View Filing Data

Document and Entity Information - shares	3 Months Ended
Document and Entity Information - shares	Mar. 31, 2019	Apr. 30, 2019
Document and Entity Information [Abstract]
Document Type	10-Q
Amendment Flag	false
Document Period End Date	Mar. 31, 2019
Document Fiscal Year Focus	2019
Document Fiscal Period Focus	Q1
Entity Registrant Name	IOVANCE BIOTHERAPEUTICS, INC.
Entity Central Index Key	0001425205
Current Fiscal Year End Date	--12-31
Entity Filer Category	Large Accelerated Filer
Trading Symbol	IOVA
Entity Common Stock, Shares Outstanding		123,514,231
Entity Emerging Growth Company	false
Entity Small Business	false

Condensed Consolidated Balance Sheets - USD ($) $ in Thousands	Mar. 31, 2019	Dec. 31, 2018
Current Assets
Cash and cash equivalents	$ 54,093	$ 82,152
Short-term investments	385,925	386,371
Prepaid expenses and other current assets	4,735	6,640
Total Current Assets	444,753	475,163
Property and equipment, net	3,504	2,683
Operating lease right-of-use assets	9,957	0
Long-term assets	3,288	2,975
Total Assets	461,502	480,821
Current Liabilities
Accounts payable	7,589	2,739
Accrued expenses	8,489	11,659
Operating lease liabilities	6,059	0
Total Current Liabilities	22,137	14,398
Non-Current Liabilities
Operating lease liabilities	4,380	0
Other liabilities	53	230
Total Non-Current Liabilities	4,433	230
Total Liabilities	26,570	14,628
Commitments and contingencies (Note 9)
Stockholders' Equity
Common stock, $0.000041666 par value; 150,000,000 shares authorized, 123,395,113 and 123,415,576 shares issued and outstanding as of March 31, 2019 and December 31, 2018, respectively	5	5
Accumulated other comprehensive income (loss)	138	(42)
Additional paid-in capital	844,789	838,984
Accumulated deficit	(410,006)	(372,760)
Total Stockholders' Equity	434,932	466,193
Total Liabilities and Stockholders' Equity	461,502	480,821
Series A Convertible Preferred stock [Member]
Stockholders' Equity
Preferred stock,Value	0	0
Total Stockholders' Equity	0	0
Series B Convertible Preferred stock [Member]
Stockholders' Equity
Preferred stock,Value	6	6
Total Stockholders' Equity	$ 6	$ 6

Condensed Consolidated Balance Sheets (Parenthetical) - USD ($)	Mar. 31, 2019	Dec. 31, 2018
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	123,395,113	123,415,576
Common Stock, Shares, Outstanding	123,395,113	123,415,576
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	194
Preferred Stock, Shares Outstanding	194	194
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	5,854,845
Preferred Stock, Shares Outstanding	5,854,845	5,854,845
Preferred Stock, Redemption Amount	$ 27,811	$ 27,811

Condensed Consolidated Statements of Operations - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2019	Mar. 31, 2018
Revenues	$ 0	$ 0
Costs and expenses
Research and development expenses	30,905	19,912
General and administrative expenses	9,081	6,965
Total costs and expenses	39,986	26,877
Loss from operations	(39,986)	(26,877)
Other income
Interest income, net	3,036	362
Net Loss	$ (36,950)	$ (26,515)
Net Loss Per Common Share, Basic and Diluted	$ (0.30)	$ (0.31)
Weighted-Average Common Shares Outstanding, Basic and Diluted	123,415	84,350

Condensed Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands	Total	Common Stock [Member]	Additional Paid-In Capital [Member]	Accumulated other Comprehensive Income (Loss) [Member]	Accumulated Deficit [Member]	Series A Convertible Preferred Stock [Member]	Series B Convertible Preferred Stock [Member]
Beginning Balance at Dec. 31, 2017	$ 145,481	$ 3	$ 394,651	$ 0	$ (249,180)	$ 0	$ 7
Beginning Balance (in Shares) at Dec. 31, 2017		73,164,914				1,694	7,378,241
Stock-based compensation expense	4,104		4,104
Vesting of restricted shares issued for services	0
Vesting of restricted shares issued for services (in shares)		11,459
Cancellation of restricted shares	0
Cancellation of restricted shares (in Shares)		(4,408)
Tax payments related to shares withheld for vested restricted stock units	(60)	$ 0	(60)
Common stock issued upon exercise of warrants	1,826		1,826
Common stock issued upon exercise of warrants (in Shares)		730,381
Common stock issued upon exercise of stock options	5,630	$ 0	5,630
Common stock issued upon exercise of stock options (in shares)		703,071
Unrealized gain on short-term investments	0
Common stock sold in public offering, net of offering costs	162,092		162,092
Common stock sold in public offering, net of offering costs (in shares)		15,000,000
Net loss	(26,515)				(26,515)
Ending Balance at Mar. 31, 2018	292,558	$ 3	568,243	0	(275,695)	$ 0	$ 7
Ending Balance (in Shares) at Mar. 31, 2018		89,605,417				1,694	7,378,241
Beginning Balance at Dec. 31, 2018	466,193	$ 5	838,984	(42)	(372,760)	$ 0	$ 6
Beginning Balance (in Shares) at Dec. 31, 2018		123,415,576				194	5,854,845
Stock-based compensation expense	5,846		5,846
Vesting of restricted shares issued for services	1	$ 1	0
Vesting of restricted shares issued for services (in shares)		7,037
Tax payments related to shares withheld for vested restricted stock units	(71)		(71)
Common stock issued upon exercise of stock options	69	$ 0	69
Common stock issued upon exercise of stock options (in shares)		5,000
Unrealized gain on short-term investments	180			180
Cancellation of common shares from settlement of dispute	(336)	$ (1)	(335)
Cancellation of common shares from settlement of dispute (in Shares)		(32,500)
Net loss	(36,950)				(36,950)
Ending Balance at Mar. 31, 2019	434,932	$ 5	844,789	$ 138	(410,006)	$ 0	$ 6
Ending Balance (in Shares) at Mar. 31, 2019		123,395,113				194	5,854,845
Adoption of ASU 2018-07	$ 0	$ 0	$ 296		$ (296)

Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2019	Mar. 31, 2018
Cash Flows from Operating Activities
Net loss	$ (36,950)	$ (26,515)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization	271	228
Noncash lease expense	1,424	0
Loss on disposal of assets	0	9
Gain on settlement of dispute	(335)	0
Accretion (amortization) of discounts and premiums on investments	(1,232)	0
Stock-based compensation expense	5,846	4,104
Changes in assets and liabilities:
Prepaid expenses, other assets, and long-term assets	1,592	(368)
Operating lease liabilities (right-of-use assets)	(942)	0
Accounts payable	4,582	5,239
Accrued expenses and other liabilities	(3,346)	(546)
Net cash used in operating activities	(29,090)	(17,849)
Cash Flows from Investing Activities
Maturities of short-term investments	91,042	0
Purchase of short-term investments	(89,185)	0
Purchase of property and equipment	(824)	(22)
Net cash provided by (used in) investing activities	1,033	(22)
Cash Flows from Financing Activities
Tax payments related to shares withheld for vested restricted stock awards	(71)	(62)
Proceeds from the issuance of common stock upon exercise of warrants	0	1,826
Proceeds from the issuance of common stock upon exercise of options	69	5,630
Proceeds from the issuance of common stock, net	0	162,186
Net cash (used in) provided by financing activities	(2)	169,580
Net (decrease) / increase in cash and cash equivalents	(28,059)	151,709
Cash and Cash Equivalents, Beginning of Period	82,152	145,373
Cash and Cash Equivalents, End of Period	54,093	297,082
Supplemental disclosure of non-cash investing and financing activities:
Unrealized gain on short-term investments	180	0
Acquisitions of property and equipment included in accounts payable	(268)	(12)
Offering costs under accounts payable and accrued expenses	$ 0	$ (93)

GENERAL ORGANIZATION AND BUSINESS

3 Months Ended

Mar. 31, 2019

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. Tumor infiltrating lymphocyte or TIL therapy is a platform technology that has been studied and continues to be studied for the treatment of metastatic melanoma, metastatic cervical cancer, and various other cancers by the National Cancer Institute, or NCI. The Company’s lead product candidate, lifileucel (formerly known as LN-144) for metastatic melanoma, is an autologous adoptive cell therapy utilizing TIL, which are T cells derived from patients’ tumors. The Company is also developing a second product candidate, an autologous adoptive cell therapy utilizing TIL for the treatment of cancers other than metastatic melanoma, which is known as LN-145. The Company is investigating the effectiveness and safety of TIL therapy for the treatment of metastatic melanoma, squamous cell carcinoma of the head and neck, cervical cancer, and metastatic non-small cell lung cancer through company sponsored trials, as well as other oncology indications. The Company is currently conducting the pivotal cohort of

its innovaTIL-01 clinical trial, also known as C-144-01, of lifileucel in patients with metastatic melanoma. The Company has recently amended the protocol of its innovaTIL-04 clinical trial, also known as C-145-04, of LN-145 in cervical cancer patients in anticipation of discussions with the U.S. Food and Drug Administration (“FDA”) on a potential registrational path. On June 1, 2017, the Company reincorporated to become a company governed by Delaware corporation laws.

Basis of Presentation of Unaudited Condensed Consolidated Financial Information

The unaudited condensed consolidated financial statements of the Company for the three months ended March 31, 2019 and 2018 have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information and pursuant to the requirements for reporting on Form 10-Q and Regulation S-K. Accordingly, they do not include all the information and footnotes required by GAAP for complete financial statements. However, such information reflects all adjustments (consisting solely of normal recurring adjustments), which are, in the opinion of management, necessary for the fair presentation of the financial position and the results of operations. Results shown for interim periods are not necessarily indicative of the results to be obtained for a full fiscal year. The balance sheet information as of December 31, 2018, was derived from the audited financial statements included in the Company's financial statements as of and for the year ended December 31, 2018 included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on February 28, 2019. These financial statements should be read in conjunction with that report.

