0001104659-20-056994 | 10-Q | XBRL Viewer | Iovance Biotherapeutics INC

STOCK BASED COMPENSATION - Stock Options (Details) - Stock option - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended	12 Months Ended
	Mar. 31, 2020	Dec. 31, 2019
Number of Options
Granted	3,276,351	9,494,712
Exercised	(404,075)
Expired/Forfeited	(230,089)
Outstanding, ending balance	12,136,899
Options exercisable, number	5,256,772
Weighted Average Exercise Price
Granted	$ 24.58	$ 12.00
Exercised	9.78
Expired/Forfeited	12.91
Outstanding, ending balance	15.46
Options exercisable, exercise price	$ 10.16
Weighted Average Remaining Contractual Life
Options outstanding, remaining term	8 years 4 months 13 days
Options exercisable, remaining term	7 years 1 month 20 days
Aggregate Intrinsic Value
Outstanding, end of period	$ 176,592
Exercisable	$ 104,569

Condensed Consolidated Balance Sheets - USD ($) $ in Thousands	Mar. 31, 2020	Dec. 31, 2019
Current Assets
Cash and cash equivalents	$ 52,540	$ 13,969
Short-term investments	193,112	293,112
Prepaid expenses and other assets	10,729	9,412
Total Current Assets	256,381	316,493
Property and equipment, net	13,607	8,536
Operating lease right-of-use assets	9,305	10,695
Restricted cash	5,525	5,450
Long-term assets	3,480	3,481
Total Assets	288,298	344,655
Current Liabilities
Accounts payable	10,614	15,567
Accrued expenses	22,500	16,265
Operating lease liabilities - current	6,431	7,252
Total Current Liabilities	39,545	39,084
Non-Current Liabilities
Operating lease liabilities - noncurrent	3,088	4,248
Other liabilities	2,352	2,352
Total Non-Current Liabilities	5,440	6,600
Total Liabilities	44,985	45,684
Commitments and contingencies (Notes 8 and 9)
Stockholders' Equity
Common stock, $0.000041666 par value; 300,000,000 shares authorized, 126,823,156 and 126,411,808 shares issued and outstanding as of March 31, 2020 and December 31, 2019, respectively	5	5
Accumulated other comprehensive income	912	220
Additional paid-in capital	882,599	869,354
Accumulated deficit	(640,207)	(570,612)
Total Stockholders' Equity	243,313	298,971
Total Liabilities and Stockholders' Equity	288,298	344,655
Series B Convertible Preferred Stock
Stockholders' Equity
Preferred stock, Value	4	4
Total Stockholders' Equity	$ 4	$ 4

LEGAL PROCEEDINGS

3 Months Ended

Mar. 31, 2020

LEGAL PROCEEDINGS

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 its 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 Company's former CEO, and the Company's 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 the Company's 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 a result of mediation, on September 28, 2018, lead plaintiff filed an unopposed motion for settlement.. The court granted preliminary approval to the proposed settlement on November 30, 2018 . A final hearing was held on April 12, 2019 to determine whether the proposed settlement was fair, reasonable, and adequate, and whether the claims should be dismissed. On April 17, 2019, the court approved the final settlement, involving a payment of $3,250,000 by the Company's insurance carrier to a settlement fund, awarded attorney's fees and costs to be paid to plaintiff's counsel from the settlement fund, approved the plan of allocation for settlement class members, and ordered that the claims against us should be dismissed with prejudice. The Company does not expect to incur any costs or expenses in connection with this settlement.

Derivative Lawsuits. On December 15, 2017, a purported stockholder derivative complaint was filed by plaintiff Kevin Fong against the Company, as nominal defendant, and certain of its 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 its 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 the 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 consolidated case is titled In re Iovance Biotherapeutics, Inc. Stockholder Derivative Litigation (lead case no. 17-cv-1806). On January 28, 2020, the parties reached a proposed settlement. On April 24, 2020, the court granted preliminary approval for the proposed settlement. The terms of the settlement will be disseminated to shareholders as part of the notice process by May 8, 2020. If the proposed settlement is given final approval by the court, the Company does not expect to incur any significant costs or expenses in connection with this settlement. Based on the current stage of the litigation, and the uncertainty of final approval by the court, 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 (the "First Solomon Suit") 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 ("Solomon Plaintiffs") against the Company in the Supreme Court of the State of New York, County of New York (index no. 651881/2016 ). The Solomon Plaintiffs allege that, between June and November 2012, they provided to the Company $0.1 million and that they advanced and paid on behalf of the Company an additional $0.2 million. The complaint further alleges that the Company agreed to (i) provide them with promissory notes totaling $0.2 million, plus interest, (ii) issue a total of 1,110 shares to the Solomon Plaintiffs (after the 1-for-100 reverse split of the Company’s common stock effected in March 2013), and (iii) allow the Solomon Plaintiffs to convert the foregoing funds into its securities in the next transaction. The Solomon Plaintiffs allege that they should have been able to convert their advances and payments into shares of the Company’s common stock in the restructuring that took effect in May 2013. Based on the foregoing, the Solomon Plaintiffs allege causes for breach of contract and unjust enrichment and demand judgment against the Company in an unspecified amount exceeding $1.5 million, plus interest. On June 3, 2016, the Company filed an answer and counterclaims in the lawsuit. The Company has asserted counterclaims for fraudulent inducement, fraudulent misrepresentation, fraudulent concealment, breach of fiduciary duty, and breach of contract, alleging principally that the counterclaim defendants misrepresented their qualifications and failed to disclose that Solomon Sharbat was the subject of an investigation by the Financial Industry Regulatory Authority (“FINRA”) that resulted in the loss of his FINRA license. In its counterclaims, the Company is seeking damages in an amount exceeding $0.5 million and an order rescinding any and all agreements that the plaintiffs contend entitled them to obtain shares of Company stock. No trial date has been set for the First Solomon Suit.

On September 27, 2019, the Solomon Plaintiffs filed a new lawsuit (through new legal counsel) (the "Second Solomon Suit") titled Solomon Capital, LLC, Solomon Capital 401(K) Trust, Solomon Sharbat and Shelhav Raff v. Iovance Biotherapeutics, Inc., f/k/a/ Lion Biotechnologies Inc. f/k/a/ Genesis Biopharma Inc., and Manish Singh in the Supreme Court of the State of New York, County of New York (index no. 655668/2019). In the Second Solomon Suit, the Solomon Plaintiffs allege that they are third party beneficiaries of a “finder’s fee agreement” that prior management entered into with a third party unlicensed entity in 2012 in connection with seeking financing, that an agreement or understanding existed between the Company and the plaintiffs that the plaintiffs would be paid fees and commissions (in cash and stock) if they obtained financing for the Company, and that they directly and indirectly introduced investors to the Company who invested in the Company, or were willing to invest in the Company. Finally, the Solomon Plaintiffs allege that they were promised a license to use the Company’s technology in Israel. The plaintiffs claim that the

Company breached the foregoing understandings, promises and agreements and, as a result, they are entitled to certain damages. The Solomon Plaintiffs also allege that Manish Singh, the Company’s former Chief Executive Officer, committed fraud and took shares belonging to them. On February 18, 2020, the Company filed a removal petition and removed the Second Solomon Suit to the United States District Court for the Southern District of New York, where the case has been assigned case no. 1:20-cv-1391. The Company has not yet responded to the complaint in the Second Solomon Suit.

The Company intends to vigorously defend these complaints and pursue its counterclaims, as applicable. At the current stage of the litigation, in both the First Solomon Suit and the Second Solomon Suit, it is not possible to estimate the amount or range of possible loss that might result from an adverse judgment or a settlement of these matters.

Litigation Involving Dr. Steven Fischkoff. On June 13, 2017, in an action titled Steven Fischkoff v. Lion Biotechnologies, Inc. and Maria Fardis, Dr. Steven Fischkoff, the Company's 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 the Company's common stock, together with prejudgment interest, costs, expenses and attorneys’ fees. On July 5, 2017, the Company filed a removal petition and removed the lawsuit to the United States District Court for the Southern District of New York, where the case has been assigned case no. 1:17-cv-05041. On July 14, 2017, the Company filed a partial answer and counterclaims against Dr. Fischkoff, denying his allegations, and alleging breach of contract and related claims, breach of fiduciary duty, and state and federal trade secret misappropriation and related claims, and sought a temporary restraining order and preliminary injunction against Dr. Fischkoff. On July 18, 2017, the court issued a temporary restraining order against Dr. Fischkoff requiring him to return the Company’s 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. No trial date has been set in this matter, and the parties are currently engaged in fact discovery.

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

Other Matters.In connection with the Company’s reincorporation from Nevada to Delaware in 2017, the Company (as a Delaware corporation) untimely filed a post-effective amendment to adopt a Form S-8 registration statement that the Company filed (as a Nevada corporation) to register the shares underlying the Company's 2011 Equity Incentive Plan. Before the Company filed the required post-effective amendment, options to purchase 200,000 shares were exercised under the 2011 Equity Incentive Plan. The effect of the delayed post-effective amendment filing on the 200,000 option shares is uncertain, but the issuance and sale of the shares may not have been in compliance with the Form S-8 registration statement. The existence of any liability to the Company, and the amount of any such liability to the Company, as a result of the issuance of the 200,000 shares is uncertain. Accordingly, no accrual for a potential claim has been made by the Company in its condensed consolidated financial statements.

