Table of Contents 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, 2023 ☐ 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) (State or other jurisdiction of (I. ...

Iovance Biotherapeutics, Inc. (NASDAQ:IOVA) Q4 2022 Earnings Conference Call February 28, 2023 4:30 PM ET Company Participants Sara Pellegrino - Senior Vice President, Investor Relations and Corporate Communications Fred Vogt - Interim President and Chief Executive Officer Igor Bilinsky - Chief Operating Officer Jim Ziegler - Executive Vice President, Commercial Friedrich Finckenstein - Chief Medical Officer Jean-Marc Bellemin - Chief Financial Officer Raj Puri - Executive Vice President, Regulatory Strateg ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 Form 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transaction period from __________ to __________ Commission file number: 001-36860 IOVANCE BIOTHERAPEUTICS, INC. (Exact Name of Registrant as Specified in Its Charter) Del ...

Iovance Biotherapeutics, Inc. (NASDAQ:IOVA) Q3 2022 Results Conference Call November 3, 2022 4:30 PM ET Company Participants Sara Pellegrino - Senior Vice President of Investor Relations and Corporate Communications Frederick Vogt - Interim President and Chief Executive Officer Jean-Marc Bellemin - Chief Financial Officer Igor Bilinsky - Chief Operating Officer James Ziegler - Executive Vice President, Commercial Friedrich Finckenstein - Chief Medical Officer Madan Jagasia - Executive Vice President, Medica ...

Table of Contents 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 September 30, 2022 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Delaware 75-3254381 825 Industrial Road, Suite 400, San Carlos, CA 94070 (Address of principal executive offices and zip code) (650) 260-7120 (Registrant's telephone number, includi ...

Iovance Biotherapeutics, Inc. (NASDAQ:IOVA) Q2 2022 Earnings Conference Call August 4, 2022 4:30 PM ET Company Participants Sara Pellegrino - Senior Vice President, Investor & Public Relations & Corporate Communications Fred Vogt - Interim President & Chief Executive Officer Igor Bilinsky - Chief Operating Officer Jim Ziegler - Executive Vice President, Commercial Friedrich Finckenstein - Chief Medical Officer Jean-Marc Bellemin - Chief Financial Officer Conference Call Participants Peter Lawson - Barclays ...

[PART I FINANCIAL INFORMATION](index=5&type=section&id=PART%20I%20FINANCIAL%20INFORMATION) This section provides the unaudited condensed consolidated financial statements, management's financial analysis, market risk disclosures, and internal controls [Condensed Consolidated Financial Statements (Unaudited)](index=5&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(Unaudited)) The company experienced increased net losses in Q2 and H1 2022 due to rising operating expenses, despite maintaining a strong cash position [Note 1: General Organization, Business and Liquidity](index=11&type=section&id=NOTE%201.%20GENERAL%20ORGANIZATION%2C%20BUSINESS%20AND%20LIQUIDITY) Iovance, a clinical-stage biopharmaceutical company, focuses on TIL therapies for cancer, with management asserting sufficient liquidity to fund operations for the next twelve months - The company's mission is to be the global leader in innovating, developing, and delivering TIL therapies for cancer patients. Lead product candidates include **lifileucel** for metastatic melanoma and cervical cancer, and **LN-145** for metastatic non-small cell lung cancer (NSCLC)[35](index=35&type=chunk) - As of June 30, 2022, the company had **$430.9 million** in cash, cash equivalents, investments, and restricted cash. Management believes this is sufficient to fund anticipated operating expenses and capital expenditures for at least the next twelve months[37](index=37&type=chunk)[38](index=38&type=chunk) [Note 7: Licenses and Agreements](index=20&type=section&id=NOTE%207.%20LICENSES%20AND%20AGREEMENTS) The company maintains key collaborations and license agreements, including extended partnerships with NCI and NIH, and manufacturing agreements with WuXi Advanced Therapies - The CRADA with the NCI was amended in August 2021, extending the term by three years to August 2024. The company is required to make quarterly payments of **$0.5 million** to the NCI[96](index=96&type=chunk)[97](index=97&type=chunk) - The company entered into an Amended and Restated Patent License Agreement with the NIH, granting additional exclusive, worldwide patent rights to cytokine-tethered TIL technology and expanding non-exclusive rights to all cancers. Milestone payments are anticipated upon BLA approval[99](index=99&type=chunk)[100](index=100&type=chunk) - The company has a manufacturing and services agreement with WuXi Advanced Therapies for two cGMP manufacturing suites. Costs associated with this agreement were **$7.1 million** for the six months ended June 30, 2022[111](index=111&type=chunk) [Note 9: Legal Proceedings](index=32&type=section&id=NOTE%209.%20LEGAL%20PROCEEDINGS) The company is involved in a stockholder derivative lawsuit with a proposed settlement and is vigorously defending against two breach of contract lawsuits from Solomon Capital, LLC - A derivative lawsuit regarding non-executive director compensation has a proposed settlement, submitted to the court on June 15, 2022, which includes governance changes and a payment for legal fees, subject to court approval[123](index=123&type=chunk) - The company is defending two lawsuits from Solomon Capital, LLC related to agreements from 2012. The company is pursuing counterclaims and intends to vigorously defend against the complaints[124](index=124&type=chunk)[128](index=128&type=chunk)[129](index=129&type=chunk) Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2022 | December 31, 2021 | | :--- | :--- | :--- | | Cash and cash equivalents | $108,075 | $78,229 | | Short-term investments | $316,383 | $426,181 | | Total Current Assets | $431,593 | $507,956 | | Total Assets | $610,878 | $777,333 | | Total Liabilities | $138,188 | $155,674 | | Accumulated deficit | $(1,363,401) | $(1,172,445) | | Total Stockholders' Equity | $472,690 | $621,659 | Condensed Consolidated Statements of Operations Highlights (in thousands, except per share data) | Metric | Three Months Ended June 30, 2022 | Three Months Ended June 30, 2021 | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $73,406 | $62,119 | $141,706 | $118,068 | | General and administrative | $26,328 | $19,307 | $49,741 | $38,928 | | **Net Loss** | **$(99,349)** | **$(81,351)** | **$(190,956)** | **$(156,800)** | | Net Loss Per Share | $(0.63) | $(0.53) | $(1.21) | $(1.04) | Condensed Consolidated Statements of Cash Flows Highlights (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | $(151,437) | $(116,399) | | Net cash provided