SEC Filings

Form 10-K
PROTAGONIST THERAPEUTICS, INC filed this Form 10-K on 03/07/2017
Document Outline
Entire Document (4673.1 KB)
Subdocument 1 - 10-K - FORM 10-K
Page 1 - UNITED STATES
Page 2 - PROTAGONIST THERAPEUTICS, INC.
Page 3 - PART I
Page 4 - Our Product Candidates
Page 5 - PTG-200
Page 6 - Our Solution for IBD: Oral, GI-Restricted Peptides
Page 7 - Overview of Inflammatory Bowel Disease
Page 8 - TNF-
Page 9 - Figure 1: Transforming the Existing IBD Treatment Paradigm with Oral Targeted Therapy Drugs
Page 10 - PTG-100 s Pre-Clinical Proof-of-Concept Studies
Page 11 - Figure 2: PTG-100 Reduces Trafficking of Memory T Cells to MLN and Peyer s Patches
Page 12 - Figure 3: (A) Percent Receptor Occupancy and (B) Receptor Expression of
Page 13 - Establishing Pharmacodynamic POC in Humans
Page 14 - Mechanism of Action and Rationale
Page 15 - Figure 4: PTG-200 Reduces Pathology in Rat TNBS-Induced Colitis
Page 16 - PTG-200 s Preliminary Pre-Clinical Safety Studies
Page 17 - PTG-300 s Pre-clinical Proof-of-Concept Studies
Page 18 - Figure 6: PTG-300 Addresses Ineffective Erythropoiesis in Mouse
Page 19 - PTG-300 s Development Program
Page 20 - Oral stability and in vitro and ex vivo assays
Page 21 - Material Agreements
Page 22 - Competition
Page 23 - IL-23R Antagonist Peptides
Page 24 - Hepcidin Mimetics Analogues
Page 25 - Manufacturing
Page 26 - Pre-clinical Studies
Page 27 - Marketing Approval
Page 28 - Orphan Designation
Page 29 - Coverage and Reimbursement
Page 30 - Other Health Care Laws and Compliance Requirements
Page 31 - Government Regulation Outside of the United States
Page 32 - N/A
Page 33 - Employees
Page 34 - Investing in our common stock involves a high degree of risk. You should carefully consider the risk
Page 35 - We will require substantial additional funding, which may not be available to us on acceptable terms
Page 36 - N/A
Page 37 - Raising additional capital may cause dilution to our existing stockholders, restrict our operations
Page 38 - The regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time co
Page 39 - Clinical development is a lengthy and expensive process with an uncertain outcome, and results of ea
Page 40 - N/A
Page 41 - Enrollment and retention of patients in clinical trials is an expensive and time-consuming process a
Page 42 - in vivo
Page 43 - We rely on third parties to conduct our pre-clinical studies and clinical trials. If these third par
Page 44 - We rely completely on third parties to manufacture our drug substance and clinical drug product and
Page 45 - We may fail to obtain orphan drug designations from the FDA for our product candidates, as applicabl
Page 46 - We may not be successful in obtaining or maintaining development and commercialization collaboration
Page 47 - N/A
Page 48 - We currently have no marketing and sales organization. To the extent any of our peptide-based produc
Page 49 - We have focused our limited resources to pursue particular product candidates and indications, and c
Page 50 - If we fail to comply with state and federal healthcare regulatory laws, we could face substantial pe
Page 51 - N/A
Page 52 - Recently enacted and future legislation may increase the difficulty and cost for us to obtain market
Page 53 - Governments outside the United States tend to impose strict price controls, which may adversely affe
Page 54 - Our future success depends on our ability to retain our executive officers and to attract, retain an
Page 55 - Significant disruptions of information technology systems or breaches of data security could adverse
Page 56 - Our employees, independent contractors, principal investigators, consultants and vendors may engage
Page 57 - We currently conduct, and intend to continue to conduct a substantial portion of the clinical trials
Page 58 - Our headquarters and certain of our data storage facilities are located near known earthquake fault
Page 59 - Risks Related to Our Intellectual Property
Page 60 - N/A
Page 61 - We may be involved in lawsuits to protect or enforce our intellectual property, which could be expen
Page 62 - Any issued patents covering our product candidates, including any patent that may issue as a result
Page 63 - Third party claims of intellectual property infringement may prevent or delay our drug discovery and
Page 64 - We may not identify relevant third party patents or may incorrectly interpret the relevance, scope o
Page 65 - Intellectual property disputes could cause us to spend substantial resources and distract our person
Page 66 - Obtaining and maintaining patent protection depends on compliance with various procedural, document
Page 67 - Intellectual property rights do not necessarily address all potential threats to our competitive adv
Page 68 - Our reliance on third parties requires us to share our trade secrets, which increases the possibilit
Page 69 - We may not be successful in obtaining or maintaining necessary rights to our product candidates thro
Page 70 - Risks Related to Ownership of our Common Stock
Page 71 - Volatility in our share price could subject us to securities class action litigation.