Liquidity

The Company is currently engaged in the development of therapeutics to 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 $37.0 million for the three months ended March 31, 2019 and used $29.1 million of cash in its operating activities during the three months ended March 31, 2019. In January 2018, the Company closed an underwritten public offering of 15,000,000 shares of the Company’s common stock at a public offering price of $11.50 per share, before underwriting discounts. The net proceeds from the offering, after deducting the underwriting discounts and commissions and other offering expenses payable by the Company, were $162.0 million. In October 2018, the Company completed an underwritten public offering of 25,300,000 shares of the Company’s common stock at a public offering price of $9.97 per share, before underwriting discounts. The net proceeds from the offering, after deducting the underwriting discounts and commissions and other offering expenses payable by the Company, were $236.7 million. As of March 31, 2019, the Company had $440.0 million of cash and cash equivalents and short-term investments ($54.1 million of cash and cash equivalents and $385.9 million in short-term investments).

The Company expects to further increase its research and development activities, which will increase the amount of cash used during 2019 and beyond. Specifically, the Company expects continued spending on its current and planned clinical trials, continued expansion of manufacturing activities, including construction of a manufacturing facility, higher payroll expenses as the Company increases its professional and scientific staff, increased research and development activities and initiation of pre-commercial activities. However, the extent and the timing of these expenditures are under the control of the Company. Based on the funds the Company has available as of the date these financial statements are issued, the Company believes that it has sufficient capital to fund its anticipated operating expenses for at least next twelve months from the date these financial statements are issued

Concentrations of Risk

The Company is subject to credit risk from our portfolio of cash equivalents and short-term investments. Under its investment policy, the Company limits amounts invested in such securities by credit rating, maturity, industry group, investment type and issuer, except for securities issued by the U.S. government. The Company does not believe it is exposed to any significant concentrations of credit risk from these financial instruments. The goals of its investment policy, in order of priority, are as follows: safety and preservation of principal and diversification of risk; liquidity of investments sufficient to meet cash flow requirements; and a competitive after-tax rate of return.

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

3 Months Ended

Mar. 31, 2019

Accounting Policies [Abstract]

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

NOTE 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Cash, Cash Equivalents, and Short-term Investments

The Company’s cash and cash equivalents include short-term investments with original maturities of three months or less when purchased. The Company's short-term investments are classified as “available-for-sale”. The Company includes these investments in current assets and carries them at fair value. Unrealized gains and losses on available-for-sale securities are included in accumulated other comprehensive loss. The cost of debt securities is adjusted for the amortization of premiums and accretion of discounts to maturity. Such amortization and accretion are included in net interest income in the consolidated statements operations. Gains and losses on securities sold are recorded based on the specific identification method and are included in net interest income in the consolidated statement of operations. The Company has not incurred any realized gains or losses from sales of securities to date. The Company’s investment policy limits investments to certain types of instruments such as certificates of deposit, money market instruments, obligations issued by the U.S. government and U.S. government agencies as well as corporate debt securities, and places restrictions on maturities and concentration by type and issuer.

Loss per Share

Basic net loss per share is computed by dividing the net loss by the weighted average number of common shares outstanding during the period.

Diluted net loss per share is computed by dividing the net loss by the sum of the weighted average number of shares of common stock outstanding and the dilutive common stock equivalent shares outstanding during the period. The Company’s potentially dilutive common stock equivalent shares, which include incremental common shares issuable upon (i) the exercise of outstanding stock options and warrants (ii) vesting of restricted stock units and restricted stock awards, and (iii) conversion of preferred stock, are only included in the calculation of diluted net loss per share when their effect is dilutive.

At March 31, 2019 and 2018, the following outstanding common stock equivalents have been excluded from the calculation of net loss per share because their impact would be anti-dilutive.

	March 31,
	2019		2018
Stock options		9,274,973		6,951,067
Warrants		-		5,570,835
Series A Convertible Preferred Stock*		97,000		847,000
Series B Convertible Preferred Stock*		5,854,845		7,378,241
Restricted stock units		57,285		103,123
		15,284,103		20,850,266

* on an as-converted basis

The dilutive effect of potentially dilutive securities would be reflected in diluted earnings per common share by application of the treasury stock method. Under the treasury stock method, an increase in the fair market value of the Company's common stock could result in a greater dilutive effect from potentially dilutive securities.

Fair Value Measurements

Under Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 820, Fair Value Measurements and Disclosures, fair value is defined as the price at which an asset could be exchanged, or a liability transferred in a transaction between knowledgeable, willing parties in the principal or most advantageous market for the asset or liability. Where available, fair value is based on observable market prices or parameters or derived from such prices or parameters. Where observable prices or parameters are not available, valuation models are applied.

Assets and liabilities recorded at fair value in the Company’s financial statements are categorized based upon the level of judgment associated with the inputs used to measure their fair value. Hierarchical levels directly related to the amount of subjectivity associated with the inputs to fair valuation of these assets and liabilities, are as follows:

Level 1—Inputs are unadjusted, quoted prices in active markets for identical assets at the reporting date. Active markets are those in which transactions for the asset or liability occur in sufficient frequency and volume to provide pricing information on an ongoing basis.

Level 2—Are inputs, other than quoted prices included in Level 1, that are either directly or indirectly observable for the asset or liability through correlation with market data at the reporting date and for the duration of the instrument’s anticipated life.

The fair valued assets the Company holds that are generally assessed under Level 2 are corporate bonds and commercial paper. The Company utilizes third party pricing services in developing fair value measurements where fair value is based on valuation methodologies such as models using observable market inputs, including benchmark yields, reported trades, broker/dealer quotes, bids, offers and other reference data. The Company uses quotes from external pricing service providers and other on-line quotation systems to verify the fair value of investments provided by its third-party pricing service providers. The Company reviews independent service auditor’s reports from its third-party pricing service providers particularly regarding the controls over pricing and valuation of financial instruments and ensure that its internal controls address certain control deficiencies, if any, and complementary user entity controls are in place.

The Company does not have fair valued assets classified under Level 2 as of March 31, 2019 and December 31, 2018.

Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities and which reflect management’s best estimate of what market participants would use in pricing the asset or liability at the reporting date. Consideration is given to the risk inherent in the valuation technique and the risk inherent in the inputs to the model.

The Company’s financial instruments consist of cash and cash equivalents, short-term investments, and accounts payable, all of which are reported at their respective fair value on its consolidated balance sheets.

The Company does not have fair valued assets classified under Level 3 as of March 31, 2019 and December 31, 2018.

As of March 31, 2019 and December 31, 2018, financial assets measured at fair value on a recurring basis are categorized in the table below based upon the lowest level of significant input to the valuations (in thousands):

	Assets at Fair Value as of March 31, 2019
	Level 1		Level 2		Level 3		Total
US treasury securities	$	234,681	$	-	$	-	$	234,681
US government agency securities		151,244		-		-		151,244
Total	$	385,925	$	-	$	-	$	385,925

	Assets at Fair Value as of December 31, 2018
	Level 1		Level 2		Level 3		Total
US treasury securities	$	265,393	$	-	$	-	$	265,393
US government agency securities		120,978		-		-		120,978
Total	$	386,371	$	-	$	-	$	368,371

Use of Estimates

The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America (“GAAP”) requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. Actual results could differ from those estimates. Significant estimates include valuation of short-term investments, 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 consolidated financial statements include the accounts of Iovance Biotherapeutics, Inc. and its wholly-owned subsidiary, Iovance Biotherapeutics GmbH. All intercompany accounts and transactions have been eliminated. The U.S. dollar is the functional currency for all the Company's consolidated operations.

Leases

The Company determines if an arrangement includes a lease at inception. Operating leases are included in its condensed consolidated balance sheet as Operating lease right-of-use assets and Operating lease liabilities as of March 31, 2019. Operating lease right-of-use assets represent our right to use an underlying asset for the lease term and operating lease liabilities represent our obligation to make lease payments arising from the lease. Operating lease right-of-use assets and liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term. In determining the net present value of lease payments, the Company uses an estimated incremental borrowing rate that is applicable to the Company based on the information available at later of the lease commencement date or the date of adoption of Accounting Standard Update (ASU) No. 2016-02 and ASU No. 2018-10, Leases (together “Topic 842”). The operating lease right-of-use assets also include any lease payments made and exclude lease incentives. The Company’s leases may include options to extend or terminate the lease, which is considered in the lease term when it is reasonably certain that the Company will exercise any such options. Lease expense is recognized on a straight-line basis over the expected lease term. The Company has elected not to apply the recognition requirements of Topic 842 for short-term leases.

For lease agreements entered into after the adoption of Topic 842 that include lease and non-lease components, such components are generally accounted for separately.

Prior period amounts continue to be reported in accordance with our historic accounting under previous lease guidance, Topic 840. See “Recently Adopted Accounting Pronouncements - Leases” below, for more information about the impact of the adoption on Topic 842.

Stock-Based Compensation

The Company periodically grants stock options and warrants to employees and non-employees in non-capital raising transactions as compensation for services rendered. The Company accounts for stock option grants to employees based on the authoritative guidance provided by the FASB where the value of the award is measured on the date of grant and recognized over the vesting period. Upon the adoption of ASU No. 2018-07, Compensation-Stock Compensation (“Topic 718”), the Company accounts for stock option grants to non-employees in the same manner as grants to employees, therefore no longer requiring a remeasurement at the then-current fair values at each reporting date until the share options have vested. The nonemployee awards that contain a performance condition that affects the quantity of other terms of the award are measured based on the outcome that is probable.

The fair value of the Company's common stock option grants is estimated using a Black-Scholes option pricing model, which uses certain assumptions related to risk-free interest rates, expected volatility, expected life of the common stock options, and future dividends. The stock-based compensation expense is recorded based upon the value derived from the Black-Scholes option pricing model. The assumptions used in the Black-Scholes option pricing model could materially affect compensation expense recorded in future periods.

The Company has in the past issued restricted 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, which is recognized as an expense over the period during which an employee is required to provide services in exchange for the award.

The fair value of restricted stock units is based on the closing price of the Company’s common stock on the grant date.