by / (used in) investing activities | $182,279 | $(81,954) | | Net cash (used in) / provided by financing activities | $(650) | $214,346 | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=37&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's clinical progress, including an upcoming BLA submission, and analyzes increased operating expenses driven by growth and pre-commercialization efforts, while affirming sufficient liquidity - The company plans to submit a Biologics License Application (BLA) for **lifileucel** in metastatic melanoma in August 2022, following a pre-BLA meeting in July 2022[139](index=139&type=chunk) Change in Operating Expenses (Six Months Ended June 30) | Expense Category | 2022 (in thousands) | 2021 (in thousands) | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Research and development | $141,706 | $118,068 | $23,638 | 20% | | General and administrative | $49,741 | $38,928 | $10,813 | 28% | - The increase in R&D expenses was driven by higher payroll and stock-based compensation from increased hiring, facility costs for the iCTC, and lab consumables, partially offset by lower clinical trial and manufacturing costs due to the completion of pivotal trial enrollment[174](index=174&type=chunk) - The increase in G&A expenses was due to increased headcount for business growth and commercial readiness, higher stock-based compensation, and increased marketing, travel, and IT infrastructure costs[176](index=176&type=chunk) - As of June 30, 2022, the company had **$430.9 million** in cash, cash equivalents, investments, and restricted cash. Management believes this is sufficient to fund operations for at least the next twelve months[286](index=286&type=chunk)[290](index=290&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=53&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's market risk is primarily limited to interest income sensitivity from its portfolio of cash and investments in short-term U.S. government debt securities - The company's primary market risk is interest rate risk on its **$409.6 million** in marketable securities. A hypothetical **1%** change in interest rates as of June 30, 2022, would impact the fair value of the investment portfolio by approximately **$1.3 million**[195](index=195&type=chunk) [Controls and Procedures](index=53&type=section&id=Item%204.%20Controls%20and%20Procedures) Management evaluated the company's disclosure controls and procedures, concluding they were effective as of June 30, 2022, with no material changes in internal control over financial reporting - Based on an evaluation as of the end of the reporting period, the principal executive officer and principal financial officer concluded that the company's disclosure controls and procedures were **effective**[196](index=196&type=chunk) - No changes in internal control over financial reporting occurred during the quarter ended June 30, 2022, that have materially affected, or are reasonably likely to materially affect, internal controls[197](index=197&type=chunk) [PART II OTHER INFORMATION](index=54&type=section&id=PART%20II%20OTHER%20INFORMATION) This section covers legal proceedings, key risk factors, and other required disclosures including securities sales, defaults, and exhibits [Legal Proceedings](index=54&type=section&id=Item%201.%20Legal%20Proceedings) This section incorporates by reference the information from Note 9 of the Condensed Consolidated Financial Statements - The company refers to Note 9 for details on legal proceedings, which include a derivative lawsuit with a proposed settlement and ongoing litigation with Solomon Capital[199](index=199&type=chunk) [Risk Factors](index=54&type=section&id=Item%201A.%20Risk%20Factors) The company outlines significant risks, including dependence on product candidate success, manufacturing complexities, regulatory hurdles, the need for additional financing, and intense competition - The business is substantially dependent on the success of its product candidates, which may not complete development, receive regulatory approval, or be successfully commercialized[204](index=204&type=chunk)[212](index=212&type=chunk) - Manufacturing of product candidates is complex and subject to risks of production failure, quality control issues, and challenges in scaling up, which could delay or stop supply for clinical trials or commercial use[204](index=204&type=chunk)[259](index=259&type=chunk) - The company may need additional financing to fund operations and commercialization. Raising capital could cause dilution to stockholders or require relinquishing rights to technologies[205](index=205&type=chunk)[286](index=286&type=chunk) - The company faces extensive and costly regulation, and the FDA approval process is lengthy and time-consuming. Even if approved, products will face ongoing regulatory scrutiny[205](index=205&type=chunk)[211](index=211&type=chunk)[299](index=299&type=chunk) - The company faces significant competition from other biotechnology and pharmaceutical companies, many of which have substantially greater resources and experience[205](index=205&type=chunk)[314](index=314&type=chunk) [Unregistered Sales of Securities and Use of Proceeds](index=141&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of securities or use of proceeds for the period - Nothing to report[457](index=457&type=chunk) [Defaults Upon Senior Securities](index=141&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities for the period - Nothing to report[458](index=458&type=chunk) [Mine Safety Disclosure](index=141&type=section&id=Item%204.%20Mine%20Safety%20Disclosure) This item is not applicable to the company - Nothing to report[459](index=459&type=chunk) [Other Information](index=141&type=section&id=Item%205.%20Other%20Information) The company reported no other information for the period - Nothing to report[460](index=460&type=chunk) [Exhibits](index=142&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including the company's amended bylaws, equity incentive plan documents, and officer certifications as required by the Sarbanes-Oxley Act - Exhibits filed include the Third Amended and Restated Bylaws, the 2018 Equity Incentive Plan, and certifications by the CEO and CFO[463](index=463&type=chunk)

1 I OVANCE 1 Corporate Overview May 2022 © 2022, Iovance Biotherapeutics, Inc. Forward-Looking Statements Certain matters discussed in this presentation are "forward-looking statements" of Iovance Biotherapeutics, Inc. (hereinafter referred to as the "Company," "we," "us," or "our") within the meaning of the Private Securities Litigation Reform Act of 1995 (the "PSLRA"). All such written or oral statements made in this presentation, other than statements of historical fact, are forward-looking statements an ...

