eliminates the separate accounting model for nonemployee share-based payment awards and generally requires companies to account for share-based payment transactions with nonemployees in the same way as share-based payment transactions with employees. The amended guidance is effective for fiscal years beginning after December 15, 2018, with early adoption permitted. The Company plans to adopt this ASU on January 1, 2019. The Company is currently evaluating the impact of the adoption of this standard on its financial statements. 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 guidance is effective for fiscal years beginning after December 15, 2019 and for interim periods within those fiscal years, with early adoption permitted. The Company plans to adopt this ASU on January 1, 2020. The Company expects the impact of the adoption of this standard on its financial statements to be immaterial. Subsequent Events Management evaluates events that have occurred after the balance sheet date but before the financial statements are issued. See Note 11 Subsequent Events. Reclassifications Certain amounts within the statements of operations for the prior periods 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 | 9 Months Ended |
Sep. 30, 2018 | |
Cash, Cash Equivalents, and Short-term Investments [Abstract] | |
CASH AND CASH EQUIVALENTS | NOTE 3. CASH EQUIVALENTS AND SHORT-TERM INVESTMENTS Cash equivalents and short-term investments consist of the following (in thousands): September 30, December 31, 2018 2017 Cash equivalents - Money market funds $ 12,351 $ 91,281 Cash equivalents - US government agency securities 13,983 - Cash equivalents total $ 26,334 $ 91,281 Cash equivalents in the tables above exclude cash demand deposits of $54.4 million and $54.1 million as of September 30, 2018 and December 31, 2017, respectively. September 30, December 31, 2018 2017 Short-term Investments US treasury securities $ 149,600 $ - US government agency securities 29,662 - Short-term investments total $ 179,262 $ - The cost and fair value of cash equivalents and short-term investments at September 30, 2018 were as follows (in thousands): Gross Gross Unrealized Unrealized As of September 30, 2018 Cost Accretion Gains Losses Fair Value US treasury securities 149,369 333 - (102 ) 149,600 US government agency securities $ 29,625 $ 55 $ - $ (18 ) $ 29,662 Total $ 178,994 $ 388 $ - $ (120 ) $ 179,262 As of December 31, 2017, the Company had no short-term investments. Unrealized gains and losses are included in accumulated other comprehensive loss. All short-term investments held by the Company as of September 30, 2018 have a maturity of less than one year. |
BALANCE SHEET COMPONENTS
BALANCE SHEET COMPONENTS | 9 Months Ended |
Sep. 30, 2018 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
BALANCE SHEET COMPONENTS | NOTE 4. BALANCE SHEET COMPONENTS Accrued expenses consist of the following (in thousands): September 30, December 31, 2018 2017 Accrued payroll and employee related expenses $ 2,897 $ 2,613 Legal and related services 498 935 Clinical related 4,029 3,310 Manufacturing related 2,442 876 Deferred rent 335 430 Accrued other 459 496 $ 10,660 $ 8,660 |
STOCKHOLDERS' EQUITY
STOCKHOLDERS' EQUITY | 9 Months Ended |
Sep. 30, 2018 | |
Stockholders' Equity Note [Abstract] | |
STOCKHOLDERS' EQUITY | NOTE 5. STOCKHOLDERS’ EQUITY Public Offering 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, are $252.2 million, with estimated net proceeds to the Company of approximately $236.6 million. Preferred stock The Company’s certificate of incorporation authorizes the issuance of up to 50,000,000 shares of “blank check” preferred stock. At September 30, 2018 and December 31, 2017, 17,000 shares have been designated as Series A Convertible Preferred Stock and 11,500,000 shares have been designated as Series B Preferred Stock, which are now convertible into common 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 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 stockholders. In the event of any dissolution or winding up of the Company, proceeds shall be paid pari passu among the holders of the shares 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. During the nine months ended September 30, 2018, 1,500 shares of Series A Convertible Preferred Stock were converted into 750,000 shares of common stock. At September 30, 2018, 194 shares of Series A Convertible Preferred 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 the 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 Company’s 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 our Series A Convertible Preferred Stock or any securities junior to the Series B Convertible Preferred Stock. During the nine months ended September 30, 2018, 1,523,396 shares of Series B Convertible Preferred Stock were converted into 1,523,396 shares of common stock. At September 30, 2018, 5,854,845 shares of Series B Convertible Preferred Stock remained outstanding. Warrants The following table summarizes the Company’s stock warrant activity for the nine months ended September 30, 2018: Weighted Weighted Shares Average Average Aggregate Under Exercise Remaining Intrinsic Warrants Price Life Value Outstanding at January 1, 2018 6,301,216 $ 2.51 $ 34,651,188 Issued - - Exercised (5,873,416 ) $ 2.50 Expired/Cancelled - - Outstanding at September 30, 2018 427,800 $ 2.62 0.1 years $ 3,734,500 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 day of the nine months ended September 30, 2018 and the exercise price of the warrants, multiplied by the number of in-the-money warrants) that would have been received by the warrant holders had all warrant holders exercised their warrants on September 30, 2018. The intrinsic value of the Company’s warrants changes based on the closing price of the Company’s common stock. |
STOCK BASED COMPENSATION
STOCK BASED COMPENSATION | 9 Months Ended |
Sep. 30, 2018 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
STOCK BASED COMPENSATION | NOTE 6. STOCK BASED COMPENSATION Stock Plans As of October 14, 2011, the Company adopted the 2011 Equity Incentive Plan (the “2011 Plan”). Employees, directors, consultants and advisors of the Company are eligible to participate in the 2011 Plan. The 2011 Plan initially had 180,000 shares of common stock reserved for issuance in the form of incentive stock options, non-qualified options, common stock, and grant appreciation rights. The 2011 Plan was not approved by the Company’s stockholders within the required one-year period following its adoption and, accordingly, no incentive stock options can be granted under that plan. In August 2013, the Company’s Board of Directors and a majority of the Company’s stockholders approved an amendment to increase the number of shares available under the 2011 Plan from 180,000 shares to 1,700,000 shares, and an amendment to increase the number options or other awards that can be granted to any one person during a twelve (12) month period from 50,000 shares to 300,000 shares. The foregoing amendment to the 2011 Plan became effective in September 2013. On August 20, 2014, the Company’s Board of Directors amended the 2011 Plan to increase the number of shares available for issuance upon the exercise of stock options under the 2011 Plan from 1,700,000 to 1,900,000 shares, effective immediately. As of September 30, 2018, 376,240 shares were available for future grant under the 2011 Plan. On September 19, 2014, the Company’s Board of Directors (the “Board”) adopted the Iovance Biotherapeutics, Inc. 2014 Equity Incentive Plan (the “2014 Plan”). The 2014 Plan was approved by the Company’s stockholders at the 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 common stock. On April 10, 2015, the Board amended the 2014 Plan to increase the total number of shares that can be issued under the 2014 Plan to 4,000,000 shares of the Company’s common stock. The increase in shares available for issuance under the 2014 Plan was approved by the Company’s stockholders at the Company’s 2015 Annual Meeting of Stockholders in June 2015. On August 16, 2016, the Company’s stockholders approved the increase of the total number of shares that can be issued under the 2014 Plan from 4,000,000 shares to 9,000,000 shares of the Company’s common stock. At September 30, 2018, 810,724 shares were available for grant under the Company’s 2014 Plan. On April 22, 2018, the Board adopted the Iovance Biotherapeutics, Inc. 2018 Equity Incentive Plan (the “2018 Plan”). The 2018 Plan was approved by the Company’s stockholders at the annual meeting of stockholders held in June 2018. The 2018 Plan as approved by the stockholders authorized the issuance up to an aggregate of 6,000,000 shares of common stock reserved for issuance in the form of incentive (qualified) stock options, non-qualified options, common stock, stock appreciation