Total stock-based compensation expense related to all of the Company’s stock-based awards was recorded on the statements of operations as follows (in thousands):

	Three Months Ended March 31,
	2019		2018
Research and development	$	2,701	$	2,000
General and administrative		3,145		2,104
Total stock-based compensation expense	$	5,846	$	4,104

Total stock-based compensation expenses broken down based on each individual instrument were as follows (in thousands):

	Three Months Ended March 31,
	2019		2018
Stock option expense	$	5,779	$	4,037

Restricted stock unit expense		67		67
Total stock-based compensation expense	$	5,846	$	4,104

Preferred Stock

The Company applies the accounting standards for distinguishing liabilities from equity when determining the classification and measurement of its preferred stock. Preferred shares subject to mandatory redemption are classified as liability instruments and are measured at fair value. Conditionally redeemable preferred shares (including preferred shares that feature redemption rights that are either within the control of the holder or subject to redemption upon the occurrence of uncertain events not solely within the Company’s control) are classified as temporary equity. At all other times, preferred shares are classified as stockholders’ equity.

Convertible Instruments

The Company applies the accounting standards for derivatives and hedging and for distinguishing liabilities from equity when accounting for hybrid contracts that feature conversion options. The accounting standards require companies to bifurcate conversion options from their host instruments and account for them as free-standing derivative financial instruments according to certain criteria. The criteria include circumstances in which (i) the economic characteristics and risks of the embedded derivative instrument are not clearly and closely related to the economic characteristics and risks of the host contract, (ii) the hybrid instrument that embodies both the embedded derivative instrument and the host contract is not re-measured at fair value under otherwise applicable generally accepted accounting principles with changes in fair value reported in earnings as they occur and (iii) a separate instrument with the same terms as the embedded derivative instrument would be considered a derivative instrument. The derivative is subsequently marked to market at each reporting date based on current fair value, with the changes in fair value reported in results of operations.

Conversion options that contain variable settlement features such as provisions to adjust the conversion price upon subsequent issuances of equity or equity linked securities at exercise prices more favorable than that featured in the hybrid contract generally result in their bifurcation from the host instrument.

The Company also records, when necessary, deemed dividends for the intrinsic value of the conversion options embedded in preferred stock based upon the difference between the fair value of the underlying common stock at the commitment date of the transaction and the effective conversion price embedded in the preferred stock.

Recently Adopted Accounting Guidance

Leases

On January 1, 2019, the Company adopted Topic 842, which establishes a new lease accounting method for lessees. The updated guidance requires an entity to recognize assets and liabilities arising from a lease for both financing and operating leases, along with additional qualitative and quantitative disclosures. The Company elected the package of practical expedients requiring no reassessment of whether any expired or existing contracts are or contain leases, the lease classification of any expired or existing leases, or initial direct costs for any existing leases. The standard had a material impact on its consolidated balance sheets by recognizing Operating lease right-of-use assets and Operating lease liabilities for operating leases but did not have an impact on our consolidated statement of operations or cash flows. The adoption of the Topic 842 resulted in recognition of Operating lease right-of-use assets of $10.4 million and $4.9 million Operating lease liabilities – current, and $5.8 million of Operating lease liabilities – noncurrent as of January 1, 2019, the date of adoption.

Improvements to Nonemployee Share-Based Payment Accounting

On January 1, 2019, the Company adopted Topic 718, which eliminates the separate accounting method for nonemployee share-based payment awards and generally requires companies to account for share-based payment transactions with nonemployees in the same manner as share-based payment transactions with employees. Under the new guidance, nonemployee share-based payment transactions are measured at the grant-date fair value and are no longer remeasured at the then-current fair values at each reporting date until the share options have vested. The guidance requires a modified-retrospective approach in transition. The Company compared the cumulative amounts that were recorded for its nonemployee share-based payments through December 31, 2018 immediately preceding the date of adoption to the cumulative amounts that should be recognized at the adoption date and recognized a cumulative effect of the transition adjustment of $0.3 million to retained earnings as of the date of adoption, January 1, 2019.

Presentation of Stockholders’ Equity

In August 2018, the Security Exchange Commission (SEC) adopted the final rule under SEC Release No. 33-10532, “Disclosure Update and Simplification,” amending certain disclosure requirements that were redundant, duplicative, overlapping, outdated or superseded. In addition, the amendments expanded the disclosure requirements on the analysis of stockholders’ equity for interim financial statements. Under the amendments, an analysis of changes in each caption of stockholders’ equity presented in the balance sheet must be provided in a note or separate statement. The Company has included its first presentation of changes in stockholders’ equity in this Quarterly Report on Form 10-Q for the three months ended March 31, 2019 and 2018.

Fair Value Measurements Disclosure

In August 2018, the FASB issued ASU No. 2018-13 Fair Value Measurement (Topic 820): Disclosure Framework- Changes to the Disclosure Requirements for Fair Value Measurement, which eliminates disclosure requirement regarding transfers between level 1 and level 2 of the fair value of hierarchy, however, adds disclosure requirements on the range and weighted average used to develop significant unobservable inputs for level 3 fair value measurements. The Company adopted the guidance on January 1, 2019, however, there was no adjustment required to its disclosures as it did not have fair value assets classified under level 2 or 3 as of March 31, 2019 and December 31, 2018.

Subsequent Event

The Company’s management evaluates events that have occurred after the balance sheet date but before the financial statements are issued. See Note 11 Subsequent Event.

Reclassifications

Certain amounts within the balance sheets for the prior period have been reclassified to conform with the current period presentation. These reclassifications had no impact on the Company's previously reported financial position or cash flows for any of the periods presented.

STOCKHOLDERS' EQUITY

3 Months Ended

Mar. 31, 2019

Stockholders' Equity Note [Abstract]

STOCKHOLDERS' EQUITY

NOTE 5. STOCKHOLDERS’ EQUITY

Public Offerings

In September 2017, the Company closed an underwritten public offering of 8,846,154 shares of the Company’s common stock at a public offering price of $6.50 per share, before underwriting discounts, which included 1,153,846 shares issued upon the exercise in full by the underwriter of its option to purchase additional shares at the public offering price less the underwriting discounts. The gross proceeds from the offering, before deducting the underwriting discounts and commissions and other offering expenses payable by the Company, were $57.5 million, with net proceeds to the Company of $53.7 million.

In January 2018, the Company closed an underwritten public offering of 15,000,000 shares of the Company’s common stock at a public offering price of $11.50 per share, before underwriting discounts, which included 1,956,521 shares issued upon the exercise in full by the underwriter of its option to purchase additional shares at the public offering price less the underwriting discount. The gross proceeds from the offering, before deducting the underwriting discounts and commissions and other offering expenses payable by the Company, were $172.5 million, with net proceeds to the Company of $162.0 million.

On October 17, 2018, the Company completed an underwritten public offering of 25,300,000 shares of the Company’s common stock at a public offering price of $9.97 per share, before underwriting discounts, which included 3,300,000 shares issued upon the exercise in full by the underwriter of its option to purchase additional shares at the public offering price less the underwriting discount. The gross proceeds from the offering, before deducting the underwriting discounts and commissions and other estimated offering expenses payable by the Company, were $252.2 million, with net proceeds to the Company of $236.7 million.

Preferred Stock

The Company’s certificate of incorporation authorizes the issuance of up to 50,000,000 shares of “blank check” preferred stock. At March 31, 2019, 17,000 shares were designated as Series A Convertible Preferred Stock (“Series A Convertible Preferred Stock”) and

11,500,000

shares were designated as Series B Convertible Preferred Stock (“Series B Convertible Preferred Stock”).

Series A Convertible Preferred Stock

A total of

17,000

shares of Series A Convertible Preferred Stock have been authorized for issuance under the Company’s Certificate of Designation of Preferences and Rights of Series A Convertible Preferred Stock. The shares of Series A Convertible Preferred Stock have a stated value of $1,000 per share and are initially convertible into shares of common stock at a price of $2.00 per share, subject to adjustment.

The Series A Convertible Preferred Stock may, at the option of each investor, be converted into fully paid and non-assessable shares of common stock. The holders of shares of Series A Convertible Preferred Stock do not have the right to vote on matters that come before the Company’s stockholders. In the event of any dissolution or winding up of the Company, proceeds shall be paid pari passu among the holders of common stock and preferred stock, pro rata based on the number of shares held by each holder. The Company may not declare, pay or set aside any dividends on shares of capital stock of the Company (other than dividends on shares of common stock payable in shares of common stock) unless the holders of the Series A Convertible Preferred Stock shall first receive an equal dividend on each outstanding share of Series A Convertible Preferred Stock. The common shares issued were determined on a formula basis of 500 common shares for each share of Series A Convertible Preferred Stock converted.

No Shares of Series A Convertible Preferred Stock were converted during the three months ended March 31, 2019 or 2018. At March 31, 2019, 194 shares of Series A Convertible Preferred Stock (that are convertible into 97,000 shares of common stock) remained outstanding.

Series B Convertible Preferred Stock

A total of 11,500,000 shares of Series B Convertible Preferred Stock are authorized for issuance under the Company’s Series B Certificate of Designation of Rights, Preferences and Privileges of Series B Convertible Preferred Stock. The shares of Series B Convertible Preferred Stock have a stated value of $4.75 per share and are convertible into shares of the Company’s common stock at an initial conversion price of $4.75 per share.

Holders of Series B Convertible Preferred Stock are entitled to dividends on an as-if-converted basis in the same form as any dividends actually paid on shares of the Series A Convertible Preferred Stock or the Company’s common stock. So long as any Series B Convertible Preferred Stock remains outstanding, the Company may not redeem, purchase or otherwise acquire any material amount of the Series A Convertible Preferred Stock or any securities junior to the Series B Convertible Preferred Stock.

No shares of Series B Convertible Preferred Stock were converted during the three months ended March 31, 2019 and 2018. At March 31, 2019, 5,854,845 shares of Series B Preferred Stock (that are convertible into 5,854,845 shares of common stock) remained outstanding.

Warrants

There were no remaining outstanding warrants as of March 31, 2019 and December 31, 2018.

Cancellation of Common Shares

September 30, 2013

, Iovance and a third party entered into an agreement under which the Company issued 50,000 shares of unregistered stock in the Company to the third party. On

January 16, 2019

, the two parties entered into a

confidential

settlement agreement in connection with a

spute

related to their prior relationship and activities. As part of the settlement, the third party returned 32,500 shares of common stock to the Company for cancellation and retained the remaining 17,500 shares. The Company included a gain of $335,000 on cancellation of

32,500

shares in Other income in its condensed consolidated statement of operations.