Iovance Biotherapeutics, Inc. (NASDAQ:IOVA) Q1 2022 Results Conference Call May 5, 2022 4:30 PM ET Company Participants Sara Pellegrino - Vice President, Investor and Public Relations Dr. Fred Vogt - Interim President and Chief Executive Officer Dr. Igor Bilinsky - Chief Operating Officer Jim Ziegler - Senior Vice President, Commercial Dr. Friedrich Finckenstein - Chief Medical Officer Dr. Madan Jagasia - Senior Vice President, Medical Affairs Jean-Marc Bellemin - Chief Financial Officer Dr. Raj Puri - Exec ...

[PART I FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%20FINANCIAL%20INFORMATION) Presents unaudited condensed consolidated financial statements and detailed notes for Iovance Biotherapeutics, Inc [Item 1. Condensed Consolidated Financial Statements](index=3&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements) Provides unaudited condensed consolidated financial statements and explanatory notes for the reporting period [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) | Metric | March 31, 2022 (in thousands) | December 31, 2021 (in thousands) | | :-------------------------- | :----------------------------- | :------------------------------- | | Cash and cash equivalents | $92,360 | $78,229 | | Short-term investments | $389,829 | $426,181 | | Long-term investments | $27,701 | $91,588 | | Total Assets | $701,251 | $777,333 | | Total Liabilities | $149,259 | $155,674 | | Total Stockholders' Equity | $551,992 | $621,659 | | Accumulated deficit | $(1,264,052) | $(1,172,445) | [Condensed Consolidated Statements of Operations](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) | Metric | Three Months Ended March 31, 2022 (in thousands) | Three Months Ended March 31, 2021 (in thousands) | | :-------------------------- | :--------------------------------------- | :--------------------------------------- | | 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) | | Net Loss | $(91,607) | $(75,449) | | Net Loss Per Share (Basic and Diluted) | $(0.58) | $(0.51) | [Condensed Consolidated Statements of Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Comprehensive%20Loss) | Metric | Three Months Ended March 31, 2022 (in thousands) | Three Months Ended March 31, 2021 (in thousands) | | :-------------------------- | :--------------------------------------- | :--------------------------------------- | | Net Loss | $(91,607) | $(75,449) | | Unrealized (loss) gain on investments | $(1,742) | $77 | | Comprehensive Loss | $(93,349) | $(75,372) | [Condensed Consolidated Statements of Stockholders' Equity](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders%27%20Equity) | Metric | March 31, 2022 (in thousands) | December 31, 2021 (in thousands) | | :-------------------------- | :----------------------------- | :------------------------------- | | Total Stockholders' Equity | $551,992 | $621,659 | | Stock-based compensation expense (Q1) | $22,265 | $16,941 | | Net loss (Q1) | $(91,607) | $(75,449) | | Unrealized loss on investments (Q1) | $(1,742) | — | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) | Metric | Three Months Ended March 31, 2022 (in thousands) | Three Months Ended March 31, 2021 (in thousands) | | :--------------------------------------- | :--------------------------------------- | :--------------------------------------- | | Net cash used in operating activities | $(73,802) | $(62,391) | | Net cash provided by investing activities | $86,516 | $77,211 | | Net cash provided by financing activities | $1,417 | $50,364 | | Net increase in cash, cash equivalents and restricted cash | $14,131 | $65,184 | [NOTE 1. GENERAL ORGANIZATION, BUSINESS AND LIQUIDITY](index=8&type=section&id=NOTE%201.%20GENERAL%20ORGANIZATION%2C%20BUSINESS%20AND%20LIQUIDITY) - Iovance Biotherapeutics, Inc. is a **clinical-stage biopharmaceutical company** focused on developing **Tumor Infiltrating Lymphocyte (TIL) therapy** to cure cancer[25](index=25&type=chunk) - The company's lead product candidates include **lifileucel** for metastatic melanoma and metastatic cervical cancer, and **LN-145** for metastatic non-small cell lung cancer (NSCLC)[25](index=25&type=chunk) Financial Metrics (in millions) | Metric | Value (in millions) | | :--------------------------------------- | :------------------ | | Net loss for Q1 2022 | $(91.6) | | Cash used in operating activities for Q1 2022 | $(73.8) | | Total cash, cash equivalents, investments, and restricted cash (Mar 31, 2022) | $516.0 | - The company believes it has **sufficient capital** to fund anticipated operating expenses and capital expenditures for at least the **next twelve months**[28](index=28&type=chunk) [NOTE 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES](index=9&type=section&id=NOTE%202.%20SUMMARY%20OF%20SIGNIFICANT%20ACCOUNTING%20POLICIES) - Investments are classified as '**available-for-sale**' and carried at **fair value**, with unrealized gains and losses recorded in accumulated other comprehensive loss[30](index=30&type=chunk) Restricted Cash (in thousands) | Metric | March 31, 2022 (in thousands) | December 31, 2021 (in thousands) | | :-------------------------- | :----------------------------- | :------------------------------- | | Restricted cash | $6,084 | $6,084 | - Potentially dilutive common stock equivalents (stock options, ESPP, restricted stock units, and convertible preferred stock) are **excluded from diluted net loss per share calculation** when their effect would be **anti-dilutive**[34](index=34&type=chunk)[35](index=35&type=chunk) - Research and development costs are **expensed as incurred**, with accruals for third-party activities based on estimates of work completed[45](index=45&type=chunk) [NOTE 3. CASH EQUIVALENTS, INVESTMENTS AND FAIR VALUE MEASUREMENTS](index=13&type=section&id=NOTE%203.