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

GENERAL ORGANIZATION AND BUSINESS (Details) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2020	Mar. 31, 2019	Dec. 31, 2019
GENERAL ORGANIZATION AND BUSINESS
Net Loss	$ 69,595	$ 36,950
Net cash used in operating activities	65,292	29,090
Cash, cash equivalents and short-term investments	251,200
cash equivalents, short-term investments, and restricted cash	52,500
Cash and cash equivalents	52,540	$ 54,093	$ 13,969
Short-term investments	193,112		293,112
Restricted cash	$ 5,525		$ 5,450

- Definition

The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

+ References + Details

LEASES (Tables)

3 Months Ended

Mar. 31, 2020

LEASES

Schedule of balance sheet classification of the Company's right-of-use asset and lease liabilities

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


	March 31, 2020		December 31, 2019

Operating lease right-of-use assets	$	9,305	$	10,695
Operating lease liabilities
Current portion included in current liabilities		6,431		7,252
long-term portion included in non-current liabilities		3,088		4,248
Total Operating lease liabilities	$	9,519	$	11,500

Schedule of components of lease expenses

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


	For the Three Months Ended
	March 31,
	2020		2019

Operating lease cost	$	1,636	$	1,594
Variable lease cost		1,371		896
Short-term lease cost		17		19
Total lease cost	$	3,024	$	2,509

Schedule of maturities of the Company's operating lease liabilities

As of March 31, 2020, the maturities of the Company’s operating lease liabilities were as follows (in thousands):


			CMO
	Facility		embedded
	leases		leases		Total
2020	$	1,425	$	3,783	$	5,208
2021		968		3,155		4,123
2022		342		—		342
2023		269		—		269
2024		253		—		253
Thereafter		—		—		—
Total lease payments	$	3,257	$	6,938	$	10,195
Less: Present value adjustment		(308)		(368)		(676)
Operating lease liabilities	$	2,949	$	6,570	$	9,519

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)

3 Months Ended

Mar. 31, 2020

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Cash, Cash Equivalents, and Short-term Investments

The Company’s cash and cash equivalents include short-term investments with original maturities of three months or less when purchased. The Company's short-term investments are classified as “available-for-sale”. The Company includes these investments in current assets and carries them at fair value. Unrealized gains and losses on available-for-sale securities are included in accumulated other comprehensive income. Any impairment losses related to credit losses (if any) are included in an allowance for credit losses with an offsetting entry to net loss. No impairment losses related to credit losses were recognized for the three months ended March 31, 2020 or for the same period in 2019. The cost of debt securities is adjusted for the amortization of premiums and accretion of discounts to maturity. Such amortization and accretion are included in net interest income in the condensed consolidated statements of operations. Gains and losses on securities sold are recorded based on the specific identification method and are included in net interest income in the condensed consolidated statements of operations. The Company has not incurred any realized gains or losses from sales of securities to date. The Company’s investment policy limits investments to certain types of instruments such as certificates of deposit, money market instruments, obligations issued by the U.S. government and U.S. government agencies as well as corporate debt securities, and places restrictions on maturities and concentration by type and issuer. Currently the Company invests excess cash only in obligations issued by the U.S. government and U.S. government agencies.

The Company maintains a certain minimum balance, currently $5.5 million in a segregated bank account in connection with two letters of credit, one for $5.45 million for the benefit of the landlord for its commercial manufacturing facility used as a security deposit for the lease (See Note 9 - Leases), and a second one for $74,685 for the benefit of a utilities service provider. The total amount is classified as Restricted Cash on the Balance Sheet. The letter of credit will expire on May 28, 2020, however, it will be automatically extended, without written agreement, for one-year periods to May 28 in each succeeding calendar year, through at least 60 days after the lease expiration rate. Further, on the expiration of the seventh year of the lease, and each anniversary date thereafter, the letter of credit may be decreased by $1,000,000, with a minimum security deposit of $1,450,000 maintained through the end of the lease term. The $74,685 letter of credit will expire on February 25, 2021, however, it will be automatically extended, without written agreement, to the expiration date of December 1, 2022. As of March 31, 2020, restricted cash consisted of $5.5 million and this amount has been classified as a non-current asset on the Company’s condensed consolidated balance sheets.

The following table provides a reconciliation of cash, cash equivalents, and restricted cash, reported within the condensed consolidated balance sheets that sum to the total of the same such amounts shown in the condensed consolidated statements of cash flows:


	March 31,		March 31,
	2020		2019
Cash and cash equivalents	$	52,540	$	54,093
Restricted cash (included in non-current assets on the condensed consolidated balance sheets)		5,525		—
Total cash, cash equivalents and restricted cash	$	58,065	$	54,093

Loss per Share

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

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

At March 31, 2020 and 2019, the following outstanding common stock equivalents have been excluded from the calculation of net loss per share because their impact would be anti-dilutive.


	March 31,
	2020	2019
Stock options	12,136,899	9,274,973
Series A Convertible Preferred Stock*	97,000	97,000
Series B Convertible Preferred Stock*	3,581,119	5,854,845
Restricted stock units	11,458	57,285
	15,826,476	15,284,103

* on an as-converted basis

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

Fair Value Measurements

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

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

Level 1–These are investments where values are based on unadjusted quoted prices for identical assets in an active market that the Company has the ability to access.

Level 2–These are investments where values are based on quoted market prices in markets that are not active or model derived valuations in which all significant inputs are observable in active markets

The Company does not have fair valued assets classified under Level 2 as of March 31, 2020 and December 31, 2019.

Level 3–These are financial instruments where values are derived from techniques in which one or more significant inputs are unobservable.

The Company does not have fair valued assets classified under Level 3 as of March 31, 2020 and December 31, 2019.

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

As of March 31, 2020 and December 31, 2019, financial assets measured at fair value on a recurring basis are categorized in the table below based upon the lowest level of significant input to the valuations (in thousands):


	Assets at Fair Value as of March 31, 2020
	Level 1		Level 2		Level 3		Total
US treasury securities	$	161,512	$	—	$	—	$	161,512
US government agency securities		31,600		—		—		31,600
Total	$	193,112	$	—	$	—	$	193,112


	Assets at Fair Value as of December 31, 2019
	Level 1		Level 2		Level 3		Total
US treasury securities	$	242,249	$	—	$	—	$	242,249
US government agency securities		50,863		—		—		50,863
Total	$	293,112	$	—	$	—	$	293,112

Use of Estimates

The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America (“GAAP”) requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. Actual results could differ from those estimates. Significant estimates include the assumptions made in valuing stock instruments issued for services and used in measuring operating right-of-use assets and operating lease liabilities, valuation of short-term investments, accounting for potential liabilities, and the valuation allowance associated with the Company’s deferred tax assets.

Principles of Consolidation

The accompanying condensed consolidated financial statements include the accounts of Iovance Biotherapeutics, Inc. and its wholly-owned subsidiaries, Iovance Biotherapeutics Manufacturing LLC, and Iovance Biotherapeutics GmbH. All intercompany accounts and transactions have been eliminated. The U.S. dollar is the functional currency for all the Company's consolidated operations.

Income Taxes

The Company accounts for income taxes using the asset and liability method whereby deferred tax assets are recognized for deductible temporary differences, and deferred tax liabilities are recognized for taxable temporary differences. Temporary differences are the differences between the reported amounts of assets and liabilities and their tax bases. Deferred tax assets are reduced by a valuation allowance when, in the opinion of management, it is more likely than not that some portion or all of the deferred tax assets will be realized. Deferred tax assets and liabilities are adjusted for the effects of changes in tax laws and rates on the date of enactment.

ASC Topic 740-10-30 clarifies the accounting for uncertainty in income taxes recognized in an enterprise’s financial statements and prescribes a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. ASC Topic 740-10-40 provides guidance on de-recognition, classification, interest and penalties, accounting in interim periods, disclosure, and transition. The Company will classify as income

tax expense any interest and penalties. The Company has no material uncertain tax positions for any of the reporting periods presented.

On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”) was enacted and signed into law, and GAAP requires recognition of the tax effects of new legislation during the reporting period that includes the enactment date. The CARES Act, among other things, includes changes to the tax provisions that benefits business entities and makes certain technical corrections to the 2017 Tax Cuts and Jobs Act. The tax relief measures for business include a five-year net operating loss (“NOL”) carrybacks, suspension of annual deduction limitation of 80% taxable income from net operating losses generated in a tax year beginning after December 31, 2017, changes in the deductibility of interest, acceleration of alternative minimum tax credit refunds, payroll tax relief, and technical correction to allow accelerated deductions for qualified improvement property. The CARES Act also provides other non-tax benefits to assist those impacted by the pandemic. The Company evaluated the impact of the CARES Act and determined no material tax provision impact for the quarter ended March 31, 2020.

Leases

The Company determines if an arrangement includes a lease at inception. Operating leases are included in its condensed consolidated balance sheet as Operating lease right-of-use assets and Operating lease liabilities as of March 31, 2020 and December 31, 2019. Operating lease right-of-use assets represent the Company’s right to use an underlying asset for the lease term and operating lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Operating lease right-of-use assets and liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term. In determining the net present value of lease payments, the Company uses an estimated incremental borrowing rate that is applicable to the Company based on the information available at the later of the lease commencement date or the date of adoption of Accounting Standard Update (ASU) No. 2016-02 and ASU No. 2018-10, Leases (together “Topic 842”). The operating lease right-of-use assets also include any lease payments made less lease incentives. The Company’s leases may include options to extend or terminate the lease, which is considered in the lease term when it is reasonably certain that the Company will exercise any such options. Lease expense is recognized on a straight-line basis over the expected lease term. The Company has elected not to apply the recognition requirements of Topic 842 for short-term leases.