STOCK BASED COMPENSATION

3 Months Ended

Mar. 31, 2019

Disclosure of Compensation Related Costs, Share-based Payments [Abstract]

STOCK BASED COMPENSATION

NOTE 6. STOCK BASED COMPENSATION

Stock Plans

On October 14, 2011, the Company adopted the 2011 Equity Incentive Plan (the “2011 Plan”). Employees, directors, consultants and advisors of the Company are eligible to participate in the 2011 Plan. The 2011 Plan initially had 180,000 shares of common stock reserved for issuance in the form of incentive stock options, non-qualified options, common stock, and grant appreciation rights. The 2011 Plan was not approved by the Company’s stockholders within the required one-year period following its adoption and, accordingly, no incentive stock options can be granted under the 2011 plan, but non-qualified options, common stock and grant appreciation rights can still be granted. In August 2013, the Company’s Board of Directors and a majority of the Company’s stockholders approved an amendment to increase the number of shares available under the 2011 Plan from 180,000 shares to 1,700,000 shares, and an amendment to increase the number of options or other awards that can be granted to any one person during a twelve (12) month period from 50,000 shares to 300,000 shares. The foregoing amendment to the 2011 Plan became effective in September 2013. On August 20, 2014, the Company’s Board of Directors amended the 2011 Plan to increase the number of shares available for issuance upon the exercise of stock options under the 2011 Plan from 1,700,000 to 1,900,000 shares, effective immediately. As of March 31, 2019, 376,240 shares were available for future grant under the 2011 Plan.

On September 19, 2014, the Company’s Board of Directors adopted the Iovance Biotherapeutics, Inc. 2014 Equity Incentive Plan (the “2014 Plan”). The 2014 Plan was approved by the Company’s stockholders at the Company’s 2014 Annual Meeting of Stockholders held in November 2014. The 2014 Plan, as approved by the stockholders, authorized the issuance up to an aggregate of 2,350,000 shares of the Company’s common stock. On April 10, 2015, the Board of Directors amended the 2014 Plan to increase the total number of shares that can be issued under the 2014 Plan to 4,000,000 shares of the Company’s common stock. The increase in shares available for issuance under the 2014 Plan was approved by the Company’s stockholders at the Company’s 2015 Annual Meeting of Stockholders in June 2015.

On August 16, 2016, the Company’s stockholders approved an increase in the total number of shares that can be issued under the 2014 Plan to 9,000,000 shares of the Company’s common stock. As of March 31, 2019, 5,223 shares were available for grant under the Company’s 2014 Plan.

On April 22, 2018, the Board of Directors adopted the Iovance Biotherapeutics, Inc. 2018 Equity Incentive Plan (the “2018 Plan”). The 2018 Plan was approved by the Company’s stockholders at the Annual Meeting of Stockholders held in June 2018. The 2018 Plan as approved by the stockholders authorized the issuance up to an aggregate of 6,000,000 shares of common stock reserved for issuance in the form of incentive (qualified) stock options, non-qualified options, common stock, stock appreciation rights, restricted stock awards, restricted stock units, other stock-based awards, other cash-based awards or any combination of the foregoing. As of March 31, 2019, 4,183,900 shares were available for grant under the 2018 Plan.

Restricted Stock Units

On June 1, 2016, the Company entered into a restricted stock unit agreement with the Company’s new Chief Executive Officer, Maria Fardis, Ph.D., pursuant to which the Company granted Dr. Fardis 550,000 non-transferrable restricted stock units at fair market value of $5.87 per share as an inducement for employment pursuant to Nasdaq Listing Rule 5635(c)(4). The 550,000 restricted stock units vest in installments as follows: (i) 137,500 restricted stock units vested upon the first anniversary of the effective date of Dr. Fardis’ employment agreement; (ii) 275,000 restricted stock units vest upon the satisfaction of certain clinical trial milestones; and (iii) 137,500 restricted stock units vest in equal monthly installments over the 36-month period following the first anniversary of the effective date of Dr. Fardis’ employment, provided that Dr. Fardis has been continuously employed with the Company as of such vesting dates. As of March 31, 2019, 57,285 restricted stock units remained unvested.

Stock-based compensation expense for restricted stock units are measured based on the closing fair market value of the Company's common stock on the date of grant. The stock-based compensation expenses relating to restricted stock units were $0.1 million and $0.1 million for the three months ended March 31, 2019 and 2018, respectively, recorded as part of general and administrative expenses.

As of March 31, 2019, $0.3 million of total unrecognized compensation costs related to non-vested restricted stock units to be recognized over a weighted average period of 1.17 years.

Stock Options

A summary of the status of stock options at March 31, 2019, and the changes during the three months then ended, is presented in the following table:

				Weighted		Weighted		Aggregate
	Number			Average		Average		Intrinsic
	of			Exercise		Remaining		Value (in
	Options			Price		Contract Life		thousands)
Outstanding at January 1, 2019		6,889,287		$	10.25
Granted		2,462,100			10.82
Exercised		(5,000	)		8.30
Expired/Forfeited		(71,414	)		11.05
Outstanding at March 31, 2019		9,274,973		$	10.40		8.46	$	9,916

Options exercisable at March 31, 2019		3,892,634		$	8.85		7.31	$	7,247

The Company recorded stock-based compensation costs related to options of $5.8 million and $4.1 million for the three months ended March 31, 2019 and 2018. As of March 31, 2019, there was $45.7 million of total unrecognized compensation expense related to the options to be recognized over a weighted average period of 2.14 years.

The weighted average grant date fair value for employee options granted under the Company's stock option plans during the three months ended March 31, 2019 and 2018 was $6.99 and $15.52 per option respectively.

The aggregate intrinsic value in the table above reflects the total pre-tax intrinsic value (the difference between the Company’s closing stock price on the last trading day of the three months ended March 31, 2019 and the exercise price of the options, multiplied by the number of in-the-money stock options) that would have been received by the option holders had all option holders exercised their options on March 31, 2019. The intrinsic value of the Company’s stock options changes based on the closing price of the Company’s common stock.

The following table summarizes the assumptions relating to options granted pursuant to the Company’s equity incentive plans for the three months ended March 31, 2019 and 2018:

	Three Months Ended March 31,
Assumptions:	2019		2018
Expected term (years)		6.06		5.13 – 6.50
Expected volatility		70.78%		170.85% - 200.28%
Risk-free interest rate		2.59%		2.27% - 2.77%
Expected dividend yield		0%		0%

Expected Dividend Yield —The Company has never paid dividends and does not expect to pay dividends in the foreseeable future.

Risk-Free Interest Rate —The risk-free interest rate was based on the market yield currently available on United States Treasury securities with maturities approximately equal to the option’s expected term.

Expected Term —The expected term of the stock option grants was calculated based on historical exercises, cancellations, and forfeitures of stock options and outstanding option shares.

Expected Volatility —The expected volatility is based on the historical volatility for the Company's stock over a period equal to the expected terms of the options.

Forfeiture Rate —The Company recognizes forfeitures as they occur.

Each of the inputs discussed above is subjective and generally requires significant management judgment.

LICENSES AND AGREEMENTS

3 Months Ended

Mar. 31, 2019

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 to the CRADA to include four new indications. As amended, in addition to metastatic melanoma, the CRADA included the development of TIL therapy for the treatment of patients with bladder, lung, triple-negative breast, and Human Papilloma Virus (“HPV”)-associated cancers.

In August 2016, the NCI and the Company entered into a second amendment to the CRADA. The principal changes effected by the second amendment included (i) extending the term of the CRADA by another five years to August 2021, and (ii) modifying the focus on the development of unmodified TIL as a stand-alone therapy or in combination with FDA licensed products and commercially available reagents routinely used for adoptive cell therapy. The parties will continue the development of improved methods for the generation and selection of TIL with anti-tumor reactivity in metastatic melanoma, bladder, lung, breast, and HPV-associated cancers.

Pursuant to the terms of the CRADA, the Company is currently required to make quarterly payments of $0.5 million to the NCI for support of research activities. To the extent the Company licenses patent rights relating to a TIL-based product candidate, the Company will be responsible for all patent-related expenses and fees, past and future, relating to the TIL-based product candidate. In addition, the Company may be required to supply certain test articles, including TIL, grown and processed under cGMP conditions, suitable for use in clinical trials, where the Company holds the investigational new drug application for such clinical trial. The extended CRADA has a five-year term expiring in August 2021. The Company or the NCI may unilaterally terminate the CRADA for any reason or for no reason at any time by providing written notice at least 60 days before the desired termination date. The Company recorded costs associated with the CRADA of $0.5 million for the three months ended March 31, 2019 and 2018 as research and development expenses.

Patent License Agreement Related to the Development and Manufacture of TIL

Effective October 5, 2011, the Company entered into an Exclusive Patent License Agreement (the “Patent License Agreement”) with the NIH, an agency of the United States Public Health Service within the Department of Health and Human Services, which was subsequently amended on February 9, 2015 and October 2, 2015. Pursuant to the Patent License Agreement, as amended, the NIH granted the Company licenses, including exclusive, co-exclusive, and non-exclusive licenses, to certain technologies relating to autologous tumor infiltrating lymphocyte adoptive cell therapy products for the treatment of metastatic melanoma, lung, breast, bladder and HPV-positive cancers. The Patent License Agreement requires the Company to pay royalties based on a percentage of net sales (which percentage is in the mid-single digits), a percentage of revenues from sublicensing arrangements, and lump sum benchmark royalty payments on the achievement of certain clinical and regulatory milestones for each of the various indications and other direct costs incurred by the NIH pursuant to the agreement.

Exclusive Patent License Agreement Related to TIL Selection

On February 10, 2015, the Company entered into an exclusive patent license agreement (the “Exclusive Patent License Agreement”) with the NIH under which the Company received an exclusive license to the NIH’s rights to patent-pending technologies related to methods for improving adoptive cell therapy through more potent and efficient production of TIL from melanoma tumors by selecting for T-cell populations that express various inhibitory receptors. Unless terminated sooner, the license shall remain in effect until the last licensed patent right expires.

Under the Exclusive Patent License Agreement, the Company agreed to pay customary royalties based on a percentage of net sales of a licensed product (which percentage is in the mid-single digits), a percentage of revenues from sublicensing arrangements, and lump sum benchmark payments upon the successful completion of clinical studies involving licensed technologies, the receipt of the first FDA approval or foreign equivalent for a licensed product or process resulting from the licensed technologies, the first commercial sale of a licensed product or process in the United States, and the first commercial sale of a licensed product or process in any foreign country.

