10-Q 1 iova-20220331x10q.htm 10-Q
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 10-Q

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended March 31, 2022

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from     to    .

Commission File Number 001-36860

IOVANCE BIOTHERAPEUTICS, INC.

(Exact name of issuer as specified in its charter)

Delaware

75-3254381

(State or other jurisdiction of

(I.R.S. employer

incorporation or organization)

identification number)

825 Industrial Road, Suite 400, San Carlos, CA 94070

(Address of principal executive offices and zip code)

(650) 260-7120

(Registrant’s telephone number, including area code)

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes þ No

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes þ No

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer  þ

Accelerated filer

Non-accelerated filer   

Smaller reporting company

 

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes No þ

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

   

Trading Symbol(s)

   

Name of each exchange on which registered

Common Stock, par value $0.000041666

 

IOVA

 

The Nasdaq Global Market

At April 25, 2022, the issuer had 157,168,321 shares of common stock, par value $0.000041666 per share, outstanding.

PART I. FINANCIAL INFORMATION

Item 1.

Condensed Consolidated Financial Statements

IOVANCE BIOTHERAPEUTICS, INC.

Condensed Consolidated Balance Sheets

(unaudited; in thousands, except share and per share information)

    

March 31, 

December 31, 

    

2022

    

2021

ASSETS

  

 

  

  

 

  

Current Assets

  

 

  

Cash and cash equivalents

$

92,360

$

78,229

Short-term investments

 

389,829

 

426,181

Prepaid expenses and other assets

 

7,779

 

3,546

Total Current Assets

 

489,968

 

507,956

 

  

 

  

Property and equipment, net

102,757

100,938

Operating lease right-of-use assets

73,475

68,983

Long-term investments

 

27,701

91,588

Restricted cash

6,084

6,084

Long-term assets

 

1,266

 

1,784

Total Assets

$

701,251

$

777,333

 

  

 

  

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

  

 

  

 

  

 

  

Current Liabilities

 

  

 

  

Accounts payable

$

20,454

$

27,377

Accrued expenses

 

48,911

 

56,766

Operating lease liabilities

7,710

5,057

Total Current Liabilities

 

77,075

 

89,200

 

  

 

  

Non-Current Liabilities

 

  

 

  

Operating lease liabilities – noncurrent

 

71,184

 

65,474

Long-term note payable

1,000

1,000

Total Non-Current Liabilities

 

72,184

 

66,474

Total Liabilities

 

149,259

 

155,674

 

  

 

  

Commitments and contingencies

 

  

 

  

 

  

 

  

Stockholders’ Equity

 

  

 

  

Series A Convertible Preferred stock, $0.001 par value; 17,000 shares designated, 194 shares issued and outstanding as of March 31, 2022 and December 31, 2021

 

 

Series B Convertible Preferred stock, $0.001 par value; 11,500,000 shares designated, 2,842,158 shares issued and outstanding as of March 31, 2022 and December 31, 2021

 

3

 

3

Common stock, $0.000041666 par value; 300,000,000 shares authorized, 157,168,321 and 157,004,742 shares issued and outstanding as of March 31, 2022 and December 31, 2021, respectively

 

7

 

7

Accumulated other comprehensive loss

 

(2,343)

 

(601)

Additional paid-in capital

 

1,818,377

 

1,794,695

Accumulated deficit

 

(1,264,052)

 

(1,172,445)

Total Stockholders’ Equity

 

551,992

 

621,659

Total Liabilities and Stockholders’ Equity

$

701,251

$

777,333

The accompanying notes are an integral part of these condensed consolidated financial statements.

2

IOVANCE BIOTHERAPEUTICS, INC.

Condensed Consolidated Statements of Operations

(unaudited; in thousands, except per share information)

Three Months Ended

March 31, 

2022

    

2021

Costs and expenses

 

 

Research and development

 

68,300

 

55,949

General and administrative

 

23,413

 

19,621

Total costs and expenses

 

91,713

 

75,570

 

 

Loss from operations

 

(91,713)

 

(75,570)

Other income

 

 

Interest income, net

 

106

 

121

Net Loss

$

(91,607)

$

(75,449)

Net Loss Per Share of Common Stock, Basic and Diluted

$

(0.58)

$

(0.51)

Weighted Average Shares of Common Stock Outstanding, Basic and Diluted

 

157,113

 

147,370

The accompanying notes are an integral part of these condensed consolidated financial statements.

3

IOVANCE BIOTHERAPEUTICS, INC.

Condensed Consolidated Statements of Comprehensive Loss

(unaudited; in thousands)

Three Months Ended

March 31, 

2022

    

2021

Net Loss

$

(91,607)

$

(75,449)

Other comprehensive (loss) income:

 

 

Unrealized (loss) gain on investments

 

(1,742)

 

77

Comprehensive Loss

$

(93,349)

$

(75,372)

The accompanying notes are an integral part of these condensed consolidated financial statements.

