Form 10-K
AERPIO PHARMACEUTICALS, INC. filed this Form 10-K on 03/07/2019
Document Outline
Entire Document (4970.3 KB)
Subdocument 1 - 10-K - 10-K
Page 1 - UNITED STATES
Page 2 - Table of Contents
Page 3 - Forward-Looking Statements
Page 4 - PART I
Page 5 - Our Strategy
Page 6 - AKB-9778 for Diabetic Retinopathy
Page 7 - Figure 2. Fundus photographs or a normal retina (left) and a retina with advanced DR (right).
Page 8 - Figure 4: Normal retina (left). Retina after panretinal laser photocoagulation (right).
Page 9 - Role of Tie2 in Diabetic Disease
Page 10 - Figure 7. Inhibiting VE-PTP with AKB-9778 robustly activates Tie2 in human endothelial cells in
Page 11 - Figure 8. Aggregate Data for Reduction in CST in Phase 2a trial in patients with DME.
Page 12 - Figure 9. Percent of patients with a 2 or more-step improvement in diabetic retinopathy from baselin
Page 13 - Ongoing Phase 2b Clinical Trial in Diabetic Retinopathy
Page 14 - Other Potential Systemic Indications
Page 15 - Emerging role of the Tie2 Pathway in the maintenance of conventional outflow:
Page 16 - Evidence Supporting Tie2 Activation as a Conventional Outflow Glaucoma Target:
Page 17 - Figure 13. IOP effects of topical ocular compared to subcutaneous AKB-9778 in male rabbits. High dos
Page 18 - Intellectual Property
Page 19 - Sales and Marketing
Page 20 - Clinical Trials
Page 21 - Submission of a BLA or NDA to the FDA
Page 22 - The FDA s Decision on a BLA or NDA
Page 23 - Post-Approval Requirements
Page 24 - Patent Term Restoration
Page 25 - Hatch-Waxman Patent Certification and the 30-Month Stay
Page 26 - Authorization Procedures in the European Union
Page 27 - New Chemical Entity Exclusivity
Page 28 - N/A
Page 29 - Other Healthcare Laws and Compliance Requirements
Page 30 - Employees
Page 31 - Item 1A. Risk Factors.
Page 32 - We will require substantial additional financing. A failure to obtain this necessary capital when ne
Page 33 - Raising additional capital may cause dilution to our existing stockholders, restrict our operations
Page 34 - Risks Related to Our Business and the Clinical Development, Regulatory Review and Approval of Produc
Page 35 - We have not obtained agreement with the FDA, EMA or other regulatory authorities on the design of ou
Page 36 - We may not be able to comply with requirements of foreign jurisdictions in conducting trials outside
Page 37 - Clinical drug development is a lengthy and expensive process with an uncertain outcome, and positive
Page 38 - Risks Related to Our Reliance on Third Parties
Page 39 - We intend to rely on third parties to conduct some or all aspects of our product manufacturing, and
Page 40 - If we are unable to manufacture our product candidates in sufficient quantities, at sufficient yield
Page 41 - Risks Related to Our Intellectual Property
Page 42 - N/A
Page 43 - Our patents covering one or more of our products or product candidates could be found invalid or une
Page 44 - Our reliance on third parties requires us to share our trade secrets, which increases the possibilit
Page 45 - Third-party claims of intellectual property infringement may be costly and time consuming, and may d
Page 46 - We may become involved in lawsuits to protect or enforce our patents or other intellectual property,
Page 47 - We may not be able to protect our intellectual property rights throughout the world.
Page 48 - If we are unable to establish sales, marketing and distribution capabilities or to enter into agreem
Page 49 - Price controls may be imposed, which may adversely affect our future profitability.
Page 50 - N/A
Page 51 - We face substantial competition, which may result in others discovering, developing or commercializi
Page 52 - Our product candidates may cause undesirable side effects or have other properties that delay or pre
Page 53 - Our employees, independent contractors, principal investigators, contract research organizations, co
Page 54 - If we fail to comply with environmental, health and safety laws and regulations, we could become sub
Page 55 - We face risks arising from the results of the public referendum held in United Kingdom and its membe
Page 56 - FINRA sales practice requirements may limit a stockholder s ability to buy and sell our stock.
Page 57 - Our principal stockholders and management own a significant percentage of our stock and will be able
Page 58 - We have broad discretion in the use of our cash and may not use them effectively.
Page 59 - Provisions in our charter documents and Delaware law may have anti-takeover effects that could disco
Page 60 - Our ability to use net operating losses to offset future taxable income may be subject to certain li
Page 61 - An active trading market for our common stock may not develop or be sustainable. If an active tradin
Page 62 - PART II
Page 63 - Item 7. Management s Discussion and Analysis of Financial Condition and Results of Operations.
Page 64 - Other Recent Developments
Page 65 - Research and Development Expenses
Page 66 - Operating Expenses
Page 67 - Operating Activities
Page 68 - Investing Activities
Page 69 - Revenue Recognition
Page 70 - Upfront License Fees:
Page 71 - Stock-Based Compensation
Page 72 - Item 7A. Quantitative and Qualitative Disclosures About Market Risk.
Page 73 - Report of Independent Registered Public Accounting Firm
Page 74 - INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
Page 75 - AERPIO PHARMACEUTICALS, INC.
Page 76 - AERPIO PHARMACEUTICALS, INC.
Page 77 - AERPIO PHARMACEUTICALS, INC.
Page 78 - AERPIO PHARMACEUTICALS, INC.
Page 79 - NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Page 80 - 2. Summary of Significant Accounting Policies
Page 81 - Segment Information
Page 82 - Upfront License Fees
Page 83 - Grant Income
Page 84 - Share-Based Payment
Page 85 - Concentrations of Credit Risk and Off-Balance Sheet Risk
Page 86 - Leases. Leases (Topic 842): Targeted Improvements
Page 87 - 3. Accounts Payable and Accrued Expenses
Page 88 - 6. Preferred Stock
Page 89 - N/A
Page 90 - Restricted Stock
Page 91 - N/A
Page 92 - 9. Net Loss per Share Attributable to Common Stockholders
Page 93 - 10. Quarterly Results (unaudited)
Page 94 - 12. Employee Retirement Plan
Page 95 - N/A
Page 96 - Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure.
Page 97 - PART III
Page 98 - PART IV
Page 99 - Exhibit Index
Page 100 - Item 16. Form of 10-K Summary
Page 101 - SIGNATURES
Subdocument 2 - EX-23.1 - EX-23.1
Page 1 - N/A
Subdocument 3 - EX-31.1 - EX-31.1
Page 1 - N/A
Subdocument 4 - EX-31.2 - EX-31.2
Page 1 - N/A
Subdocument 5 - EX-32.1 - EX-32.1
Page 1 - N/A
Subdocument 6 - EX-32.2 - EX-32.2
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