ASCO Update Call June 6, 2021 © 2021, Iovance Biotherapeutics, Inc 1 | --- | --- | |---------------------------------------------------------------------------------------------------------------------------|-------------------------| | Agenda | | | | | | • Corporate Update : Fred Vogt, incoming Interim CEO and President • ASCO Updates for Lifileucel in Advanced Melanoma | : Omid Hamid, MD, Chief | | of Research/Immuno-Oncology, The Angeles Clinic & Research Institute | | | • Financial Summary : Jean-Marc B ...

Iovance Biotherapeutics, Inc. (NASDAQ:IOVA) Q1 2021 Earnings Conference Call May 6, 2021 4:30 PM ET Company Participants Maria Fardis - Chief Executive Officer & President Friedrich Finckenstein - Chief Medical Officer Jean Marc Bellemin - Chief Financial Officer Sara Pellegrino - Vice President, Investor and Public Relations Jim Ziegler - Senior Vice President, Commercial Conference Call Participants Michael Yee - Jefferies LLC Peter Lawson - Barclays Bank Mark Breidenbach - Oppenheimer Boris Peaker - Cowe ...

[PART I FINANCIAL INFORMATION](index=4&type=section&id=PART%20I%20FINANCIAL%20INFORMATION) [Item 1. Condensed Consolidated Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(Unaudited)) This section provides the unaudited condensed consolidated financial statements for Iovance Biotherapeutics, Inc., detailing its financial position and performance - The company is a clinical-stage biopharmaceutical company focused on developing and commercializing cell therapies, specifically Tumor Infiltrating Lymphocyte (TIL) therapy, with lead candidates lifileucel for metastatic melanoma and cervical cancer[25](index=25&type=chunk) - The company has not generated any revenue and incurred a net loss of **$75.4 million** for the three months ended March 31, 2021, though management believes existing capital is sufficient for the next twelve months[27](index=27&type=chunk)[28](index=28&type=chunk) [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet shows total assets decreased slightly to **$750.6 million** as of March 31, 2021, primarily due to reduced short-term investments Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2021 | December 31, 2020 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $131,954 | $67,329 | | Short-term investments | $461,976 | $562,108 | | Total Current Assets | $605,218 | $636,100 | | Total Assets | $750,573 | $768,458 | | **Liabilities & Equity** | | | | Total Current Liabilities | $55,059 | $54,871 | | Total Liabilities | $103,142 | $111,960 | | Total Stockholders' Equity | $647,431 | $656,498 | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The company reported a net loss of **$75.4 million** for Q1 2021, an increase from the prior year, primarily due to higher general and administrative expenses Statement of Operations Summary (in thousands, except per share data) | Item | Three Months Ended March 31, 2021 | Three Months Ended March 31, 2020 | | :--- | :--- | :--- | | Research and development expenses | $55,949 | $56,952 | | General and administrative expenses | $19,621 | $13,858 | | Total costs and expenses | $75,570 | $70,810 | | Loss from operations | ($75,570) | ($70,810) | | Net Loss | ($75,449) | ($69,595) | | Net Loss Per Share, Basic and Diluted | ($0.51) | ($0.55) | [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities was **$62.4 million** in Q1 2021, offset by cash from investing and financing, leading to a **$65.2 million** net increase in cash Cash Flow Summary (in thousands) | Activity | Three Months Ended March 31, 2021 | Three Months Ended March 31, 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | ($62,391) | ($65,292) | | Net cash provided by investing activities | $77,211 | $100,105 | | Net cash provided by financing activities | $50,364 | $3,833 | | **Net increase in cash, cash equivalents, and restricted cash** | **$65,184** | **$38,646** | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=48&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial condition and operational results, highlighting clinical program progress, expense changes, and liquidity, while noting BLA submission delays and COVID-19 impacts [Overview and Clinical Development](index=48&type=section&id=Overview%20and%20Clinical%20Development) This section provides an overview of the company's TIL cell therapy development, focusing on lifileucel's clinical progress in melanoma and cervical cancer, including BLA submission updates - The Biologics License Application (BLA) for lifileucel in metastatic melanoma was delayed due to FDA feedback on potency assays, with submission now anticipated in **2021**[176](index=176&type=chunk) - In the C-144-01 trial for metastatic melanoma (Cohort 2), lifileucel demonstrated an objective response rate (ORR) of **36%** in 66 patients, with a median duration of response (DOR) not yet reached after **28.1 months** of follow-up[173](index=173&type=chunk) - For metastatic cervical cancer (C-145-04), lifileucel showed an ORR of **44%** in 27 patients and received Breakthrough Therapy Designation, with BLA submission discussions planned for **2021**[177](index=177&type=chunk) [Results of Operations](index=55&type=section&id=Results%20of%20Operations) Q1 2021 results show a **2%** decrease in R&D expenses to **$55.9 million** and a **42%** increase in G&A expenses to **$19.6 million**, leading to an **8%** higher net loss Comparison of Operating Expenses (in thousands) | Expense Category | Q1 2021 | Q1 2020 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Research and development | $55,949 | $56,952 | ($1,003) | (2)% | | General and administrative | $19,621 | $13,858 | $5,763 | 42% | - The decrease in R&D expense was primarily due to a **$10.0 million** license cost from Novartis recognized in Q1 2020 and a **$5.0 million** decrease in manufacturing costs in Q1 2021[201](index=201&type=chunk) - The increase in G&A expense was mainly driven by a **$2.8 million** increase in payroll and a **$2.6 million** increase in stock-based compensation[202](index=202&type=chunk) [Liquidity and Capital Resources](index=57&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2021, the company held **$604.2 million** in cash and investments, with management confident in sufficient capital for at least the next 12 months despite expected increased spending - As of March 31, 2021, the company had **$604.2 million** in cash, cash equivalents, and investments[216](index=216&type=chunk)[322](index=322&type=chunk) - In Q1 2021, the company received approximately **$42.9 million** in net proceeds from its 'at the market' (ATM) offering program by selling **1,278,243 shares**[214](index=214&type=chunk)[88](index=88&type=chunk) - Management believes that existing capital is sufficient to fund anticipated operating expenses and capital expenditures for at least **12 months** from the filing date[217](index=217&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=60&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk is interest rate sensitivity on its **$472.2 million** investment portfolio, with a **1%** rate change impacting fair value by **$1.9 million** - The company's main market risk is interest income sensitivity from its **$472.2 million** in marketable securities, primarily short-term U.S. government debt[229](index=229&type=chunk) - A hypothetical **1%** change in interest rates would cause the fair value of the investment portfolio to change by approximately **$1.9 million**[229](index=229&type=chunk) [Item 4. Controls and Procedures](index=60&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2021, with no material changes to internal control over financial reporting during the quarter - Management, including the principal executive and financial officers, concluded that disclosure controls and procedures were effective as of the end of the quarter[230](index=230&type=chunk) - No changes in internal control over financial reporting occurred during the quarter that have materially affected, or are reasonably likely to materially affect, these controls[231](index=231&type=chunk) [PART II OTHER INFORMATION](index=61&type=section&id=PART%20II%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=61&type=section&id=Item%201.%20Legal%20Proceedings) This section details legal proceedings, including a December 2020 stockholder derivative complaint and ongoing lawsuits with Solomon Capital, LLC, with no other material pending matters - Information on legal proceedings is incorporated by reference from Note 9 to the Condensed Consolidated Financial Statements[232](index=232&type=chunk) - Key legal matters include a derivative lawsuit filed in December 2020 concerning director compensation and lawsuits involving Solomon Capital, LLC[123](index=123&type=chunk)[124](index=124&type=chunk) [Item 1A. Risk Factors](index=61&type=section&id=Item%201A.%20Risk%20Factors) This section outlines key risks, including dependence on product candidate success, clinical trial delays, manufacturing challenges, competition, financing needs, regulatory hurdles, third-party reliance, and health epidemics - The company is substantially dependent on the success of its product candidates and cannot guarantee they will receive regulatory approval or be successfully commercialized[235](index=235&type=chunk)[245](index=245&type=chunk) - The manufacturing of cell-based therapies is complex and subject to difficulties in process development, quality control, and scaling, which could delay or stop the supply of product candidates[235](index=235&type=chunk)[299](index=299&type=chunk) - The company may need additional financing to fund operations and complete development, which may cause dilution to existing stockholders or require relinquishing rights to technologies[235](index=235&type=chunk)[322](index=322&type=chunk) - The business could be adversely affected by health epidemics, including the COVID-19 pandemic, impacting manufacturing, clinical trial sites, and third-party partner operations[239](index=239&type=chunk)[392](index=392&type=chunk) [Item 2. Unregistered Sales of Securities and Use of Proceeds](index=147&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of securities or specific uses of proceeds to report for the period - Nothing to report[505](index=505&type=chunk) [Item 3. Defaults Upon Senior Securities](index=147&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) There were no defaults upon senior securities during the period - Nothing to report[506](index=506&type=chunk) [Item 4. Mine Safety Disclosure](index=147&type=section&id=Item%204.%20Mine%20Safety%20Disclosure) This item is not applicable to the company - Nothing to report[507](index=507&type=chunk) [Item 5. Other Information](index=147&type=section&id=Item%205.%20Other%20Information) There was no other information to report for the period - Nothing to report[508](index=508&type=chunk) [Item 6. Exhibits](index=148&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including lease agreements, an executive employment agreement, and required officer certifications - The report includes several exhibits, such as new and amended lease agreements, an executive employment agreement, and required officer certifications[510](index=510&type=chunk) [Signatures](index=149&type=section&id=SIGNATURES) - The report was duly signed and authorized on May 6, 2021, by the Chief Executive Officer, Maria Fardis, and the Chief Financial Officer, Jean-Marc Bellemin[514](index=514&type=chunk)[516](index=516&type=chunk)