4

IOVANCE BIOTHERAPEUTICS, INC.

Condensed Consolidated Statements of Stockholders’ Equity

For the Three Months Ended March 31, 2022 and 2021

(unaudited; in thousands, except share information)

Series A 

Series B

Convertible

Convertible

Additional

Accumulated other

Total

Preferred Sock

Preferred Stock

Common Stock

Paid-In

Comprehensive

Accumulated

Stockholders’

    

Shares

    

Amount

    

Shares

    

Amount

    

Shares

    

Amount

    

Capital

    

Income (Loss)

    

Deficit

    

Equity

Balance - December 31, 2021

 

194

$

2,842,158

$

3

157,004,742

$

7

$

1,794,695

$

(601)

$

(1,172,445)

$

621,659

Stock-based compensation expense

 

22,265

 

22,265

Common stock issued upon exercise of stock options

 

163,579

 

 

1,417

 

1,417

Unrealized loss on investments

 

(1,742)

 

(1,742)

Net loss

 

(91,607)

 

(91,607)

Balance - March 31, 2022

 

194

$

 

2,842,158

$

3

 

157,168,321

$

7

$

1,818,377

$

(2,343)

$

(1,264,052)

$

551,992

Balance - December 31, 2020

 

194

$

 

3,581,119

$

4

 

146,874,917

$

6

$

1,486,662

$

19

$

(830,193)

$

656,498

Stock-based compensation expense

16,941

 

16,941

Common stock issued upon exercise of stock options

423,178

6,479

 

6,479

Common stock sold in public offering, net of offering costs

1,278,243

42,885

42,885

Common stock issued from preferred stock conversion

(738,961)

(1)

738,961

1

Unrealized gain on investments

77

 

77

Net loss

 

(75,449)

 

(75,449)

Balance - March 31, 2021

 

194

$

 

2,842,158

$

3

 

149,315,299

$

6

$

1,552,968

$

96

$

(905,642)

$

647,431

5

IOVANCE BIOTHERAPEUTICS, INC.

Condensed Consolidated Statements of Cash Flows

(unaudited; in thousands)

Three Months Ended

March 31, 

    

2022

    

2021

Cash Flows from Operating Activities

Net loss

$

(91,607)

$

(75,449)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

Stock-based compensation expense

22,265

16,941

Amortization of right of use asset

3,181

2,402

Depreciation and amortization

1,797

 

372

Accretion (amortization) of discounts and premiums on investments

541

2,066

Loss on write-off of fixed assets

314

Changes in assets and liabilities:

Prepaid expenses, other assets and long-term assets

(3,715)

 

(4,067)

Operating lease liabilities

690

 

(1,374)

Accounts payable

(2,104)

 

(15)

Accrued expenses and other liabilities

 

(5,164)

 

(3,267)

Net cash used in operating activities

 

(73,802)

 

(62,391)

Cash Flows from Investing Activities

Maturities of investments

 

143,508

 

158,286

Purchase of investments

 

(45,552)

 

(70,370)

Purchase of property and equipment

 

(11,440)

 

(10,705)

Net cash provided by investing activities

 

86,516

 

77,211

Cash Flows from Financing Activities

Proceeds from the issuance of common stock upon exercise of options

1,417

6,479

Proceeds from the issuance of common stock, net

42,885

Proceeds from the issuance of debt

1,000

Net cash provided by financing activities

 

1,417

 

50,364

Net increase in cash, cash equivalents and restricted cash

 

14,131

 

65,184

Cash, Cash Equivalents and Restricted Cash Beginning of Period

 

84,313

 

72,854

Cash, Cash Equivalents and Restricted Cash End of Period

$

98,444

$

138,038

Supplemental disclosure of non-cash investing and financing activities:

Net unrealized (loss) gain on short-term investments

$

(1,742)

$

77

Acquisition of property and equipment included in accounts payable and accrued expenses

 

4,900

 

8,352

Conversion of convertible preferred stock to common stock

(1)

Lease liabilities arising from obtaining right-of-use asset from lease modifications

7,673

The accompanying notes are an integral part of these condensed consolidated financial statements.

6

IOVANCE BIOTHERAPEUTICS, INC.

NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(unaudited)

NOTE 1. GENERAL ORGANIZATION, BUSINESS AND LIQUIDITY

General Organization and Business

Iovance Biotherapeutics, Inc. (the “Company”) is a clinical-stage biopharmaceutical company pioneering a transformational approach to cure cancer by harnessing the human immune system’s ability to recognize and destroy diverse cancer cells in each patient. Tumor infiltrating lymphocyte (“TIL”) therapy is an autologous cell therapy platform technology that was originally developed by the National Cancer Institute (“NCI”), which conducted initial clinical trials in diseases such as metastatic melanoma and cervical cancer, as well as non-small cell lung cancer. The Company’s mission is to be the global leader in innovating, developing and delivering TIL therapy for patients with cancer. The Company has developed a new, shorter proprietary TIL manufacturing process known as Generation 2 (“Gen 2”), which yields a cryopreserved TIL product. This centralized, proprietary, and scalable manufacturing method is being investigated in multiple indications. The Company’s lead product candidates include lifileucel for metastatic melanoma and metastatic cervical cancer, as well as LN-145 for metastatic non-small cell lung cancer (“NSCLC”). In addition, the Company is investigating the effectiveness and safety of combinations of TIL therapy with immune checkpoint inhibitors (“ICI”), in metastatic melanoma, cervical cancer, NSCLC, and head and neck squamous cell carcinoma (“HNSCC”). The Company is investigating peripheral blood lymphocyte (“PBL”) therapy for patients with relapsed or refractory chronic lymphocytic leukemia (“CLL”) and small lymphocytic lymphoma (“SLL”) through its sponsored trials. The Company is also investigating the potential for TIL therapy in other oncology indications through academic collaborations with leading cancer research centers. On June 1, 2017, the Company reincorporated from a Nevada corporation to a Delaware corporation.

Basis of Presentation of Unaudited Condensed Consolidated Financial Information

The accompanying unaudited condensed consolidated financial statements of the Company for the three months ended March 31, 2022 and 2021 have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information and pursuant to the requirements for reporting on Form 10-Q and Regulation S-X. Accordingly, they do not include all the information and footnotes required by GAAP for audited financial statements. However, such information reflects all adjustments (consisting solely of normal recurring adjustments), which are, in the opinion of management, necessary for the fair presentation of the Company's financial position and results of operations. Results shown for interim periods are not necessarily indicative of the results that may be expected for the year ended December 31, 2022 or for any other period. The condensed consolidated balance sheet as of December 31, 2021 was derived from the audited consolidated financial statements included in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on February 24, 2022. These interim financial statements should be read in conjunction with that report. Certain prior period amounts reported in our condensed consolidated financial statements and accompanying notes have been reclassified to conform to the current period presentation.

Liquidity

The Company is currently engaged in the development of therapeutics to fight cancer, specifically solid tumors. The Company currently does not have any commercial products and has not yet generated any revenues from its business, nor does the Company currently anticipate that it will generate any significant revenues from the sale or licensing of any of its product candidates during the twelve months from the date these financial statements are issued. The Company has incurred a net loss of $91.6 million for the three months ended March 31, 2022 and used $73.8 million of cash in its operating activities during the three months ended March 31, 2022. As of March 31, 2022, the Company had $516.0 million in cash, cash equivalents, investments, and restricted cash ($92.4 million of cash and cash equivalents, $389.8 million in short-term investments, $27.7 million in long-term investments, and $6.1 million in restricted cash).

7

The Company expects to continue its research and development activities, increase pre-commercial activities and complete construction of the remaining tenant improvements for the Iovance Cell Therapy Center (the “iCTC”), which are expected to increase the amount of cash used during the remainder of 2022 and beyond. Specifically, the Company expects continued spending on its current and planned clinical trials, continued expansion of manufacturing activities, higher payroll expenses as the Company increases its professional and scientific staff and continuation of pre-commercial activities. Based on the funds the Company has available as of the date these financial statements are issued, the Company believes that it has sufficient capital to fund its anticipated operating expenses and capital expenditures as planned for at least the next twelve months from the date these financial statements are issued.

Concentrations of Risk

The Company is subject to credit risk from its portfolio of cash, cash equivalents and investments. Under its investment policy, the Company limits amounts invested in securities by credit rating, maturity, industry group, investment type and issuer, except for securities issued by the U.S. government. The Company does not believe it is exposed to any significant concentrations of credit risk from these financial instruments. The goals of its investment policy are safety and preservation of principal, diversification of risk, and liquidity of investments sufficient to meet cash flow requirements.

NOTE 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Cash, Cash Equivalents, and 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 investments are classified as “available-for-sale.” The Company includes these investments in current assets or non-current assets in the Condensed Consolidated Balance Sheets based on the length of maturity from the reporting date and carries them at fair value. Unrealized gains and losses on available-for-sale securities are recorded in accumulated other comprehensive loss. Impairment losses related to credit losses (if any) are recorded as an allowance for credit losses with an offsetting entry to Interest income, net. No impairment losses related to credit losses were recognized for the three months ended March 31, 2022 and 2021. The cost of debt securities is adjusted for the amortization of premiums and accretion of discounts to maturity. Such amortization and accretion are included in Interest income, net 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 Interest income, net 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 commercial paper, and places restrictions on maturities and concentration by type and issuer, except for securities issued by the U.S. government.

