1 I OVANCE 1 Corporate Overview March 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 ...

Financial Data and Key Metrics Changes - As of December 31, 2021, Iovance held $602.1 million in cash, cash equivalents, investments, and restricted cash, a decrease from $635 million on December 31, 2020, indicating a strong cash position expected to last into 2024 [37] - The net loss for Q4 2021 was $99.3 million or $0.63 per share, compared to a net loss of $68.4 million or $0.47 per share in Q4 2020 [38] - For the full year 2021, the net loss was $342.3 million or $2.23 per share, compared to a net loss of $259.6 million or $1.88 per share in 2020 [39] Business Line Data and Key Metrics Changes - Research and development expenses for Q4 2021 were $75.6 million, an increase of $23.1 million from $52.5 million in Q4 2020, primarily due to growth in the internal R&D team and increasing clinical trial costs [40] - General and administrative expenses for Q4 2021 were $23.8 million, up from $16.1 million in Q4 2020, attributed to growth in the internal team and increased intellectual property filing costs [43] Market Data and Key Metrics Changes - The company is focused on onboarding at least 40 authorized treatment centers (ATCs) for the commercialization of lifileucel, informed by CAR-T market data indicating that top centers account for a significant portion of treated patients [22] Company Strategy and Development Direction - The company aims to submit its Biologics License Application (BLA) for lifileucel in metastatic melanoma in the first half of 2022 and expand TIL therapy into non-small cell lung cancer and cervical cancer [13][14] - Iovance is preparing for commercial manufacturing and launch, with a focus on owning its manufacturing capabilities to ensure success [14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strength of Iovance's position to lead in developing TIL therapies for cancer, emphasizing the importance of their manufacturing capabilities [14] - The company is actively engaged in discussions with the FDA regarding regulatory plans and is preparing for potential BLA submission [9][10] Other Important Information - The Iovance Cell Therapy Center (ICTC) has completed commissioning activities and initiated TIL clinical supply, with the first patient receiving TIL manufactured at ICTC in September 2021 [16][17] - The company has a robust intellectual property portfolio with over 35 granted or allowed patents, providing exclusivity into 2038 [18][19] Q&A Session Summary Question: Resolution on potency assay for BLA submission - Management confirmed the need for resolution on the potency assay to proceed with BLA submission and indicated ongoing discussions with the FDA [51][52] Question: Filing and validation process - Management clarified that the BLA submission process involves ongoing interactions with the FDA, and they aim to address any concerns raised during the review period [60][62] Question: Cervical cancer filing timelines - Management acknowledged changes in the treatment landscape for cervical cancer and is planning a registrational strategy based on FDA feedback [70] Question: Cohort 4 data status - Management stated that Cohort 4 data is still being worked on and will be included in the BLA submission [58][59] Question: European filing strategy - Management indicated that the European strategy hinges on the outcome of the FDA submission, with plans to move quickly if the FDA approval is granted [124][125]

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, 2021 ☐ 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 ...

| --- | --- | --- | --- | --- | |-------|-------|-------|-------|-------| | | | | | | | | | | | | | | | | | | | | | | | | 1 Certain matters discussed in this presentation are "forward-looking statements" of Iovance Biotherapeutics, Inc, 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 forwar ...

| --- | --- | --- | --- | --- | |-------------------------------------------|-------------------------------------------------------------------------|-------------------|-------|-------| | | | | | | | | | | | | | | | | | | | | | | | | | Conference Call & Webcast: Annual Meeting | Clinical Data Highlights at Society for Immunotherapy of Cancer (SITC) | | | | | | | November 13, 2021 | | | | | © 2021, Iovance Biotherapeutics, Inc | | | | 1 Certain matters discussed in this presentation are "forward-looking st ...

