Financial Data and Key Metrics Changes - As of June 30, 2023, the company had $317.3 million in cash, cash equivalents, investments, and restricted cash, down from $478.3 million as of December 31, 2022, primarily due to cash used for the acquisition of Proleukin [7] - The net loss for the second quarter ended June 30, 2023, was $106 million or $0.47 per share, compared to a net loss of $99.3 million or $0.63 per share for the same period in 2022 [123] - Revenue for the second quarter and six months ended June 30, 2023, was $0.2 million, comprised entirely of Proleukin product sales, marking the first revenue recognition for the company [123] Business Line Data and Key Metrics Changes - Research and development expenses increased to $85.8 million for the second quarter of 2023, up from $73.4 million in the same period of 2022, driven by growth in the internal R&D team and the initiation of the Phase 3 TILVANCE-301 trial [27] - Selling, general, and administrative expenses decreased to $21.9 million for the second quarter of 2023, down from $26.3 million in the same period of 2022, primarily due to the capitalization of expenses related to the Proleukin acquisition [152] Market Data and Key Metrics Changes - The company is preparing for the commercial launch of lifileucel, with a PDUFA date set for November 25, 2023, and anticipates significant revenue from Proleukin following the launch [113][101] - The market access team is engaging key national and regional payers, expecting coverage consistent with the label and similar to recent CAR-T therapies [105] Company Strategy and Development Direction - The company aims to establish TIL therapy as a new paradigm in cancer treatment, integrating Proleukin into its offerings to enhance the TIL regimen [101] - The company is focused on expanding its clinical pipeline, with seven active clinical trials aimed at solid tumors, including ongoing studies in melanoma and non-small cell lung cancer [114] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the prospects for approval of lifileucel, citing strong clinical data and positive interactions with the FDA [4] - The company noted significant pent-up demand for lifileucel, supported by an expanded access program and ongoing engagement with patient advocacy groups [36] Other Important Information - The company has successfully provided TIL therapy for over 600 patients with a manufacturing success rate exceeding 90% [103] - The company plans to report detailed data from its IOV-COM-202 trial at the upcoming World Congress on Lung Cancer [102] Q&A Session All Questions and Answers Question: Can you provide an update on the cash runway and any internal changes? - Management indicated that the cash runway extends to the end of 2024, influenced by the recent $161 million capital raise and anticipated revenues from Proleukin and lifileucel [10] Question: What is the anticipated demand for lifileucel upon launch? - Management noted significant pent-up demand and plans to prioritize patient populations based on characteristics during the initial launch phase [18] Question: How is the onboarding process for treatment centers progressing? - The onboarding process is on track, with a goal to onboard 40 authorized treatment centers within the first 90 days post-approval [104] Question: What are the expectations regarding the FDA's review process for lifileucel? - Management reported that the FDA has not identified any major review issues and does not plan to hold an advisory committee meeting [113][137] Question: Can you elaborate on the expected efficacy benchmarks for the lung cancer trials? - Management highlighted that the overall response rate (ORR) in the lung cancer trials is promising, with specific benchmarks set against existing therapies [149]

PART I FINANCIAL INFORMATION This part presents the unaudited condensed consolidated financial statements and management's discussion and analysis for the reporting period [Item 1. Condensed Consolidated Financial Statements (Unaudited)](index=6&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20%28Unaudited%29) This section presents the unaudited condensed consolidated financial statements for Iovance Biotherapeutics, Inc. as of June 30, 2023, and for the three and six-month periods then ended. It includes the balance sheets, statements of operations, comprehensive loss, stockholders' equity, and cash flows, along with detailed notes explaining significant accounting policies and events, such as the recent acquisition of