H. Lee Moffitt Cancer Center

Research Collaboration and Clinical Grant Agreements with Moffitt

In December 2016, the Company entered into a new three-year Sponsored Research Agreement with H. Lee Moffitt Cancer Center (“Moffitt”). At the same time, the Company entered into a clinical grant agreement with Moffitt to support an ongoing clinical trial at Moffitt that combines TIL therapy with nivolumab for the treatment of patients with metastatic melanoma. In June 2017, the Company entered into a second clinical grant agreement with Moffitt to support a new clinical trial at Moffitt that combines TIL therapy with nivolumab for the treatment of patients with non-small cell lung cancer, under which the Company obtained a non-exclusive, royalty-free license to any new Moffitt inventions made in the performance of the agreement. Under both clinical grant agreements with Moffit, the Company has non-exclusive rights to clinical data arising from the respective clinical trials. The Company recorded research and development costs of $0.3 million and $0.6 million for the three months ended March 31, 2019 and 2018, respectively, in connection with the research collaboration and clinical grant agreements with Moffitt.

Exclusive License Agreements with Moffitt

The Company entered into a license agreement with Moffitt (the “First Moffitt License”), effective as of June 28, 2014, under which the Company received a world-wide license to Moffitt’s rights to patent-pending technologies related to methods for improving TIL for adoptive cell therapy using toll-like receptor agonists. Unless earlier terminated, the term of the license extends until the earlier of the expiration of the last issued patent related to the licensed technology or 20 years after the effective date of the license agreement.

Pursuant to the First Moffitt License, the Company paid an upfront licensing fee in the amount of $0.1 million. A patent issuance fee will also be payable under the First Moffitt License, upon the issuance of the first U.S. patent covering the subject technology. In addition, the Company agreed to pay milestone license fees upon completion of specified milestones, customary royalties based on a specified percentage of net sales (which percentage is in the low single digits) and sublicensing payments, as applicable, and annual minimum royalties beginning with the first sale of products based on the licensed technologies, which minimum royalties will be credited against the percentage royalty payments otherwise payable in that year. The Company will also be responsible for all costs associated with the preparation, filing, maintenance and prosecution of the patent applications and patents covered by the First Moffitt License related to the treatment of any cancers in the United States, Europe and Japan and in other countries designated by the Company in agreement with Moffitt. No expenses were recorded for the First Moffitt License for the three months ended March 31, 2019 and 2018.

The Company entered into a license agreement with Moffitt effective as of May 7, 2018 (the “Second Moffitt License”), under which the Company received a license to Moffitt’s rights to patent-pending technologies related to the use of 4-1BB agonists in conjunction with TIL manufacturing processes and therapies. The Company continues to develop TIL therapies using 4-1BB agonists in manufacturing in conjunction with M.D. Anderson Cancer Center.

Pursuant to the Second Moffitt License, the Company paid an upfront licensing fee in the amount of $0.1 million in 2018. An annual license maintenance fee will be also payable commencing on the first anniversary of the effective date. In addition, the Company agreed to pay an annual commercial use payment for each indication for which a first sale has occurred, which in the aggregate amounts to up to $0.4 million a year. No expenses were recorded for the Second Moffitt License for the three months ended March 31, 2019 and 2018.

PolyBioCept

PolyBioCept Exclusive and Co-Exclusive License Agreement

On September 14, 2016, the Company entered into an exclusive and co-exclusive license agreement (the “PolyBioCept Agreement”) with PolyBioCept AB, a corporation organized under the laws of Sweden (“PolyBioCept”). 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 for the three months ended March 31, 2019 and 2018 in connection with this agreement.

M.D. Anderson Cancer Center

Strategic Alliance Agreement

On April 17, 2017, the Company entered into a Strategic Alliance Agreement (the “SAA”) with M.D. Anderson Cancer Center (“MDACC”) under which the Company and MDACC agreed to conduct clinical and preclinical research studies. The Company agreed in the SAA to provide total funding not to exceed approximately $14.2 million for the performance of the multi-year studies under the SAA. In return, the Company acquired all rights to inventions resulting from the studies and has been granted a non-exclusive, sub-licensable, royalty-free, and perpetual license to specified background intellectual property of MDACC reasonably necessary to exploit, including the commercialization thereof. The Company has also been granted certain rights in clinical data generated by MDACC outside of the clinical trials to be performed under the SAA. The SAA’s term shall continue in effect until the later of the fourth anniversary of the SAA or the completion or termination of the research and receipt by the Company of all deliverables due from MDACC thereunder. In May 2017, the Company made a prepayment of $1.4 million under this agreement. The Company recorded $1.2 million associated with the MDACC SAA for the three months ended March 31, 2019 as research and development expenses. No expense was recognized for the same period in 2018.

MedImmune

In December 2015, the Company entered into a collaboration agreement (the “MedImmune Agreement”) with MedImmune, the global biologics research and development arm of AstraZeneca (“MedImmune”), to conduct clinical and preclinical research immuno-oncology. Under the MedImmune Agreement, the Company funded and sought to conduct at least one clinical trial combining MedImmune's PD-L1 inhibitor, durvalumab, with TIL for the treatment of patients. MedImmune supplied durvalumab for the clinical trials. On April 3, 2019, the Company and MedImmune announced that the study was closed because of a changing treatment landscape and a lack of enrollment, and the collaboration agreement was terminated as of April 1, 2019.

WuXi Apptech, Inc. (“WuXi”)

In November 2016, the Company entered into a three-year manufacturing and services agreement (“MSA”) with WuXi AppTech, Inc. (“Wuxi”) pursuant to which WuXi agreed to provide manufacturing and other services. Under the agreement, the Company entered into two statements of work for two cGMP manufacturing suites to be established and operated by WuXi for the Company, one of the suites is expected to be capable of being used for the commercial manufacture of our products. The statements of work for each facility include a fixed component to reserve a dedicated suite and a variable component, mainly labor and materials used during the manufacturing process. The fee payable under the first statement of work for the use of one of the manufacturing suites during the first year of the agreement, including the fees for the necessary personnel, was $2.5 million. The second statement of work, under which WuXi agreed to establish and operate a second, dedicated 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 $3.8 million and $2.8 million for three months ended March 31, 2019 and 2018 respectively, as research and development expenses.

LEGAL PROCEEDINGS

3 Months Ended

Mar. 31, 2019

Loss Contingency [Abstract]

LEGAL PROCEEDINGS

NOTE 8. LEGAL PROCEEDINGS

Class Action Lawsuit.

On April 10, 2017, the SEC announced settlements with the Company and with other public companies and unrelated parties in the

In the Matter of Certain Stock Promotion

investigation. The

Company’s

settlement with the SEC is consistent with its previous disclosures (including in our Annual Report on Form 10-K that the Company 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. 3:17cv2086) against the Company and three of its 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, the former CEO, and the 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 its 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 the Company’s insurance carrier and would result in no loss to the Company. The court gave preliminary approval to the proposed settlement on November 30, 2018. A hearing was held on April 12, 2019 to determine whether the proposed settlement was fair, reasonable, and adequate, and whether the claims should be dismissed. On April 17, 2019, the court approved the final settlement, involving a payment of $3,250,000 by the Company’s insurance carrier to a settlement fund, awarded attorney’s fees and costs to be paid to plaintiff’s counsel from the settlement fund, approved the plan of allocation for settlement class members, and ordered that the claims against the Company should be dismissed with prejudice. The Company does not expect to incur any costs or expenses in connection with this settlement.

Derivative Lawsuits.

On December 15, 2017, a purported stockholder derivative complaint was filed by plaintiff Kevin Fong against the Company, as nominal defendant, and certain of the 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 the 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 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 our 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 the Company 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 plaintiffs’ 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. On January 2, 2019, plaintiffs filed their memorandum of law in opposition to the appeal. On January 18, 2019, the Company filed its reply brief in support of its appeal of the order dismissing its amended counterclaims and affirmative defense for fraudulent inducement. On April 4, 2019, the appellate court ordered that the Company’s amended counterclaims and its affirmative defense for fraudulent inducement be reinstated.

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 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, we 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 our materials, prohibiting him from disclosing or using the Company’s 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 the Company and Dr. Fardis. On October 18, 2018, Dr. Fischkoff amended his complaint to assert a new claim for defamation arising from SEC filings in which the Company provided the information about this litigation.

The Company intends to vigorously defend against Dr. Fischkoff’s lawsuit and pursue the Company’s counterclaims. Based on the current stage of the litigation, it is not possible to estimate the amount or range of (i) a possible loss that might result from an adverse judgment or settlement of this action, or (ii) the potential recovery that might result from a favorable judgment or a settlement of this action.

Other Matters.

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, the Company believes 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 of 1933, as amended, 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 2011 Plan. Before the Company filed the required post-effective amendment, options to purchase 200,000 shares were exercised under the 2011 Plan. The effect of the delayed post-effective amendment filing on the 200,000 option shares is uncertain, but the issuance and sale of the shares may not have been in compliance with the Form S-8 registration statement. The existence of any liability to the Company, and the amount of any such liability to the Company, as a result of the issuance of the 200,000 shares is uncertain. Accordingly, no accrual for a potential claim has been made by the Company in its financial statements.

The Company may be involved, from time to time, in legal proceedings and claims arising in the ordinary course of our business. Such matters are subject to many uncertainties and outcomes are not predictable with assurance. The Company accrues amounts, to the extent they can be reasonably estimated, that it believes are adequate to address any liabilities related to legal proceedings and other loss contingencies that it believes will result in a probable loss. While there can be no assurances as to the ultimate outcome of any legal proceeding or other loss contingency involving the Company, management does not believe any pending matter will be resolved in a manner that would have a material adverse effect on our financial position, results of operations or cash flows.

LEASES

3 Months Ended

Mar. 31, 2019

Leases [Abstract]

Lessee, Operating Leases [Text Block]

NOTE 9. LEASES

As described further in “Note 2. Summary of Significant Accounting Policies”, the Company adopted Topic 842 as of January 1, 2019. Prior period amounts have not been adjusted and continue to be reported in accordance with its historic accounting under ASU Topic 840- Leases (Topic 840).