rights, restricted stock awards, restricted stock units, other stock-based awards, other cash-based awards or any combination of the foregoing. At September 30, 2018, 6,000,000 shares of common stock were available for grant under the Company’s 2018 Plan. The Company anticipates granting the remaining shares under the 2011 and 2014 Plans prior to granting shares from the 2018 Plan. Restricted Stock Units On June 1, 2016, the Company entered into a restricted stock unit agreement with the Company’s Chief Executive Officer, Maria Fardis, Ph.D., pursuant to which the Company granted Dr. Fardis 550,000 non-transferrable restricted stock units at fair market value of $5.87 per share as an inducement of employment pursuant to the exception to The NASDAQ Global Market rules that generally require stockholder approval of equity incentive plans. The 550,000 restricted stock units vest in installments as follows: (i) 137,500 restricted stock units vested upon the first anniversary of the effective date of Dr. Fardis’ employment agreement; (ii) 275,000 restricted stock units vested 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 September 30, 2018, 80,200 restricted stock units remained unvested. Stock-based compensation expenses 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 September 30, 2018 and 2017, respectively, and $0.2 million and $1.0 million for the nine months ended September 30, 2018 and 2017, respectively, recorded as part of general and administrative expenses. As of September 30, 2018, there was $0.5 million of total unrecognized compensation expense related to the non-vested restricted stock units to be recognized over a period of 1.67 years. Stock Options The following table summarizes the Company’s stock options activity for the nine months ended September 30, 2018: Weighted Weighted Number Average Average Aggregate of Exercise Remaining Intrinsic Options Price Contract Life Value Outstanding at January 1, 2018 6,072,368 $ 7.42 Granted 2,673,720 15.26 Exercised (1,081,954 ) 7.73 Expired/Forfeited (751,202 ) 9.78 Outstanding at September 30, 2018 6,912,932 $ 10.15 8.27 $ 18,597,172 Options exercisable at September 30, 2018 3,042,373 $ 7.68 7.33 $ 11,762,590 The Company recorded stock-based compensation costs related to options of $5.4 million and $2.6 million for the three months ended September 30, 2018 and 2017, respectively and $14.6 million and $8.2 million for the nine months ended September 30, 2018 and 2017 respectively. As of September 30, 2018, there was $38.5 million of total unrecognized compensation expense related to the options to be recognized over a weighted average period of 1.94 years. The weighted-average grant date fair values per share of options granted under the 2011 and 2014 Plan were $15.26 and $6.46 for the nine months ended September 30, 2018 and 2017, respectively. Options for 1,081,954 shares and 484,850 shares were exercised during the nine months ended September 30, 2018 and 2017 with intrinsic value of $3.8 million and $1.2 million 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 nine months ended September 30, 2018 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 September 30, 2018. The intrinsic value of the Company’s stock options changes based on the closing price of the Company’s common stock. |
LICENSES AND AGREEMENTS
LICENSES AND AGREEMENTS | 9 Months Ended |
Sep. 30, 2018 | |
Licenses And Agreements [Abstract] | |
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 (the “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 a second amendment to the CRADA. The principal changes effected by the second amendment included (i) extending the term of the CRADA by another five years to August 2021, and (ii) modifying the focus on the development of unmodified TIL as a stand-alone therapy or in combination with U.S. Food and Drug Administration (“FDA”) licensed products and commercially available reagents routinely used for adoptive cell therapy. The parties will continue the development of improved methods for the generation and selection of TIL with anti-tumor reactivity in metastatic melanoma, bladder, lung, breast, and HPV-associated cancers. Pursuant to the terms of the CRADA, we are 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 each of the three months ended September 30, 2018 and 2017, and $1.5 million for each of the nine months ended September 30, 2018 and 2017 as research and development expenses. Patent License Agreement Related to the Development and Manufacture of TIL Effective October 5, 2011, the Company entered into a Patent License Agreement (the “Patent License Agreement”) with the National Institutes of Health, an agency of the United States Public Health Service within the Department of Health and Human Services (NIH), which Patent License Agreement 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 costs associated with Moffitt of $0.6 million and $2.0 million for the three months ended September 30, 2018 and 2017, respectively, and $2.2 million and $4.3 million for the nine months ended September 30, 2018 and 2017, respectively, as research and development expenses. 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. The Company entered into a license agreement with Moffitt effective as of May 7, 2018 (the “Second Moffitt License”), under which the Company received a license to Moffitt’s rights to patent-pending technologies related to the use of 4-1BB agonists in conjunction with TIL manufacturing processes and therapies. Pursuant to the Second Moffitt License, the Company paid an upfront licensing fee in the amount of $0.1 million for the nine months ended September 30, 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. PolyBioCept and Karolinska University Hospital 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”). PolyBioCept has filed two patent applications with claims related to a cytokine cocktail for use in expansion of lymphocytes, one of which has been abandoned. 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 are for the use in all cancers and are worldwide in scope, with the exception that the uses in melanoma are not included for certain countries of the former Soviet Union. The Company paid PolyBioCept a total of $2.5 million as an up-front exclusive license payment. The Company will also have to make additional milestone payments to PolyBioCept under the PolyBioCept Agreement if, and when, (i) certain product development milestones are achieved, (ii) certain regulatory approvals have been obtained from the FDA and/or the European Medicines Agency, and (iii) certain product sales targets are achieved. The milestone payments will be payable both in cash (U.S. dollars) and in shares of the Company’s common stock. If all of the foregoing product development, regulatory approval and sales milestone payments are met, the Company will have to pay PolyBioCept an additional $8.7 million and will have to issue to PolyBioCept a total 2,219,376 shares of unregistered common stock. In addition to these potential payments, the Company reimbursed PolyBioCept up to $0.2 million in expenses related to the transfer of know-how and paid PolyBioCept $0.1 million as a clinical trials management fee. The PolyBioCept Agreement has an initial term of 30 years and may be extended for additional five-year periods. No expense was recorded during the three and nine months ended September 30, 2018. During the three and nine months period ended September 30, 2017, the Company recorded $0.2 million and $0.4 million associated with the PolyBioCept Agreement, respectively, as research and development expenses. Karolinska University Hospital and Karolinska Institute Agreements In connection with the execution of the PolyBioCept Agreement, the Company also (i) entered into a clinical trials agreement with the Karolinska University Hospital to conduct clinical trials in glioblastoma and pancreatic cancer at the Karolinska University Hospital, and (ii) agreed to enter into a sponsored research agreement with the Karolinska Institute for the research of the cytokine cocktail in additional indications. In the year ended December 31, 2016, the Company paid Karolinska University Hospital $1.6 million under the clinical trials agreement to conduct the clinical trials. As of April 9, 2018, the Company terminated the clinical trials agreement with the Karolinska University Hospital. In June 2018, the Company received a refund of $1.6 million from Karolinska, which resulted in a reversal of prior period expense and a credit of $0.4 million in the condensed consolidated statement of operations for the nine months ended September 30, 2018. No expense was recorded in the three months ended September 30, 2018. 