Proleukin® [Financial Statements](index=6&type=section&id=Financial%20Statements) This section provides the unaudited condensed consolidated balance sheets, statements of operations, comprehensive loss, stockholders' equity, and cash flows Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2023 | December 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $230,010 | $231,731 | | Total Current Assets | $274,878 | $479,116 | | Intangible assets, net | $235,511 | $0 | | Total Assets | $757,293 | $663,982 | | **Liabilities & Equity** | | | | Total Current Liabilities | $88,643 | $91,485 | | Total Liabilities | $178,724 | $164,344 | | Total Stockholders' Equity | $578,569 | $499,638 | Condensed Consolidated Statements of Operations Highlights (in thousands, except per share data) | Metric | Three Months Ended June 30, 2023 | Three Months Ended June 30, 2022 | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :--- | :--- | :--- | :--- | :--- | | Product revenue | $238 | $0 | $238 | $0 | | Research and development | $86,347 | $73,406 | $169,081 | $141,706 | | Selling, general and administrative | $21,927 | $26,328 | $50,049 | $49,741 | | Loss from operations | ($110,086) | ($99,734) | ($220,942) | ($191,447) | | Net Loss | ($106,528) | ($99,349) | ($213,898) | ($190,956) | | Net Loss Per Share | ($0.47) | ($0.63) | ($0.98) | ($1.21) | Condensed Consolidated Statements of Cash Flows Highlights (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | ($193,767) | ($151,437) | | Net cash (used in) provided by investing activities | ($3,383) | $182,279 | | Net cash provided by (used in) financing activities | $259,197 | ($650) | | Net increase in cash, cash equivalents and restricted cash | $58,279 | $30,192 | [Note 1: General Organization, Business and Liquidity](index=15&type=section&id=NOTE%201.%20GENERAL%20ORGANIZATION%2C%20BUSINESS%20AND%20LIQUIDITY) This note details the company's core business, strategic developments, and assessment of its liquidity position - The company is a biopharmaceutical firm focused on developing and delivering tumor-infiltrating lymphocyte (TIL) therapies for solid tumor cancers. Its lead product candidate is lifileucel for advanced melanoma[32](index=32&type=chunk) - In **May 2023**, the company acquired the worldwide rights to Proleukin® (aldesleukin), a commercialized IL-2 product, to secure its supply chain and create a new revenue source[32](index=32&type=chunk) - The FDA accepted the Biologics License Application (BLA) for lifileucel in advanced melanoma in **May 2023**, granted it Priority Review, and set a PDUFA target action date of **November 25, 2023**[33](index=33&type=chunk) - As of **June 30, 2023**, the company had **$317.3 million** in cash, cash equivalents, investments, and restricted cash. Management believes it has sufficient capital to fund operations for at least the next twelve months, including proceeds from a **July 2023** public offering[37](index=37&type=chunk)[38](index=38&type=chunk) [Note 4: Proleukin® Acquisition](index=26&type=section&id=NOTE%204.%20PROLEUKIN%C2%AE%20ACQUISITION) This note describes the financial details and accounting treatment of the Proleukin® acquisition - On **May 18, 2023**, the company completed the acquisition of the worldwide rights to Proleukin® from Clinigen for an upfront payment of **£166.9 million** (approx. **$207.2 million**) plus inventory costs[81](index=81&type=chunk)[82](index=82&type=chunk) - The transaction was accounted for as an asset acquisition, with the total cost of **$222.7 million** allocated primarily to developed technology (**$232.7 million**) and inventory (**$9.7 million**), offset by a deferred tax liability (**$20.4 million**)[83](index=83&type=chunk)[84](index=84&type=chunk) - The agreement includes a potential milestone payment of **£41.7 million** (approx. **$50.0 million**) upon the first approval of lifileucel in advanced melanoma, as well as future sales-based deferred consideration and earnout payments[84](index=84&type=chunk) [Note 10: Stockholders' Equity](index=30&type=section&id=NOTE%2010.