%20CASH%20EQUIVALENTS%2C%20INVESTMENTS%20AND%20FAIR%20VALUE%20MEASUREMENTS) Investment Portfolio Fair Value (in thousands) | Investment Type | March 31, 2022 Fair Value (in thousands) | December 31, 2021 Fair Value (in thousands) | | :-------------------------- | :--------------------------------------- | :--------------------------------------- | | U.S. treasury securities | $246,484 | $246,767 | | U.S. government agency securities | $5,046 | $5,097 | | Corporate securities | $34,329 | $35,588 | | Commercial paper | $158,095 | $235,316 | | Money market funds | $45,249 | $56,250 | | Total investments | $489,203 | $579,018 | - All available-for-sale securities held as of March 31, 2022, and December 31, 2021, had contractual maturities of **less than two years**[51](index=51&type=chunk) [NOTE 4. PROPERTY AND EQUIPMENT, NET](index=16&type=section&id=NOTE%204.%20PROPERTY%20AND%20EQUIPMENT%2C%20NET) Property and Equipment, Net (in thousands) | Asset Category | March 31, 2022 (in thousands) | December 31, 2021 (in thousands) | | :-------------------------- | :----------------------------- | :------------------------------- | | Leasehold improvements | $65,767 | $57,817 | | Construction in progress | $23,732 | $35,782 | | Total Property and equipment, net | $102,757 | $100,938 | | Depreciation expense (Q1) | $1,800 | $400 | [NOTE 5. ACCRUED EXPENSES](index=16&type=section&id=NOTE%205.%20ACCRUED%20EXPENSES) Accrued Expenses (in thousands) | Accrued Expense Category | March 31, 2022 (in thousands) | December 31, 2021 (in thousands) | | :-------------------------- | :----------------------------- | :------------------------------- | | Accrued payroll and employee related expenses | $18,204 | $21,513 | | Clinical related | $17,910 | $18,167 | | Manufacturing related | $6,295 | $6,566 | | Total accrued expenses | $48,911 | $56,766 | [NOTE 6. STOCKHOLDERS' EQUITY](index=16&type=section&id=NOTE%206.%20STOCKHOLDERS%27%20EQUITY) - As of March 31, 2022, **157,168,321 shares** of common stock were issued and outstanding[56](index=56&type=chunk) - No sales were made under the 'at the market' offering program during the three months ended March 31, 2022, compared to **$42.9 million in net proceeds** from sales in the same period of 2021[60](index=60&type=chunk) Equity Award Details | Equity Award Type | March 31, 2022 Outstanding | Unrecognized Compensation Expense (in thousands) | | :-------------------------- | :------------------------- | :--------------------------------------- | | Stock options | 14,101,526 | $94,100 | | Restricted stock units (RSUs) and Performance Restricted Stock Units (PRSUs) | 3,095,177 | $37,000 | Stock-Based Compensation Expense (in thousands) | Expense Category | Three Months Ended March 31, 2022 (in thousands) | Three Months Ended March 31, 2021 (in thousands) | | :-------------------------- | :--------------------------------------- | :--------------------------------------- | | Total stock-based compensation expense | $22,265 | $16,941 | [NOTE 7. LICENSES AND AGREEMENTS](index=22&type=section&id=NOTE%207.%20LICENSES%20AND%20AGREEMENTS) - The Cooperative Research and Development Agreement (CRADA) with the NCI was extended by **three years to August 2024**, requiring quarterly payments of **$0.5 million** for research activities[85](index=85&type=chunk)[86](index=86&type=chunk) - An Amended and Restated Patent License Agreement with NIH grants additional **exclusive worldwide patent rights** to cytokine-tethered TIL technology and expands the non-exclusive field of use to all cancers[89](index=89&type=chunk) - The company has an exclusive patent license agreement with NIH for TIL selection technologies, which includes customary royalties based on a percentage of net sales (**mid-single digits**)[90](index=90&type=chunk)[91](index=91&type=chunk) Manufacturing and Gene-Editing Agreements (in thousands) | Agreement | Three Months Ended March 31, 2022 (in thousands) | Three Months Ended March 31, 2021 (in thousands) | | :-------------------------- | :--------------------------------------- | :--------------------------------------- | | WuXi Advanced Therapies, Inc. (manufacturing) | $3,900 | $3,400 | | Cellectis S.A. (gene-editing technology) | $100 | $100 | [NOTE 8. LEASES](index=25&type=section&id=NOTE%208.%20LEASES) Lease Assets and Liabilities (in thousands) | Metric | March 31, 2022 (in thousands) | December 31, 2021 (in thousands) | | :-------------------------- | :----------------------------- | :------------------------------- | | Operating lease right-of-use assets | $73,475 | $68,983 | | Total operating lease liabilities | $78,894 | $70,531 | Lease Costs (in thousands) | Lease Cost Type | Three Months Ended March 31, 2022 (in thousands) | Three Months Ended March 31, 2021 (in thousands) | | :-------------------------- | :--------------------------------------- | :--------------------------------------- | | Operating lease cost | $4,555 | $3,398 | | Variable lease cost | $980 | $710 | | Short-term lease cost | $42 | $36 | | Total lease cost | $5,577 | $4,144 | - The weighted-average remaining lease term as of March 31, 2022, was **14.13 years**, with a weighted-average discount rate of **7.2%**[111](index=111&type=chunk) [NOTE 9. LEGAL PROCEEDINGS](index=28&type=section&id=NOTE%209.