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 (“M.D. Anderson”) under which the Company and M.D. Anderson 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 will acquire 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 M.D. Anderson reasonably necessary to exploit, including the commercialization thereof. The Company has also been granted certain rights in clinical data generated by M.D. Anderson 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 us of all deliverables due from M.D. Anderson thereunder. In May 2017, the Company paid $1.4 million under this agreement. The Company recorded $0.1 million and $0.2 million associated with the M.D. Anderson SAA for the three and nine months ended September 30, 2018, respectively, as research and development expenses. No costs were recorded for the same periods in 2017. 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 in immuno-oncology. Under the MedImmune Agreement, the Company will fund and conduct at least one clinical trial combining MedImmune's PD-L1 inhibitor, durvalumab, with TIL for the treatment of patients. MedImmune will supply durvalumab for the clinical trials. The purpose of the studies is to establish a dosing regimen for this combination therapy and assess its safety and efficacy. WuXi Apptech, Inc. (“WuXi”) In November 2016, the Company entered into a three-year manufacturing and services agreement (“MSA”) with 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 facility for a late stage/commercial manufacturing cGMP suite requires the Company to pay approximately $5.85 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 $4.5 million and $3.1 million for the three months ended September 30, 2018 and 2017, respectively, and $10.6 million and $10.6 million for the nine months ended September 30, 2018 and 2017, respectively, as research and development expenses. |
LEGAL PROCEEDINGS
LEGAL PROCEEDINGS | 9 Months Ended |
Sep. 30, 2018 | |
Loss Contingency [Abstract] | |
LEGAL PROCEEDINGS | NOTE 8. LEGAL PROCEEDINGS Class Action Lawsuit. On April 10, 2017, the SEC announced settlements with and with other public companies and unrelated parties in the In the Matter of Certain Stock Promotion investigation. settlement with the SEC is consistent with our previous disclosures (including in our Annual Report on Form 10-K that we filed with the SEC on March 9, 2017). On April 14, 2017, a purported shareholder filed a complaint seeking class action status in the United States District Court, Northern District of California for violations of the federal securities laws ( Leonard DeSilvio v. Lion Biotechnologies, Inc., et al., case no. 3:17-cv-2086) against our company and three of our former officers and directors. On April 19, 2017, a second class action complaint (Amra Kuc vs. Lion Biotechnologies, Inc., et al., case no. 3:17-cv-2188) was filed in the same court. Both complaints allege, among other things, that the defendants violated the federal securities laws by making materially false and misleading statements, or by failing to make certain disclosures, regarding the actions taken by Manish Singh, our former CEO, and our former investor relations firm that were the subject of the In the Matter of Certain Stock Promotions investigation. On July 20, 2017, the plaintiff in the Kuc case filed a notice to voluntarily dismiss that case. The court entered an order dismissing the Kuc complaint on July 21, 2017. On July 26, 2017, the court appointed a movant as lead plaintiff. On September 8, 2017, the lead plaintiff filed an amended complaint ( Jay Rabkin v. Lion Biotechnologies, Inc., et al., case no. 3:17-cv-2086) seeking class action status that alleges, among other things, that the defendants violated federal securities laws by making materially false and misleading statements, or by failing to make certain disclosures, regarding the actions taken by Manish Singh and our former investor relations firm that were the subject of the In the Matter of Certain Stock Promotions SEC investigation. On February 5, 2018, the court entered an order dismissing two of plaintiff’s six claims. As the result of mediation, on September 28, 2018, lead plaintiff filed an unopposed motion for settlement, the cost of which, if approved, is expected to be borne by our insurance carrier and would result in no loss to us. A hearing on preliminary approval of the settlement is set for November 9, 2018. Derivative Lawsuits. On December 15, 2017, a purported stockholder derivative complaint was filed by plaintiff Kevin Fong on behalf of the Company, against the Company, as nominal defendant, and certain of the 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. 1:17-cv-1806). The complaint alleges breaches of fiduciary duties, unjust enrichment, and violations of Section 14(a) of the Securities Exchange Act of 1934 and Rule 14a-9 promulgated thereunder arising from the SEC’s investigation in the In the Matter of Certain Stock Promotions investigation and our April 10, 2017 settlement thereof, and seeks unspecified damages on behalf of our company and injunctive relief. On March 28, 2018, a purported stockholder derivative complaint was filed by plaintiff Nazeer Khaleeluddin on behalf of the Company, against the Company, as nominal defendant, and certain of the 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 investigation and the Company’s April 10, 2017 settlement thereof, and seeks unspecified damages on behalf of our company and injunctive relief. On May 1, 2018, the court consolidated this case with the aforementioned purported stockholder derivative case filed by plaintiff Kevin Fong. The Company intends to vigorously defend against the foregoing complaints. Based on the very early stage of the litigation, it is not possible to estimate the amount or range of possible loss that might result from an adverse judgment or a settlement of these matters. Solomon Capital, LLC. On April 8, 2016, a lawsuit titled Solomon Capital, LLC, Solomon Capital 401(K) Trust, Solomon Sharbat and Shelhav Raff v. Lion Biotechnologies, Inc. was filed by Solomon Capital, LLC, Solomon Capital 401(k) Trust, Solomon Sharbat and Shelhav Raff against the Company in the Supreme Court of the State of New York, County of New York (index no. 651881/2016). The plaintiffs allege that, between June and November 2012 they provided to the Company $0.1 million and that they advanced and paid on our behalf an additional $0.2 million. The complaint further alleges that the Company agreed to (i) provide them with promissory notes totaling $0.2 million, plus interest, (ii) issue a total of 111,425 shares to the plaintiffs (before the 1-for-100 reverse split of our common stock effected in March 2013), and (iii) allow the plaintiffs to convert the foregoing funds into our securities in the next transaction. The plaintiffs allege that they should have been able to convert their advances and payments into shares of the Company’s common stock in the restructuring that was affected in May 2013. Based on the foregoing, the plaintiffs allege causes for breach of contract and unjust enrichment and demand judgment against the Company in an unspecified amount exceeding $1.5 million, plus interest and attorneys’ fees. On June 3, 2016, the Company filed an answer and counterclaims in the lawsuit. In its counterclaims, the Company alleges that the plaintiffs misrepresented their qualifications to assist it in fundraising and that they failed to disclose that they were under investigation for securities laws violations. The Company is seeking damages in an amount exceeding $0.5 million and an order rescinding any and all agreements that the plaintiffs contend entitled them to obtain stock in the Company. On April 19, 2017, the court granted plaintiffs’ counsel’s motion to withdraw from the case. On May 25, 2017, plaintiffs filed a notice that they had hired new counsel. On June 7, 2017, the judge presiding over the case recused herself because of a conflict of interest arising from her relationship with plaintiffs’ new attorneys, and the case was subsequently assigned to a new judge. On April 20, 2018, the court held a hearing regarding plaintiff’s motion to dismiss the Company’s amended counterclaims and affirmative defense for fraudulent inducement. On August 15, 2018, the court entered an order granting the plaintiff’s motion and dismissed the Company’s amended counterclaims and eleventh affirmative defense for fraudulent inducement without leave to amend. On September 14, 2018, the Company filed a notice of appeal related to this order, and on November 5, 2018, the Company filed its memorandum of law in support of its appeal of the order dismissing the Company’s amended counterclaims and affirmative defense for fraudulent inducement. The Company intends to vigorously defend the complaint and pursue its counterclaims. Litigation Involving Dr. Steven Fischkoff. On June 13, 2017, in an action titled Steven Fischkoff v. Lion Biotechnologies, Inc. and Maria