%20STOCKHOLDERS%27%20EQUITY) This note outlines changes in stockholders' equity, including capital raises and stock-based compensation - During the **six months ended June 30, 2023**, the company received approximately **$260.1 million** in net proceeds from the sale of **36,080,226 shares** through its "at the market" (ATM) offering program at a weighted average price of **$7.35 per share**[103](index=103&type=chunk) - In **June 2023**, stockholders approved an amendment to the 2018 Equity Incentive Plan, increasing the number of shares available for issuance from **20.7 million** to **29.7 million**[113](index=113&type=chunk) - Stock-based compensation expense was **$16.7 million** for **Q2 2023** and **$32.4 million** for the **six months ended June 30, 2023**, a decrease from **$22.5 million** and **$44.7 million** in the respective prior-year periods[129](index=129&type=chunk) [Note 13: Legal Proceedings](index=47&type=section&id=NOTE%2013.%20LEGAL%20PROCEEDINGS) This note provides an overview of the company's ongoing legal disputes and related developments - The company is involved in a stockholder derivative complaint filed in December 2020, alleging excessive compensation for certain non-executive directors. A proposed settlement has been submitted to the court[165](index=165&type=chunk) - Two lawsuits filed by Solomon Capital, LLC and related plaintiffs are ongoing, alleging breach of contract and other claims related to financing activities in 2012. The company is vigorously defending these claims and has asserted counterclaims[166](index=166&type=chunk)[171](index=171&type=chunk)[172](index=172&type=chunk) [Note 15: Subsequent Events](index=51&type=section&id=NOTE%2015.%20SUBSEQUENT%20EVENTS) This note discloses significant events that occurred after the reporting period, impacting the company's financial position - On **July 13, 2023**, the company closed a public offering of **23,000,000 shares** of its common stock at **$7.50 per share**, generating estimated net proceeds of approximately **$161.4 million**[179](index=179&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. It details the business strategy, focusing on the development of TIL therapies and the recent acquisition of Proleukin®. The discussion covers the progress of key clinical trials, an analysis of financial results for the three and six months ended June 30, 2023, compared to the prior year, and an assessment of liquidity and capital resources [Overview and Clinical Development](index=33&type=section&id=Overview%20and%20Clinical%20Development) This section outlines the company's strategic focus, lead product candidates, and progress in key clinical trials - The company's lead product candidate, lifileucel, is under FDA review for advanced melanoma, with a PDUFA target action date of **November 25, 2023**. A Phase 3 confirmatory trial, TILVANCE-301, is underway in frontline advanced melanoma[183](index=183&type=chunk) - Registrational strategies are being pursued for lifileucel in advanced cervical cancer and for TIL therapy LN-145 in metastatic non-small cell lung cancer (NSCLC)[184](index=184&type=chunk) - Preliminary analysis of the IOV-LUN-202 trial in **23 NSCLC patients** showed an objective response rate of **26.1%**. The company plans to enroll a total of approximately **120 patients** in this registrational trial[191](index=191&type=chunk) - The company is advancing next-generation approaches, including its first genetically modified TIL therapy (IOV-4001), a shorter manufacturing process, and a novel IL-2 analog (IOV-3001)[184](index=184&type=chunk)[192](index=192&type=chunk) [Results of Operations](index=38&type=section&id=Results%20of%20Operations) This section analyzes the company's revenues, costs, and net loss for the current and prior reporting periods Comparison of Costs and Expenses (in thousands) | Expense Category | Three Months Ended June 30, 2023 | Three Months Ended June 30, 2022 | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :--- | :--- | :--- | :--- | :--- | | Revenue | $238 | $0 | $238 | $0 | | Cost of sales | $2,050 | $0 | $2,050 | $0 | | Research and development | $86,347 | $73,406 | $169,081 | $141,706 | | Selling, general and administrative | $21,927 | $26,328 | $50,049 | $49,741 | - **Revenue & Cost of Sales:** The company recorded its first product revenue of **$0.2 million** and cost of sales of **$2.1 million** in **Q2 2023**, following the acquisition of Proleukin® in **May 2023**[227](index=227&type=chunk)[229](index=229&type=chunk) - **R&D Expense Increase:** R&D expenses rose by **18%** in **Q2 2023** YoY, primarily due to increased payroll from hiring, higher clinical trial costs for the Phase 3 TILVANCE-301 trial, and increased manufacturing costs related to commercial readiness activities at the iCTC facility[231](index=231&type=chunk) - **SG&A Expense Decrease:** SG&A expenses decreased by **17%** in **Q2 2023** YoY, mainly due to a **$4.2 million** decrease in legal fees (as some costs were