Facilities Leases

The Company has evaluated the following facility leases and determined that, effective upon the adoption of Topic 842, they were all operating leases. Operating lease right-of-use assets and liabilities were recognized as of January 1, 2019 based on the present value of the remaining lease payments over the lease term. As the Company’s leases do not provide an implicit rate, the Company utilized a third party in determining an incremental borrowing rate based on the information available as of the adoption date of Topic 842 to obtain the present value of lease payments. The Company’s lease terms may include options to extend or terminate the lease which are included in the lease term when it is reasonably certain that it will exercise any such options. Lease expense is recognized on a straight-line basis over the expected lease term. The Company elected not to apply the recognition requirements of Topic 842 for short-term leases that have a lease term of 12 months or less.

Tampa Lease

In December 2014, the Company commenced a five-year non-cancellable operating lease with the University of South Florida Research Foundation for a 5,115 square foot facility located in Tampa, Florida. The facility is part of the University of South Florida research park and is used as the Company’s research and development facilities. The Company has the option to extend the lease term of this facility for an additional five-year period on the same terms and conditions, except that the base rent for the renewal term will be increased in accordance with the applicable consumer price index.

In April 2015, the Company amended the original lease agreement to increase the rentable space to 6,043 square feet. In September 2016, the Company further increased the rentable space to 8,673 square feet. The per square foot cost and term of the lease were unchanged, and rent payments are approximately $20,000 per month. The lease expires in December 2019.

San Carlos Lease

On August 4, 2016, the Company entered into an agreement to lease 8,733 square feet in San Carlos, California. The term of the lease is 54 months subsequent to the commencement date and will expire in April 2021. Monthly lease payments are approximately $38,000.

On April 28, 2017, the Company entered into a sublease agreement with Teradata US, Inc., pursuant to which the Company agreed to sublease certain office space located adjacent to the Company's headquarters for approximately $26,000 per month. The space consists of approximately 11,449 rentable square feet in the building located in San Carlos, California. The sublease for this space expired on October 31, 2018. Monthly lease payments were approximately $26,000.

On October 19, 2018, the Company entered into an agreement to lease 12,322 square feet of office space located adjacent to the Company's headquarters in San Carlos, California. This lease replaces the sublease of 11,449 square feet of office space in the same facility that expired on October 31, 2018. The term of the lease is 30 months subsequent to the commencement date, November 1, 2018, and will expire in April 2021. Monthly lease payments are approximately $59,000, subject to an annual increase of 3%.

New York Lease

The Company leased office space in New York for a monthly rental of approximately $18,000 a month from January 2017 through July 2017. On June 5, 2017, the Company entered into an agreement whereby the Company will lease office space from August 1, 2017 to July 31, 2018, for approximately $9,000 a month. On April 20, 2018, the Company entered into an agreement to extend the lease term to January 31, 2019 for approximately $7,000 a month. On November 2, 2018, the Company entered into an agreement to extend the lease term to July 31, 2019 for approximately $4,000 a month.

Manufacturing Contracts

The Company uses contract manufacturing organizations (collectively the “CMOs” and each a “CMO”) to manufacture and supply TILs for clinical and commercial purposes. The CMO contractual obligations consist of the use of manufacturing facilities and minimum fixed commitment fees, such as personnel, general support fees, and minimum production or material fees. In addition to the minimum fixed commitment fees, the CMO contractual obligations include variable costs such as production and material costs in excess of the minimum quantity specified in each CMO agreement. During the term of each CMO agreement, the Company has access to and control of the use of a dedicated suite in each of the CMOs’ facilities for manufacturing activities. In conjunction with the adoption of Topic 842 on January 1, 2019, the Company reevaluated all of its material contracts it has, to determine whether they contain a lease under the current lease guidance Topic 840. An arrangement is considered a lease or contains a lease if an underlying asset is explicitly or implicitly identified and use of the asset is controlled by the customer. Based on this evaluation, the Company concluded that all of its contracts with CMOs contained embedded operating leases because the suites used for its production are implicitly identified, is only used by the Company exclusively during the contractual term of the arrangements, and the CMOs have no substantive contractual rights to substitute the facilities used by the Company. Further, the Company controls the use of the facilities by obtaining all of the economic benefits from the use of the facilities and direct the use of the facilities throughout the period of use. The terms of the CMO contracts include options to terminate the lease with an advance notice of five to six months. The termination clauses and extension clauses are included in the calculation of the lease term for each of the CMOs when it is reasonably certain that it will not exercise such options.

The guidance requires the Company to first identify a lease deliverable and non-lease deliverable included in the arrangements, and then allocate the fixed contractual consideration to the lease deliverable(s) and the non-lease deliverable(s) on a relative standalone selling price basis to determine the amount of operating lease right-of-use assets and liabilities. The Company identified the use of a dedicated suite as a single lease deliverable, and related labor services as a single non-lease deliverable in each of the CMO arrangements. Judgment is required to determine the relative standalone selling price of each deliverable as the observable standalone selling prices are not readily available. Therefore, management used estimates and assumptions in determining relative standalone selling price of lease of a suite and labor service using information that includes market and other observable inputs to the extent possible.

The Company leases certain furniture and equipment that has a lease term of 12 months or less. Since the commencement date does not include an option to purchase the underlying asset, the Company elected not to apply the recognition requirements of Topic 842 for short-term leases, however, the lease costs that pertain to the short-term leases are disclosed in the components of lease costs table below.

The balance sheet classification of the Company’s right-of-use asset and lease liabilities was as follows:

	March 31, 2019

Operating lease right-of-use assets	$	9,957
Operating lease liabilities
Current portion included in current liabilities		6,059
long-term portion included in non-current liabilities		4,380
Total Operating lease liabilities	$	10,439

The components of lease expenses, which were included in Total expenses in the Company’s consolidated statement of operations, were as follows:

	For the Three Months Ended March 31, 2019

Operating lease cost	$	1,594
Variable lease cost		896
Short-term lease cost		19
Total lease cost		2,509

Variable lease cost is determined based on performance or usage in accordance with the contractual agreements, and not based on an index or rate.

Cash paid for amounts included in the measurement of lease liabilities for the three months ended March 31, 2019 was $1.4 million and were included in Net cash provided by operating activities in its consolidated statement of cash flows. Upon the adoption of Topic 842 on January 1, 2019, the Company increased noncash balances of operating lease right-of-use assets and operating lease liabilities by $10.4 million and $10.7 million, respectively. During the three months ended March 31, 2019, the Company additionally increased noncash balance of operating lease right-of-use assets and operating lease liability by $1.0 million as a result of lease modifications.

As of March 31, 2019, the maturities of the Company’s operating lease liabilities were as follows (in thousands):

	Facility leases			CMO embedded leases			Total
Remainder of 2019	$	1,066		$	3,975		$	5,041
2020		1,223			3,366			4,589
2021		419			994			1,413
2022		-			144			144
2023		-			-			-
Thereafter		-			-			-
Total lease payments	$	2,708		$	8,479		$	11,187
Less: Present value adjustment		(189	)		(559	)		(748	)
Operating lease liabilities	$	2,519		$	7,920		$	10,439

Operating lease liabilities are based on the net present value of the remaining lease payments over the remaining lease term. In determining the present value of lease payments, the Company used its incremental borrowing rate based on the information available at the date of adoption of Topic 842. As of March 31, 2019, the weighted average remaining lease term is 1.86 years and the weighted average discount rate used to determine the operating lease liabilities was 8.4%.

Disclosures related to periods prior to adoption of Topic 842

As required, the following disclosure is provided for periods prior to adoption. Minimum lease commitments as of December 31, 2018 that have initial or remaining lease terms in excess of one year are as follows:

	Facility leases		CMO embedded leases		Total
2019	$	1,373	$	5,088	$	6,461
2020		1,223		3,366		4,589
2021		418		994		1,412
2022		-		144		144
2023		-		-		-
Thereafter		-		-		-
Total lease payments	$	3,014	$	9,592	$	12,606

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)

3 Months Ended

Mar. 31, 2019

Accounting Policies [Abstract]

Cash and Cash Equivalents

Cash, Cash Equivalents, and Short-term Investments

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.

At March 31, 2019 and 2018, the following outstanding common stock equivalents have been excluded from the calculation of net loss per share because their impact would be anti-dilutive.

	March 31,
	2019		2018
Stock options		9,274,973		6,951,067
Warrants		-		5,570,835
Series A Convertible Preferred Stock*		97,000		847,000
Series B Convertible Preferred Stock*		5,854,845		7,378,241
Restricted stock units		57,285		103,123
		15,284,103		20,850,266

* on an as-converted basis

Fair Value Measurements

The Company does not have fair valued assets classified under Level 2 as of March 31, 2019 and December 31, 2018.

The Company does not have fair valued assets classified under Level 3 as of March 31, 2019 and December 31, 2018.

	Assets at Fair Value as of March 31, 2019
	Level 1		Level 2		Level 3		Total
US treasury securities	$	234,681	$	-	$	-	$	234,681
US government agency securities		151,244		-		-		151,244
Total	$	385,925	$	-	$	-	$	385,925

	Assets at Fair Value as of December 31, 2018
	Level 1		Level 2		Level 3		Total
US treasury securities	$	265,393	$	-	$	-	$	265,393
US government agency securities		120,978		-		-		120,978
Total	$	386,371	$	-	$	-	$	368,371

Use of Estimates

Principles of Consolidation

Leases

For lease agreements entered into after the adoption of Topic 842 that include lease and non-lease components, such components are generally accounted for separately.

Stock-Based Compensation

The fair value of restricted stock units is based on the closing price of the Company’s common stock on the grant date.

Total stock-based compensation expense related to all of the Company’s stock-based awards was recorded on the statements of operations as follows (in thousands):

	Three Months Ended March 31,
	2019		2018
Research and development	$	2,701	$	2,000
General and administrative		3,145		2,104
Total stock-based compensation expense	$	5,846	$	4,104

Total stock-based compensation expenses broken down based on each individual instrument were as follows (in thousands):

	Three Months Ended March 31,
	2019		2018
Stock option expense	$	5,779	$	4,037

Restricted stock unit expense		67		67
Total stock-based compensation expense	$	5,846	$	4,104

Preferred Stock

Convertible Instruments

Recently Adopted Accounting Guidance

Leases

Improvements to Nonemployee Share-Based Payment Accounting

Presentation of Stockholders’ Equity

Fair Value Measurements Disclosure

Subsequent Events

Subsequent Event

The Company’s management evaluates events that have occurred after the balance sheet date but before the financial statements are issued. See Note 11 Subsequent Event.