Fardis , Dr. Steven Fischkoff, our former Vice President and Chief Medical Officer, filed a lawsuit against the Company and Dr. Fardis in the Supreme Court of the State of New York County of New York. Dr. Fischkoff was dismissed by the Company on March 28, 2017. Dr. Fischkoff was terminated “for cause” as that term is defined in his employment agreement. In his complaint, Dr. Fischkoff alleges breaches of his employment agreement and violation of New York Labor Law for failure to pay monies purportedly owed to him, and seeks to recover amounts including severance pay and retention bonus (totaling $300,000), a prorated incentive bonus, and amounts relating to unvested options to 150,000 shares of our common stock, together with prejudgment interest, costs, expenses and attorneys’ fees. On July 5, 2017, the Company filed a removal petition and removed the lawsuit to the United States District Court for the Southern District of New York, where the case has been assigned case no. 1:17-cv-05041. On July 14, 2017, the Company filed a partial answer and counterclaims against Dr. Fischkoff, denying his allegations, and alleging breach of contract and related claims, breach of fiduciary duty, and state and federal trade secret misappropriation and related claims, and sought a temporary restraining order and preliminary injunction against Dr. Fischkoff. On July 18, 2017, the court issued a temporary restraining order against Dr. Fischkoff requiring him to return Company materials, prohibiting him from disclosing or using Company materials, and granting expedited discovery. On June 25, 2018, pursuant to a stipulation between the parties, the court entered a permanent injunction prohibiting Dr. Fischkoff from disclosing, 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 us 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 information about this litigation. The Company intends to vigorously defend against Dr. Fischkoff’s lawsuit and pursue the Company’s counterclaims. Based on the very early 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. During the second quarter of 2016, warrants representing 128,500 shares were exercised. The 128,500 shares of common stock had previously been registered for re-sale. However, we believe that these 128,500 warrant shares were sold by the holders in open market transactions in May 2016 at a time when the registration statement was ineffective. Accordingly, those sales were not made in accordance with Sections 5 and 10(a)(3) of the Securities Act , and the purchasers of those shares may have rescission rights (if they still own the shares) or claims for damages (if they no longer own the shares). The amount of any such liability is uncertain and as such, an accrual for any potential loss has not been made. The Company believes that any claims brought against it would not result in a material impact to the Company’s financial position or results of operations. The Company has not accrued a loss for a potential claim associated with this matter as it is unable to estimate any at this time. 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 Company’s 2011 Equity Incentive Plan. Before the Company filed the required post-effective amendment, options to purchase 200,000 shares were exercised under the 2011 Equity Incentive 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 the Company 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. |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 9 Months Ended |
Sep. 30, 2018 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | NOTE 9. COMMITMENTS AND CONTINGENCIES Facilities Leases 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 November 2019. 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 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 in San Carlos, California. 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 a lease agreement with Hudson Skyway Landing, LLC. See Note 11 Subsequent Events. New York Lease The Company leased office space in New York for a monthly rental of approximately $18,000 a month 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 As of September 30, 2018, the Company's future minimum lease payments under non-cancelable operating leases, excluding the new lease entered subsequent to the quarter ended September 30, 2018, are as follows (in thousands): Year Operating Lease Commitments 2018 (remaining three months) $ 225 2019 707 2020 495 2021 169 $ 1,596 See Note 11 Subsequent Events for the revised future minimum lease payments reflecting the new lease entered in October 2018. Rent expense was $0.2 million and $0.3 million for the three months ended September 30, 2018 and 2017, respectively, and was $0.7 million and $0.7 million for each of the nine months ended September 30, 2018 and 2017. |
RELATED PARTY TRANSACTIONS
RELATED PARTY TRANSACTIONS | 9 Months Ended |
Sep. 30, 2018 | |
Related Party Transactions [Abstract] | |
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 for the three months ended September 30, 2018 and 2017, respectively, and $0.4 million and $0.5 million for the nine months ended September 2018 and 2017, respectively. On September 14, 2017, the Company entered into a three-year consulting agreement with Iain Dukes, D. Phil, the Chairman of the Company’s 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 stock based compensation expenses relating to this consulting agreement of $0.4 million and $0.1 million for the three months ended September 30, 2018 and 2017, respectively, and $1.0 million and $0.1 million for the nine months ended September 30, 2018 and 2017, respectively. |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 9 Months Ended |
Sep. 30, 2018 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENTS | NOTE 11. SUBSEQUENT EVENTS October 2018 Public Financing On October 17, 2018, the Company completed an underwritten public offering of 25,300,000 shares of its common stock. See Note 5 Stockholders’ Equity. San Carlos Lease 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 The Company’s future minimum lease payments including this lease under non-cancelable operating leases are as follows (in thousands): Year Operating Lease Commitments 2018 (remaining three months) $ 225 2019 1,414 2020 1,223 2021 418 $ 3,280 |
SUMMARY OF SIGNIFICANT ACCOUN_2
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 9 Months Ended |
Sep. 30, 2018 | |
Accounting Policies [Abstract] | |
Cash, Cash Equivalents, and Short-term Investments | Cash, Cash Equivalents, and Short-term Investments The Company’s cash and cash equivalents include short-term investments with original maturities of three months or less when purchased. The Company's short-term investments are classified as “available-for-sale”. The Company includes these investments in current assets and carries them at fair value. Unrealized gains and losses on available-for-sale securities are included in accumulated other comprehensive 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 interest expense and income. Gains and losses on securities sold are recorded based on the specific identification method and are included in interest income in the condensed consolidated statement of operations. We have not incurred any realized gains or losses from sales of securities to date. |
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 September 30, 2018 and 2017, the following outstanding common stock equivalents have been excluded from the calculation of net loss per share because their impact would be anti-dilutive. September 30, 2018 2017 Stock options 6,912,932 6,706,964 Warrants 427,800 6,411,216 Series A Convertible Preferred Stock* 97,000 847,000 Series B Convertible Preferred Stock* 5,854,845 7,946,673 Restricted stock awards - 834 Restricted stock units 80,200 126,041 13,372,777 22,038,728 * on an as-converted basis The dilutive effect of potentially dilutive securities is 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 can 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 our 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 we held are generally assessed under Level 2 were corporate bonds and commercial paper. We utilize 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. We use quotes from external pricing service providers and other on-line quotation systems to verify the fair value of investments provided by our third-party pricing service providers. We review independent auditor’s reports from our third-party pricing service providers particularly regarding the controls over pricing and valuation of financial instruments and ensure that our 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 September 30, 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 does not have fair valued assets classified under Level 3 as of September 30, 2018. As of September 30, 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 September 30, 2018 Level 1 Level 2 Level 3 Total US treasury securities $ 149,600 $ - $ - $ 149,600 US government agency securities 29,662 - - 29,662 Total $ 179,262 $ - $ - $ 179,262 As of December 31, 2017, the Company had no financial assets measured at fair value on a recurring basis. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. Actual results could differ from those estimates. Significant estimates include valuation of short-term investments, the useful lives of property and equipment, accounting for potential liabilities, the valuation allowance associated with the Company’s deferred tax assets, and the assumptions made in valuing stock instruments issued for services. |