capitalized for the Proleukin acquisition) and a **$1.2 million** decrease in stock-based compensation[233](index=233&type=chunk) - **Net Loss Increase:** Net loss increased to **$106.5 million** in **Q2 2023** from **$99.3 million** in **Q2 2022**, driven by the expansion of R&D activities, clinical trials, and pre-commercialization efforts for lifileucel[237](index=237&type=chunk) [Liquidity and Capital Resources](index=41&type=section&id=Liquidity%20and%20Capital%20Resources) This section assesses the company's cash position, funding sources, and ability to meet its operational and capital needs - The company has historically funded operations through equity offerings. It began generating revenue from Proleukin® sales in **Q2 2023** but does not expect material revenue in the next 12 months[238](index=238&type=chunk) - Management believes existing capital, including the **$161.4 million** net proceeds from the **July 2023** public offering, is sufficient to fund operations and capital expenditures for at least the next twelve months[238](index=238&type=chunk) - Net cash used in operating activities increased to **$193.8 million** for the **six months ended June 30, 2023**, up from **$151.4 million** in the prior-year period, due to higher net loss and increased operational activities[244](index=244&type=chunk) - Net cash provided by financing activities was **$259.2 million** for the first **six months of 2023**, primarily from **$260.1 million** in net proceeds from the "at the market" offering program[247](index=247&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=43&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section outlines the company's exposure to market risks, primarily interest rate risk and foreign currency exchange risk. Interest rate risk is considered minimal due to the investment portfolio's focus on short-term U.S. government securities. Foreign currency risk has increased following the acquisition of Proleukin®, with exposure mainly to the Great Britain Pound - Interest rate risk is limited as a significant portion of investments are in short-term U.S. government debt securities, with the primary objective being principal preservation[252](index=252&type=chunk) - Foreign currency exchange risk has emerged following the Proleukin® acquisition due to foreign subsidiaries and sales denominated in foreign currencies. The most significant exposure is to the Great Britain Pound[255](index=255&type=chunk) [Item 4. Controls and Procedures](index=44&type=section&id=Item%204.%20Controls%20and%20Procedures) This section provides management's conclusion on the effectiveness of the company's disclosure controls and procedures. As of June 30, 2023, these controls were deemed effective. It also notes that internal controls were implemented during the quarter related to the Proleukin® acquisition - Management, including the principal executive and financial officers, concluded that the company's disclosure controls and procedures were effective as of **June 30, 2023**[257](index=257&type=chunk) - During the quarter, the company implemented new internal controls over financial reporting related to revenue and inventory processes resulting from the Proleukin® acquisition[258](index=258&type=chunk) PART II OTHER INFORMATION This part covers legal proceedings, comprehensive risk factors, and other required disclosures [Item 1. Legal Proceedings](index=45&type=section&id=Item%201.%20Legal%20Proceedings) This section incorporates by reference the information on legal proceedings from Note 13 of the Condensed Consolidated Financial Statements, which details ongoing litigation, including a stockholder derivative lawsuit and two lawsuits from Solomon Capital, LLC - The company incorporates information on legal proceedings from Note 13 of the financial statements, which details the Shumacher derivative lawsuit and the Solomon Capital lawsuits[260](index=260&type=chunk) [Item 1A. Risk Factors](index=45&type=section&id=Item%201A.