SEC Filings

Form 10-Q
IOVANCE BIOTHERAPEUTICS, INC. filed this Form 10-Q on 11/06/2018
Document Outline
Entire Document (3782.9 KB)
Subdocument 1 - 10-Q - FORM 10-Q
Page 1 - U. S. SECURITIES AND EXCHANGE COMMISSION
Page 2 - IOVANCE BIOTHERAPEUTICS, INC.
Page 3 - PART I. FINANCIAL INFORMATION
Page 4 - IOVANCE BIOTHERAPEUTICS, INC.
Page 5 - IOVANCE BIOTHERAPEUTICS, INC.
Page 6 - IOVANCE BIOTHERAPEUTICS, INC.
Page 7 - IOVANCE BIOTHERAPEUTICS, INC.
Page 8 - Concentrations of Risk
Page 9 - Use of Estimates
Page 10 - Preferred Stock
Page 11 - Recent Accounting Standards Not Yet Adopted
Page 12 - NOTE 4. BALANCE SHEET COMPONENTS
Page 13 - Warrants
Page 14 - NOTE 6. STOCK BASED COMPENSATION
Page 15 - NOTE 7. LICENSES AND AGREEMENTS
Page 16 - H. Lee Moffitt Cancer Center
Page 17 - PolyBioCept and Karolinska University Hospital
Page 18 - WuXi Apptech, Inc. ( WuXi )
Page 19 - N/A
Page 20 - NOTE 9. COMMITMENTS AND CONTINGENCIES
Page 21 - NOTE 10. RELATED PARTY TRANSACTIONS
Page 22 - Forward-Looking Statements
Page 23 - N/A
Page 24 - Results of Operations
Page 25 - N/A
Page 26 - Liquidity and Capital Resources
Page 27 - Off-Balance Sheet Arrangements
Page 28 - PART II. OTHER INFORMATION
Page 29 - N/A
Page 30 - Risks Related to Our Business
Page 31 - We have limited experience as a company conducting clinical trials and face risks due to the need to
Page 32 - N/A
Page 33 - We may encounter substantial delays in our clinical trials or may not be able to conduct our trials
Page 34 - N/A
Page 35 - It may take longer and cost more to complete our clinical trials than we project, or we may not be a
Page 36 - Our clinical trials may fail to demonstrate adequately the safety and efficacy of our product candid
Page 37 - Our product candidates may cause undesirable side effects or have other properties that could halt t
Page 38 - The manufacture of our product candidates is complex, and we may encounter difficulties in productio
Page 39 - N/A
Page 40 - Cell-based therapies rely on the availability of reagents, specialized equipment, and other specialt
Page 41 - Our historical research and development efforts have been to a large extent dependent upon the CRADA
Page 42 - We will need additional financing to fund our operations and complete the development and commercial
Page 43 - Subject to various spending levels approved by the Board of Directors, our management will have broa
Page 44 - We are subject to extensive regulation, which can be costly, time consuming and can subject us to un
Page 45 - We are required to pay substantial royalties and lump sum benchmark payments under our license agree
Page 46 - No assurance can be given that the Gen 2 manufacturing process we have selected will be FDA-complian
Page 47 - We are dependent on third parties to support our research, development and manufacturing activities
Page 48 - N/A
Page 49 - Development of a product candidate intended for use in combination with an already approved product
Page 50 - As a condition of approval, the FDA may require that we implement various post-marketing requirement
Page 51 - Our product candidates may face competition sooner than anticipated.
Page 52 - We will need to obtain FDA approval of any proposed product names, and any failure or delay associat
Page 53 - We will need to grow the size and capabilities of our organization, and we may experience difficulti
Page 54 - We may rely on third parties to perform many essential services for any products that we commerciali
Page 55 - We are, and in the future may be, subject to Federal or state securities or related legal actions th
Page 56 - Obtaining and maintaining regulatory approval of our product candidates in one jurisdiction does not
Page 57 - If we fail to comply with federal and state healthcare and promotional laws, including fraud and abu
Page 58 - Coverage and reimbursement may be limited or unavailable in certain market segments for our product
Page 59 - N/A
Page 60 - We are subject to new legislation, regulatory proposals, and healthcare payor initiatives that may i
Page 61 - Governments outside the United States tend to impose strict price controls, which may adversely affe
Page 62 - Risks Related to Our Intellectual Property
Page 63 - We cannot prevent other companies from licensing most of the same intellectual properties that we ha
Page 64 - Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our abi
Page 65 - You may experience future dilution as a result of future equity offerings or other equity issuances.
Page 66 - If we fail to maintain an effective system of internal control over financial reporting, we may not
Page 67 - Our certificate of incorporation designates the state or federal courts located in the State of Dela
Page 68 - N/A
Page 69 - SIGNATURES
Subdocument 2 - EX-31.1 - EXHIBIT 31.1
Page 1 - N/A
Subdocument 3 - EX-31.2 - EXHIBIT 31.2
Page 1 - N/A
Subdocument 4 - EX-32.1 - EXHIBIT 32.1
Page 1 - N/A
Subdocument 5 - EX-32.2 - EXHIBIT 32.2
Page 1 - N/A
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