Principles of Consolidation | Principles of Consolidation The accompanying condensed 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 in consolidation. The U.S. dollar is the functional currency for all the Company's consolidated operations. |
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. The Company accounts for stock option grants to non-employees in accordance with the authoritative guidance of the FASB where the value of the stock compensation is determined based upon the measurement date at either a) the date at which a performance commitment is reached, or b) at the date at which the necessary performance to earn the equity instruments is complete. Non-employee stock-based compensation charges generally are amortized over the vesting period on a straight-line basis. In certain circumstances where there are no future performance requirements by the non-employee, option grants are immediately vested and the total stock-based compensation charge is recorded in the period of the measurement date. 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. Compensation expense is recorded based upon the value derived from the Black-Scholes option pricing model and based on actual experience. 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 shares of its common stock for share-based compensation programs. The Company measures the compensation cost with respect to restricted shares issued to employees based upon the estimated fair value of the equity instruments at the date of the grant and is recognized as expense over the period 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 expenses related to all our stock-based awards were recorded on the statements of operations as follows (in thousands): Three Months Ended Nine Months Ended 2018 2017 2018 2017 Research and development $ 2,255 $ 881 $ 6,636 $ 3,873 General and administrative 3,261 1,738 8,206 5,335 Total stock-based compensation expenses $ 5,516 $ 2,619 $ 14,842 $ 9,208 Total stock-based compensation expenses broken down based on each individual instrument were as follows (in thousands): Three Months Ended Nine Months Ended 2018 2017 2018 2017 Stock option expenses $ 5,448 $ 2,562 $ 14,640 $ 8,193 Restricted stock award expenses - 6 - 33 Restricted stock unit expenses 68 51 202 982 Total stock-based compensation expenses $ 5,516 $ 2,619 $ 14,842 $ 9,208 |
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 per certain criteria. The criteria includes circumstances in which (i) the economic characteristics and risks of the embedded derivative instrument are not clearly and closely related to the economic characteristics and risks of the host contract, (ii) the hybrid instrument that embodies both the embedded derivative instrument and the host contract is not re-measured at fair value under otherwise applicable generally accepted accounting principles with changes in fair value reported in earnings as they occur and (iii) a separate instrument with the same terms as the embedded derivative instrument would be considered a derivative instrument. The derivative is subsequently marked to market at each reporting date based on current fair value, with the changes in fair value reported in results of operations. Conversion options that contain variable settlement features such as provisions to adjust the conversion price upon subsequent issuances of equity or equity linked securities at exercise prices more favorable than that featured in the hybrid contract generally result in their bifurcation from the host instrument. The Company also records, when necessary, deemed dividends for the intrinsic value of the conversion options embedded in preferred stock based upon the difference between the fair value of the underlying common stock at the commitment date of the transaction and the effective conversion price embedded in the preferred stock. |
Recent Accounting Standards | Recent Accounting Standards Not Yet Adopted In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842), which establishes a new lease accounting model 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. In June 2018, the FASB issued ASU No. 2018-10, Codification Improvements to Topic 842, Leases, which further clarifies how to apply certain aspects of the new lease standard. Both of the guidance are effective for fiscal years, and interim periods within those years, beginning after December 15, 2018, with early adoption permitted. The Company plans to adopt this ASU on January 1, 2019. The Company is currently evaluating the impact of the adoption of this standard on its financial statements. However, the Company expects the adoption of this accounting guidance to result in an increase in lease assets and a corresponding increase in lease liabilities on its balance sheets. In June 2018, the FASB issued ASU No. 2018-07, Compensation- Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting, which eliminates the separate accounting model for nonemployee share-based payment awards and generally requires companies to account for share-based payment transactions with nonemployees in the same way as share-based payment transactions with employees. The amended guidance is effective for fiscal years beginning after December 15, 2018, with early adoption permitted. The Company plans to adopt this ASU on January 1, 2019. The Company is currently evaluating the impact of the adoption of this standard on its financial statements. 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 guidance is effective for fiscal years beginning after December 15, 2019 and for interim periods within those fiscal years, with early adoption permitted. The Company plans to adopt this ASU on January 1, 2020. The Company expects the impact of the adoption of this standard on its financial statements to be immaterial. |
Subsequent Events | Subsequent Events Management evaluates events that have occurred after the balance sheet date but before the financial statements are issued. See Note 11 Subsequent Events. |
Reclassifications | Reclassifications Certain amounts within the statements of operations for the prior periods 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) | 9 Months Ended |
Sep. 30, 2018 | |
Accounting Policies [Abstract] | |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share | At September 30, 2018 and 2017, the following outstanding common stock equivalents have been excluded from the calculation of net loss per share because their impact would be anti-dilutive. September 30, 2018 2017 Stock options 6,912,932 6,706,964 Warrants 427,800 6,411,216 Series A Convertible Preferred Stock* 97,000 847,000 Series B Convertible Preferred Stock* 5,854,845 7,946,673 Restricted stock awards - 834 Restricted stock units 80,200 126,041 13,372,777 22,038,728 * on an as-converted basis |
Schedule of Assets Measured at Fair Value | As of September 30, 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 September 30, 2018 Level 1 Level 2 Level 3 Total US treasury securities $ 149,600 $ - $ - $ 149,600 US government agency securities 29,662 - - 29,662 Total $ 179,262 $ - $ - $ 179,262 |
Schedule of Stock-Based Compensation | Total stock-based compensation expenses related to all our stock-based awards were recorded on the statements of operations as follows (in thousands): Three Months Ended Nine Months Ended 2018 2017 2018 2017 Research and development $ 2,255 $ 881 $ 6,636 $ 3,873 General and administrative 3,261 1,738 8,206 5,335 Total stock-based compensation expenses $ 5,516 $ 2,619 $ 14,842 $ 9,208 |
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 Nine Months Ended 2018 2017 2018 2017 Stock option expenses $ 5,448 $ 2,562 $ 14,640 $ 8,193 Restricted stock award expenses - 6 - 33 Restricted stock unit expenses 68 51 202 982 Total stock-based compensation expenses $ 5,516 $ 2,619 $ 14,842 $ 9,208 |
CASH EQUIVALENTS AND SHORT-TE_2
CASH EQUIVALENTS AND SHORT-TERM INVESTMENTS (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Cash, Cash Equivalents, and Short-term Investments [Abstract] | |