Restricted Cash

The Company maintains a required minimum balance in a segregated bank account in connection with three letters of credit, one for $5.45 million for the benefit of the landlord for the iCTC used as a security deposit for the lease (See Note 8 - Leases), one for $0.1 million for the benefit of a utilities service provider to cover the use of certain minimum established levels of utilities, and one for $0.6 million for the benefit of the landlord for the Company’s current headquarters’ lease. The total amount is classified as Restricted Cash on the Condensed Consolidated Balance Sheets. The first letter of credit for $5.45 million originally expired on May 28, 2020, however, it automatically extends for additional one-year periods, without written agreement, to May 28 in each succeeding calendar year, through at least 60 days after the lease expiration date. Further, on the expiration of the seventh year of the lease, and each anniversary date thereafter, the letter of credit may be decreased by $1.0 million with a minimum security deposit of $1.5 million maintained through the end of the lease term. The second letter of credit for $0.1 million expired on March 9, 2021, however, it automatically extends, without written agreement, to the expiration date of December 1, 2022, or until such established minimum service levels are achieved, whichever is earlier. The third letter of credit for $0.6 million expires on February 1, 2032, however, it will be automatically extended, without written agreement, for one-year periods to February in each succeeding calendar year. As of March 31, 2022 and December 31, 2021, restricted cash totaled $6.1 million and has been classified as a non-current asset on the Company’s Condensed Consolidated Balance Sheets.

8

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 (in thousands):

    

March 31, 

2022

2021

Cash and cash equivalents

$

92,360

$

131,954

Restricted cash

 

6,084

 

6,084

Total cash, cash equivalents and restricted cash

$

98,444

$

138,038

Net 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 equivalents 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, (ii) purchases though the 2020 Employee Stock Purchase Plan (the “2020 ESPP”), (iii) vesting of restricted stock units, and (iv) conversion of preferred stock, are only included in the calculation of diluted net loss per share when their effect is dilutive.

As of March 31, 2022 and 2021, 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, 

    

2022

    

2021

Stock options

14,101,526

 

15,419,226

Employee Stock Purchase Plan

86,448

55,963

Restricted stock units

3,095,177

Series A Convertible Preferred Stock*

97,000

97,000

Series B Convertible Preferred Stock*

2,842,158

 

2,842,158

20,222,309

 

18,414,347

* on an as-converted basis

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

Use of Estimates

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates. Significant items subject to such estimates and assumptions include assumptions made in the fair value of equity awards and related stock-based compensation, assumptions used in measuring operating right-of-use assets and operating lease liabilities, accounting for potential liabilities, including estimates inherent in accruals related to clinical trials, and the realizability of 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, Iovance Biotherapeutics GmbH, and Iovance Biotherapeutics B.V. All intercompany accounts and transactions have been eliminated. The U.S. dollar is the functional currency for all the Company's consolidated operations.

9

Leases

The Company determines if an arrangement includes a lease at inception and thereafter, if modified. Operating leases are included in its Condensed Consolidated Balance Sheets as Operating lease right-of-use assets and Operating lease liabilities as of March 31, 2022 and December 31, 2021. 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 or modification 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 or modification date.

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 and recorded in costs and expenses in the Condensed Consolidated Statements of Operations. The Company has elected not to apply the recognition requirements of Accounting Standards Update (“ASU”) No. 2016-02 and No. 2018-10 (together “Topic 842”) for short-term leases.

For lease agreements entered into by the Company 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 and non-employees as compensation for services rendered. The Company accounts for all stock-based payment awards made to employees, including the employee stock purchase plans, and non-employees in accordance with the authoritative guidance provided by the Financial Accounting Standards Board (“FASB”) where the value of the award is measured on the date of grant and recognized over the vesting period. Forfeitures are recognized in the period in which they occur. 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 shares underlying the options have vested. The non-employee 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 term 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 affect compensation expense recorded in future periods.

The Company issues restricted stock units (“RSUs”) from time to time as part of its equity incentive plans. The Company measures the compensation cost with respect to RSUs 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 is based on the closing price of the Company’s common stock on the grant date.

Accrued Research and Development Costs

Research and development costs are expensed as incurred. Clinical development costs compose a significant component of research and development costs. The Company has a history of contracting with third parties, including contract research organizations (“CROs”), independent clinical investigators, and contract manufacturing organizations (“CMOs”) that perform various clinical trial activities on the Company’s behalf in connection with the ongoing development of the Company’s product candidates. The financial terms of these contracts are subject to negotiations and may vary from contract to contract and may result in uneven payment flow. The Company accrues and expenses costs for clinical trial activities performed by third parties based upon estimates of work completed to date for each clinical trial in accordance with agreements established with CROs, hospitals, and clinical investigators. Accruals for CROs and CMOs are recorded based on estimates of services received and efforts expended pursuant to agreements established with CROs, CMOs and other outside service providers. The Company determines its estimates through discussions with internal clinical stakeholders and outside service providers as to the progress or stage of completion of clinical trials or services and the contracted fee to be paid for such services.

