IOVANCE BIOTHERAPEUTICS, INC. Files 2023 10-K

TL;DR

<b>IOVANCE BIOTHERAPEUTICS, INC. filed its annual 10-K report for the fiscal year ending December 31, 2023.</b>

AI Summary

IOVANCE BIOTHERAPEUTICS, INC. (IOVA) filed a Annual Report (10-K) with the SEC on February 28, 2024. IOVA filed its 2023 10-K on February 28, 2024. The company's fiscal year ends on December 31. IOVA was formerly known as Lion Biotechnologies, Inc. The company is incorporated in Delaware. IOVA's business address is 825 Industrial Road, 4th Floor, San Carlos, CA 94070.

Why It Matters

For investors and stakeholders tracking IOVANCE BIOTHERAPEUTICS, INC., this filing contains several important signals. This 10-K filing provides a comprehensive overview of IOVA's financial performance, business operations, and risk factors for the fiscal year 2023. Investors and stakeholders can use this report to assess the company's financial health, strategic direction, and potential future performance.

Risk Assessment

Risk Level: medium — IOVANCE BIOTHERAPEUTICS, INC. shows moderate risk based on this filing. The company is in the biotechnology sector, which is inherently risky due to long development cycles, high R&D costs, and regulatory hurdles. Specific financial performance data is not yet available in this header information.

Analyst Insight

Review the full 10-K filing to understand IOVA's financial health, operational performance, and strategic outlook for 2024.

Key Numbers

• 2023-12-31 — Fiscal Year End (Conformed period of report)
• 2024-02-28 — Filing Date (Conformed submission type)
• 101 — Public Document Count (Conformed submission type)
• 001-36860 — SEC File Number (Filing values)

Key Players & Entities

• IOVANCE BIOTHERAPEUTICS, INC. (company) — Filer name
• IOVA (company) — Ticker symbol
• Lion Biotechnologies, Inc. (company) — Former company name
• Genesis Biopharma, Inc (company) — Former company name
• FREIGHT MANAGEMENT CORP (company) — Former company name
• DE (company) — State of incorporation
• San Carlos, CA (company) — Business address city and state
• 2024-02-28 (date) — Filing date

FAQ

Industry Context

IOVANCE BIOTHERAPEUTICS, INC. operates in the biotechnology sector, focusing on the development of cell therapies for cancer treatment.

Regulatory Implications

As a biotechnology company, IOVA is subject to stringent regulatory oversight from bodies like the FDA regarding drug development, clinical trials, and market approval.

What Investors Should Do

1. Analyze the financial statements within the 10-K for revenue, expenses, and cash flow.
2. Review the 'Risk Factors' section for potential challenges and uncertainties facing the company.
3. Examine management's discussion and analysis (MD&A) for insights into business strategy and outlook.

Key Dates

• 2023-12-31: Fiscal Year End — Marks the end of the reporting period for the 10-K.
• 2024-02-28: Filing Date — Date the 10-K was officially filed with the SEC.

Year-Over-Year Comparison

This is the initial header information for the 2023 10-K filing; a comparison to the prior year's filing would require access to the full document.

Key Financial Figures

• $0.000041666 — ch registered Common stock, par value $0.000041666 per value IOVA The Nasdaq Stock Marke

Filing Documents

• iova-20231231x10k.htm (10-K) — 3081KB
• iova-20231231xex19d1.htm (EX-19.1) — 101KB
• iova-20231231xex21d1.htm (EX-21.1) — 3KB
• iova-20231231xex23d1.htm (EX-23.1) — 11KB
• iova-20231231xex31d1.htm (EX-31.1) — 11KB
• iova-20231231xex31d2.htm (EX-31.2) — 11KB
• iova-20231231xex32d1.htm (EX-32.1) — 6KB
• iova-20231231xex32d2.htm (EX-32.2) — 6KB
• iova-20231231xex97d1.htm (EX-97.1) — 24KB
• iova-20231231x10k001.jpg (GRAPHIC) — 70KB
• iova-20231231xex19d1001.jpg (GRAPHIC) — 18KB
• 0001558370-24-002036.txt (&nbsp;) — 11370KB
• iova-20231231.xsd (EX-101.SCH) — 66KB
• iova-20231231_cal.xml (EX-101.CAL) — 66KB
• iova-20231231_def.xml (EX-101.DEF) — 300KB
• iova-20231231_lab.xml (EX-101.LAB) — 523KB
• iova-20231231_pre.xml (EX-101.PRE) — 475KB
• iova-20231231x10k_htm.xml (XML) — 1856KB

Business

Business 4 Item 1A.