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

Stock-Based Compensation

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

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

The Company has in the past issued restricted stock units (RSU) and restricted stock awards (RSA) as part of its share-based compensation programs. The Company measures the compensation cost with respect to RSUs and RSAs issued to employees based upon the estimated fair value of the equity instruments at the date of the grant, which is recognized as an expense over the period during which an employee is required to provide services in exchange for the awards.

The fair value of RSUs and RSAs is based on the closing price of the Company’s common stock on the grant date.

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


	Three Months Ended
	March 31,
	2020		2019
Research and development	$	4,318	$	2,701
General and administrative		5,094		3,145
Total stock-based compensation expense	$	9,412	$	5,846

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


	Three Months Ended
	March 31,
	2020		2019
Stock option expense	$	9,345	$	5,779
Restricted stock unit expense		67		67
Total stock-based compensation expense	$	9,412	$	5,846

Preferred Stock

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

Convertible Instruments

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

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

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

Recent Accounting Standards

Financial Instruments

In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses, and also issued subsequent amendments to the initial guidance, ASU 2018-19, ASU 2019-04, ASU 2019-05, and ASU 2019-11 (collectively, Topic 326), to introduce a new impairment model for recognizing credit losses on financial instruments based on an estimate of current expected credit losses (“CECL”). Under Topic 326, an entity is required to estimate CECL on available-for-sale (“AFS”) debt securities only when the fair value is below the amortized cost of the asset and is no longer based on an impairment being “other-than-temporary”. Topic 326 also

requires the impairment calculation on an individual security level and requires an entity use present value of cash flows when estimating the CECL. The credit-related losses are required to be recognized through earnings and non-credit related losses are reported in other comprehensive income. In April 2019, the FASB further clarified the scope of Topic 326 and addressed issues related to accrued interest receivable balances, recoveries, variable interest rates and prepayment. Topic 326 will be effective for public entities in fiscal years beginning after December 15, 2019, including interim periods within those fiscal years. The new guidance requires modified retrospective application to all outstanding instruments, with a cumulative effect adjustment recorded to opening retained earnings as of the beginning of the first period in which the guidance becomes effective. The Company adopted this guidance on January 1, 2020, however, the adoption of this new guidance did not have any material impact on its condensed consolidated financial statements.

Cloud Computing Arrangements

In August 2018, the FASB issued ASU 2018-15, Intangibles-Goodwill and Other-Internal-Use Software (Subtopic 350-40) Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract (ASU 2018-15). The guidance requires a customer in a cloud computing arrangement that is a service contract to follow the internal use software guidance to determine which implementation costs to defer and recognize as an asset. It therefore requires a customer to defer potentially significant implementation costs incurred in a cloud computing arrangement that were often expensed as incurred under the legacy GAAP and recognize them as expense over the term of the hosting arrangement. ASU 2018-15 is effective for fiscal years beginning subsequent to December 15, 2019. The Company adopted this guidance on January 1, 2020. There was no impact on its condensed consolidated balance sheets and statements of operations as of and for the three months ended March 31, 2020, however, the Company believes it will have a material impact on its condensed consolidated balance sheets and statements of operations in 2020 by deferring recognition of costs as it prepares to invest in information technology infrastructure for its commercial manufacturing build-out.

Subsequent Event

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

Reclassifications

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

STOCK BASED COMPENSATION

3 Months Ended

Mar. 31, 2020

STOCK BASED COMPENSATION

STOCK BASED COMPENSATION

NOTE 6. STOCK BASED COMPENSATION

Stock Plans

On October 14, 2011, the Company adopted the 2011 Equity Incentive Plan (the “2011 Plan”). Employees, directors, consultants and advisors of the Company are eligible to participate in the 2011 Plan. The 2011 Plan initially had 180,000 shares of common stock reserved for issuance in the form of incentive stock options, non-qualified options, common stock, and grant appreciation rights. The 2011 Plan was not approved by the Company’s stockholders within the required one-year period following its adoption and, accordingly, no incentive stock options can be granted under that plan. In August 2013, the Company’s Board of Directors and a majority of the Company’s stockholders approved an amendment to increase the number of shares available under the 2011 Plan from 180,000 shares to 1,700,000 shares, and an amendment to increase the number options or other awards that can be granted to any one person during a twelve (12) month period from 50,000 shares to 300,000 shares. The foregoing amendment to the 2011 Plan became effective in September 2013. On August 20, 2014, the Company’s Board of Directors amended the 2011 Plan to increase the number of shares available for issuance upon the exercise of stock options under the 2011 Plan from 1,700,000 to 1,900,000 shares, effective immediately. At March 31, 2020, 151,240 shares were available for future grant under the 2011 Plan.

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

On August 16, 2016, the Company’s stockholders approved an increase in the total number of shares that can be issued under the 2014 Plan to 9,000,000 shares of the Company’s common stock. At March 31, 2020, 89,408 shares were available for grant under the Company’s 2014 Plan.

On April 22, 2018, the Board of Directors adopted the Iovance Biotherapeutics, Inc. 2018 Equity Incentive Plan (the “2018 Plan”). The 2018 Plan was approved by the Company’s stockholders at the annual meeting of stockholders held in June 2018. The 2018 Plan as approved by the stockholders authorized the issuance up to an aggregate of 6,000,000 shares of common stock reserved for issuance in the form of incentive (qualified) stock options, non-qualified options, common stock, stock appreciation rights, restricted stock awards, restricted stock units, other stock-based awards, other cash-based awards or any combination of the foregoing. At March 31, 2020, 336,222 shares of common stock were available for grant under the Company’s 2018 Plan.

Restricted Stock Units

On June 1, 2016, the Company entered into a restricted stock unit agreement with the Company’s new Chief Executive Officer, Maria Fardis, Ph.D., pursuant to which the Company granted Dr. Fardis 550,000 non-transferrable restricted stock units at fair market value of $5.87 per share as an inducement of employment pursuant to the exception to The Nasdaq Global Market rules that generally require stockholder approval of equity incentive plans. The 550,000 restricted stock units vest in installments as follows: (i) 137,500 restricted stock units vested upon the first anniversary of the effective date of Dr. Fardis’ employment agreement; (ii) 275,000 restricted stock units vest upon the satisfaction of certain clinical trial milestones; and (iii) 137,500 restricted stock units vest in equal monthly installments over the 36-month period following the first anniversary of the effective date of Dr. Fardis’ employment, provided that Dr. Fardis has been continuously employed with the Company as of such vesting dates. At March 31, 2020, 11,458 restricted stock units remained unvested.

Stock-based compensation expense for restricted stock units are measured based on the closing fair market value of the Company’s common stock on the date of grant. The stock-based compensation expenses relating to restricted stock units were $0.1 million and $0.1 million for the three months ended March 31, 2020 and 2019, respectively, recorded as part of general and administrative expenses.

As of March 31, 2020, $0.04 million of total unrecognized compensation costs related to non-vested restricted stock units to be recognized over a weighted average period of 0.17 years.

Stock Options

A summary of the status of stock options at March 31, 2020, and the changes during the three months then ended, is presented in the following table:



		Weighted		Weighted	Aggregate
	Number	Average		Average	Intrinsic
	of	Exercise		Remaining	Value (in
	Options	Price		Contract Life	thousands)
Outstanding at January 1, 2020	9,494,712	$	12.00
Granted	3,276,351		24.58
Exercised	(404,075)		9.78
Expired/Forfeited	(230,089)		12.91
Outstanding at March 31, 2020	12,136,899	$	15.46	8.37	$	176,592

Options exercisable at March 31, 2020	5,256,772	$	10.16	7.14	$	104,569

The Company recorded stock-based compensation expenses related to stock options of $9.3 million and $5.8 million for the three months ended March 31, 2020 and 2019. As of March 31, 2020, there was $81.1 million of total unrecognized compensation expense related to the options to be recognized over a weighted average period of 2.24 years.

The weighted average grant date fair value for employee options granted under the Company’s stock option plans during the three months ended March 31, 2020 and 2019 was $15.67 and $6.99 per option respectively.

The aggregate intrinsic value in the table above reflects the total pre-tax intrinsic value (the difference between the Company’s closing stock price on the last trading day of the three months ended March 31, 2020 and the exercise price of the options, multiplied by the number of in-the-money stock options) that would have been received by the option holders had all option holders exercised their options on March 31, 2020. The intrinsic value of the Company’s stock options changes based on the closing price of the Company’s common stock.

The following table summarizes the assumptions relating to options granted pursuant to the Company’s equity incentive plans for the three months ended March 31, 2020 and 2019:


	Three Months Ended March 31,
Assumptions:	2020	2019
Expected term (years)	6.19	6.06
Expected volatility	69.99%	70.78%
Risk-free interest rate	1.83%	2.59%
Expected dividend yield	0%	0%

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

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

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

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

Forfeiture Rate —The Company recognizes forfeitures as they occur.