10

Included in the Company’s clinical development costs are investigator costs, which are costs associated with treatments administered at clinical sites as required under each clinical study protocol. The Company’s estimates for clinical investigator costs and timing of expense recognition will depend on a number of factors that include, but are not limited to, (i) the overall number of patients that enroll in the trial at each individual site, (ii) the length of study enrollment period, (iii) discontinuation and completion rates of patients, (iv) duration of patient safety follow-ups, (v) the number of sites included in the clinical trial, and (vi) the contracted fee of each participating site for patient treatment while on study, which can vary greatly for several reasons including, but not limited to, geographic region, medical center or physician costs, and overhead costs. In addition, the Company’s estimates for per patient trial costs will vary based on a number of factors that include, but are not limited to, the extent of additional treatments that may be administered by investigators as a result of patient health status, recoverability of patient costs through insurance carriers of patients, and unanticipated cost of injuries incurred as a result of the study treatment. The Company accrues for estimated expenses resulting from obligations under investigator site agreements as the timing of payments does not always timely align with the periods over which the treatments are administered by the clinical investigators. These estimates are typically based on contracted amounts, patient visit data, discussions with internal clinical stakeholders and outside service providers, and historical look-back analysis of actual payments made to date.

The Company makes judgements and estimates in determining the accrual balance in each reporting period.

In the event advance payments are made to a CRO, CMO or other outside service provider, the payments are recorded within prepaid expenses and other current assets in the Condensed Consolidated Balance Sheets and subsequently recognized as research and development expense in the Condensed Consolidated Statements of Operations when the associated services have been performed. As actual costs become known, the Company adjusts its estimates, liabilities and assets. Inputs used in the determination of estimates discussed above may vary from actual, which will result in adjustments to research and development expense in future periods. Changes in these estimates that result in material changes to the Company’s accruals could materially affect its results of operations. The Company’s historical estimates have not been materially different from actual amounts recorded.

Segment Reporting

The Company operates in one segment, focused on developing and commercializing therapies using autologous TIL for the treatment of metastatic melanoma and other solid tumor cancers.

NOTE 3. CASH EQUIVALENTS, INVESTMENTS AND FAIR VALUE MEASUREMENTS

The amortized cost, fair value measurements, and fair value of cash equivalents and investments as of March 31, 2022 and December 31, 2021 were as follows (in thousands):

Gross

Gross

Amortized

Unrealized

Unrealized

As of March 31, 2022

    

Cost

    

Gains

    

Losses

    

Fair Value

U.S. treasury securities

$

248,546

$

$

(2,062)

$

246,484

U.S. government agency securities

 

5,067

 

 

(21)

 

5,046

Corporate securities

34,408

(79)

34,329

Commercial paper

158,276

1

(182)

158,095

Money market funds

45,249

45,249

Total investments

$

491,546

$

1

$

(2,344)

$

489,203

Gross

Gross

Amortized

Unrealized

Unrealized

As of December 31, 2021

    

Cost

    

Gains

    

Losses

    

Fair Value

U.S. treasury securities

$

247,287

$

$

(520)

$

246,767

U.S. government agency securities

 

5,104

 

 

(7)

 

5,097

Corporate securities

35,627

(39)

35,588

Commercial paper

235,352

10

(46)

235,316

Money market funds

56,250

56,250

Total investments

$

579,620

$

10

$

(612)

$

579,018

11

The fair value of cash equivalents and investments as of March 31, 2022 and December 31, 2021 are classified as follows in the Company’s Consolidated Balance Sheets (in thousands):

March 31, 

December 31, 

Classified as:

2022

    

2021

Cash equivalents

$

71,673

$

61,249

Short-term investments

389,829

426,181

Long-term investments

27,701

91,588

Total investments

$

489,203

$

579,018

Cash equivalents in the tables above exclude cash demand deposits of $20.7 million and $17.0 million as of March 31, 2022 and December 31, 2021, respectively. Unrealized gains and losses are included in accumulated other comprehensive loss, and as of March 31, 2022 and December 31, 2021 no unrealized losses on available-for-sale securities have resulted from credit risk. All available-for-sale securities held as of March 31, 2022 and December 31, 2021 had contractual maturities of less than two years. No available-for-sale securities held as of the periods presented have been in a continuous unrealized loss position for more than 12 months. The Company determined that it has the ability and intent to hold all marketable securities that have been in a continuous loss position until maturity or recovery. To date, the Company has not recorded any impairment charges on its marketable securities.