Risk Factors

Risk Factors 32 Item 1B. Unresolved Staff Comments 83 Item 1C. Cybersecurity 83 Item 2.

Properties

Properties 84 Item 3.

Legal Proceedings

Legal Proceedings 85 Item 4. Mine Safety Disclosures 86 PART II 86 Item 5. Market for Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 86 Item 6. [Reserved] 87 Item 7.

Management's Discussion and Analysis of Financial Condition and Results of Operations

Management's Discussion and Analysis of Financial Condition and Results of Operations 87 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 102 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 103 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 103 Item 9A.

Controls and Procedures

Controls and Procedures 103 Item 9B. Other Information 104 PART III 104 Item 10. Directors, Executive Officers and Corporate Governance 104 Item 11.

Executive Compensation

Executive Compensation 104 Item 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 104 Item 13. Certain Relationships and Related Transactions, and Director Independence 105 Item 14. Principal Accounting Fees and Services 105 PART IV 105 Item 15. Exhibits, Financial Statements Schedules 105 Item 16. 10-K Summary 108

Signatures

Signatures 109 2 Table of Contents

Forward-Looking Statements and Market Data

Forward-Looking Statements and Market Data This Annual Report on Form 10-K contains forward-looking statements that are based on management's beliefs and assumptions and on information currently available to management. All statements other than statements of historical facts contained in this report are forward-looking statements. In some cases, you can identify forward-looking statements by the following words: "may," "will," "might," "could," "would," "should," "expect," "intend," "plan," "anticipate," "believe," "estimate," "predict," "project," "aim," "potential," "continue," "ongoing," "goal," "forecast," "guidance," "outlook," or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this report, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. Forward-looking statements in this Annual Report on Form 10-K include, but are not limited to, statements about: the success, cost, enrollment, and timing of our clinical trials; the success, cost, and timing of our product development activities; the ability of us or our third-party contract manufacturers to continue to manufacture tumor infiltrating lymphocytes, or TIL, in accordance with our selected process; our ability to design, construct and staff our own manufacturing facility on a timely basis and within the estimated expenses; the success of competing therapies that are or may become available; regulatory developments in the United States of America, or U.S., and fo

Business

Item 1. Business Overview We are a commercial-stage biopharmaceutical company pioneering a transformational approach to treating cancer by harnessing the human immune system's ability to recognize and destroy diverse cancer cells using therapies personalized for each patient. Our mission is to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte, or TIL, cell therapies for patients with solid tumor cancers. With the recent approval of our biologics license application, or BLA, we are executing the U.S. launch of Amtagvi (lifileucel), the first product within our autologous TIL cell therapy platform, while also marketing Proleukin (aldesleukin), an interleukin-2, or IL-2, product used in the Amtagvi treatment regimen. Amtagvi is a tumor-derived autologous T cell immunotherapy indicated for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor. This indication is approved under accelerated approval based on an endpoint of overall response rate, or ORR. Continued approval for this indication may be contingent upon verification and description of clinical benefit in future confirmatory trials. Amtagvi is the first and the only one-time, individualized T cell therapy to receive FDA approval for a solid tumor cancer. Amtagvi and Proleukin are part of a treatment regimen that also includes lymphodepletion. Iovance was founded to build upon the promise of TIL cell therapy that was previously demonstrated in single-center clinical trials at academic centers, including the National Cancer Institute, or the NCI. Our multi-center trials, novel TIL products, manufacturing processes, facilities, and bioanalytical platforms have transformed TIL cell therapy into a commercially viable treatment, which many more patients with cancer can access. We manufacture Amtagvi and our investigati

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View this 10-K filing on SEC EDGAR