Schedule of Cash, Money Market Funds and Short-Term Investments | Cash equivalents and short-term investments consist of the following (in thousands): September 30, December 31, 2018 2017 Cash equivalents - Money market funds $ 12,351 $ 91,281 Cash equivalents - US government agency securities 13,983 - Cash equivalents total $ 26,334 $ 91,281 Cash equivalents in the tables above exclude cash demand deposits of $54.4 million and $54.1 million as of September 30, 2018 and December 31, 2017, respectively. September 30, December 31, 2018 2017 Short-term Investments US treasury securities $ 149,600 $ - US government agency securities 29,662 - Short-term investments total $ 179,262 $ - |
Unrealized Gain (Loss) on Investments | The cost and fair value of cash equivalents and short-term investments at September 30, 2018 were as follows (in thousands): Gross Gross Unrealized Unrealized As of September 30, 2018 Cost Accretion Gains Losses Fair Value US treasury securities 149,369 333 - (102 ) 149,600 US government agency securities $ 29,625 $ 55 $ - $ (18 ) $ 29,662 Total $ 178,994 $ 388 $ - $ (120 ) $ 179,262 |
BALANCE SHEET COMPONENTS (Table
BALANCE SHEET COMPONENTS (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Accrued Liabilities | Accrued expenses consist of the following (in thousands): September 30, December 31, 2018 2017 Accrued payroll and employee related expenses $ 2,897 $ 2,613 Legal and related services 498 935 Clinical related 4,029 3,310 Manufacturing related 2,442 876 Deferred rent 335 430 Accrued other 459 496 $ 10,660 $ 8,660 |
STOCKHOLDERS' EQUITY (Tables)
STOCKHOLDERS' EQUITY (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Stockholders' Equity Note [Abstract] | |
Schedule of Stockholders' Equity Note, Warrants or Rights | The following table summarizes the Company’s stock warrant activity for the nine months ended September 30, 2018: Weighted Weighted Shares Average Average Aggregate Under Exercise Remaining Intrinsic Warrants Price Life Value Outstanding at January 1, 2018 6,301,216 $ 2.51 $ 34,651,188 Issued - - Exercised (5,873,416 ) $ 2.50 Expired/Cancelled - - Outstanding at September 30, 2018 427,800 $ 2.62 0.1 years $ 3,734,500 |
STOCK BASED COMPENSATION (Table
STOCK BASED COMPENSATION (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Schedule of Status of Stock Options | The following table summarizes the Company’s stock options activity for the nine months ended September 30, 2018: Weighted Weighted Number Average Average Aggregate of Exercise Remaining Intrinsic Options Price Contract Life Value Outstanding at January 1, 2018 6,072,368 $ 7.42 Granted 2,673,720 15.26 Exercised (1,081,954 ) 7.73 Expired/Forfeited (751,202 ) 9.78 Outstanding at September 30, 2018 6,912,932 $ 10.15 8.27 $ 18,597,172 Options exercisable at September 30, 2018 3,042,373 $ 7.68 7.33 $ 11,762,590 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
New York Lease [Member] | |
License And Commitments [Line Items] | |
Schedule of Future Minimum Rental Payments for Operating Leases | As of September 30, 2018, the Company's future minimum lease payments under non-cancelable operating leases, excluding the new lease entered subsequent to the quarter ended September 30, 2018, are as follows (in thousands): Year Operating Lease Commitments 2018 (remaining three months) $ 225 2019 707 2020 495 2021 169 $ 1,596 |
SUBSEQUENT EVENTS (Tables)
SUBSEQUENT EVENTS (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
San Carlos Lease [Member] | |
Subsequent Event [Line Items] | |
Schedule of Future Minimum Rental Payments for Operating Leases | Year Operating Lease Commitments 2018 (remaining three months) $ 225 2019 1,414 2020 1,223 2021 418 $ 3,280 |
GENERAL ORGANIZATION AND BUSI_2
GENERAL ORGANIZATION AND BUSINESS (Details Textual) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||||
Oct. 17, 2018 | Jan. 31, 2018 | Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | Dec. 31, 2017 | Dec. 31, 2016 | |
Net Income (Loss) Attributable to Parent | $ (33,830) | $ (22,149) | $ (91,005) | $ (66,210) | ||||
Net Cash Provided by (Used in) Operating Activities | (69,700) | (57,745) | ||||||
Proceeds from Issuance of Common Stock | 162,093 | 54,050 | ||||||
Available-for-sale Securities, Current | 179,262 | 179,262 | $ 0 | |||||
Cash and Cash Equivalents, at Carrying Value | $ 80,738 | $ 163,380 | 80,738 | $ 163,380 | $ 145,373 | $ 106,717 | ||
Proceeds from Stock Options and Warrants Exercised | 23,100 | |||||||
Subsequent Event [Member] | ||||||||
Stock Issued During Period, Shares, New Issues | 25,300,000 | |||||||
Proceeds from Issuance of Common Stock | $ 236,600 | |||||||
Shares Issued, Price Per Share | $ 9.97 | |||||||
Subsequent Event [Member] | Underwriter [Member] | ||||||||
Stock Issued During Period, Shares, New Issues | 3,300,000 | |||||||
Proceeds From Issuance Of Common Stock, Gross | $ 252,200 | |||||||
IPO [Member] | ||||||||
Stock Issued During Period, Shares, New Issues | 15,000,000 | |||||||
Proceeds from Issuance of Common Stock | $ 162,000 | $ 162,000 | ||||||
Shares Issued, Price Per Share | $ 11.50 | |||||||
IPO [Member] | Underwriter [Member] | ||||||||
Stock Issued During Period, Shares, New Issues | 1,956,521 | |||||||
Proceeds From Issuance Of Common Stock, Gross | $ 172,500 | |||||||
Common Stock [Member] | Subsequent Event [Member] | ||||||||
Stock Issued During Period, Shares, New Issues | 25,300,000 | |||||||
Shares Issued, Price Per Share | $ 9.97 |
SUMMARY OF SIGNIFICANT ACCOUN_4
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details) - shares | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 13,372,777 | 22,038,728 | |
Employee Stock Option [Member] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 6,912,932 | 6,706,964 | |
Warrant [Member] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 427,800 | 6,411,216 | |
Restricted Stock Awards [Member] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 0 | 834 | |
Restricted Stock [Member] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 80,200 | 126,041 | |
Series A Preferred Stock [Member] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | [1] | 97,000 | 847,000 |
Series B Preferred Stock [Member] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | [1] | 5,854,845 | 7,946,673 |
[1] | on an as-converted basis |
SUMMARY OF SIGNIFICANT ACCOUN_5
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details 1) $ in Thousands | Sep. 30, 2018USD ($) |
Assets, Fair Value Disclosure | $ 179,262 |
US Government agency securities [Member] | |
Assets, Fair Value Disclosure | 29,662 |
US Treasury Securities [Member] | |
Assets, Fair Value Disclosure | 149,600 |
Fair Value, Inputs, Level 1 [Member] | |
Assets, Fair Value Disclosure | 179,262 |
Fair Value, Inputs, Level 1 [Member] | US Government agency securities [Member] | |
Assets, Fair Value Disclosure | 29,662 |
Fair Value, Inputs, Level 1 [Member] | US Treasury Securities [Member] | |
Assets, Fair Value Disclosure | 149,600 |
Fair Value, Inputs, Level 2 [Member] | |
Assets, Fair Value Disclosure | 0 |
Fair Value, Inputs, Level 2 [Member] | US Government agency securities [Member] | |
Assets, Fair Value Disclosure | 0 |
Fair Value, Inputs, Level 2 [Member] | US Treasury Securities [Member] | |
Assets, Fair Value Disclosure | 0 |
Fair Value, Inputs, Level 3 [Member] | |
Assets, Fair Value Disclosure | 0 |
Fair Value, Inputs, Level 3 [Member] | US Government agency securities [Member] | |
Assets, Fair Value Disclosure | 0 |
Fair Value, Inputs, Level 3 [Member] | US Treasury Securities [Member] | |
Assets, Fair Value Disclosure | $ 0 |
SUMMARY OF SIGNIFICANT ACCOUN_6
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details 2) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost, Total | $ 5,516 | $ 2,619 | $ 14,842 | $ 9,208 |
Research and Development Expense [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost, Total | 2,255 | 881 | 6,636 | 3,873 |
General and Administrative Expense [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost, Total | $ 3,261 | $ 1,738 | $ 8,206 | $ 5,335 |
SUMMARY OF SIGNIFICANT ACCOUN_7
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details 3) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost | $ 5,516 | $ 2,619 | $ 14,842 | $ 9,208 |
Employee Stock Option [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost | 5,448 | 2,562 | 14,640 | 8,193 |
Restricted Stock Awards [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost | 0 | 6 | 0 | 33 |
Restricted Stock [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost | $ 68 | $ 51 | $ 202 | $ 982 |
CASH EQUIVALENTS AND SHORT-TE_3
CASH EQUIVALENTS AND SHORT-TERM INVESTMENTS (Details) - USD ($) $ in Thousands | Sep. 30, 2018 | Dec. 31, 2017 |
Short-term Investments | ||
Cash Equivalents, at Carrying Value | $ 26,334 | $ 91,281 |
Demand Deposits [Member] | ||
Short-term Investments | ||
Cash Equivalents, at Carrying Value | 54,400 | 54,100 |
Money Market Funds [Member] | ||