The following table summarizes the Company’s cash equivalents and available-for-sale investments by contractual maturity (in thousands):

March 31, 2022

Amortized Cost

    

Fair Value

Within one year

$

463,385

$

461,502

One year to two years

28,161

27,701

Total investments

$

491,546

$

489,203

Recurring Fair Value Measurements

As of March 31, 2022 and December 31, 2021, the fair value of the Company’s financial assets that are measured at fair value on a recurring basis, which consist of cash equivalents and short-term and long-term investments classified as available-for-sale securities, 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, 2022

    

Level 1

    

Level 2

    

Level 3

    

Total

U.S. treasury securities

$

246,484

$

$

$

246,484

U.S. government agency securities

 

 

5,046

 

 

5,046

Corporate securities

34,329

34,329

Commercial paper

158,095

158,095

Money market funds

45,249

45,249

Total

$

291,733

$

197,470

$

$

489,203

Assets at Fair Value as of December 31, 2021

    

Level 1

    

Level 2

    

Level 3

    

Total

U.S. treasury securities

$

246,767

$

$

$

246,767

U.S. government agency securities

 

 

5,097

 

 

5,097

Corporate securities

35,588

35,588

Commercial paper

235,316

235,316

Money market funds

56,250

56,250

Total

$

303,017

$

276,001

$

$

579,018

Level 2 assets consist of commercial paper and government agency securities. Level 2 inputs for the valuations are limited to quoted prices for similar assets or liabilities in active markets and inputs other than quoted prices that are observable for the asset.

12

NOTE 4. PROPERTY AND EQUIPMENT, NET

Property and equipment, net consists of the following (in thousands):

March 31, 

December 31, 

    

2022

    

2021

Leasehold improvements

$

65,767

$

57,817

Lab, process, and validation equipment

9,173

8,686

Utility equipment

 

4,179

 

4,179

Office furniture and equipment

 

2,136

 

1,244

Computer software

6,264

1,163

Computer equipment

 

674

 

674

Machinery and equipment

82

82

Construction in progress

 

23,732

 

35,782

Total Property and equipment, cost

 

112,007

 

109,627

Less: Accumulated depreciation and amortization

 

(9,250)

 

(8,689)

Property and equipment, net

$

102,757

$

100,938

Depreciation expense for the three months ended March 31, 2022 and 2021, was $1.8 million and $0.4 million, respectively.

NOTE 5. ACCRUED EXPENSES

Accrued expenses consist of the following (in thousands):

March 31, 

December 31, 

2022

    

2021

Accrued payroll and employee related expenses

$

18,204

$

21,513

Clinical related

17,910

18,167

Manufacturing related

 

6,295

 

6,566

Facilities related

2,077

4,857

Legal and related services

 

1,654

 

1,907

Other accrued expenses

 

2,771

 

3,756

Total accrued expenses

$

48,911

$

56,766

NOTE 6. STOCKHOLDERS’ EQUITY

Common Stock

The Company’s certificate of incorporation, as amended, authorizes the issuance of up to 300,000,000 shares of the Company’s common stock, par value $0.000041666. As of March 31, 2022, 157,168,321 shares of the Company’s common stock were issued and outstanding.

At the Market Offering Program

On February 8, 2021, the Company entered into an Open Market Sale Agreement (the “Sales Agreement”) with Jefferies LLC (“Jefferies”) with respect to an “at the market” offering program, under which the Company may, from time to time, in its sole discretion, issue and sell through Jefferies, acting as sales agent, up to $350.0 million of shares of the Company’s common stock (the “Common Shares”). The issuance and sale, if any, of the Common Shares by the Company under the Sales Agreement will be made pursuant to a prospectus supplement, dated February 8, 2021, to the Company’s Registration Statement on Form S-3ASR, which became effective immediately upon filing with the Securities and Exchange Commission on May 27, 2020.

13

Pursuant to the Sales Agreement, Jefferies may sell the Common Shares by any method permitted by law deemed to be an “at the market” offering as defined in Rule 415 of the Securities Act of 1933, as amended. Jefferies will use commercially reasonable efforts consistent with its normal trading and sales practices to sell the Common Shares from time to time, based upon instructions from the Company (including any price or size limits or other customary parameters or conditions the Company may impose). The Company will pay Jefferies a commission of up to 3.0% of the gross sales proceeds of any Common Shares sold through Jefferies under the Sales Agreement.

The Company is not obligated to make any sales of Common Shares under the Sales Agreement. The offering of Common Shares pursuant to the Sales Agreement will terminate upon the earlier to occur of (i) the issuance and sale, through Jefferies, of all Common Shares subject to the Sales Agreement and (ii) termination of the Sales Agreement in accordance with its terms.

No sales were made pursuant to the Sales Agreement during the three months ended March 31, 2022. For the three months ended March 31, 2021, the Company received approximately $42.9 million in net proceeds, net of offering costs, through the sale of 1,278,243 shares of its common stock through the Sales Agreement at a weighted average price per share of $34.67.

Preferred Stock

The Company’s certificate of incorporation authorizes the issuance of up to 50,000,000 shares of “blank check” preferred stock. As of March 31, 2022, 17,000 shares were designated as Series A Convertible Preferred Stock (“Series A Convertible Preferred Stock”) and 11,500,000 shares were designated as Series B Convertible Preferred Stock (“Series B Convertible Preferred Stock”).