%20LEGAL%20PROCEEDINGS) - A derivative lawsuit was filed on **December 11, 2020**, alleging breach of fiduciary duty and unjust enrichment related to excessive non-executive director compensation[112](index=112&type=chunk) - The company is involved in two lawsuits with Solomon Capital, LLC, concerning alleged unpaid funds and shares, with one suit's damages for the Equity Claim limited to **$47,420** by court order[113](index=113&type=chunk)[115](index=115&type=chunk)[116](index=116&type=chunk) - In the Second Solomon Suit, claims against the former CEO and two claims against the company were dismissed by the Court on **January 5, 2022**[117](index=117&type=chunk) - The company intends to vigorously defend against these complaints and pursue its counterclaims, with the amount or range of possible loss currently **not estimable**[118](index=118&type=chunk) [NOTE 10. INCOME TAXES](index=32&type=section&id=NOTE%2010.%20INCOME%20TAXES) - The company did not record income tax expense for the three months ended March 31, 2022, and 2021, due to expected **taxable losses**[120](index=120&type=chunk) - Net deferred tax assets are fully offset by a valuation allowance, as it is **not more likely than not** that the benefit will be realized[120](index=120&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=33&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial condition and results of operations, detailing its clinical-stage biopharmaceutical focus, product pipeline, intellectual property, the impact of COVID-19, and a breakdown of operating expenses, liquidity, and capital resources [Overview](index=33&type=section&id=Overview) - Iovance Biotherapeutics is a **clinical-stage biopharmaceutical company** focused on pioneering Tumor Infiltrating Lymphocyte (TIL) therapy to cure cancer[123](index=123&type=chunk) - The company has developed a new, shorter proprietary TIL manufacturing process known as **Generation 2 (Gen 2)**, which yields a cryopreserved TIL product[123](index=123&type=chunk) - Lead product candidates include **lifileucel** for metastatic melanoma and metastatic cervical cancer, and **LN-145** for metastatic non-small cell lung cancer (NSCLC)[123](index=123&type=chunk) - The company is also investigating combinations of TIL therapy with immune checkpoint inhibitors (ICIs), peripheral blood lymphocyte (PBL) therapy, genetically edited TIL products (**IOV-4001**), and an alternative interleukin-2 (IL-2) co-therapy (**IOV-3001**)[123](index=123&type=chunk) [Product Candidate Pipeline and Clinical Development](index=34&type=section&id=Product%20Candidate%20Pipeline%20and%20Clinical%20Development) - **Lifileucel** for metastatic melanoma (C-144-01 trial, Cohort 4) completed patient dosing in **January 2020**, with a Biologics License Application (BLA) submission expected by **August 2022**[127](index=127&type=chunk)[128](index=128&type=chunk) - **Lifileucel** for metastatic cervical cancer (C-145-04 trial, Cohort 2) received **Breakthrough Therapy Designation (BTD)** and completed enrollment in **January 2021**[129](index=129&type=chunk) - The **IOV-LUN-202 clinical trial** is enrolling patients with metastatic NSCLC, with Cohort 3 exploring TIL manufacturing from core biopsies using the **third-generation (Gen 3) process**[130](index=130&type=chunk) - The Iovance Cell Therapy Center (iCTC) successfully manufactured and delivered its first clinical batch of **LN-145** for the IOV-COM-202 trial in **September 2021**[136](index=136&type=chunk) - The FDA allowed an Investigational New Drug (IND) to proceed for the first genetically modified TIL therapy, **IOV-4001**, in **March 2022**, with the first clinical trial expected to initiate in **2022**[140](index=140&type=chunk) [Intellectual Property](index=38&type=section&id=Intellectual%20Property) - The company owns over **40 U.S. patents** related to TIL therapy, including compositions and methods of treatment in a broad range of cancers[144](index=144&type=chunk) - More than **30 of these patents** are related to the Gen 2 TIL manufacturing processes and are anticipated to extend to **January 2038**[144](index=144&type=chunk) - The intellectual property portfolio also includes patent applications for frozen tumor-based TIL technologies, remnant TIL and digest TIL compositions, costimulatory molecules, genetically-modified TIL therapies, and ICI combination methods[144](index=144&type=chunk) [Impact of COVID-19 on our Business Operations and Liquidity](index=38&type=section&id=Impact%20of%20COVID-19%20on%20our%20Business%20Operations%20and%20Liquidity) - The COVID-19 pandemic has **not had a material impact** on the company's liquidity or results of operations for the three months ended March 31, 2022[145](index=145&type=chunk) - Clinical trial enrollment has **not been significantly affected** by the pandemic to date[145](index=145&type=chunk) - The company believes its current cash reserves are **well-positioned** to manage its business through the ongoing crisis[146](index=146&type=chunk) - The dynamic nature of the COVID-19 pandemic makes it **difficult to forecast future effects** on financial condition, results