SEC Filings

Form 10-K
IOVANCE BIOTHERAPEUTICS, INC. filed this Form 10-K on 02/28/2019
Document Outline
Entire Document (6948 KB)
Subdocument 1 - 10-K - 10-K
Page 1 - UNITED STATES
Page 2 - TABLE OF CONTENTS
Page 3 - Forward-Looking Statements and Market Data
Page 4 - PART I
Page 5 - 2018 Developments
Page 6 - Corporate Strategy
Page 7 - Continue to improve our TIL manufacturing process and develop new TIL manufacturing technology to be
Page 8 - Lifileucel for Metastatic Melanoma
Page 9 - LN-145 for Head and Neck Cancer
Page 10 - Tumor-infiltrating lymphocytes
Page 11 - Overall Survival of patients in TIL TBI study
Page 12 - Next Generation TIL Product Strategies
Page 13 - WuXi AppTec
Page 14 - Research, Development and License Agreements
Page 15 - H. Lee Moffitt Cancer Center
Page 16 - M.D. Anderson Cancer Center
Page 17 - Government Regulations
Page 18 - N/A
Page 19 - N/A
Page 20 - BLA Submission and Review by the FDA
Page 21 - Orphan Drugs
Page 22 - Market and Data Exclusivity and Biosimilars
Page 23 - Post-Approval Requirements
Page 24 - Other Healthcare Laws and Compliance Requirements
Page 25 - N/A
Page 26 - Coverage and Reimbursement
Page 27 - Healthcare Reform
Page 28 - Foreign Regulation
Page 29 - We are substantially dependent on the success of our product candidates and cannot guarantee that th
Page 30 - N/A
Page 31 - We may encounter substantial delays in our clinical trials or may not be able to conduct our trials
Page 32 - It may take longer and cost more to complete our clinical trials than we project, or we may not be a
Page 33 - Clinical trials are expensive, time-consuming and difficult to design and implement, and our clinica
Page 34 - If we encounter difficulties enrolling patients in our clinical trials, our clinical development act
Page 35 - Our product candidates may cause undesirable side effects or have other properties that could halt t
Page 36 - N/A
Page 37 - Cell-based therapies rely on the availability of reagents, specialized equipment, and other specialt
Page 38 - The deviations in our proposed new products from existing products may require us to perform additio
Page 39 - We will need additional financing to fund our operations and complete the development and commercial
Page 40 - Subject to various spending levels approved by the Board of Directors, our management will have broa
Page 41 - We may not be able to license new TIL technology from the NIH and others.
Page 42 - No assurance can be given that the Gen 2 manufacturing process we have selected will be FDA-complian
Page 43 - We face significant competition from other biotechnology and pharmaceutical companies and from non-p
Page 44 - We are dependent on third parties to support our research, development and manufacturing activities
Page 45 - Development of a product candidate intended for use in combination with an already approved product
Page 46 - As a condition of approval, the FDA may require that we implement various post-marketing requirement
Page 47 - If our product candidates do not achieve broad market acceptance, the revenues that we generate from
Page 48 - We will need to obtain FDA approval of any proposed branded product names, and any failure or delay
Page 49 - We will need to grow the size and capabilities of our organization, and we may experience difficulti
Page 50 - We may rely on third parties to perform many essential services for any products that we commerciali
Page 51 - Risks Related to Government Regulation
Page 52 - We are, and if we receive regulatory approval of our product candidates, will continue to be subject
Page 53 - If we fail to comply with federal and state healthcare and promotional laws, including fraud and abu
Page 54 - Coverage and reimbursement may be limited or unavailable in certain market segments for our product
Page 55 - We are subject to new legislation, regulatory proposals, and healthcare payor initiatives that may i
Page 56 - Governments outside the United States tend to impose strict price controls, which may adversely affe
Page 57 - Risks Related to Our Intellectual Property
Page 58 - Issued patents covering our product candidates could be found invalid or unenforceable if challenged
Page 59 - The use of our technologies could potentially conflict with the rights of others.
Page 60 - Risks Related to Our Securities
Page 61 - If we fail to maintain an effective system of internal control over financial reporting, we may not
Page 62 - We may be subject to claims for rescission or damages in connection with certain sales of shares of
Page 63 - N/A
Page 64 - PART II
Page 65 - Dividends
Page 66 - Overview
Page 67 - N/A
Page 68 - Financial Overview
Page 69 - Interest Income (in thousands)
Page 70 - Interest Income (in thousands)
Page 71 - N/A
Page 72 - Significant Accounting Policies and Recent Accounting Standards
Page 73 - N/A
Page 74 - PART III
Page 75 - N/A
Page 76 - N/A
Page 77 - SIGNATURES
Page 78 - IOVANCE BIOTHERAPEUTICS, INC.
Page 79 - Opinion on the Financial Statements
Page 80 - Opinion on Internal Control over Financial Reporting
Page 81 - IOVANCE BIOTHERAPEUTICS, INC.
Page 82 - IOVANCE BIOTHERAPEUTICS, INC.
Page 83 - IOVANCE BIOTHERAPEUTICS, INC.
Page 84 - IOVANCE BIOTHERAPEUTICS, INC.
Page 85 - IOVANCE BIOTHERAPEUTICS, INC.
Page 86 - NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Page 87 - NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Page 88 - NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Page 89 - NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Page 90 - NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Page 91 - NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Page 92 - NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Page 93 - NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Page 94 - NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Page 95 - NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Page 96 - NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Page 97 - NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Page 98 - NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Page 99 - NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Page 100 - NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Page 101 - NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Page 102 - NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Page 103 - NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Page 104 - NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Page 105 - NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Page 106 - NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Subdocument 2 - EX-23.1 - EXHIBIT 23.1
Page 1 - N/A
Subdocument 3 - EX-31.1 - EXHIBIT 31.1
Page 1 - N/A
Subdocument 4 - EX-31.2 - EXHIBIT 31.2
Page 1 - N/A
Subdocument 5 - EX-32.1 - EXHIBIT 32.1
Page 1 - N/A
Subdocument 6 - EX-32.2 - EXHIBIT 32.2
Page 1 - N/A
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