Series A Convertible Preferred Stock

A total of 17,000 shares of Series A Convertible Preferred Stock have been authorized for issuance under the Company’s Certificate of Designation of Preferences and Rights of Series A Convertible Preferred Stock. The shares of Series A Convertible Preferred Stock have a stated value of $1,000 per share and are initially convertible into shares of common stock at a price of $2.00 per share, subject to adjustment. Each share of Series A Preferred Stock is initially convertible into 500 shares of common stock.

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

No shares of Series A Convertible Preferred Stock were converted during the three months ended March 31, 2022 or 2021. As of March 31, 2022, and December 31, 2021, 194 shares of Series A Convertible Preferred Stock (that are convertible into 97,000 shares of common stock) remained outstanding.

Series B Convertible Preferred Stock

A total of 11,500,000 shares of Series B Convertible Preferred Stock are authorized for issuance under the Company’s Series B Certificate of Designation of Rights, Preferences and Privileges of Series B Convertible Preferred Stock. The shares of Series B Convertible Preferred Stock have a stated value of $4.75 per share and are convertible into shares of the Company’s common stock at an initial conversion price of $4.75 per share. Each share of Series B Preferred Stock is initially convertible into 1 share of common stock.

The Series B Convertible Preferred Stock may, at the option of each investor, be converted into fully paid and non-assessable shares of common stock. The holders of shares of Series B Convertible Preferred Stock do not have the right to vote on matters that come before the Company's stockholders. In the event of any dissolution or winding up of the Company, proceeds shall be paid pari passu among the holders of common stock and preferred stock, pro rata based on the number of shares held by each holder. Holders of Series B Convertible Preferred Stock are entitled to dividends on an as-if-converted basis in the same form as any dividends actually paid on shares of the Series A Convertible Preferred Stock or the Company’s common stock. So long as any Series B Convertible Preferred Stock remains outstanding, the Company may not redeem, purchase, or otherwise acquire any material amount of the Series A Convertible Preferred Stock or any securities junior to the Series B Convertible Preferred Stock.

14

During the three months ended March 31, 2022, no shares of Series B Convertible Preferred Stock were converted into shares of common stock. During the three months ended March 31, 2021, a total of 738,961 of Series B Convertible Preferred Stock were converted into 738,961 shares of common stock. As of March 31, 2022, and December 31, 2021, 2,842,158 shares of Series B Preferred Stock (that are convertible into 2,842,158 shares of common stock) remained outstanding.

Equity Incentive Plans

The Company has multiple equity incentive plans under which it grants awards. As of March 31, 2022, there are 79,465 shares available to grant under the 2014 Equity Incentive Plan (the “2014 Plan”).

On April 22, 2018, the Company’s board of directors (the “Board”) adopted the Iovance Biotherapeutics, Inc. 2018 Equity Incentive Plan (the “2018 Plan”), which was approved by the Company’s stockholders in June 2018. The 2018 Plan as approved initially authorized the issuance up to an aggregate of 6,000,000 shares of common stock 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. On June 8, 2020, the Company's stockholders approved an amendment to the 2018 Plan to increase the number of shares available for issuance upon the exercise of stock options under the 2018 Plan from 6,000,000 to 14,000,000 shares, which became effective immediately. As of March 31, 2022, 1,058,461 shares of common stock were available for grant under the Company’s 2018 Plan.

On September 22, 2021, the Board adopted the Iovance Biotherapeutics, Inc. 2021 Inducement Plan (the “2021 Inducement Plan”). The 2021 Inducement Plan provides for the grant of 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. The 2021 Inducement Plan was recommended for approval by the Compensation Committee of the Board (the “Compensation Committee”), and subsequently approved and adopted by the Board without stockholder approval pursuant to Rule 5635(c)(4) of the rules and regulations of The Nasdaq Stock Market, LLC (the “Nasdaq Listing Rules”).

The Board initially reserved 1,000,000 shares of the Company’s common stock for issuance pursuant to equity awards granted under the 2021 Inducement Plan, and the 2021 Inducement Plan is administered by the Compensation Committee. On January 12, 2022, the Compensation Committee approved an amendment to the 2021 Inducement Plan solely to increase the number of shares reserved for issuance under the 2021 Inducement Plan from 1,000,000 shares of the Company’s common stock to 1,750,000 shares of the Company’s common stock without stockholder approval pursuant to Rule 5635(c)(4) of the Nasdaq Listing Rules.

In accordance with Rule 5635(c)(4) of the Nasdaq Listing Rules, equity awards under the 2021 Inducement Plan may only be made to an employee if such employee is granted such equity awards in connection with his or her commencement of employment with the Company or a subsidiary and such grant is an inducement material to his or her entering into employment with the Company or such subsidiary. In addition, awards under the 2021 Inducement Plan may only be made to employees who have not previously been an employee or member of the Board (or any parent or subsidiary of the Company) or following a bona fide period of non-employment of the employee by the Company (or a parent or subsidiary of the Company). As of March 31, 2022, 552,925 shares of common stock were available for grant under the 2021 Inducement Plan.