Page 72 - We have identified a material weakness in our internal control over financial reporting and may iden
Page 73 - We are an emerging growth company and as a result of the reduced disclosure and governance requireme
Page 74 - Future sales of our common stock may depress our share price.
Page 75 - Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud.
Page 76 - Claims for indemnification by our directors and officers may reduce our available funds to satisfy s
Page 77 - Our amended and restated certificate of incorporation provides that the Court of Chancery of the Sta
Page 78 - Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be
Page 79 - PART II
Page 80 - The stock price performance included in this graph is not necessarily indicative of future stock pri
Page 81 - N/A
Page 82 - You should read the following discussion and analysis of our financial condition and results of oper
Page 83 - Components of Our Results of Operations
Page 84 - General and Administrative Expenses
Page 85 - Critical Accounting Policies and Estimates
Page 86 - Expected Term
Page 87 - Income Taxes
Page 88 - Research and Development Expenses
Page 89 - General and Administrative Expenses
Page 90 - Cash Flows from Operating Activities
Page 91 - Cash Flows from Investing Activities
Page 92 - Contractual Obligations and Other Commitments
Page 93 - Income Taxes (Topic 740): Balance Sheet Classification of Deferred Taxes
Page 94 - N/A
Page 95 - PROTAGONIST THERAPEUTICS, INC.
Page 96 - Report of Independent Registered Public Accounting Firm
Page 97 - PROTAGONIST THERAPEUTICS, INC.
Page 98 - PROTAGONIST THERAPEUTICS, INC.
Page 99 - PROTAGONIST THERAPEUTICS, INC.
Page 100 - PROTAGONIST THERAPEUTICS, INC.
Page 101 - PROTAGONIST THERAPEUTICS, INC.
Page 102 - PROTAGONIST THERAPEUTICS, INC.