of operations, or cash flows[147](index=147&type=chunk)[149](index=149&type=chunk) [Components of Results of Operations](index=40&type=section&id=Components%20of%20Results%20of%20Operations) - The company has **not generated any revenues** since its formation and does not anticipate significant revenues from product sales or licensing in the next **12 months**[150](index=150&type=chunk) - Research and development expenses are expected to **increase** due to preparations for commercial manufacturing and ongoing clinical trials[153](index=153&type=chunk) - General and administrative expenses are anticipated to **increase** as the company prepares for commercialization and expands its internal team and corporate infrastructure[155](index=155&type=chunk) [Results of Operations for the Three Months Ended March 31, 2022 and 2021](index=42&type=section&id=Results%20of%20Operations%20for%20the%20Three%20Months%20Ended%20March%2031%2C%202022%20and%202021) Operating Results Comparison (in thousands) | Metric | Three Months Ended March 31, 2022 (in thousands) | Three Months Ended March 31, 2021 (in thousands) | Change (in thousands) | Change (%) | | :-------------------------- | :--------------------------------------- | :--------------------------------------- | :-------------------- | :--------- | | Research and development expense | $68,300 | $55,949 | $12,351 | 22 | | General and administrative expense | $23,413 | $19,621 | $3,792 | 19 | | Interest income, net | $106 | $121 | $(15) | (12) | | Net loss | $(91,607) | $(75,449) | $(16,158) | 21 | - The increase in research and development expense was primarily due to a **$6.5 million increase** in payroll and related expenses and a **$4.4 million increase** in stock-based compensation, driven by increased hiring and facility costs, partially offset by a **$5.8 million decrease** in clinical trial costs[158](index=158&type=chunk) - The increase in general and administrative expenses was mainly due to a **$1.4 million increase** in payroll and related expenses, a **$0.9 million increase** in stock-based compensation, and a **$1.5 million increase** in other costs to support business growth and pre-commercialization activities[159](index=159&type=chunk) [Liquidity and Capital Resources](index=43&type=section&id=Liquidity%20and%20Capital%20Resources) - The company has incurred losses and generated negative cash flows from operations since inception, with an accumulated deficit of **$1.3 billion** as of March 31, 2022[162](index=162&type=chunk) - As of March 31, 2022, the company had **$516.0 million** in cash, cash equivalents, and investments, which is believed to be sufficient to fund operations for at least the **next twelve months**[162](index=162&type=chunk) - Future funding requirements are expected to **increase** due to expanded research and development, pre-commercial activities, and completion of the iCTC facility[162](index=162&type=chunk) Cash Flow Activities (in thousands) | Cash Flow Activity | Three Months Ended March 31, 2022 (in thousands) | Three Months Ended March 31, 2021 (in thousands) | | :--------------------------------------- | :--------------------------------------- | :--------------------------------------- | | Net cash used in operating activities | $(73,802) | $(62,391) | | Net cash provided by investing activities | $86,516 | $77,211 | | Net cash provided by financing activities | $1,417 | $50,364 | - The increase in cash used in operating activities was due to **increased net loss** and higher non-cash charges, partially offset by changes in operating assets and liabilities[170](index=170&type=chunk) - The decrease in net cash provided by financing activities was primarily due to **lower proceeds from common stock sales** through the 'at the market' offering program in Q1 2022 compared to Q1 2021[172](index=172&type=chunk) [Off-Balance Sheet Arrangements](index=45&type=section&id=Off-Balance%20Sheet%20Arrangements) - As of March 31, 2022, the company had **no obligations** that would require disclosure as off-balance sheet arrangements[173](index=173&type=chunk) [Significant Accounting Policies and Recent Accounting Standards](index=46&type=section&id=Significant%20Accounting%20Policies%20and%20Recent%20Accounting%20Standards) - There were **no recently issued accounting standards** applicable to the company, and no accounting standards were adopted during the three months ended March 31, 2022[174](index=174&type=chunk) [Inflation](index=46&type=section&id=Inflation) - Inflation has **not had a material effect** on the company's business, financial condition, or results of operations over the two most recent fiscal years[175](index=175&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=46&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's market risk is primarily limited to interest income sensitivity from its investment portfolio, which consists mainly of short-term U.S. government debt securities - The company's exposure to market risk is primarily limited to **interest income sensitivity**, affected by changes in U.S. interest rates[176](index=176&type=chunk) - The investment policy limits amounts invested in securities by credit rating, maturity, industry group, investment type, and issuer, except for U.S. government securities[176](index=176&type=chunk) - As of March 31, 2022, **$489.2 million** was invested in marketable securities with