Stock Options

A summary of the stock option activity during the three months ended March 31, 2022, is presented in the following table:

Weighted

 

Weighted

Average

Aggregate

Number

Average

Remaining

Intrinsic

of

Exercise

Contract

Value

    

Options

    

Price

    

Life

    

(in thousands)

Outstanding at December 31, 2021

12,520,865

 

$

25.05

Issued

1,887,052

 

14.69

Exercised

(163,579)

 

8.65

Expired/Cancelled

(142,812)

 

29.52

Outstanding at March 31, 2022

14,101,526

 

$

23.81

 

7.83

$

27,587

Ending vested and expected to vest at March 31, 2022

14,101,526

$

23.81

7.83

$

27,587

Options exercisable at March 31, 2022

 

7,543,738

$

20.50

 

6.74

$

23,859

15

As of March 31, 2022, there was $94.1 million of total unrecognized compensation expense related to the options that is expected to be recognized over a weighted average period of 1.97 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, 2022 and 2021 was $8.81 and $26.42 per option, respectively.

The aggregate intrinsic value in the table above reflects the total pre-tax intrinsic value (calculated as the difference between the Company’s closing stock price on the last trading day of the quarter ended March 31, 2022 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, 2022. The intrinsic value of the Company’s stock options changes based on the closing price of the Company’s common stock.

Employee Stock Purchase Plan

In June 2020, the Company adopted the 2020 ESPP upon its approval by the Company’s shareholders at its Annual Stockholders Meeting on June 8, 2020. The Company reserved 500,000 shares of its common stock for issuance under the 2020 ESPP.

Under the 2020 ESPP, employees of the Company can purchase shares of its common stock based on a percentage of their compensation subject to certain limits. The purchase price per share is equal to the lower of 85% of the fair market value of its common stock on the offering date or the purchase date with a six month look-back feature. The 2020 ESPP purchases are settled with common stock from the 2020 ESPP’s previously authorized and available pool of shares.

The compensation expense related to the 2020 ESPP for the three months ended March 31, 2022 and 2021 was $0.2 million and $0.3 million, respectively. As of March 31, 2022, 94,148 shares had been issued to date under the 2020 ESPP and there was $0.2 million of unrecognized compensation cost associated with the 2020 ESPP, which is expected to be recognized over the remaining 2.3 months.

Restricted Stock Units and Performance Restricted Stock Units

In addition to RSUs that have time-based vesting requirements, from time to time the Company may issue RSUs that include certain performance vesting criteria based upon the satisfaction of stated objectives  (“PRSUs”).  Compensation expense related to PRSUs is based on the grant date fair value of the award and recorded from the period that achievement is determined to be probable through the stated service period associated with the award. 

Activity for RSUs and PRSUs units during the three months ended March 31, 2022 is presented in the following table:

Weighted

Number

Average

of

Grant Date

    

RSUs and PRSUs

    

Fair Value

Outstanding, non-vested as of December 31, 2021

1,110,010

$

23.87

Granted

2,027,774

15.18

Canceled/Forfeited

(42,607)

19.43

Outstanding, non-vested as of March 31, 2022

3,095,177

$

18.24

As of March 31, 2022, there was $37.0 million of unrecognized stock-based compensation expense associated with unvested RSU and PRSUs, which the Company expects to recognize over a remaining weighted-average period of 1.88 years. The aggregate intrinsic value of the unvested RSUs and PRSUs outstanding as of March 31, 2022 was $51.5 million.

16

Stock-Based Compensation

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

Three Months Ended

March 31, 

    

2022

    

2021

Research and development

$

13,651

$

9,202

General and administrative

 

8,614

 

7,739

Total stock-based compensation expense

$

22,265

$

16,941

Total stock-based compensation expense by type of award was as follows (in thousands):

Three Months Ended

March 31, 

    

2022

    

2021

Stock option expense

$

14,867

$

16,660

Restricted stock expense

 

7,162

 

ESPP expense

 

236

 

281

Total stock-based compensation expense

$

22,265

$

16,941

NOTE 7. LICENSES AND AGREEMENTS

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

Cooperative Research and Development Agreement (the “CRADA”)

In August 2011, the Company signed a five-year CRADA with the NCI to work on the development of adoptive cell immunotherapies that are designed to destroy metastatic melanoma cells. The CRADA was amended in 2015 and 2016 to, among other things, extend the term of the CRADA through August 2021, include new indications such as the development of TIL therapy for the treatment of patients with bladder, lung, triple-negative breast, and Human Papilloma Virus (“HPV”)-associated cancers, and modify the focus on the development of unmodified TIL as a stand-alone therapy or in combination. The parties have continued 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.