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

LICENSES AND AGREEMENTS

3 Months Ended

Mar. 31, 2020

LICENSES AND AGREEMENTS

LICENSES AND AGREEMENTS

NOTE 7. LICENSES AND AGREEMENTS

National Institutes of Health (NIH) and the National Cancer Institute (NCI)

Cooperative Research and Development Agreement (CRADA)

In August 2011, the Company signed a five-year CRADA with the NCI to work with Dr. Steven Rosenberg on developing adoptive cell immunotherapies that are designed to destroy metastatic melanoma cells using a patient’s tumor infiltrating lymphocytes.

In January 2015, the Company executed an amendment to the CRADA to include four new indications. As amended, in addition to metastatic melanoma, the CRADA included the development of TIL therapy for the treatment of patients with bladder, lung, triple-negative breast, and Human Papilloma Virus (“HPV”)-associated cancers.

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

Pursuant to the terms of the CRADA, as amended, the Company is required to make quarterly payments of $0.5 million to the NCI for support of research activities. To the extent the Company licenses patent rights relating to a TIL-based product candidate, the Company will be responsible for all patent-related expenses and fees, past and future, relating to the TIL-based product candidate. In addition, the Company may be required to supply certain test articles, including TIL, grown and processed under cGMP conditions, suitable for use in clinical trials, where the Company holds the investigational new drug application for such clinical trial. The extended CRADA has a five-year term expiring in August 2021. The Company or the NCI may unilaterally terminate the CRADA for any reason or for no reason at any time by providing written notice at least 60 days before the desired termination date. The Company recorded costs associated with the CRADA of $0.5 million for the three months ended March 31, 2020 and 2019 as research and development expenses.

Patent License Agreement Related to the Development and Manufacture of TIL

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

Exclusive Patent License Agreement Related to TIL Selection

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

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

H. Lee Moffitt Cancer Center

Research Collaboration and Clinical Grant Agreements with Moffitt

In December 2016, the Company entered into a new three-year Sponsored Research Agreement with H. Lee Moffitt Cancer Center (“Moffitt”). At the same time, the Company entered into a clinical grant agreement with Moffitt to support an ongoing clinical trial at Moffitt that combines TIL therapy with nivolumab for the treatment of patients with metastatic melanoma. In June 2017, the Company entered into a second clinical grant agreement with Moffitt to support a new clinical trial at Moffitt that combines TIL therapy with nivolumab for the treatment of patients with non-small cell lung cancer, under which the Company obtained a non-exclusive, royalty-free license to any new Moffitt inventions made in the performance of the agreement. Under both clinical grant agreements with Moffit, the Company has non-exclusive rights to clinical data arising from the respective clinical trials. The Company recorded research and development costs of $0.2 million and $0.3 million for the three months ended March 31, 2020 and 2019, respectively, in connection with the research collaboration and clinical grant agreements with Moffitt.

Exclusive License Agreements with Moffitt

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

Pursuant to the First Moffitt License, the Company paid an upfront licensing fee in the amount of $0.1 million. A patent issuance fee will also be payable under the First Moffitt License, upon the issuance of the first U.S. patent covering the subject technology. In addition, the Company agreed to pay milestone license fees upon completion of specified milestones, customary royalties based on a specified percentage of net sales (which percentage is in the low single digits) and sublicensing payments, as applicable, and annual minimum royalties beginning with the first sale of products based on the licensed technologies, which minimum royalties will be credited against the percentage royalty payments otherwise payable in that year. The Company will also be responsible for all costs associated with the preparation, filing, maintenance and prosecution of the patent applications and patents covered by the First Moffitt License related to the treatment of any cancers in the United States, Europe and Japan and in other countries designated by the Company in agreement with Moffitt. No expenses were recorded for the First Moffitt License for the three months ended March 31, 2020 and 2019.

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

Pursuant to the Second Moffitt License, the Company paid an upfront licensing fee in the amount of $0.1 million in 2018. An annual license maintenance fee will be also payable commencing on the first anniversary of the effective date. In addition, the Company agreed to pay an annual commercial use payment for each indication for which a first sale has occurred, which in the aggregate amounts to up to $0.4 million a year. The Company recorded research and development costs of $0.02 million for the Second Moffit License for the three months ended March 31, 2020. No expenses were recorded for the same period in 2019.

M.D. Anderson Cancer Center

Strategic Alliance Agreement

On April 17, 2017, the Company entered into a Strategic Alliance Agreement (the “SAA”) with M.D. Anderson Cancer Center (“MDACC”) under which the Company and MDACC agreed to conduct clinical and preclinical research studies. The Company agreed in the SAA to provide total funding not to exceed approximately $14.2 million for the performance of the multi-year studies under the SAA. In return, the Company acquired all rights to inventions resulting from the studies and has been granted a non-exclusive, sub-licensable, royalty-free, and perpetual license to specified background intellectual property of MDACC reasonably necessary to exploit, including the commercialization thereof. The Company has also been granted certain rights in clinical data generated by MDACC outside of the clinical trials to be performed under the SAA. The SAA’s term shall continue in effect until the later of the fourth anniversary of the SAA or the completion or termination of the research and receipt by the Company of all deliverables due from MDACC thereunder. In May 2017, the Company made a prepayment of $1.4 million under this agreement. In light of the COVID-19 Pandemic, MDACC has temporarily suspended their research programs and decommissioned their research

labs, and as a result, enrollment in our MDACC-sponsored studies under the SAA is temporarily paused. The Company recorded $0.2 million and $1.2 million associated with the MDACC SAA for the three months ended March 31, 2020 and 2019, respectively as research and development expenses.

WuXi Apptech, Inc. (WuXi)

In November 2016, the Company entered into a three-year manufacturing and services agreement (“MSA”) with WuXi AppTech, Inc. (“WuXi”) pursuant to which WuXi agreed to provide manufacturing and other services. Under the agreement, the Company entered into two statements of work for two cGMP manufacturing suites to be established and operated by WuXi for the Company, both of the suites are expected to be capable of being used for the commercial manufacture of its products. The statements of work for each of the suites were amended in 2019. The statements of work for facility include a fixed component to reserve a dedicated suite and a trained work force, and a variable component, mainly materials and testing used during the manufacturing processes. Both statements of work provide for adjustments to the targeted production capacity levels and the corresponding fixed quarterly fees upon written notice from the Company of 30 days and 90 days for the first and second dedicated suites, respectively. The quarterly fixed fees payable for each of the dedicated manufacturing suites ranges from $1.2 million to $2.7 million depending on the production capacity level targeted. The terms of the related statements of work for the first and second dedicated manufacturing suites currently extend to May 2020 and June 2021, respectively. The Company recorded costs associated with agreements with WuXi of $6.7 million and $3.8 million for the three months ended March 31, 2020 and 2019 respectively, as research and development expenses.

Cellectis S.A. (Cellectis)

On January 12, 2020, the Company announced that it had entered into a research collaboration and exclusive worldwide license agreement whereby the Company will license gene-editing technology from Cellectis S.A. ("Cellectis"), a clinical-stage biopharmaceutical company, in order to develop TIL therapies that have been genetically edited. Financial terms of the license include development, regulatory and sales milestone payments from the Company to Cellectis, as well as royalty payments based on net sales of TALEN-modified TIL products. The Company recorded costs associated with the license agreement from Cellectis of $0.1 million for the three months ended March 31, 2020

Novartis Pharma AG (Novartis)

On January 12, 2020, the Company announced that it had obtained a license from Novartis Pharma AG (“Novartis”) to develop and commercialize an antibody cytokine engrafted protein, which the Company refers to as IOV-3001. Under the agreement, the Company has paid an upfront payment to Novartis and may pay future milestones related to initiation of patient dosing in various phases of clinical development for IOV-3001 and approval of the product in the U.S, EU and Japan. Novartis is also entitled to low-to-mid single digit royalties from commercial sales of the product. The Company recorded costs associated with the license agreement from Novartis of $10.0 million as research and development expenses for the three months ended March 31, 2020.

STOCKHOLDERS' EQUITY (Details) - USD ($) $ / shares in Units, $ in Thousands				1 Months Ended	3 Months Ended		12 Months Ended
	Jan. 16, 2019	Oct. 17, 2018	Sep. 30, 2013	Jan. 31, 2018	Mar. 31, 2020	Mar. 31, 2019	Dec. 31, 2019	Jun. 10, 2019	Jun. 09, 2019
Common Stock
Common stock sold in public offering, net of offering costs (in shares)		25,300,000	50,000
Share price (in dollars per share)		$ 9.97
Stock repurchased (in shares)	32,500
Common stock, par or stated value per share					$ 0.000041666		$ 0.000041666	$ 0.000041666
Common stock, shares authorized					300,000,000		300,000,000	300,000,000	150,000,000
Other Income
Common Stock
Proceeds from cancellation of shares sold	$ 335,000
Underwriter
Common Stock
Common stock sold in public offering, net of offering costs (in shares)		3,300,000
IPO
Common Stock
Common stock sold in public offering, net of offering costs (in shares)				15,000,000
Share price (in dollars per share)				$ 11.50
Proceeds from the issuance of common stock, net		$ 236,700		$ 162,000
IPO \| Underwriter
Common Stock
Common stock sold in public offering, net of offering costs (in shares)				1,956,521
Proceeds from the issuance of common stock, net		$ 252,200		$ 172,500
Series A Convertible Preferred Stock
Common Stock
Preferred stock, shares authorized					17,000
Preferred stock, shares outstanding					194		194
Conversion of stock, shares issued					500
Conversion of Stock, shares converted					0	0
Series A Convertible Preferred Stock \| Common Stock
Common Stock
Conversion of Stock, shares converted					97,000		97,000
Series A Convertible Preferred Stock \| Private Placement
Common Stock
Sale of stock, price per share					$ 2.00
Preferred stock, par or stated value per share					$ 1,000
Series B Convertible Preferred Stock
Common Stock
Preferred stock, shares authorized					11,500,000		11,500,000
Preferred stock, par or stated value per share					$ 0.001		$ 0.001
Convertible price per shares					$ 4.75
Preferred stock, shares outstanding					3,581,119		3,581,119
Conversion of Stock, shares converted					0	0
Series B Convertible Preferred Stock \| Common Stock
Common Stock
Conversion of Stock, shares converted					3,581,119		3,581,119
Series B Convertible Preferred Stock \| IPO
Common Stock
Preferred stock, shares authorized					11,500,000
Preferred stock, par or stated value per share					$ 4.75
Blank check
Common Stock
Preferred stock, shares authorized					50,000,000