%20Risk%20Factors) This section provides a comprehensive discussion of the risks and uncertainties that could materially affect the company's business, financial condition, and results of operations. The risks are categorized into those related to the business, government regulation, intellectual property, and the company's securities [Risks Related to Our Business](index=46&type=section&id=Risks%20Related%20to%20Our%20Business) This section details risks inherent to the company's operations, product development, manufacturing, and financial sustainability - The company is substantially dependent on the success of its product candidates, particularly lifileucel, and cannot guarantee they will receive regulatory approval or be successfully commercialized[273](index=273&type=chunk) - Manufacturing of TIL therapies is complex and susceptible to product loss, contamination, and scalability issues. Difficulties with the Gen 2 manufacturing process or potency assays could delay or prevent BLA approval[332](index=332&type=chunk)[334](index=334&type=chunk) - The company may need additional financing to fund operations and commercialization. As of **June 30, 2023**, the company had an accumulated deficit of **$1.8 billion**[356](index=356&type=chunk)[269](index=269&type=chunk) - The business faces significant competition from other biotechnology companies developing advanced T-cell therapies, immunotherapies, and novel IL-2 treatments[390](index=390&type=chunk)[392](index=392&type=chunk) [Risks Related to Government Regulation](index=79&type=section&id=Risks%20Related%20to%20Government%20Regulation) This section discusses regulatory challenges, approval processes, and compliance requirements affecting the company's products - The FDA regulatory approval process is lengthy, time-consuming, and uncertain. The BLA for lifileucel was accepted with a PDUFA date of **November 25, 2023**, but approval is not guaranteed[470](index=470&type=chunk) - Even if approved, products will be subject to ongoing regulatory obligations, including potential post-marketing studies (like the TILVANCE-301 confirmatory trial) and REMS, which can be costly and limit commercial prospects[414](index=414&type=chunk)[479](index=479&type=chunk) - Coverage and reimbursement from third-party payors (government and private) are critical for commercial success but may be limited or unavailable, making it difficult to sell products profitably[498](index=498&type=chunk) [Risks Related to Our Intellectual Property](index=87&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) This section addresses risks related to protecting and enforcing the company's patents and intellectual property rights - The company may be involved in expensive and time-consuming lawsuits to protect its patents or defend against infringement claims, and an adverse result could invalidate or narrow the scope of its patent protection[523](index=523&type=chunk) - Patent law in the biotechnology field is complex and evolving, creating uncertainty about the strength and enforceability of the company's licensed and owned patents[530](index=530&type=chunk) - The company has limited foreign intellectual property rights, which may not be sufficient to prevent competitors from practicing its inventions or selling competing products in markets outside the U.S[541](index=541&type=chunk) [Risks Related to Our Securities](index=91&type=section&id=Risks%20Related%20to%20Our%20Securities) This section highlights factors that could impact the market price and liquidity of the company's common stock - The market price of the company's common stock is likely to be volatile due to factors such as clinical trial results, regulatory developments, and market conditions[546](index=546&type=chunk) - Future sales of common stock, including under the ATM program or other offerings, could cause the stock price to fall and result in substantial dilution to existing stockholders[547](index=547&type=chunk) - Provisions in the company's charter documents and Delaware law could discourage or prevent a change in control, potentially limiting the stock price[561](index=561&type=chunk) [Other Items (Items 2, 3, 4, 5, 6)](index=94&type=section&id=Other%20Items) This concluding section of the report confirms that there were no unregistered sales of securities, defaults upon senior securities, or mine safety disclosures during the period. It also states that no directors or executive officers adopted or terminated a Rule 10b5-1 trading plan in the second quarter of 2023. The section concludes with an index of exhibits filed with the report - There were no unregistered sales of securities, defaults upon senior securities, or mine safety disclosures to report for the period[569](index=569&type=chunk)[570](index=570&type=chunk)[571](index=571&type=chunk) - During the **second quarter of 2023**, no directors or executive officers adopted or terminated a Rule 10b5-1 trading plan or a non-Rule 10b5-1 trading arrangement[572](index=572&type=chunk)

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 ...