Financial Data and Key Metrics Changes - As of September 30, 2021, Iovance held $660.8 million in cash, cash equivalents, investments, and restricted cash, compared to $635 million on December 31, 2020, indicating a strong cash position sufficient to support operations into 2023 [40] - The net loss for Q3 2021 was $86.1 million or $0.55 per share, compared to a net loss of $58.6 million or $0.40 per share for Q3 2020 [41] - Research and development expenses increased to $65.4 million for Q3 2021, up from $43.1 million in Q3 2020, primarily due to growth in the internal R&D team and clinical trial costs [42][43] - General and administrative expenses rose to $20.9 million for Q3 2021, compared to $15.9 million in Q3 2020, attributed to team growth and higher stock-based compensation [45] Business Line Data and Key Metrics Changes - The company continues to advance its tumor-infiltrating lymphocyte (TIL) platform into new indications and earlier treatment settings, with a focus on lifileucel for metastatic melanoma [9][10] - Clinical data shows promise for TIL therapy across four solid tumor types, with ongoing studies demonstrating increasing long-term durability following treatment [11][12] Market Data and Key Metrics Changes - The FDA granted Fast Track designation for lifileucel in combination with pembrolizumab for metastatic melanoma, allowing for potential accelerated approval and priority review [13] - Initial clinical data in metastatic non-small cell lung cancer showed a 21.4% overall response rate in heavily pretreated patients, highlighting a significant unmet need [14] Company Strategy and Development Direction - Iovance aims to be a global leader in TIL cell therapy, focusing on enhancing partnerships with leading U.S. cancer centers and ensuring timely access to lifileucel upon approval [26][27] - The company is advancing a next-generation TIL product, IOV-4001, and a novel IL-2 analog, IOV-3001, through IND-enabling studies [15] Management's Comments on Operating Environment and Future Outlook - Management remains confident in the anticipated BLA submission for lifileucel in the first half of 2022, despite ongoing discussions with the FDA regarding potency assays [10][51] - The company is focused on maintaining operational excellence and ensuring timely access to lifileucel for patients [29] Other Important Information - The Iovance Cell Therapy Center (iCTC) in Philadelphia has initiated manufacturing of investigational TIL therapies, with a manufacturing success rate above 90% [19] - The company has over 30 granted and allowed patents in the U.S. and internationally, with a robust IP portfolio supporting its TIL therapies [23][24] Q&A Session Summary Question: Update on FDA discussions regarding potency assays - Management confirmed ongoing engagement with the FDA and reiterated the plan to submit the BLA in the first half of 2022 [50][51] Question: Clarification on filing guidance and what is being awaited - Management indicated that they are not waiting on any specific item and are continuing to prepare for the BLA submission while engaging with the FDA [58][59] Question: Concerns about potential FDA requests for randomized trials - Management stated that the FDA is not currently asking for randomized trials and they plan to use existing pivotal study data for the submission [64] Question: Guidance on potency assays and patent protection - Management discussed the complexity of potency assays and indicated that they have multiple assays under consideration, some of which have associated IP [97][99] Question: Timing for data collection related to clinical trials - Management explained that patient assessments are ongoing and data collection will proceed according to predefined schedules without additional patient calls [91][92]

Table of Contents U. S. SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 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, 2021 ☐ 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.R.S. e ...

Start Time: 16:30 January 1, 0000 5:12 PM ET Iovance Biotherapeutics, Inc. (NASDAQ:IOVA) Q2 2021 Earnings Conference Call August 05, 2021, 16:30 PM ET Company Participants Frederick Vogt - Interim President and CEO Igor Bilinsky - COO Jim Zigler - SVP, Commercial Friedrich Finckenstein - CMO Jean-Marc Bellemin - CFO Madan Jagasia - SVP of Medical Affairs Sara Pellegrino - VP, Investor and Public Relations Conference Call Participants Michael Yee - Jefferies Mark Breidenbach - Oppenheimer Benjamin Burnett - ...