Document And Entity Information - shares	3 Months Ended
Document And Entity Information - shares	Mar. 31, 2020	Apr. 28, 2020
Document And Entity Information [Abstract]
Document Type	10-Q
Document Quarterly Report	true
Document Transition Report	false
Document Period End Date	Mar. 31, 2020
Entity File Number	001-36860
Entity Registrant Name	IOVANCE BIOTHERAPEUTICS, INC.
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	75-3254381
Entity Address, Address Line One	999 Skyway Road, Suite 150
Entity Address, City or Town	San Carlos
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	94070
City Area Code	650
Local Phone Number	260-7120
Title of 12(b) Security	Common stock, par value $0.000041666 per share
Trading Symbol	IOVA
Security Exchange Name	NASDAQ
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Large Accelerated Filer
Entity Small Business	false
Entity Emerging Growth Company	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		126,861,580
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2020
Document Fiscal Period Focus	Q1
Entity Central Index Key	0001425205
Amendment Flag	false

CASH EQUIVALENTS AND SHORT-TERM INVESTMENTS (Tables)

3 Months Ended

Mar. 31, 2020

CASH EQUIVALENTS AND SHORT-TERM INVESTMENTS

Schedule of cash, money market funds and short-term investments

Cash equivalents and short-term investments consist of the following (in thousands):


	March 31,		December 31,
	2020		2019
Cash equivalents - Money market funds	$	39,924	$	10,049
Cash equivalents total	$	39,924	$	10,049

Schedule of cost and fair value of cash equivalents and short-term investments

Cash equivalents in the tables above exclude cash demand deposits of $12.6 million and $3.9 million as of March 31, 2020 and December 31, 2019, respectively (in thousands).


	March 31,		December 31,
Short-term Investments	2020		2019
US treasury securities	$	161,512	$	242,249
US government agency securities		31,600		50,863
Short-term investments total	$	193,112	$	293,112

The cost and fair value of cash equivalents and short-term investments at March 31, 2020 and December 31, 2019 were as follows (in thousands):


					Gross		Gross
			Accretion		Unrealized		Unrealized
As of March 31, 2020	Cost		(Amortization)		Gains		Losses		Fair Value

US treasury securities	$	160,708	$	(16)	$	820	$	—	$	161,512
US government agency securities		31,463		45		92		—		31,600
Total	$	192,171	$	29	$	912	$	—	$	193,112


					Gross		Gross
					Unrealized		Unrealized
As of December 31, 2019	Cost		Accretion		Gains		Losses		Fair Value

US treasury securities	$	241,709	$	364	$	179	$	(3)	$	242,249
US government agency securities		50,712		107		44		—		50,863
Total	$	292,421	$	471	$	223	$	(3)	$	293,112

Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2020	Mar. 31, 2019
Cash Flows from Operating Activities
Net loss	$ (69,595)	$ (36,950)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense	9,412	5,846
Noncash lease expense	1,870	1,424
Amortization of premiums on investments	(50)	(1,232)
Depreciation and amortization	252	271
Gain on settlement of dispute		(336)
Changes in assets and liabilities:
Prepaid expenses, other assets, and long-term assets	(1,316)	1,592
Operating lease liabilities (Right-of-use assets)	(2,461)	(942)
Accounts payable	(7,768)	4,583
Accrued expenses and other liabilities	4,364	(3,346)
Net cash used in operating activities	(65,292)	(29,090)
Cash Flows from Investing Activities
Maturities of short-term investments	113,665	91,042
Purchase of short-term investments	(12,923)	(89,185)
Purchase of property and equipment	(637)	(824)
Net cash provided by investing activities	100,105	1,033
Cash Flows from Financing Activities
Tax payments related to shares withheld for vested restricted stock awards	(118)	(71)
Proceeds from the issuance of common stock upon exercise of options	3,951	69
Net cash provided by / (used in) financing activities	3,833	(2)
Net increase / (decrease) in cash, cash equivalents and restricted cash	38,646	(28,059)
Cash, Cash Equivalents, and Restricted Cash, Beginning of Period	19,419	82,152
Cash, Cash Equivalents, and Restricted Cash, End of Period (Note 2)	58,065	54,093
Supplemental disclosure of non-cash investing and financing activities:
Net unrealized gain on short-term investments	692	180
Acquisitions of property and equipment included in accounts payable and accrued expenses	$ 4,686	$ 268

LEASES

3 Months Ended

Mar. 31, 2020

LEASES

LEASES

NOTE 9. LEASES

Facilities Leases

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

Tampa Lease

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

In April 2015, the Company amended the original lease agreement to increase the rentable space to 6,043 square feet. In September 2016, the Company further increased the rentable space to 8,673 square feet. The per square foot cost and term of the lease were unchanged, and rent payments are approximately $20,000 per month. In December 2019, the Company entered into an agreement to extend the lease term to December 18, 2024 for approximately $20,500 a month.

San Carlos Lease

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

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

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

On June 19, 2019, the Company entered into a first amendment (the “Amended Lease”) to its previously disclosed lease agreement with Hudson Skyway Landing, LLC (the “Lease”) for additional space at its corporate headquarters in San Carlos, California. Under the Amended Lease, the Company will lease an additional 8,110 square feet (the “Expansion Space”), for a total of approximately 20,432 square feet of space on the first floor of the building located at 999 Skyway Road, San Carlos, California, commonly known as Skyway Landing II. The term of the Amended Lease remains the same as that of the Lease and expires on April 30, 2021, unless earlier terminated in accordance with the Amended Lease. The Company’s monthly base rent for the Expansion Space under the Amended Lease will be approximately $39,000 for the first year, and $40,000 for the second year.

New York Lease

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

agreement to extend the lease term to January 31, 2020 for approximately $4,000 a month. On October 24, 2019, the Company entered into an agreement to extend the lease term to April 30, 2020 for approximately $4,000 a month. On January 23, 2020, the Company entered into an agreement to extend the lease term to July 31, 2020 for approximately $4,000 a month.

Philadelphia Office Lease

On May 2, 2019, the Company entered into an agreement to lease approximately 1,500 square feet of office space in Philadelphia, Pennsylvania until July 1, 2019 for a rate of $2,000 a month, and then approximately 4,500 square feet of office space for the remainder of a three-year term at an initial rate of $11,063 per month, subject to annual increases of 2.5%.

Commercial Manufacturing Facility Agreement

On May 28, 2019, the Company entered into a lease agreement with 300 Rouse Boulevard, LLC (the “Commercial Manufacturing Facility Lease”) for a build-to-suit commercial manufacturing facility, laboratories, and offices located in Philadelphia, Pennsylvania. Under the Commercial Manufacturing Facility Lease, the Company will lease approximately 136,000 rentable square feet of space in a building to be located at 300 Rouse Boulevard, Philadelphia, Pennsylvania (the “Premises”). The commercial manufacturing facility is expected to be constructed in two phases: Phase I-A, the construction of the commercial manufacturing facility, with approximately 66,000 rentable square feet of space; and Phase I-B, the construction of offices and laboratories, with approximately 70,000 rentable square feet of space. The Commercial Manufacturing Facility Lease is for a term of 242 months, commencing on the earlier of (i) the date on which the Company occupies any portion of the Premises for the normal operation of its business or (ii) the date that is the later of (A) one hundred sixty (160) days after the Phase I-A substantial completion date, currently anticipated to be July 16, 2020, or (B) the Phase I-B Substantial Completion Date (the “Commencement Date”). The Commencement Date shall be extended by one day for each day of landlord delay, net of any tenant delay, as defined in the Lease. The Commercial Manufacturing Facility Lease includes an option to extend the term of the lease, exercisable under certain conditions as described in the Commercial Manufacturing Facility Lease, such that the overall term, when added to the initial term, shall be 359 months, by giving the landlord prior written notice thereof at least 18 months in advance of the expiration date.

Beginning on the Commencement Date, the Company’s monthly base rent under the Lease will be approximately $320,000, subject to an annual increase of 2% for the first ten years, and an annual increase of the greater of 2% or 75% of the average ten-year consumer price index. The Company will also be responsible for paying operating expenses, which are expected to be approximately $53,000 per month in 2020.