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| --- | --- | --- | --- | --- | |---------------------------------------------------------------------------|--------------------------------------|-------|---------------|-------| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Tumor Infiltrating Lymphocyte Cell Therapy for Treatment of Solid Tumors | | | February 2021 | | | | © 2021, Iovance Biotherapeutics, Inc | | | 1 | | --- ...

Iovance Biotherapeutics, Inc. (NASDAQ:IOVA) Q4 2020 Earnings Conference Call February 25, 2021 4:30 PM ET Company Participants Maria Fardis - Chief Executive Officer & President Friedrich Finckenstein - Chief Medical Officer Jean Marc Bellemin - Chief Financial Officer Sara Pellegrino - Vice President, Investor and Public Relations Conference Call Participants Mark Breidenbach - Oppenheimer Peter Lawson - Barclays Bank Biren Amin - Jefferies Reni Benjamin - JMP Securities Mara Goldstein - Mizuho Securities ...

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, 2020 ☐ 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 ...

| --- | --- | --- | --- | --- | |-------------------------------------------------------------------------------------|---------------------------------|-------|---------------|-------| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Investigating the Power of Tumor Infiltrating Lymphocytes for Treatment of Cancer | | | November 2020 | | | | © 2020, Iovance Biotherapeutics | | | | ongoing clinical trials and anticipated clinical trials for our current product candidates (including both Company ...

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