maturity dates of **less than two years**[176](index=176&type=chunk) - A **1% change in interest rates** as of March 31, 2022, would result in an approximate **$2.0 million increase or decrease** in the fair value of the investment portfolio[176](index=176&type=chunk) [Item 4. Controls and Procedures](index=46&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of the end of the period covered by this report, and there were no material changes in internal control over financial reporting during the quarter ended March 31, 2022 - The company's principal executive officer and principal financial officer concluded that disclosure controls and procedures were **effective** as of March 31, 2022[177](index=177&type=chunk) - There have been **no material changes** in internal control over financial reporting during the quarter ended March 31, 2022[178](index=178&type=chunk) [PART II OTHER INFORMATION](index=47&type=section&id=PART%20II%20OTHER%20INFORMATION) Presents additional information including legal proceedings, risk factors, sales of securities, and exhibits [Item 1. Legal Proceedings](index=47&type=section&id=Item%201.%20Legal%20Proceedings) This section incorporates by reference the legal proceedings detailed in Note 9 to the Condensed Consolidated Financial Statements, confirming no other material pending legal matters - Information on legal proceedings is incorporated by reference from **Note 9** to the Condensed Consolidated Financial Statements[180](index=180&type=chunk) - There are **no other matters** that constitute material pending legal proceedings[180](index=180&type=chunk) [Item 1A. Risk Factors](index=47&type=section&id=Item%201A.%20Risk%20Factors) This section outlines the significant risks and uncertainties facing the company, including those related to its business operations, government regulation, intellectual property, and securities - The company is **substantially dependent** on the success of its product candidates, which may not complete development, receive regulatory approval, or be commercialized[183](index=183&type=chunk) - **Significant risks** include substantial delays in clinical trials, difficulties in manufacturing and scaling capabilities, and the need for additional financing[183](index=183&type=chunk) - The company is subject to **extensive and costly regulation**, faces **significant competition**, and its business could be **adversely affected** by health epidemics like COVID-19[186](index=186&type=chunk) [Risks Related to Our Business](index=50&type=section&id=Risks%20Related%20to%20Our%20Business) - The company has a history of operating losses, with an accumulated deficit of **$1.3 billion** as of March 31, 2022, and expects to continue incurring losses[187](index=187&type=chunk) - Success is entirely dependent on the development and commercialization of product candidates (**lifileucel, LN-145, IOV-2001, IOV-3001**), which may never occur[191](index=191&type=chunk) - Reliance on third parties (CROs, CMOs, clinical trial sites) for clinical trials and manufacturing exposes the company to risks of **delays, failures, and lack of control**[197](index=197&type=chunk)[199](index=199&type=chunk)[200](index=200&type=chunk) - Clinical trials are **expensive, time-consuming, and uncertain**, with risks of undesirable side effects, failure to demonstrate safety and efficacy, and difficulties in patient enrollment[222](index=222&type=chunk)[223](index=223&type=chunk)[231](index=231&type=chunk) - Manufacturing of product candidates is complex, highly regulated, and susceptible to **product loss, contamination, and scaling difficulties**, potentially delaying supply or increasing costs[234](index=234&type=chunk)[236](index=236&type=chunk) - The company needs **additional financing** to fund future operations, with risks of dilution to stockholders, increased debt, or relinquishing rights to technologies[254](index=254&type=chunk)[256](index=256&type=chunk) - The ongoing military conflict between Russia and Ukraine and resulting geopolitical instability could **materially adversely affect** the global economy, capital markets, and the company's business[323](index=323&type=chunk)[325](index=325&type=chunk) [Risks Related to Government Regulation](index=98&type=section&id=Risks%20Related%20to%20Government%20Regulation) - The FDA regulatory approval process is **lengthy, time-consuming, and uncertain**, especially for novel cell therapies, with no prior BLA submission experience[329](index=329&type=chunk)[330](index=330&type=chunk) - Obtaining regulatory approval in one jurisdiction does **not guarantee approval in others**, and foreign regulatory requirements can vary significantly[333](index=333&type=chunk) - Ongoing regulatory obligations post-approval, such as REMS and Phase 4 studies, will result in **significant additional expense** and potential penalties for non-compliance[335](index=335&type=chunk)[336](index=336&type=chunk)[339](index=339&type=chunk) - Failure to comply with federal and state healthcare and promotional laws (e.g., fraud and abuse, off-label promotion) could lead to **substantial penalties** and adverse business impact[341](index=341&type=chunk)[344](index=344&type=chunk)[347](index=347&type=chunk) - Coverage and reimbursement for product candidates may be **limited or unavailable**, impacting profitability, particularly for novel therapies in inpatient