Page 103 - Use of Estimates
Page 104 - Fair Value of Financial Instruments
Page 105 - Comprehensive Loss
Page 106 - SBIR Grants
Page 107 - Income Taxes (Topic 740): Balance Sheet Classification of Deferred Taxes
Page 108 - 3. Fair Value Measurements
Page 109 - N/A
Page 110 - 4. Balance Sheet Components
Page 111 - Prepaid Expenses and Other Current Assets
Page 112 - 6. Government Programs
Page 113 - 7. Commitments and Contingencies
Page 114 - 9. Redeemable Convertible Preferred Stock
Page 115 - 10. Redeemable Convertible Preferred Stock Tranche Liability
Page 116 - 11. Common Stock
Page 117 - Stock Options
Page 118 - Expected Term
Page 119 - Stock-Based Compensation
Page 120 - N/A
Page 121 - 15. Net Loss per Share Attributable to Common Stockholders
Page 122 - 16. Subsequent Events
Page 123 - Evaluation of disclosure controls and procedures
Page 124 - Changes in internal control over financial reporting
Page 125 - PART III
Page 126 - PART IV
Page 127 - SIGNATURES
Page 128 - EXHIBIT INDEX
Page 129 - N/A
Page 130 - Exhibit
Subdocument 2 - EX-10.9 - EX-10.9
Page 1 - Exhibit 10.9
Page 2 - Table of Contents
Page 3 - N/A
Page 4 - LEASE
Page 5 - North Campus
Page 6 - Section 11.7
Page 7 - Term
Page 8 - Section
Page 9 - provided
Page 10 - Rentable Area
Page 11 - provided
Page 12 - HVAC
Page 13 - provided
Page 14 - Section
Page 15 - provided
Page 16 - provided
Page 17 - provided
Page 18 - provided
Page 19 - i.e
Page 20 - L/C Security Reduction Date
Page 21 - Lender
Page 22 - Section 12.7
Page 23 - ADA
Page 24 - Rules and Regulations, CC Rs, Parking Facilities
Page 25 - provided
Page 26 - Utilities and Services
Page 27 - provided
Page 28 - Generator
Page 29 - Alterations
Page 30 - provided
Page 31 - Exhibit H
Page 32 - Repairs and Maintenance
Page 33 - Article 24
Page 34 - Estoppel Certificate
Page 35 - provided
Page 36 - Article 27
Page 37 - Odors and Exhaust
Page 38 - Insurance; Waiver of Subrogation
Page 39 - Section
Page 40 - Exhibit B-1
Page 41 - Damage or Destruction
Page 42 - Section
Page 43 - provided
Page 44 - Eminent Domain
Page 45 - Article 27
Page 46 - Indemnification and Exculpation
Page 47 - Article 21
Page 48 - Transfer Date
Page 49 - N/A
Page 50 - provided
Page 51 - provided
Page 52 - Defaults and Remedies
Page 53 - Section
Page 54 - Article 20
Page 55 - Section 31.5(c)(i)(A)
Page 56 - Section
Page 57 - provided
Page 58 - Brokers
Page 59 - Limitation of Landlord
Page 60 - Representations
Page 61 - Subsection 39(a)
Page 62 - provided
Page 63 - AS IS AND WITH ALL FAULTS
Page 64 - Section 23.3(c)
Page 65 - N/A
Page 66 - EXHIBIT A
Page 67 - EXHIBIT B
Page 68 - Tenant s Architects, Contractors and Consultants
Page 69 - Work Plans
Page 70 - Approval of Changes
Page 71 - provided
Page 72 - Workers Compensation Insurance
Page 73 - provided
Page 74 - LANDLORD
Page 75 - EXHIBIT B-1
Page 76 - provided
Page 77 - EXHIBIT C
Page 78 - N/A
Page 79 - N/A
Page 80 - EXHIBIT D
Page 81 - EXHIBIT E
Page 82 - Payment Deadline
Page 83 - ISP 98
Page 84 - ATTACHMENT 1 TO EXHIBIT E
Page 85 - ATTACHMENT 2 TO EXHIBIT E
Page 86 - EXHIBIT F
Page 87 - provided
Page 88 - Waste Regulations
Page 89 - provided
Page 90 - ATTACHMENT 1 TO EXHIBIT F
Page 91 - N/A
Page 92 - EXHIBIT G
Page 93 - EXHIBIT H
Page 94 - EXHIBIT I
Page 95 - N/A
Page 96 - EXHIBIT J
Subdocument 3 - EX-21.1 - EX-21.1
Page 1 - Exhibit 21.1
Subdocument 4 - EX-23.1 - EX-23.1
Page 1 - Exhibit 23.1
Subdocument 5 - EX-31.1 - EX-31.1
Page 1 - Exhibit 31.1
Subdocument 6 - EX-31.2 - EX-31.2
Page 1 - Exhibit 31.2
Subdocument 7 - EX-32.1 - EX-32.1
Page 1 - Exhibit 32.1
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