PART I FINANCIAL INFORMATION [Condensed Consolidated Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(Unaudited)) This section presents the unaudited condensed consolidated financial statements for the three and six months ended June 30, 2021, detailing financial position, operations, and cash flows, with a net loss of $156.8 million and sufficient liquidity for the next twelve months Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2021 | December 31, 2020 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $82,763 | $67,329 | | Short-term investments | $573,605 | $562,108 | | Total Current Assets | $666,640 | $636,100 | | Total Assets | $852,790 | $768,458 | | **Liabilities & Equity** | | | | Total Current Liabilities | $60,534 | $54,871 | | Total Liabilities | $108,377 | $111,960 | | Total Stockholders' Equity | $744,413 | $656,498 | Condensed Consolidated Statements of Operations (in thousands, except per share data) | Metric | Three Months Ended June 30, 2021 | Three Months Ended June 30, 2020 | Six Months Ended June 30, 2021 | Six Months Ended June 30, 2020 | | :--- | :--- | :--- | :--- | :--- | | Research and development expenses | $62,119 | $49,274 | $118,068 | $106,226 | | General and administrative expenses | $19,307 | $14,353 | $38,928 | $28,211 | | Loss from operations | $(81,426) | $(63,627) | $(156,996) | $(134,437) | | Net Loss | $(81,351) | $(63,018) | $(156,800) | $(132,613) | | Net Loss Per Share, Basic and Diluted | $(0.53) | $(0.47) | $(1.04) | $(1.02) | Condensed Consolidated Statements of Cash Flows (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2021 | Six Months Ended June 30, 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | $(116,399) | $(101,927) | | Net cash used by investing activities | $(81,954) | $(323,651) | | Net cash provided by financing activities | $214,346 | $572,298 | - The company is a clinical-stage biopharmaceutical firm focused on developing and commercializing **TIL cell therapies** for cancer, with **lifileucel** as its lead product candidate for metastatic melanoma and cervical cancer, utilizing a proprietary **Gen 2 manufacturing process**[25](index=25&type=chunk) - As of June 30, 2021, the company held **$708.7 million** in cash, cash equivalents, and investments, which management deems sufficient to fund operations for at least the **next twelve months**, despite a **net loss of $156.8 million** for the first half of 2021 and no commercial revenue[27](index=27&type=chunk)[28](index=28&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=35&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's clinical-stage operations, focusing on TIL therapies, with a BLA for lifileucel in melanoma now expected in H1 2022, alongside increased operating expenses and a strong liquidity position [Overview](index=35&type=section&id=Overview) This overview details the company's focus on TIL cell therapies, particularly lifileucel, with a BLA submission for metastatic melanoma now anticipated in H1 2022 pending FDA feedback, alongside progress in other pivotal and combination trials - The **BLA submission for lifileucel in metastatic melanoma** is now anticipated in **H1 2022**, pending resolution of FDA feedback on potency assays[156](index=156&type=chunk) - Lifileucel demonstrated a **36% objective response rate (ORR)** in the C-144-01 trial for metastatic melanoma (Cohort 2), with median duration of response (DOR) not yet reached after **33.1 months** of median follow-up[154](index=154&type=chunk) - In the C-145-04 trial for metastatic cervical cancer, lifileucel achieved a **44% ORR** in 27 patients, with median DOR not yet reached[157](index=157&type=chunk) - Combination therapy of lifileucel with pembrolizumab showed an **86% ORR** in melanoma (IOV-COM-202 Cohort 1A) and a **44% ORR** in HNSCC (Cohort 2A), while LN-145 monotherapy in NSCLC (Cohort 3B) achieved a **21.4% ORR**[162](index=162&type=chunk)[163](index=163&type=chunk)[164](index=164&type=chunk) [Results of Operations](index=41&type=section&id=Results%20of%20Operations) For the six months ended June 30, 2021, R&D expenses increased by 11% to $118.1 million, and G&A expenses increased by 38% to $38.9 million, leading to an 18% rise in net loss to $156.8 million Change in Research and Development Expenses (in thousands) | Period | 2021 | 2020 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | **Three Months Ended June 30** | $62,119 | $49,274 | $12,845 | 26% | | **Six Months Ended June 30** | $118,068 | $106,226 | $11,842 | 11% | - The **11% increase in H1 2021 R&D expense** was primarily due to a **$14.0 million increase in payroll**, an **$8.0 million increase in stock-based compensation**, and a **$4.0 million increase in commercial manufacturing facility activities**, partially offset by a **$10.0 million license cost** recognized in 2020[179](index=179&type=chunk) Change in General and Administrative Expenses (in thousands) | Period | 2021 | 2020 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | **Three Months Ended June 30** | $19,307 | $14,353 | $4,954 | 35% | | **Six Months Ended June 30** | $38,928 | $28,211 | $10,717 | 38% | - The **38% increase in H1 2021 G&A expense** was mainly due to a **$4.7 million increase in payroll**, a **$3.4 million increase in stock-based compensation**, and a **$2.3 million increase in intellectual property, insurance, and license fees**[181](index=181&type=chunk) [Liquidity and Capital Resources](index=43&type=section&id=Liquidity%20and%20Capital%20Resources) The company has historically funded operations through equity offerings, holding $82.8 million in cash and $619.9 million in investments as of June 30, 2021, with management believing existing capital is sufficient for at least the next 12 months - As of June 30, 2021, the company had **$82.8 million in cash and cash equivalents**, **$619.9 million in investments**, and **$744.4 million in stockholders' equity**[193](index=193&type=chunk) - In the first six months of 2021, the