Short-term Investments | ||
Cash Equivalents, at Carrying Value | 12,351 | 91,281 |
US Government Corporations and Agencies Securities [Member] | ||
Short-term Investments | ||
Cash Equivalents, at Carrying Value | $ 13,983 | $ 0 |
CASH EQUIVALENTS AND SHORT-TE_4
CASH EQUIVALENTS AND SHORT-TERM INVESTMENTS (Details 1) - USD ($) $ in Thousands | Sep. 30, 2018 | Dec. 31, 2017 |
Cash, Cash Equivalents, and Short-term Investments | $ 179,262 | $ 0 |
US Treasury Securities [Member] | ||
Cash, Cash Equivalents, and Short-term Investments | 149,600 | 0 |
US Government Corporations and Agencies Securities [Member] | ||
Cash, Cash Equivalents, and Short-term Investments | $ 29,662 | $ 0 |
CASH EQUIVALENTS AND SHORT-TE_5
CASH EQUIVALENTS AND SHORT-TERM INVESTMENTS (Details 2) $ in Thousands | 9 Months Ended |
Sep. 30, 2018USD ($) | |
Amortized Cost | $ 178,994 |
Accretion | 388 |
Gross Unrealized Gains | 0 |
Gross Unrealized Losses | (120) |
Fair Value | 179,262 |
US Government Debt Securities [Member] | |
Amortized Cost | 29,625 |
Accretion | 55 |
Gross Unrealized Gains | 0 |
Gross Unrealized Losses | (18) |
Fair Value | 29,662 |
US Treasury Securities [Member] | |
Amortized Cost | 149,369 |
Accretion | 333 |
Gross Unrealized Gains | 0 |
Gross Unrealized Losses | (102) |
Fair Value | $ 149,600 |
BALANCE SHEET COMPONENTS (Detai
BALANCE SHEET COMPONENTS (Details) - USD ($) $ in Thousands | Sep. 30, 2018 | Dec. 31, 2017 |
Accrued payroll and employee related expenses | $ 2,897 | $ 2,613 |
Legal and related services | 498 | 935 |
Clinical related | 4,029 | 3,310 |
Manufacturing related | 2,442 | 876 |
Deferred rent | 335 | 430 |
Accrued other | 459 | 496 |
Accrued liabilities | $ 10,660 | $ 8,660 |
STOCKHOLDERS' EQUITY (Details)
STOCKHOLDERS' EQUITY (Details) - Warrant [Member] - USD ($) | 9 Months Ended | |
Sep. 30, 2018 | Dec. 31, 2017 | |
Shares Under Warrants | ||
Outstanding, beginning balance | 6,301,216 | |
Issued | 0 | |
Exercised | (5,873,416) | |
Expired/Cancelled | 0 | |
Outstanding, ending balance | 427,800 | |
Weighted Average Exercise Price | ||
Outstanding, beginning balance | $ 2.51 | |
Granted | 0 | |
Exercised | 2.50 | |
Expired/Cancelled | 0 | |
Outstanding, ending balance | $ 2.62 | |
Weighted Average Remaining Contractual Life | ||
Outstanding | 1 month 6 days | |
Aggregate Intrinsic Value | ||
Outstanding, ending balance | $ 3,734,500 | $ 34,651,188 |
STOCKHOLDERS' EQUITY (Details T
STOCKHOLDERS' EQUITY (Details Textual) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 9 Months Ended | |||
Oct. 17, 2018 | Jan. 31, 2018 | Sep. 30, 2018 | Sep. 30, 2017 | Dec. 31, 2017 | |
Class of Stock [Line Items] | |||||
Proceeds from Issuance of Common Stock | $ 162,093 | $ 54,050 | |||
Conversion of Stock, Shares Converted | 1,523,396 | ||||
Subsequent Event [Member] | |||||
Class of Stock [Line Items] | |||||
Stock Issued During Period, Shares, New Issues | 25,300,000 | ||||
Proceeds from Issuance of Common Stock | $ 236,600 | ||||
Shares Issued, Price Per Share | $ 9.97 | ||||
Underwriter [Member] | Subsequent Event [Member] | |||||
Class of Stock [Line Items] | |||||
Stock Issued During Period, Shares, New Issues | 3,300,000 | ||||
Proceeds From Issuance Of Common Stock, Gross | $ 252,200 | ||||
Common Stock [Member] | |||||
Class of Stock [Line Items] | |||||
Conversion of Stock, Shares Converted | 1,523,396 | ||||
Common Stock [Member] | Subsequent Event [Member] | |||||
Class of Stock [Line Items] | |||||
Stock Issued During Period, Shares, New Issues | 25,300,000 | ||||
Shares Issued, Price Per Share | $ 9.97 | ||||
Common Stock [Member] | Issuance Of Common Stock Upon Conversion Of Preferred Stock [Member] | |||||
Class of Stock [Line Items] | |||||
Conversion of Stock, Shares Issued | 1,500 | ||||
Conversion of Stock, Shares Converted | 750,000 | ||||
IPO [Member] | |||||
Class of Stock [Line Items] | |||||
Stock Issued During Period, Shares, New Issues | 15,000,000 | ||||
Proceeds from Issuance of Common Stock | $ 162,000 | $ 162,000 | |||
Shares Issued, Price Per Share | $ 11.50 | ||||
IPO [Member] | Underwriter [Member] | |||||
Class of Stock [Line Items] | |||||
Stock Issued During Period, Shares, New Issues | 1,956,521 | ||||
Proceeds From Issuance Of Common Stock, Gross | $ 172,500 | ||||
Series A Convertible Preferred Stock [Member] | |||||
Class of Stock [Line Items] | |||||
Conversion of Stock, Shares Issued | 500 | ||||
Preferred Stock, Shares Authorized | 17,000 | ||||
Series A Convertible Preferred Stock [Member] | Private Placement [Member] | |||||
Class of Stock [Line Items] | |||||
Sale of Stock, Price Per Share | $ 2 | ||||
Preferred Stock, Par or Stated Value Per Share | $ 1,000 | ||||
Series B Preferred Stock [Member] | |||||
Class of Stock [Line Items] | |||||
Preferred Stock, Shares Authorized | 11,500,000 | 11,500,000 | |||
Preferred Stock, Par or Stated Value Per Share | $ 0.001 | $ 0.001 | |||
Preferred Stock, Shares Outstanding | 5,854,845 | 7,378,241 | |||
Series B Convertible Preferred Stock [Member] | |||||
Class of Stock [Line Items] | |||||
Preferred Stock, Shares Authorized | 11,500,000 | ||||
Preferred Stock, Par or Stated Value Per Share | $ 4.75 | ||||
Convertible Price Per Shares | $ 4.75 | ||||
Blank Check [Member] | |||||
Class of Stock [Line Items] | |||||
Preferred Stock, Shares Authorized | 50,000,000 | ||||
Series A Preferred Stock [Member] | |||||
Class of Stock [Line Items] | |||||
Preferred Stock, Shares Authorized | 17,000 | 17,000 | |||
Preferred Stock, Par or Stated Value Per Share | $ 0.001 | $ 0.001 | |||
Preferred Stock, Shares Outstanding | 194 | 1,694 |
STOCK BASED COMPENSATION (Detai
STOCK BASED COMPENSATION (Details) - Employee Stock Option [Member] | 9 Months Ended |
Sep. 30, 2018USD ($)$ / sharesshares | |
Number of Options | |
Outstanding, beginning balance | shares | 6,072,368 |
Granted | shares | 2,673,720 |
Exercised | shares | (1,081,954) |
Expired/Forfeited | shares | (751,202) |
Outstanding, ending balance | shares | 6,912,932 |
Exercisable | shares | 3,042,373 |
Weighted Average Exercise Price | |
Outstanding, beginning balance | $ / shares | $ 7.42 |
Granted | $ / shares | 15.26 |
Exercised | $ / shares | 7.73 |
Expired/Forfeited | $ / shares | 9.78 |
Outstanding, ending balance | $ / shares | 10.15 |
Exercisable | $ / shares | $ 7.68 |
Weighted Average Remaining Contractual Life | |
Outstanding | 8 years 3 months 7 days |
Exercisable | 7 years 3 months 29 days |
Aggregate Intrinsic Value | |
Outstanding, ending balance | $ | $ 18,597,172 |
Exercisable | $ | $ 11,762,590 |
STOCK BASED COMPENSATION (Det_2
STOCK BASED COMPENSATION (Details Textual) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||||||||||
Jun. 30, 2016 | Aug. 31, 2013 | Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | Apr. 22, 2018 | Aug. 16, 2016 | Apr. 10, 2015 | Nov. 30, 2014 | Aug. 20, 2014 | Aug. 01, 2014 | Aug. 02, 2013 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized | $ 38,500 | $ 38,500 | |||||||||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Period for Recognition | 1 year 11 months 8 days | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period, Intrinsic Value | $ 3,800 | $ 1,200 | |||||||||||
Share-based Compensation | $ 5,400 | $ 2,600 | $ 14,842 | $ 9,208 | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Vested in Period | 137,500 | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value | $ 15.26 | $ 6.46 | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number | 80,200 | 80,200 | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Description | an amendment to increase the number options or other awards that can be granted to any one person during a twelve (12) month period from 50,000 shares to 300,000 shares. | ||||||||||||
Restricted Common Stock [Member] | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||
Allocated Share-based Compensation Expense | $ 100 | $ 100 | $ 200 | $ 1,000 | |||||||||
Restricted Stock [Member] | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||
Allocated Share-based Compensation Expense | $ 500 | ||||||||||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Period for Recognition | 1 year 8 months 1 day | ||||||||||||
Restricted Stock [Member] | Chief Executive Officer [Member] | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Grants in Period | 550,000 | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Grants in Period, Weighted Average Grant Date Fair Value | $ 5.87 | ||||||||||||
First Anniversary [Member] | Restricted Stock [Member] | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period | 36 months | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Vested in Period | 137,500 | ||||||||||||
Satisfaction Of Clinical Trial Milestones [Member] | Restricted Stock [Member] | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Vested in Period | 275,000 | ||||||||||||