Reclassifications

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables)

3 Months Ended

Mar. 31, 2019

Accounting Policies [Abstract]

Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share

At March 31, 2019 and 2018, the following outstanding common stock equivalents have been excluded from the calculation of net loss per share because their impact would be anti-dilutive.

	March 31,
	2019		2018
Stock options		9,274,973		6,951,067
Warrants		-		5,570,835
Series A Convertible Preferred Stock*		97,000		847,000
Series B Convertible Preferred Stock*		5,854,845		7,378,241
Restricted stock units		57,285		103,123
		15,284,103		20,850,266

* on an as-converted basis

Schedule of Assets Measured at Fair Value

	Assets at Fair Value as of March 31, 2019
	Level 1		Level 2		Level 3		Total
US treasury securities	$	234,681	$	-	$	-	$	234,681
US government agency securities		151,244		-		-		151,244
Total	$	385,925	$	-	$	-	$	385,925

	Assets at Fair Value as of December 31, 2018
	Level 1		Level 2		Level 3		Total
US treasury securities	$	265,393	$	-	$	-	$	265,393
US government agency securities		120,978		-		-		120,978
Total	$	386,371	$	-	$	-	$	368,371

Schedule of Stock-Based Compensation

Total stock-based compensation expense related to all of the Company’s stock-based awards was recorded on the statements of operations as follows (in thousands):

	Three Months Ended March 31,
	2019		2018
Research and development	$	2,701	$	2,000
General and administrative		3,145		2,104
Total stock-based compensation expense	$	5,846	$	4,104

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 March 31,
	2019		2018
Stock option expense	$	5,779	$	4,037

Restricted stock unit expense		67		67
Total stock-based compensation expense	$	5,846	$	4,104

GENERAL ORGANIZATION AND BUSINESS (Details Textual) - USD ($) $ / shares in Units, $ in Thousands	1 Months Ended				3 Months Ended
	Oct. 17, 2018	Jan. 31, 2018	Sep. 30, 2017	Sep. 30, 2013	Mar. 31, 2019	Mar. 31, 2018	Dec. 31, 2018	Dec. 31, 2017
Net Income (Loss) Attributable to Parent					$ (36,950)	$ (26,515)
Cash, Cash Equivalents, and Short-term Investments					385,925		$ 386,371
Cash and Cash Equivalents, at Carrying Value					54,093	297,082	$ 82,152	$ 145,373
Short-term Investments					385,900
Stock Issued During Period, Shares, New Issues	25,300,000			50,000
Proceeds from Issuance of Common Stock	$ 236,700				0	162,186
Shares Issued, Price Per Share	$ 9.97
Net Cash Provided by (Used in) Operating Activities					$ (29,090)	$ (17,849)
Underwriter [Member]
Stock Issued During Period, Shares, New Issues	3,300,000
IPO [Member]
Stock Issued During Period, Shares, New Issues		15,000,000	8,846,154
Proceeds from Issuance of Common Stock		$ 162,000	$ 53,700
Shares Issued, Price Per Share		$ 11.50	$ 6.50
IPO [Member] \| Underwriter [Member]
Stock Issued During Period, Shares, New Issues		1,956,521	1,153,846
Proceeds from Issuance of Common Stock		$ 162,000	$ 57,500
Common Stock [Member]
Stock Issued During Period, Shares, New Issues	25,300,000					15,000,000

BALANCE SHEET COMPONENTS (Details) - USD ($) $ in Thousands	Mar. 31, 2019	Dec. 31, 2018
Accrued payroll and employee related expenses	$ 2,225	$ 4,113
Legal and related services	1,033	825
Clinical related	2,560	3,424
Manufacturing related	1,789	2,684
Accrued other	882	489
Deferred rent - current	0	124
Accrued liabilities	$ 8,489	$ 11,659

STOCKHOLDERS' EQUITY (Details Textual) - USD ($)	1 Months Ended					3 Months Ended
STOCKHOLDERS' EQUITY (Details Textual) - USD ($)	Jan. 16, 2019	Oct. 17, 2018	Jan. 31, 2018	Sep. 30, 2017	Sep. 30, 2013	Mar. 31, 2019	Mar. 31, 2018	Dec. 31, 2018
Class of Stock [Line Items]
Stock Issued During Period, Shares, New Issues		25,300,000			50,000
Proceeds from Issuance of Common Stock		$ 236,700,000				$ 0	$ 162,186,000
Shares Issued, Price Per Share		$ 9.97
Stock Repurchased and Retired During Period, Shares	32,500
Common Stock Shares Retained	17,500
Other Income [Member]
Class of Stock [Line Items]
Gain loss On cancel of Shares	$ 335,000
Underwriter [Member]
Class of Stock [Line Items]
Stock Issued During Period, Shares, New Issues		3,300,000
Proceeds From Issuance Of Common Stock Gross		$ 252,200,000
Common Stock [Member]
Class of Stock [Line Items]
Stock Issued During Period, Shares, New Issues		25,300,000					15,000,000
Conversion of Stock, Shares Issued						5,854,845
IPO [Member]
Class of Stock [Line Items]
Stock Issued During Period, Shares, New Issues			15,000,000	8,846,154
Proceeds from Issuance of Common Stock			$ 162,000,000	$ 53,700,000
Shares Issued, Price Per Share			$ 11.50	$ 6.50
IPO [Member] \| Underwriter [Member]
Class of Stock [Line Items]
Stock Issued During Period, Shares, New Issues			1,956,521	1,153,846
Proceeds from Issuance of Common Stock			$ 162,000,000	$ 57,500,000
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		194
Series A Convertible Preferred Stock [Member]
Class of Stock [Line Items]
Conversion of Stock, Shares Issued						500
Preferred Stock, Shares Authorized						17,000
Preferred Stock, Shares Outstanding						194
Series A Convertible Preferred Stock [Member] \| Common Stock [Member]
Class of Stock [Line Items]
Conversion of Stock, Shares Converted						97,000
Series A Convertible Preferred Stock [Member] \| Private Placement [Member]
Class of Stock [Line Items]
Sale of Stock, Price Per Share						$ 2.00
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		5,854,845
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

STOCK BASED COMPENSATION (Details) - Employee Stock Option [Member]	3 Months Ended
	Mar. 31, 2019 USD ($) $ / shares shares
Number of Options
Outstanding, beginning balance \| shares	6,889,287
Granted \| shares	2,462,100
Exercised \| shares	(5,000)
Expired/Cancelled \| shares	(71,414)
Outstanding, ending balance \| shares	9,274,973
Exercisable \| shares	3,892,634
Weighted Average Exercise Price
Outstanding, beginning balance \| $ / shares	$ 10.25
Granted \| $ / shares	10.82
Exercised \| $ / shares	8.30
Expired/Cancelled \| $ / shares	11.05
Outstanding, ending balance \| $ / shares	10.40
Exercisable \| $ / shares	$ 8.85
Weighted Average Remaining Contractual Life
Outstanding	8 months 13 days
Exercisable	7 months 9 days
Aggregate Intrinsic Value
Outstanding, beginning balance \| $	$ 9,916
Exercisable \| $	$ 7,247

STOCK BASED COMPENSATION (Details Textual) - USD ($) $ / shares in Units, $ in Thousands		1 Months Ended	3 Months Ended
	Jun. 02, 2016	Aug. 31, 2013	Mar. 31, 2019	Mar. 31, 2018	Apr. 22, 2018	Apr. 16, 2016	Apr. 10, 2015	Sep. 19, 2014	Aug. 20, 2014	Oct. 14, 2011
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized			$ 45,700
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Period for Recognition			2 years 1 month 20 days
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			$ 6.99	$ 15.52
Share-based Compensation Arrangement by Share-based Payment Award, Description		an amendment to increase the number of options or other awards that can be granted to any one person during a twelve (12) month period from 50,000 shares to 300,000 shares
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number			57,285
Share-based Compensation			$ 5,846	$ 4,104
Restricted Common Stock [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Allocated Share-based Compensation Expense			100	$ 100
Restricted Stock [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Allocated Share-based Compensation Expense			$ 300
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Period for Recognition			1 year 2 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, Equity Instruments Other than Options, Vested in Period	137,500
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period	36 months
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
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, Number of Shares Available for Grant			376,240
Common Stock, Capital Shares Reserved for Future Issuance		1,700,000							1,900,000	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
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			5,223
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
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			4,183,900

LICENSES AND AGREEMENTS (Details Textual) - USD ($) $ in Thousands		1 Months Ended		3 Months Ended
	Sep. 14, 2016	Apr. 17, 2017	Nov. 30, 2016	Mar. 31, 2019	Mar. 31, 2018	May 31, 2017
Research and Development Expense				$ 30,905	$ 19,912
Research and Development Arrangement [Member]
Prepaid Expense, Current						$ 1,400
Research Collaboration And Clinical Grant Agreements [Member]
Research and Development Expense				300	600
Maximum [Member] \| Research and Development Arrangement [Member]
Research and Development Arrangement, Contract to Perform for Others, Costs Incurred, Gross		$ 14,200
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
Agreement Term				5 years
PolyBioCept, AB - Exclusive and Co-Exclusive License Agreement [Member]
Additional Milestone Payable	$ 8,700
Number Of Unregistered Common Stock To Be Issued	2,219,376
Reimbursement In Relation To Transfer Of Knowhow	$ 200
Clinical Trials Management Fees Payable	$ 100
Initial Term Of Licence Agreement	30 years
Payment For Upfront Exclusive License	$ 2,500
WuXi Apptech, Inc - Manufacturing and Services Agreement [Member]
Research and Development Expense				$ 3,800	$ 2,800
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
Research Collaboration and Clinical Grant Agreements with Moffitt [Member]
Research and Development Expense				1,200
Moffitt License Agreement One [Member]
Payments For Upfront Licensing Fee				100
Moffitt License Agreement Two [Member]
Payments For Upfront Licensing Fee				100
Additional Milestone Payable				$ 400