company received net proceeds of approximately **$203.2 million** from its "at the market" offering program by selling **6,474,099 shares**[191](index=191&type=chunk) - Management believes that available funds are sufficient to fund anticipated operating expenses and capital expenditures for at least **12 months** from the filing date of this report[194](index=194&type=chunk) [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 exposure is primarily limited to interest income sensitivity from its portfolio of cash and short-term debt securities, with a hypothetical 1% interest rate change impacting fair value by approximately $2.7 million - The company's primary market risk is **interest rate sensitivity** on its investment portfolio, which consists mainly of short-term U.S. government debt securities[206](index=206&type=chunk) - A **1% change in interest rates** as of June 30, 2021, would cause the fair value of the investment portfolio to change by approximately **$2.7 million**[206](index=206&type=chunk) [Controls and Procedures](index=46&type=section&id=Item%204.%20Controls%20and%20Procedures) Based on management's evaluation, the company's disclosure controls and procedures were effective as of June 30, 2021, with no material changes to internal control over financial reporting during the quarter - Management, including the CEO and CFO, concluded that **disclosure controls and procedures were effective** as of the end of the quarter[207](index=207&type=chunk) - No changes in internal control over financial reporting occurred during the quarter ended June 30, 2021, that materially affected, or are reasonably likely to materially affect, internal controls[208](index=208&type=chunk) PART II OTHER INFORMATION [Legal Proceedings](index=46&type=section&id=Item%201.%20Legal%20Proceedings) This section incorporates by reference the legal proceedings detailed in Note 9 of the financial statements, including a stockholder derivative complaint and two ongoing lawsuits initiated by Solomon Capital, LLC, which the company intends to vigorously defend - The company is facing a **stockholder derivative complaint** filed in December 2020, alleging breach of fiduciary duty related to excessive compensation for certain non-executive directors[115](index=115&type=chunk) - Two lawsuits are ongoing with **Solomon Capital, LLC**, concerning alleged agreements from 2012 for financing services and equity claims, which the company is defending against and has asserted counterclaims[116](index=116&type=chunk)[118](index=118&type=chunk)[119](index=119&type=chunk) [Risk Factors](index=46&type=section&id=Item%201A.%20Risk%20Factors) This section details significant risks, including substantial dependence on product candidate success, potential delays in clinical trials and regulatory approval due to FDA feedback on potency assays, complexities in manufacturing cell-based therapies, intense competition, and challenges in market acceptance and reimbursement - The company is substantially dependent on the success of its product candidates, which may never receive regulatory approval or be successfully commercialized[220](index=220&type=chunk) - The **BLA submission for lifileucel has been delayed to H1 2022** due to the need to resolve FDA feedback on potency assays, highlighting regulatory risk and uncertainty[268](index=268&type=chunk)[374](index=374&type=chunk) - Manufacturing of cell-based therapies is complex and susceptible to product loss, contamination, and scalability issues, with the company relying on third-party CMOs and building its own facility, both carrying significant risks[263](index=263&type=chunk)[264](index=264&type=chunk)[269](index=269&type=chunk) - The business could be adversely affected by health epidemics like the **COVID-19 pandemic**, which could disrupt clinical trials, supply chains, and commercial launch preparations[352](index=352&type=chunk)[356](index=356&type=chunk) - The company faces intense competition from other biotechnology companies with greater resources, and its novel therapies may struggle to gain market acceptance and adequate reimbursement coverage[307](index=307&type=chunk)[317](index=317&type=chunk) [Unregistered Sales of Securities and Use of Proceeds](index=116&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 for this item[450](index=450&type=chunk) [Defaults Upon Senior Securities](index=116&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities for the period - Nothing to report for this item[451](index=451&type=chunk) [Mine Safety Disclosure](index=118&type=section&id=Item%204.%20Mine%20Safety%20Disclosure) The company reported no mine safety disclosures for the period - Nothing to report for this item[452](index=452&type=chunk) [Other Information](index=118&type=section&id=Item%205.%20Other%20Information) The company reported no other information for the period - Nothing to report for this item[453](index=453&type=chunk) [Exhibits](index=119&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the quarterly report, including the Amended and Restated Patent License Agreement with the National Institutes of Health, forms of equity award agreements under the 2018 Equity Incentive Plan, and certifications by the Chief Executive Officer and Chief Financial Officer - Key exhibits filed include an **Amended and Restated Patent License Agreement with the NIH** and forms for stock unit and stock option agreements related to June 2021 retention equity awards[456](index=456&type=chunk) Signatures [Signatures](index=120&type=section&id=Signatures) The report was duly signed and authorized on August 5, 2021, by Frederick G. Vogt, Ph.D., Esq., as Interim Chief Executive Officer and President, and Jean-Marc Bellemin, as Chief Financial Officer and Treasurer - The report was signed on **August 5, 2021**, by **Frederick G. Vogt, Ph.D., Esq.** (Interim CEO) and **Jean-Marc Bellemin** (CFO)[461](index=461&type=chunk)

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 ...