Manufacturing Contracts

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

The guidance requires the Company to first identify a lease deliverable and non-lease deliverable included in the arrangements, and then allocate the fixed contractual consideration to the lease deliverable(s) and the non-lease deliverable(s) on a relative standalone selling price basis to determine the amount of operating lease right-of-use assets and liabilities. The Company identified the use of a dedicated suite as a single lease deliverable, and related labor services as a single non-lease deliverable in each of the CMO arrangements. Judgment is required to determine the relative standalone selling price of each deliverable as the observable

standalone selling prices are not readily available. Therefore, management used estimates and assumptions in determining relative standalone selling price of lease of a suite and labor service using information that includes market and other observable inputs to the extent possible.

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

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


	March 31, 2020		December 31, 2019

Operating lease right-of-use assets	$	9,305	$	10,695
Operating lease liabilities
Current portion included in current liabilities		6,431		7,252
long-term portion included in non-current liabilities		3,088		4,248
Total Operating lease liabilities	$	9,519	$	11,500

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


	For the Three Months Ended
	March 31,
	2020		2019

Operating lease cost	$	1,636	$	1,594
Variable lease cost		1,371		896
Short-term lease cost		17		19
Total lease cost	$	3,024	$	2,509

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

Cash paid for amounts included in the measurement of lease liabilities for the three months ended March 31, 2020 and 2019 were $2.2 million and $1.4 million, respectively, and were included in Net cash provided by operating activities in its condensed consolidated statement of cash flows. During the three months ended March 31, 2020 and 2019, the Company increased operating lease right-of-use assets by $0.5 million and $1.0 million, respectively, and operating lease liability by $0.01 million and $1.0 million, respectively, as a result of lease modifications.

As of March 31, 2020, the maturities of the Company’s operating lease liabilities were as follows (in thousands):


			CMO
	Facility		embedded
	leases		leases		Total
2020	$	1,425	$	3,783	$	5,208
2021		968		3,155		4,123
2022		342		—		342
2023		269		—		269
2024		253		—		253
Thereafter		—		—		—
Total lease payments	$	3,257	$	6,938	$	10,195
Less: Present value adjustment		(308)		(368)		(676)
Operating lease liabilities	$	2,949	$	6,570	$	9,519

Operating lease liabilities are based on the net present value of the remaining lease payments over the remaining lease term. In determining the present value of lease payments, the Company used its incremental borrowing rate based on the information available at the date of adoption of Topic 842. As of March 31, 2020, the weighted average remaining lease term is 1.73 years and the weighted average discount rate used to determine the operating lease liabilities was 7.5%. As of March 31, 2020, the Company has a finance lease for the commercial manufacturing facility that has not yet commenced. This finance lease will commence in December 2020 with a lease term of 20 years.

STOCK BASED COMPENSATION (Tables)

3 Months Ended

Mar. 31, 2020

STOCK BASED COMPENSATION

Schedule of status of stock options



		Weighted		Weighted	Aggregate
	Number	Average		Average	Intrinsic
	of	Exercise		Remaining	Value (in
	Options	Price		Contract Life	thousands)
Outstanding at January 1, 2020	9,494,712	$	12.00
Granted	3,276,351		24.58
Exercised	(404,075)		9.78
Expired/Forfeited	(230,089)		12.91
Outstanding at March 31, 2020	12,136,899	$	15.46	8.37	$	176,592

Options exercisable at March 31, 2020	5,256,772	$	10.16	7.14	$	104,569

Schedule of share-based payment award, stock options, valuation assumptions


	Three Months Ended March 31,
Assumptions:	2020	2019
Expected term (years)	6.19	6.06
Expected volatility	69.99%	70.78%
Risk-free interest rate	1.83%	2.59%
Expected dividend yield	0%	0%

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables)

3 Months Ended

Mar. 31, 2020

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Schedule of cash and cash equivalents and restricted cash


	March 31,		March 31,
	2020		2019
Cash and cash equivalents	$	52,540	$	54,093
Restricted cash (included in non-current assets on the condensed consolidated balance sheets)		5,525		—
Total cash, cash equivalents and restricted cash	$	58,065	$	54,093

Schedule of Antidilutive securities excluded from computation of earnings per share


	March 31,
	2020	2019
Stock options	12,136,899	9,274,973
Series A Convertible Preferred Stock*	97,000	97,000
Series B Convertible Preferred Stock*	3,581,119	5,854,845
Restricted stock units	11,458	57,285
	15,826,476	15,284,103

* on an as-converted basis

Schedule of assets measured at fair value


	Assets at Fair Value as of March 31, 2020
	Level 1		Level 2		Level 3		Total
US treasury securities	$	161,512	$	—	$	—	$	161,512
US government agency securities		31,600		—		—		31,600
Total	$	193,112	$	—	$	—	$	193,112


	Assets at Fair Value as of December 31, 2019
	Level 1		Level 2		Level 3		Total
US treasury securities	$	242,249	$	—	$	—	$	242,249
US government agency securities		50,863		—		—		50,863
Total	$	293,112	$	—	$	—	$	293,112

Schedule of stock-based compensation


	Three Months Ended
	March 31,
	2020		2019
Research and development	$	4,318	$	2,701
General and administrative		5,094		3,145
Total stock-based compensation expense	$	9,412	$	5,846

Schedule of compensation cost for share-based payment arrangements, allocation of share-based compensation costs by plan


	Three Months Ended
	March 31,
	2020		2019
Stock option expense	$	9,345	$	5,779
Restricted stock unit expense		67		67
Total stock-based compensation expense	$	9,412	$	5,846

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

3 Months Ended

Mar. 31, 2020

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

NOTE 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Cash, Cash Equivalents, and Short-term Investments


	March 31,		March 31,
	2020		2019
Cash and cash equivalents	$	52,540	$	54,093
Restricted cash (included in non-current assets on the condensed consolidated balance sheets)		5,525		—
Total cash, cash equivalents and restricted cash	$	58,065	$	54,093

Loss per Share

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

At March 31, 2020 and 2019, the following outstanding common stock equivalents have been excluded from the calculation of net loss per share because their impact would be anti-dilutive.


	March 31,
	2020	2019
Stock options	12,136,899	9,274,973
Series A Convertible Preferred Stock*	97,000	97,000
Series B Convertible Preferred Stock*	3,581,119	5,854,845
Restricted stock units	11,458	57,285
	15,826,476	15,284,103

* on an as-converted basis

Fair Value Measurements

Level 1–These are investments where values are based on unadjusted quoted prices for identical assets in an active market that the Company has the ability to access.

The Company does not have fair valued assets classified under Level 2 as of March 31, 2020 and December 31, 2019.

Level 3–These are financial instruments where values are derived from techniques in which one or more significant inputs are unobservable.

The Company does not have fair valued assets classified under Level 3 as of March 31, 2020 and December 31, 2019.


	Assets at Fair Value as of March 31, 2020
	Level 1		Level 2		Level 3		Total
US treasury securities	$	161,512	$	—	$	—	$	161,512
US government agency securities		31,600		—		—		31,600
Total	$	193,112	$	—	$	—	$	193,112


	Assets at Fair Value as of December 31, 2019
	Level 1		Level 2		Level 3		Total
US treasury securities	$	242,249	$	—	$	—	$	242,249
US government agency securities		50,863		—		—		50,863
Total	$	293,112	$	—	$	—	$	293,112

Use of Estimates

Principles of Consolidation

Income Taxes

tax expense any interest and penalties. The Company has no material uncertain tax positions for any of the reporting periods presented.

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 RSUs and RSAs is based on the closing price of the Company’s common stock on the grant date.

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


	Three Months Ended
	March 31,
	2020		2019
Research and development	$	4,318	$	2,701
General and administrative		5,094		3,145
Total stock-based compensation expense	$	9,412	$	5,846

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


	Three Months Ended
	March 31,
	2020		2019
Stock option expense	$	9,345	$	5,779
Restricted stock unit expense		67		67
Total stock-based compensation expense	$	9,412	$	5,846

Preferred Stock

Convertible Instruments

Recent Accounting Standards

Financial Instruments

Cloud Computing Arrangements

Subsequent Event

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

Reclassifications

Condensed Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands	Series A Convertible Preferred Stock	Series B Convertible Preferred Stock	Common Stock	Additional Paid-in Capital	Accumulated other Comprehensive Income	Accumulated Deficit	Total
Beginning Balance at Dec. 31, 2018		$ 6	$ 5	$ 838,984	$ (42)	$ (372,760)	$ 466,193
Beginning Balance (in Shares) at Dec. 31, 2018	194	5,854,845	123,415,576
Stock-based compensation expense				5,846			5,846
Vesting of restricted shares issued for services			$ 1				1
Vesting of restricted shares issued for services (in shares)			7,037
Tax payments related to shares withheld for vested restricted stock units				(71)			(71)
Common stock issued upon exercise of stock options			$ 0	69			69
Common stock issued upon exercise of stock options (in shares)			5,000
Unrealized gain on short-term investments					180		180
Cancellation of common shares from settlement of dispute			$ (1)	(335)			(336)
Cancellation of common shares from settlement of dispute (In Shares)			(32,500)
Net loss						(36,950)	(36,950)
Ending Balance at Mar. 31, 2019		$ 6	$ 5	844,789	138	(410,006)	434,932
Ending Balance (in Shares) at Mar. 31, 2019	194	5,854,845	123,395,113
Adoption of ASU 2018-07				296		(296)
Beginning Balance at Dec. 31, 2019		$ 4	$ 5	869,354	220	(570,612)	298,971
Beginning Balance (in Shares) at Dec. 31, 2019	194	3,581,119	126,411,808
Stock-based compensation expense				9,412			9,412
Vesting of restricted shares issued for services (in shares)			7,273
Tax payments related to shares withheld for vested restricted stock units				(118)			(118)
Common stock issued upon exercise of stock options				3,951			3,951
Common stock issued upon exercise of stock options (in shares)			404,075
Unrealized gain on short-term investments					692		692
Net loss						(69,595)	(69,595)
Ending Balance at Mar. 31, 2020		$ 4	$ 5	$ 882,599	$ 912	$ (640,207)	$ 243,313
Ending Balance (in Shares) at Mar. 31, 2020	194	3,581,119	126,823,156