settings[349](index=349&type=chunk)[351](index=351&type=chunk)[357](index=357&type=chunk) - New legislation, regulatory proposals, and healthcare payor initiatives (e.g., ACA, drug pricing controls) may **increase compliance costs** and adversely affect marketability and profitability[358](index=358&type=chunk)[362](index=362&type=chunk) [Risks Related to Our Intellectual Property](index=111&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) - The company may be involved in lawsuits to protect or enforce its patents or those of its licensors, or lawsuits accusing its products of patent infringement, which could be **expensive, time-consuming, and unsuccessful**[368](index=368&type=chunk) - Issued patents covering product candidates could be found **invalid or unenforceable** if challenged in court or the USPTO, leading to a loss of patent protection[372](index=372&type=chunk) - The patent law relating to biotechnology is still evolving, leading to **uncertainty in patent positions** and potential for competitors to license similar intellectual properties or duplicate the business model[374](index=374&type=chunk)[377](index=377&type=chunk)[378](index=378&type=chunk) - The use of the company's technologies could potentially **conflict with the rights of others**, requiring alterations, licensing fees, or cessation of activities[379](index=379&type=chunk) - Changes in U.S. patent law could **diminish the value of patents**, and limited foreign intellectual property rights may hinder global protection efforts[381](index=381&type=chunk)[382](index=382&type=chunk) [Risks Related to Our Securities](index=117&type=section&id=Risks%20Related%20to%20Our%20Securities) - Officers, directors, and principal stockholders own a **substantial percentage** of the company's stock, enabling them to exert significant control over matters subject to stockholder approval[385](index=385&type=chunk) - The market price of the common stock is likely to be **volatile** and could fluctuate widely due to clinical trial results, regulatory developments, competition, and general market conditions[386](index=386&type=chunk) - Future sales of common stock in the public market, including from equity offerings or the exercise of common stock equivalents, could cause the stock price to **fall** and result in **substantial dilution** to existing stockholders[387](index=387&type=chunk)[388](index=388&type=chunk)[389](index=389&type=chunk) - The company does **not anticipate paying cash dividends** for the foreseeable future, so investors should not expect cash dividends[396](index=396&type=chunk) - Provisions in corporate charter documents and Delaware law may **prevent or frustrate attempts** by stockholders to change management or acquire a controlling interest in the company[397](index=397&type=chunk)[398](index=398&type=chunk) [Item 2. Unregistered Sales of Securities and Use of Proceeds](index=122&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Securities%20and%20Use%20of%20Proceeds) This section states that there is nothing to report regarding unregistered sales of securities and use of proceeds for the period - **Nothing to report**[405](index=405&type=chunk) [Item 3. Defaults Upon Senior Securities](index=122&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This section indicates that there are no defaults upon senior securities to report for the period - **Nothing to report**[406](index=406&type=chunk) [Item 4. Mine Safety Disclosure](index=122&type=section&id=Item%204.%20Mine%20Safety%20Disclosure) This section states that there is no information to disclose regarding mine safety for the period - **Nothing to report**[407](index=407&type=chunk) [Item 5. Other Information](index=122&type=section&id=Item%205.%20Other%20Information) This section indicates that there is no other information to report for the period - **Nothing to report**[408](index=408&type=chunk) [Item 6. Exhibits](index=123&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed as part of the Form 10-Q, including certifications from the Chief Executive Officer and Chief Financial Officer, as well as various Inline XBRL documents - Includes Rule 13a-14(a)/15d-14(a) Certifications of Chief Executive Officer and Chief Financial Officer (**Exhibits 31.1 and 31.2**)[410](index=410&type=chunk) - Includes Section 1350 Certifications of Chief Executive Officer and Chief Financial Officer (**Exhibits 32.1 and 32.2**)[410](index=410&type=chunk) - Includes Inline XBRL Instance Document and various Inline XBRL Taxonomy Linkbase Documents[410](index=410&type=chunk) [SIGNATURES](index=124&type=section&id=SIGNATURES) Confirms the due authorization and signing of the Quarterly Report on Form 10-Q by the company's executive officers [SIGNATURES](index=124&type=section&id=SIGNATURES) This section confirms the due authorization and signing of the Quarterly Report on Form 10-Q on May 5, 2022, by the company's Interim Chief Executive Officer and President, and General Counsel, and its Chief Financial Officer and Treasurer - The report was signed on **May 5, 2022**[413](index=413&type=chunk) - Signed by **Frederick G. Vogt, Ph.D., J.D.**, Interim Chief Executive Officer and President, and General Counsel (Principal Executive Officer)[413](index=413&type=chunk) - Signed by **Jean-Marc Bellemin**, Chief Financial Officer and Treasurer (Principal Financial and Accounting Officer)[413](index=413&type=chunk)