LEGAL PROCEEDINGS (Details Textual)			1 Months Ended		3 Months Ended
LEGAL PROCEEDINGS (Details Textual)	Jun. 13, 2017 USD ($) shares	Jun. 03, 2016 USD ($)	Nov. 30, 2012 USD ($)	Jun. 30, 2012 USD ($)	Mar. 31, 2019 shares	Jun. 30, 2016 shares	Apr. 08, 2016 USD ($)
Loss Contingency, Damages Sought, Value \| $		$ 500,000
Common Stock Registered For Resale \| shares						128,500
Number of share options or share units exercised during the current period. \| shares						128,500
Twenty Eleven Equity Incentive Plan [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period \| shares					200,000
Dr. Steven Fischkoff [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross \| shares	150,000
Severance Pay And Retention Bonus \| $	$ 300,000
Warrant [Member]
Shares Sold Under Ineffective Registration \| shares						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
Solomon Capital, LLC [Member] \| Commercial Paper [Member]
Debt Instrument, Face Amount \| $							$ 200,000

LEASES (Details 2) - USD ($) $ in Thousands	Mar. 31, 2019	Jan. 01, 2019
Remainder of 2019	$ 5,041
2020	4,589
2021	1,413
2022	144
2023	0
Thereafter	0
Total lease payments	11,187
Less: Present value adjustment	(748)
Operating lease liabilities	10,439	$ 10,700
Facility Leases [Member]
Remainder of 2019	1,066
2020	1,223
2021	419
2022	0
2023	0
Thereafter	0
Total lease payments	2,708
Less: Present value adjustment	(189)
Operating lease liabilities	2,519
CMO Embedded Leases [Member]
Remainder of 2019	3,975
2020	3,366
2021	994
2022	144
2023	0
Thereafter	0
Total lease payments	8,479
Less: Present value adjustment	(559)
Operating lease liabilities	$ 7,920

LEASES (Details Textual)		1 Months Ended				3 Months Ended	13 Months Ended
LEASES (Details Textual)	Nov. 02, 2018 USD ($)	Oct. 19, 2018 USD ($)	Jul. 31, 2017 USD ($)	Sep. 30, 2016 USD ($) ft²	Aug. 04, 2016 USD ($) ft²	Mar. 31, 2019 USD ($)	Apr. 20, 2019 USD ($)	Jan. 01, 2019 USD ($)	Dec. 31, 2018 USD ($)	Jun. 05, 2017 USD ($)	Apr. 28, 2017 ft²	Apr. 30, 2015 ft²	Dec. 31, 2014 ft²
Lease Expiration Term		30 months
Operating Leases, Future Minimum Payments Due						$ 11,187,000
Operating Leases of Lessee, Contingent Rentals, Basis Spread on Variable Rate		3.00%
Operating Lease, Weighted Average Remaining Lease Term						1 year 10 months 9 days
Operating Lease, Weighted Average Discount Rate, Percent						8.40%
Increase Decrease In Operating Lease Liability And Right Of Use Asset						$ 1,000,000
Operating Lease, Liability						10,439,000		$ 10,700,000
Operating lease right-of-use assets						9,957,000		$ 10,400,000	$ 0
Operating Lease, Payments		$ 59,000				$ 1,400,000
Teradata Us Inc [Member]
Area of Land \| ft²											11,449
San Carlos Lease [Member] \| Land [Member]
Area of Land \| ft²					8,733						26,000
Lease Expiration Term					54 months
Operating Leases, Future Minimum Payments Due					$ 38,000
New York Lease [Member]
Operating Leases, Rent Expense	$ 4,000
New York Lease [Member] \| Office Space [Member]
Operating Leases, Rent Expense							$ 7,000
Operating Leases, Future Minimum Payments Due										$ 9,000
Operating Leases, Rent Expense, Minimum Rentals			$ 18,000
Tampa Lease [Member]
Area of Land \| ft²				8,673								6,043	5,115
Operating Leases, Rent Expense				$ 20,000

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details 1) - USD ($) $ in Thousands	Mar. 31, 2019	Dec. 31, 2018
Assets, Fair Value Disclosure	$ 385,925	$ 368,371
US treasury securities [Member]
Assets, Fair Value Disclosure	234,681	265,393
US Government agency securities [Member]
Assets, Fair Value Disclosure	151,244	120,978
Fair Value, Inputs, Level 1 [Member]
Assets, Fair Value Disclosure	385,925	386,371
Fair Value, Inputs, Level 1 [Member] \| US treasury securities [Member]
Assets, Fair Value Disclosure	234,681	265,393
Fair Value, Inputs, Level 1 [Member] \| US Government agency securities [Member]
Assets, Fair Value Disclosure	151,244	120,978
Fair Value, Inputs, Level 2 [Member]
Assets, Fair Value Disclosure	0	0
Fair Value, Inputs, Level 2 [Member] \| US treasury securities [Member]
Assets, Fair Value Disclosure	0	0
Fair Value, Inputs, Level 2 [Member] \| US Government agency securities [Member]
Assets, Fair Value Disclosure	0	0
Fair Value, Inputs, Level 3 [Member]
Assets, Fair Value Disclosure	0	0
Fair Value, Inputs, Level 3 [Member] \| US treasury securities [Member]
Assets, Fair Value Disclosure	0	0
Fair Value, Inputs, Level 3 [Member] \| US Government agency securities [Member]
Assets, Fair Value Disclosure	$ 0	$ 0

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details 2) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2019	Mar. 31, 2018
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost, Total	$ 5,846	$ 4,104
Research and Development Expense [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost, Total	2,701	2,000
General and Administrative Expense [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost, Total	$ 3,145	$ 2,104

CASH EQUIVALENTS AND SHORT-TERM INVESTMENTS (Details) - USD ($) $ in Thousands	Mar. 31, 2019	Dec. 31, 2018	Mar. 31, 2018	Dec. 31, 2017
Cash equivalents total	$ 54,093	$ 82,152	$ 297,082	$ 145,373
Demand Deposits [Member]
Cash equivalents total	11,300	56,200
Money market funds [Member]
Cash equivalents total	$ 42,795	$ 25,968

CASH EQUIVALENTS AND SHORT-TERM INVESTMENTS (Details 2) - USD ($) $ in Thousands	Mar. 31, 2019	Dec. 31, 2018
Cost	$ 383,841	$ 385,272
Accretion	1,946	1,141
Gross Unrealized Gains	156	40
Gross Unrealized Losses	(18)	(82)
Fair Value	385,925	386,371
US treasury securities [Member]
Cost	233,427	264,619
Accretion	1,204	813
Gross Unrealized Gains	66	19
Gross Unrealized Losses	(16)	(58)
Fair Value	234,681	265,393
US Government agency securities [Member]
Cost	150,414	120,653
Accretion	742	328
Gross Unrealized Gains	90	21
Gross Unrealized Losses	(2)	(24)
Fair Value	$ 151,244	$ 120,978

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Textual) - USD ($) $ in Thousands	Mar. 31, 2019	Jan. 01, 2019	Dec. 31, 2018
Cumulative Effect of New Accounting Principle in Period of Adoption	$ 0	$ 300
Operating lease right-of-use assets	9,957	10,400	$ 0
Operating Lease, Liability, Noncurrent	4,380	5,800	0
Operating Lease, Liability, Current	$ 6,059	$ 4,900	$ 0

STOCK BASED COMPENSATION (Details 1)	3 Months Ended
STOCK BASED COMPENSATION (Details 1)	Mar. 31, 2019	Mar. 31, 2018
Expected dividend yield	0.00%	0.00%
Risk-free interest rate	2.59%
Expected term (in years)	6 years 21 days
Expected volatility	70.78%
Maximum [Member]
Risk-free interest rate		2.77%
Expected term (in years)		6 years 6 months
Expected volatility		200.28%
Minimum [Member]
Risk-free interest rate		2.27%
Expected term (in years)		5 years 1 month 17 days
Expected volatility		170.85%

LEASES (Details) - USD ($) $ in Thousands	Mar. 31, 2019	Jan. 01, 2019	Dec. 31, 2018
Leases [Abstract]
Operating lease right-of-use assets	$ 9,957	$ 10,400	$ 0
Operating lease liabilities
Current portion included in current liabilities	6,059	4,900	0
long-term portion included in non-current liabilities	4,380	5,800	$ 0
Total Operating lease liabilities	$ 10,439	$ 10,700

LEASES (Details 1) $ in Thousands	3 Months Ended
LEASES (Details 1) $ in Thousands	Mar. 31, 2019 USD ($)
Leases [Abstract]
Operating lease cost	$ 1,594
Variable lease cost	896
Short-term lease cost	19
Total lease cost	$ 2,509

LEASES (Details 3)	Dec. 31, 2018 USD ($)
2019	$ 6,461
2020	4,589
2021	1,412
2022	144
2023	0
Thereafter	0
Total lease payments	12,606
Facility Leases [Member]
2019	1,373
2020	1,223
2021	418
2022	0
2023	0
Thereafter	0
Total lease payments	3,014
CMO Embedded Leases [Member]
2019	5,088
2020	3,366
2021	994
2022	144
2023	0
Thereafter	0
Total lease payments	$ 9,592

RELATED PARTY TRANSACTIONS (Details Textual) - USD ($) $ / shares in Units, $ in Thousands		3 Months Ended
	Sep. 14, 2017	Mar. 31, 2019	Mar. 31, 2018	Jan. 01, 2019	Dec. 31, 2018
Payments for Legal Services		$ 100	$ 100
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		5,846	4,104
Retained Earnings (Accumulated Deficit)		(410,006)			$ (372,760)
Accounting Standards Update 2018-07 [Member]
Retained Earnings (Accumulated Deficit)				$ 300
Consulting Agreement [Member]
Share-based Compensation		$ 100	$ 400
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 EVENT (Details Textual)		1 Months Ended		3 Months Ended
SUBSEQUENT EVENT (Details Textual)	Jul. 02, 2019 USD ($) ft²	May 02, 2019 USD ($) ft²	Oct. 19, 2018 USD ($)	Mar. 31, 2019 USD ($)
Operating Lease, Payments			$ 59,000	$ 1,400,000
Operating Leases of Lessee, Contingent Rentals, Basis Spread on Variable Rate			3.00%
Lease Expiration Term			30 months
Subsequent Event [Member]
Area of Land \| ft²	4,500	1,500
Operating Lease, Payments	$ 11,063	$ 2,000
Operating Leases of Lessee, Contingent Rentals, Basis Spread on Variable Rate	2.50%
Lease Expiration Term	3 years