Form 10-K
VACCINEX, INC. filed this Form 10-K on 03/13/2019
Document Outline
Entire Document (6092.9 KB)
Subdocument 1 - 10-K - 10-K
Page 1 - UNITED STATES
Page 2 - SPECIAL NOTE REGARDING FORWARD LOOKING STATEMENTS
Page 3 - Table of Contents
Page 4 - PART I
Page 5 - Vaccinex Product Pipeline
Page 6 - Huntington s Disease
Page 7 - N/A
Page 8 - Background on the Immune System and Antibodies
Page 9 - Our SEMA4D Antibody Platform
Page 10 - UCLA Jonsson Comprehensive Cancer Center
Page 11 - The Role of SEMA4D in Cancer
Page 12 - Figure 2. Pepinemab Breaks Down SEMA4D Barrier in Colon26 Tumor
Page 13 - Figure 4. Anti-SEMA4D Antibody Enhances Tumor-specific Cytotoxic TIL
Page 14 - Figure 6. Anti-SEMA4D Treatment Shifts the Balance of Cytokines and Chemokines in the Tumor Microenv
Page 15 - Single agent treatments (anti-SEMA4D and anti-CTLA-4) induce a modest inhibition of tumor growth but
Page 16 - Our Approach to a Combination Therapy in Cancer
Page 17 - Figure 8. Treatment of PLXNB1 and ErbB-2 Double Positive Mammary Carcinoma with Anti-SEMA4D Delays T
Page 18 - Completed Phase 1 Clinical Trials
Page 19 - Osteosarcoma
Page 20 - The Role of SEMA4D in Neurodegenerative Disease
Page 21 - The Unmet Medical Need for Huntington s Disease
Page 22 - Our Approach to Huntington s Disease
Page 23 - Figure 12. Pepinemab Treatment Significantly Inhibits Cortical and Corpus Callosum Degeneration in B
Page 24 - Figure 13. Pepinemab May Improve Spatial Memory in the YAC128 Mouse Model
Page 25 - Figure 14. MRI: Mean Change from Baseline in Regions of Frontal and Parietal Cortex
Page 26 - Figure 15. FDG-PET: Mean Change from Baseline in Regions of Frontal and Parietal Cortex
Page 27 - Our Approach to Antibody Discovery
Page 28 - Discovery Collaborations with Third Parties
Page 29 - Our NKT Vaccine Platform
Page 30 - Commercialization
Page 31 - SEMA4D Antibody Platform and Pepinemab
Page 32 - ActivMAb Antibody Discovery Platform
Page 33 - e.g.
Page 34 - Trade Secret Protection
Page 35 - Preclinical Testing.
Page 36 - The BLA Process
Page 37 - Postmarketing Commitments.
Page 38 - Advertising and Promotion.
Page 39 - Federal and State Fraud and Abuse and Data Privacy and Security Laws and Regulations
Page 40 - N/A
Page 41 - Healthcare Reform
Page 42 - Regulation Outside of the United States
Page 43 - N/A
Page 44 - VX3
Page 45 - Item 1A. Risk Factors.
Page 46 - We will require additional capital to finance our operations prior to the commencement of the fourth
Page 47 - We may have higher than anticipated tax liabilities, including related to our ability to use net ope
Page 48 - If we experience delays in clinical testing, we will be delayed in obtaining approval of our product
Page 49 - We may not successfully identify, develop or commercialize potential product candidates.
Page 50 - We may be required to suspend, repeat or terminate our clinical trials if they are not conducted in
Page 51 - Even if our product candidates receive regulatory approval, they may still face future development a
Page 52 - One of the indications we are pursuing for our lead product candidate pepinemab is for the treatment
Page 53 - Our failure to obtain regulatory approval in international jurisdictions would prevent us from marke
Page 54 - We may not be able to achieve the benefits or synergistic effects of pepinemab in combination with o
Page 55 - We may need to develop or obtain additional capabilities, or enter into arrangements with third part
Page 56 - Current and future legislation may increase the difficulty and cost for commercialization of our pro
Page 57 - If we are able to successfully commercialize any of our product candidates and if we participate in
Page 58 - Our relationships with customers and third-party payors will be subject to applicable anti-kickback,
Page 59 - Our internal computer systems, or those used by our CROs or other contractors or consultants, may fa
Page 60 - Risks Related to our Dependence on Third Parties
Page 61 - We may not succeed in establishing and maintaining additional collaborations, which could adversely
Page 62 - Risks Related to Intellectual Property
Page 63 - We may not be able to protect our intellectual property rights throughout the world.
Page 64 - Obtaining and maintaining our patent rights depends on compliance with various different procedural,
Page 65 - Third parties may initiate legal proceedings against us alleging that we infringe their intellectual
Page 66 - Risks Related to Our Securities
Page 67 - If securities or industry analysts do not publish research or publish inaccurate or unfavorable rese
Page 68 - Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud.
Page 69 - Item 1B. Unresolved Staff Comments.
Page 70 - PART II
Page 71 - Item 7. Management s Discussion and Analysis of Financial Condition and Results of Operations.
Page 72 - Operating Expenses
Page 73 - Results of Operations
Page 74 - Interest Expense
Page 75 - Cash Flows
Page 76 - Capital Contributions from Noncontrolling Interests
Page 77 - Recently Adopted Accounting Pronouncements
Page 78 - PART III
Page 79 - PART IV
Page 80 - N/A
Page 81 - Item 16. Form 10-K Summary.
Page 82 - Signatures
Page 83 - INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
Page 84 - REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
Page 85 - VACCINEX, INC.
Page 86 - VACCINEX, INC.
Page 87 - VACCINEX, INC.
Page 88 - VACCINEX, INC.
Page 89 - VACCINEX, INC.
Page 90 - VACCINEX, INC.
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Page 101 - VACCINEX, INC.
Page 102 - VACCINEX, INC.
Page 103 - VACCINEX, INC.
Page 104 - VACCINEX, INC.
Page 105 - VACCINEX, INC.
Page 106 - VACCINEX, INC.
Page 107 - VACCINEX, INC.
Page 108 - VACCINEX, INC.
Subdocument 2 - EX-10.24 - EX-10.24
Page 1 - Exhibit 10.24
Page 2 - LPA
Page 3 - N/A
Page 4 - N/A
Page 5 - N/A
Page 6 - signature pages follow
Page 7 - IN WITNESS WHEREOF
Page 8 - IN WITNESS WHEREOF
Page 9 - IN WITNESS WHEREOF
Page 10 - IN WITNESS WHEREOF
Page 11 - IN WITNESS WHEREOF
Page 12 - IN WITNESS WHEREOF
Page 13 - IN WITNESS WHEREOF
Page 14 - IN WITNESS WHEREOF
Page 15 - IN WITNESS WHEREOF
Page 16 - IN WITNESS WHEREOF
Page 17 - IN WITNESS WHEREOF
Page 18 - SCHEDULE A
Page 19 - N/A
Page 20 - SCHEDULE B
Subdocument 3 - EX-23.1 - EX-23.1
Page 1 - N/A
Subdocument 4 - EX-31.1 - EX-31.1
Page 1 - N/A
Subdocument 5 - EX-31.2 - EX-31.2
Page 1 - N/A
Subdocument 6 - EX-32.1 - EX-32.1
Page 1 - N/A
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