CASH EQUIVALENTS AND SHORT-TERM INVESTMENTS

3 Months Ended

Mar. 31, 2020

CASH EQUIVALENTS AND SHORT-TERM INVESTMENTS

CASH EQUIVALENTS AND SHORT-TERM INVESTMENTS

NOTE 3. CASH EQUIVALENTS AND SHORT-TERM INVESTMENTS

Cash equivalents and short-term investments consist of the following (in thousands):


	March 31,		December 31,
	2020		2019
Cash equivalents - Money market funds	$	39,924	$	10,049
Cash equivalents total	$	39,924	$	10,049

Cash equivalents in the tables above exclude cash demand deposits of $12.6 million and $3.9 million as of March 31, 2020 and December 31, 2019, respectively (in thousands).


	March 31,		December 31,
Short-term Investments	2020		2019
US treasury securities	$	161,512	$	242,249
US government agency securities		31,600		50,863
Short-term investments total	$	193,112	$	293,112

The cost and fair value of cash equivalents and short-term investments at March 31, 2020 and December 31, 2019 were as follows (in thousands):


					Gross		Gross
			Accretion		Unrealized		Unrealized
As of March 31, 2020	Cost		(Amortization)		Gains		Losses		Fair Value

US treasury securities	$	160,708	$	(16)	$	820	$	—	$	161,512
US government agency securities		31,463		45		92		—		31,600
Total	$	192,171	$	29	$	912	$	—	$	193,112


					Gross		Gross
					Unrealized		Unrealized
As of December 31, 2019	Cost		Accretion		Gains		Losses		Fair Value

US treasury securities	$	241,709	$	364	$	179	$	(3)	$	242,249
US government agency securities		50,712		107		44		—		50,863
Total	$	292,421	$	471	$	223	$	(3)	$	293,112

Upon adoption of Topic 326 on January 1, 2020, the Company is required to assess and estimate CECL on AFS debt securities only when the fair value is below the amortized cost of the asset and is no longer based on an impairment being “other-than-temporary”. The credit-related losses are required to be recognized through the statements of operations and non-credit related losses are reported in other comprehensive income. For the three months ended March 31, 2020, no CECL was recognized in the condensed consolidated statement of operations and all unrealized gains and losses are included in accumulated other comprehensive income. All short-term investments held by the Company as of March 31, 2020 and December 31, 2019 have a maturity of less than one year.

STOCK BASED COMPENSATION - Additional information (Details) - USD ($) $ / shares in Units, $ in Thousands		1 Months Ended		3 Months Ended
	Jun. 01, 2016	Aug. 31, 2013	Jul. 31, 2013	Mar. 31, 2020	Mar. 31, 2019	Apr. 22, 2018	Aug. 16, 2016	Apr. 10, 2015	Nov. 30, 2014	Aug. 20, 2014	Aug. 19, 2014	Oct. 14, 2011
STOCK BASED COMPENSATION
Vested	(137,500)
Weighted average grant date fair value, options granted				$ 15.67	$ 6.99
Unvested shares				11,458
Share-based Compensation				$ 9,412	$ 5,846
Restricted Common Stock
STOCK BASED COMPENSATION
Stock-based compensation expense				100	100
Restricted stock units
STOCK BASED COMPENSATION
Unrecognized compensation cost				$ 40
Unrecognized compensation cost recognition period				2 months 1 day
Restricted stock units \| Chief Executive Officer
STOCK BASED COMPENSATION
Granted	550,000
Granted	$ 5.87
Stock option
STOCK BASED COMPENSATION
Stock-based compensation expense				$ 9,300	$ 5,800
Total unrecognized compensation expense				$ 81,100
Unrecognized compensation cost recognition period				2 years 2 months 26 days
First Anniversary \| Restricted stock units
STOCK BASED COMPENSATION
Vested	(137,500)
Vesting period	36 months
Satisfaction Of Clinical Trial Milestones \| Restricted stock units
STOCK BASED COMPENSATION
Vested	(275,000)
2011 Equity Incentive Plan
STOCK BASED COMPENSATION
Number of shares available				151,240
Common stock, capital shares reserved for future issuance		1,700,000								1,900,000	1,700,000	180,000
Maximum award per person per year (in shares)		300,000	50,000
2011 Equity Incentive Plan \| Minimum
STOCK BASED COMPENSATION
Number of shares available												180,000
2014 Equity Incentive Plan
STOCK BASED COMPENSATION
Shares authorized								4,000,000	2,350,000
Number of shares available				89,408
2014 Equity Incentive Plan \| Maximum
STOCK BASED COMPENSATION
Shares authorized							9,000,000
The 2018 Plan
STOCK BASED COMPENSATION
Shares authorized						6,000,000
Number of shares available				336,222

LEASES - Additional information (Details)			1 Months Ended					3 Months Ended		6 Months Ended	8 Months Ended	9 Months Ended
LEASES - Additional information (Details)	Jun. 19, 2019 USD ($) ft²	May 28, 2019 USD ($) ft² item	Oct. 19, 2018 USD ($) ft²	Jul. 31, 2017 USD ($)	Sep. 30, 2016 USD ($) ft²	Aug. 04, 2016 USD ($) ft²	Dec. 31, 2014 ft²	Mar. 31, 2020 USD ($)	Mar. 31, 2019 USD ($)	Jul. 31, 2020 USD ($)	Jun. 30, 2020 USD ($)	Jan. 31, 2020 USD ($)	Jul. 31, 2019 USD ($)	Jan. 31, 2019 USD ($)	Dec. 31, 2019 USD ($)	May 02, 2019 USD ($) ft²	Oct. 31, 2018 ft²	Jul. 31, 2018 USD ($)	Apr. 28, 2017 USD ($) ft²	Apr. 30, 2015 ft²
Option to extend		option to extend
Monthly lease payments								$ 10,195,000
First year								5,208,000
Second year								4,123,000
Lease Expiration Term			30 months
Monthly lease payments			$ 59,000					2,200,000	$ 1,400,000
Operating lease liabilities								9,519,000							$ 11,500,000
Operating lease right-of-use assets								9,305,000							10,695,000
Operating Leases of Lessee, Contingent Rentals, Basis Spread on Variable Rate			3.00%
Increase in operating lease right-of-use assets								500,000	1,000,000.0
Increase in operating lease liability								$ 10,000.00	$ 1,000,000.0
Weighted average remaining lease term (in years)								1 year 8 months 23 days
Weighted average discount rate (as a percent)								7.50%
Finance lease term for not yet commenced (in years)								20 years
Tampa Lease
Term of contract (in years)							5 years
Option to extend							option to extend
Renewal term (in months)							5 years
Monthly lease payments															$ 20,500
Rent expense					$ 20,000
Area of Land \| ft²					8,673		5,115													6,043
New York Lease
Rent expense										$ 4,000	$ 4,000	$ 4,000	$ 4,000
New York Lease \| Office Space
Monthly lease payments																		$ 9,000
Operating Leases, Rent Expense, Minimum Rentals				$ 18,000
Rent expense														$ 7,000
Teradata US, Inc
Area of Land \| ft²																			11,449
San Carlos Lease
Additional space of lease \| ft²	8,110
First year	$ 39,000
Second year	$ 40,000
San Carlos Lease \| Land
Monthly lease payments						$ 38,000													$ 26,000
Lease Expiration Term						54 months
Area of Land \| ft²			12,322			8,733											11,449
San Carlos Lease \| Office Space
Area of Land \| ft²	20,432
Philadelphia Office Lease for first year \| Office Space
Monthly lease payments																$ 2,000
Area of Land \| ft²																1,500
Philadelphia Office Lease for next three Years
Operating Leases of Lessee, Contingent Rentals, Basis Spread on Variable Rate																2.50%
Philadelphia Office Lease for next three Years \| Office Space
Term of contract (in years)																3 years
Monthly lease payments																$ 11,063
Area of Land \| ft²																4,500
Commercial Manufacturing Facility Agreement
Term of contract (in years)		242 months
Renewal term (in months)		359 months
Monthly lease payments		$ 320,000
Number of phases \| item		2
Prior written notice period (in months)		18 months
Minimum annual increase in basis spread on variable rate (as a percent)		2.00%
Maximum annual increase in basis spread on variable rate (as a percent)		75.00%
Operating expenses		$ 53,000
Operating Leases of Lessee, Contingent Rentals, Basis Spread on Variable Rate		2.00%
Commercial Manufacturing Facility Agreement \| Office Space
Area of Land \| ft²		136,000
Commercial Manufacturing Facility Agreement for Phase I-A
Term of Phase I-A		160 days
Commercial Manufacturing Facility Agreement for Phase I-A \| Office Space
Area of Land \| ft²		66,000
Commercial Manufacturing Facility Agreement for Phase I-B \| Office Space
Area of Land \| ft²		70,000