2014 Equity Incentive Plan [Member] | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized | 4,000,000 | 2,350,000 | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant | 810,724 | 810,724 | |||||||||||
2014 Equity Incentive Plan [Member] | Maximum [Member] | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized | 9,000,000 | ||||||||||||
2014 Equity Incentive Plan [Member] | Minimum [Member] | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized | 4,000,000 | ||||||||||||
2011 Equity Incentive Plan [Member] | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period | 200,000 | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant | 376,240 | 376,240 | |||||||||||
Common Stock, Capital Shares Reserved for Future Issuance | 1,900,000 | 1,700,000 | 180,000 | ||||||||||
2011 Equity Incentive Plan [Member] | Minimum [Member] | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant | 180,000 | 180,000 | |||||||||||
2018 Equity Incentive Plan [Member] | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized | 6,000,000 | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant | 6,000,000 | 6,000,000 | |||||||||||
Employee Stock Option [Member] | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period | 1,081,954 | 484,850 |
LICENSES AND AGREEMENTS (Detail
LICENSES AND AGREEMENTS (Details Textual) - USD ($) $ in Thousands | Sep. 14, 2016 | Jun. 30, 2018 | Apr. 17, 2017 | Nov. 30, 2016 | Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | Dec. 31, 2016 | May 31, 2017 |
Research and Development Expense | $ 27,947 | $ 16,679 | $ 72,410 | $ 50,919 | ||||||
Reversal of Prior Period Expense | 400 | |||||||||
Research and Development Arrangement [Member] | ||||||||||
Prepaid Expense, Current | $ 1,400 | |||||||||
Research Collaboration and Clinical Grant Agreements [Member] | ||||||||||
Research and Development Expense | 600 | 2,000 | 2,200 | 4,300 | ||||||
Strategic Alliance Agreement [Member] | ||||||||||
Research and Development Expense | 100 | 200 | ||||||||
Maximum [Member] | Research and Development Arrangement [Member] | ||||||||||
Research and Development Arrangement, Contract to Perform for Others, Costs Incurred, Gross | $ 14,200 | |||||||||
Karolinska University Hospital [Member] | ||||||||||
Payments For Clinical Trials Agreement | $ 1,600 | |||||||||
Proceeds from Refund of Clinical Trials Agreement | $ 1,600 | |||||||||
National Cancer Institute [Member] | ||||||||||
Research and Development Expense | $ 500 | |||||||||
Moffitt License Agreement [Member] | ||||||||||
Agreement Term | 20 years | |||||||||
Cooperative Research and Development Agreement [Member] | ||||||||||
Research and Development Expense | 500 | 500 | $ 1,500 | 1,500 | ||||||
Agreement Term | 5 years | |||||||||
PolyBioCept, AB - Exclusive and Co-Exclusive License Agreement [Member] | ||||||||||
Research and Development Expense | 200 | 400 | ||||||||
Payment For Upfront Exclusive License | $ 2,500 | |||||||||
Additional Milesone Payable | $ 8,700 | |||||||||
Number Of Unregistered Common Stock To Be Issued | 2,219,376 | |||||||||
ReimbursementIn Relation To Transfer Of Knowhow | $ 200 | |||||||||
Clinical Trials Management Fees Payable | $ 100 | |||||||||
Initial Term Of Licence Agreement | 30 years | |||||||||
WuXi Apptech, Inc - Manufacturing and Services Agreement [Member] | ||||||||||
Research and Development Expense | 4,500 | $ 3,100 | $ 10,600 | $ 10,600 | ||||||
WuXi Apptech, Inc - Manufacturing and Services Agreement [Member] | Manufacturing Suites [Member] | ||||||||||
Manufacturing and Services Agreement, Amount Payable | $ 2,500 | |||||||||
WuXi Apptech, Inc - Manufacturing and Services Agreement [Member] | Commercial Manufacturing cGMP Suite [Member] | ||||||||||
Manufacturing and Services Agreement, Amount Payable | $ 5,850 | |||||||||
Moffitt License Agreement One [Member] | ||||||||||
Payments For Upfront Licensing Fee | 100 | |||||||||
Moffitt License Agreement Two [Member] | ||||||||||
Payments For Upfront Licensing Fee | 100 | |||||||||
Additional Milesone Payable | $ 400 | $ 400 |
LEGAL PROCEEDINGS (Details Text
LEGAL PROCEEDINGS (Details Textual) | Jun. 13, 2017USD ($)shares | Jun. 03, 2016USD ($) | Nov. 30, 2012USD ($) | Jun. 30, 2012USD ($) | Sep. 30, 2016shares | Sep. 30, 2018shares | Apr. 08, 2016USD ($) |
Loss Contingency, Damages Sought, Value | $ | $ 500,000 | ||||||
Common Stock Registered For Resale | 128,500 | ||||||
Number of share options or share units exercised during the current period. | 128,500 | ||||||
Twenty Eleven Equity Incentive Plan [Member] | |||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period | 200,000 | ||||||
Dr. Steven Fischkoff [Member] | |||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | 150,000 | ||||||
Severance Pay And Retention Bonus | $ | $ 300,000 | ||||||
Warrant [Member] | |||||||
Shares Sold Under Ineffective Registration | 128,500 | ||||||
Minimum [Member] | |||||||
Loss Contingency, Estimate of Possible Loss | $ | $ 1,500,000 | ||||||
Solomon Capital, LLC [Member] | |||||||
Proceeds from Related Party Debt | $ | $ 100,000 | $ 200,000 | |||||
Debt Instrument, Convertible, Number of Equity Instruments | 111,425 |
COMMITMENTS AND CONTINGENCIES_2
COMMITMENTS AND CONTINGENCIES (Details) - New York Lease [Member] $ in Thousands | Sep. 30, 2018USD ($) |
2018 (remaining three months) | $ 225 |
2,019 | 707 |
2,020 | 495 |
2,021 | 169 |
Total | $ 1,596 |
COMMITMENTS AND CONTINGENCIES_3
COMMITMENTS AND CONTINGENCIES (Details Textual) | Aug. 04, 2016USD ($)ft² | Apr. 20, 2018USD ($) | Jul. 31, 2017USD ($) | Apr. 28, 2017USD ($)ft² | Sep. 30, 2016USD ($)ft² | Sep. 30, 2018USD ($) | Sep. 30, 2017USD ($) | Sep. 30, 2018USD ($) | Sep. 30, 2017USD ($) | Jun. 05, 2017USD ($) | Apr. 30, 2015ft² | Dec. 31, 2014ft² |
License And Commitments [Line Items] | ||||||||||||
Operating Leases, Rent Expense | $ 200,000 | $ 300,000 | $ 700,000 | $ 700,000 | ||||||||
Tampa Lease [Member] | ||||||||||||
License And Commitments [Line Items] | ||||||||||||
Area of Land | ft² | 8,673 | 6,043 | 5,115 | |||||||||
Operating Leases, Rent Expense | $ 20,000 | |||||||||||
New York Lease [Member] | ||||||||||||
License And Commitments [Line Items] | ||||||||||||
Operating Leases, Future Minimum Payments Due | $ 1,596,000 | $ 1,596,000 | ||||||||||
New York Lease [Member] | Office Space [Member] | ||||||||||||
License And Commitments [Line Items] | ||||||||||||
Operating Leases, Rent Expense | $ 7,000 | |||||||||||
Operating Leases, Future Minimum Payments Due | $ 9,000 | |||||||||||
Operating Leases, Rent Expense, Minimum Rentals | $ 18,000 | |||||||||||
San Carlos Lease [Member] | ||||||||||||
License And Commitments [Line Items] | ||||||||||||
Operating Leases, Rent Expense, Sublease Rentals | $ 26,000 | |||||||||||
San Carlos Lease [Member] | Land [Member] | ||||||||||||
License And Commitments [Line Items] | ||||||||||||
Area of Land | ft² | 8,733 | |||||||||||
Lease Expiration Term | 54 months | |||||||||||
Operating Leases, Future Minimum Payments Due | $ 38,000 | |||||||||||
Teradata US, Inc [Member] | ||||||||||||
License And Commitments [Line Items] | ||||||||||||
Area of Land | ft² | 11,449 |
RELATED PARTY TRANSACTIONS (Det
RELATED PARTY TRANSACTIONS (Details Textual) - USD ($) $ / shares in Units, $ in Thousands | Sep. 14, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 |
Payments for Legal Services | $ 100 | $ 100 | $ 400 | $ 500 | |
Share-based Compensation Arrangement by Share-based Payment Award, 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). | ||||
Share-based Compensation | 5,400 | 2,600 | 14,842 | 9,208 | |
Consulting Agreement [Member] | |||||
Share-based Compensation | $ 400 | $ 100 | $ 1,000 | $ 100 | |
Board of Directors Chairman [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized | 150,000 | ||||
Share-based Compensation Arrangements by Share-based Payment Award, Options, Grants in Period, Weighted Average Exercise Price | $ 7.30 |
SUBSEQUENT EVENTS (Details)
SUBSEQUENT EVENTS (Details) - Subsequent Event [Member] - San Carlos Lease [Member] $ in Thousands | Oct. 19, 2018USD ($) |
Subsequent Event [Line Items] | |
2018 (remaining three months) | $ 225 |
2,019 | 1,414 |
2,020 | 1,223 |
2,021 | 418 |
Total | $ 3,280 |
SUBSEQUENT EVENTS (Details Text
SUBSEQUENT EVENTS (Details Textual) - Subsequent Event [Member] | 1 Months Ended | |
Oct. 19, 2018USD ($)ft² | Oct. 17, 2018shares | |
Subsequent Event [Line Items] | ||
Stock Issued During Period, Shares, New Issues | shares | 25,300,000 | |
Area of Land | ft² | 12,322 | |
Sublease of Office Space | ft² | 11,449 | |
Operating Lease, Payments | $ | $ 59,000 | |
Lease Expiration Term | 30 months | |
Operating Leases of Lessee, Contingent Rentals, Basis Spread on Variable Rate | 3.00% | |
Equity [Member] | ||
Subsequent Event [Line Items] | ||
Stock Issued During Period, Shares, New Issues | shares | 25,300,000 |