RELATED PARTY TRANSACTIONS (Details Textual) - USD ($) $ / shares in Units, $ in Thousands			3 Months Ended
	Sep. 14, 2017	Sep. 14, 2017	Mar. 31, 2020	Mar. 31, 2019	Dec. 31, 2019	Jan. 01, 2019
Term of consulting agreement (in years)	3 years
Terms of award		The granted stock options vest in 12 quarterly installments (with 1/12th of the option shares having vested on the date of grant).
Stock-based compensation expense			$ 9,412	$ 5,846
Retained earnings			(640,207)		$ (570,612)	$ 300
Consulting Agreement
Stock-based compensation expense			$ 100	$ 100
Board of Directors Chairman
Shares authorized	150,000	150,000
Granted		$ 7.30

LEGAL PROCEEDINGS (Details)				1 Months Ended		3 Months Ended
LEGAL PROCEEDINGS (Details)	Apr. 17, 2019 USD ($)	Jun. 13, 2017 USD ($) shares	Apr. 08, 2016 USD ($)	Nov. 30, 2012 USD ($)	Jun. 30, 2012 USD ($)	Mar. 31, 2020 shares
Damages claimed			$ 500,000
Class Action Lawsuit
Settlement amount	$ 3,250,000
Twenty Eleven Equity Incentive Plan
Common stock issued upon exercise of stock options (in shares) \| shares						200,000
Steven Fischkoff
Granted \| shares		150,000
Severance pay and retention bonus		$ 300,000
Minimum
Estimate of possible loss			$ 1,500,000
Solomon Capital, LLC
Proceeds from related party debt				$ 100,000	$ 200,000
Debt instrument, convertible, number of equity instruments			1,110
Solomon Capital, LLC \| Commercial Paper
Face amount			$ 200,000

LICENSES AND AGREEMENTS (Details) - USD ($) $ in Thousands	1 Months Ended			3 Months Ended		12 Months Ended
LICENSES AND AGREEMENTS (Details) - USD ($) $ in Thousands	Apr. 17, 2017	Nov. 30, 2016	Aug. 31, 2011	Mar. 31, 2020	Mar. 31, 2019	Dec. 31, 2019	May 31, 2017
Research and development expenses				$ 56,952	$ 30,905
Research and Development Arrangement
Prepaid expense, current							$ 1,400
Research Collaboration And Clinical Grant Agreement
Research and development expenses				200	300
Research Collaboration And Clinical Grant Agreements With Moffitt
Research and development expenses				200		$ 1,200
Maximum \| Research and Development Arrangement
Research and development arrangement, contract to perform for others, costs incurred, gross	$ 14,200
National Cancer Institute
Research and development expenses				$ 500
Moffitt License Agreement
Agreement term				20 years
Novartis Pharma AG - License Agreement [Member]
Research and development expenses				$ 10,000
Cooperative Research and Development Agreement
Research and development expenses				500
Agreement term			5 years
WuXi Apptech, Inc - Manufacturing and Services Agreement
Research and development expenses				6,700	$ 3,800
WuXi Apptech, Inc - Manufacturing and Services Agreement \| Manufacturing Suites
Manufacturing and services agreement, amount payable		$ 1,200
WuXi Apptech, Inc - Manufacturing and Services Agreement \| Commercial Manufacturing cGMP Suite
Manufacturing and services agreement, amount payable		$ 2,700
Moffitt License Agreement Two
Research and development expenses				20
Payments for upfront licensing fee				100
Additional milestone payable				400
Moffitt License Agreement One
Payments for upfront licensing fee				100
Research Collaboration And Clinical Grant Agreements With Moffitt
Research and development expenses						$ 1,200
Cellectis S.A
Research and development expenses				$ 100

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Cash, Cash equivalents and Restricted Cash (Details) - USD ($)	Mar. 31, 2020	Dec. 31, 2019	Mar. 31, 2019	Dec. 31, 2018
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Security deposit	$ 5,500,000
Security deposit for the benefit of the landlord for its commercial manufacturing facility	5,450,000
Security deposit for the benefit of utilities service provider	74,685,000
Letter of credit	1,000,000
Cash and cash equivalents	52,540,000	$ 13,969,000	$ 54,093,000
Restricted cash (included in non-current assets on the condensed consolidated balance sheets)	5,525,000	5,450,000
Total cash, cash equivalents and restricted cash	58,065,000	$ 19,419,000	$ 54,093,000	$ 82,152,000
Minimum
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Security deposit	$ 1,450,000

BALANCE SHEET COMPONENTS (Details) - USD ($) $ in Thousands	Mar. 31, 2020	Dec. 31, 2019
BALANCE SHEET COMPONENTS
Clinical related	$ 10,211	$ 4,692
Accrued payroll and employee related expenses	4,118	6,866
Manufacturing related	3,527	2,184
Commercial manufacturing facility related	1,869	17
Legal and related services	1,100	866
Accrued other	1,675	1,640
Accrued liabilities	$ 22,500	$ 16,265

Condensed Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2020	Mar. 31, 2019
Condensed Consolidated Statements of Comprehensive Loss
Net Loss	$ (69,595)	$ (36,950)
Other comprehensive income:
Unrealized gain on short-term investments	692	180
Comprehensive Loss	$ (68,903)	$ (36,770)

CASH EQUIVALENTS AND SHORT-TERM INVESTMENTS - Short-term investments (Details) - USD ($) $ in Thousands	Mar. 31, 2020	Dec. 31, 2019
Short-term Investments	$ 193,112	$ 293,112
Available-for-sale Securities, Current	193,112	293,112
US treasury securities
Available-for-sale Securities, Current	161,512	242,249
US government agency securities
Available-for-sale Securities, Current	$ 31,600	$ 50,863

Condensed Consolidated Statements of Operations - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2020	Mar. 31, 2019
Costs and expenses
Research and development expenses	$ 56,952	$ 30,905
General and administrative expenses	13,858	9,081
Total costs and expenses	70,810	39,986
Loss from operations	(70,810)	(39,986)
Other income
Interest income, net	1,215	3,036
Net Loss	$ (69,595)	$ (36,950)
Net Loss Per Common Share, Basic and Diluted	$ (0.55)	$ (0.30)
Weighted Average Common Shares Outstanding, Basic and Diluted	126,568	123,415

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Stock-based compensation expense (Details) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2020	Mar. 31, 2019
Total stock-based compensation expenses	$ 9,412	$ 5,846
Research and development
Total stock-based compensation expenses	4,318	2,701
General and administrative
Total stock-based compensation expenses	$ 5,094	$ 3,145

LEASES - Company's right-of-use asset and lease liabilities (Details) - USD ($) $ in Thousands	Mar. 31, 2020	Dec. 31, 2019
LEASES
Operating lease right-of-use assets	$ 9,305	$ 10,695
Operating lease liabilities
Current portion included in current liabilities	6,431	7,252
Long-term portion included in non-current liabilities	3,088	4,248
Total Operating lease liabilities	$ 9,519	$ 11,500

CASH EQUIVALENTS AND SHORT-TERM INVESTMENTS - Cost and fair value (Details) - USD ($) $ in Thousands	Mar. 31, 2020	Dec. 31, 2019
Cost	$ 192,171	$ 292,421
Accretion (Amortization)	29	471
Gross Unrealized Gains	912	223
Gross Unrealized Losses		(3)
Fair Value	193,112	293,112
US treasury securities
Cost	160,708	241,709
Accretion (Amortization)	(16)	364
Gross Unrealized Gains	820	179
Gross Unrealized Losses		(3)
Fair Value	161,512	242,249
US government agency securities
Cost	31,463	50,712
Accretion (Amortization)	45	107
Gross Unrealized Gains	92	44
Fair Value	$ 31,600	$ 50,863

LEASES - maturities of the Company's operating lease liabilities (Details) - USD ($) $ in Thousands	Mar. 31, 2020	Dec. 31, 2019
2020	$ 5,208
2021	4,123
2022	342
2023	269
2024	253
Total lease payments	10,195
Less: Present value adjustment	(676)
Operating lease liabilities	9,519	$ 11,500
Facility leases
2020	1,425
2021	968
2022	342
2023	269
2024	253
Total lease payments	3,257
Less: Present value adjustment	(308)
Operating lease liabilities	2,949
CMO embedded leases
2020	3,783
2021	3,155
Total lease payments	6,938
Less: Present value adjustment	(368)
Operating lease liabilities	$ 6,570

STOCK BASED COMPENSATION - Assumptions (Details)	3 Months Ended
STOCK BASED COMPENSATION - Assumptions (Details)	Mar. 31, 2020	Mar. 31, 2019
STOCK BASED COMPENSATION
Expected term (years)	6 years 2 months 8 days	6 years 21 days
Expected volatility	69.99%	70.78%
Risk-free interest rate	1.83%	2.59%
Expected dividend yield	0.00%	0.00%

CASH EQUIVALENTS AND SHORT-TERM INVESTMENTS (Details) - USD ($) $ in Thousands	Mar. 31, 2020	Dec. 31, 2019
Cash equivalents total	$ 39,924	$ 10,049
Money Market Funds
Cash equivalents total	39,924	10,049
Demand Deposits
Cash equivalents total	$ 12,600	$ 3,900