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Form S-1/A
PROTEON THERAPEUTICS INC filed this Form S-1/A on 10/07/2014
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Entire Document (4404.7 KB)
Subdocument 1 - S-1/A - S-1/A
Page 1 - As filed with the Securities and Exchange Commission on October 7, 2014.
Page 2 - PRELIMINARY PROSPECTUS
Page 3 - TABLE OF CONTENTS
Page 4 - PROSPECTUS SUMMARY
Page 5 - PRT-201
Page 6 - Secondary Endpoints
Page 7 - Additional PRT-201 Indications
Page 8 - Phase 3 endpoints same as our Phase 2 trial.
Page 9 - Corporate Information
Page 10 - N/A
Page 11 - THE OFFERING
Page 12 - N/A
Page 13 - SUMMARY FINANCIAL DATA
Page 14 - N/A
Page 15 - RISK FACTORS
Page 16 - We will require substantial additional financing to achieve our goals, and a failure to obtain this
Page 17 - We have never generated any revenue from product sales and may never be profitable.
Page 18 - Risks Related to Clinical Development, Regulatory Review and Approval of Our Product
Page 19 - Clinical development is a lengthy and expensive process with an uncertain outcome due to many factor
Page 20 - If clinical trials of PRT-201 or any additional product candidates fail to demonstrate safety and ef
Page 21 - We may be unable to obtain regulatory approval for PRT-201 or any additional product candidates unde
Page 22 - We may face difficulty in enrolling patients for clinical trials.
Page 23 - If we experience any of a number of possible unforeseen events in connection with clinical trials of
Page 24 - Any product for which we obtain FDA approval will be subject to extensive ongoing regulatory require
Page 25 - PRT-201 may cause undesirable side effects or have other properties that could delay or prevent thei
Page 26 - Even if we obtain and maintain approval for PRT-201 or additional product candidates from the FDA, w
Page 27 - We may not be able to comply with requirements of foreign jurisdictions in conducting trials outside
Page 28 - Risks Related to Commercialization of Our Product
Page 29 - Even if PRT-201 or any additional product candidates receive regulatory approval, they may fail to a
Page 30 - PRT-201 or any additional product candidates for which we intend to seek approval as biologic produc
Page 31 - Risks Related to Dependence on Third Parties
Page 32 - We rely on third parties to conduct some or all aspects of our product manufacturing, protocol devel
Page 33 - We rely on third parties to conduct, supervise and monitor our clinical trials. If these third parti
Page 34 - We may seek to form partnerships in the future with respect to PRT-201 or any additional product can
Page 35 - inter partes
Page 36 - Confidentiality agreements with employees and third parties may not prevent unauthorized disclosure
Page 37 - Third-party claims of intellectual property infringement or misappropriation may prevent or delay ou
Page 38 - If we are unable to adequately protect our proprietary technology, or obtain and maintain issued pat
Page 39 - ex parte
Page 40 - We may be subject to claims challenging the inventorship or ownership of our patents and other intel
Page 41 - We will not seek to protect our intellectual property rights in all jurisdictions throughout the wor
Page 42 - Some of our intellectual property may have been discovered through government funded programs and th
Page 43 - Changes in United States patent law could diminish the value of patents in general, thereby impairin
Page 44 - Numerous factors may limit any potential competitive advantage provided by our intellectual property
Page 45 - We will need to significantly increase the size of our organization, and we may experience difficult
Page 46 - Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud.
Page 47 - If we engage in acquisitions in the future, we will incur a variety of costs and we may never realiz
Page 48 - Our business and operations would suffer in the event of system failures.
Page 49 - N/A
Page 50 - Governments outside the United States tend to impose strict price controls, which may adversely affe
Page 51 - There has been no public market for our common stock prior to this offering, and you may not be able
Page 52 - N/A
Page 53 - Raising additional funds through debt or equity financing could be dilutive and may cause the market
Page 54 - Sales of a substantial number of shares of our common stock by our existing stockholders in the publ
Page 55 - We have broad discretion in the use of net proceeds from this offering and may not use them effectiv
Page 56 - We do not expect to pay any cash dividends for the foreseeable future.
Page 57 - N/A
Page 58 - SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
Page 59 - USE OF PROCEEDS
Page 60 - CAPITALIZATION
Page 61 - Series D Convertible Preferred Stock
Page 62 - Anti-dilution protection for Series D convertible preferred stock.
Page 63 - N/A
Page 64 - DILUTION
Page 65 - N/A
Page 66 - N/A
Page 67 - SELECTED FINANCIAL DATA
Page 68 - N/A
Page 69 - MANAGEMENT'S DISCUSSION AND ANALYSIS
Page 70 - Financial Overview
Page 71 - General and Administrative Expenses
Page 72 - Critical Accounting Policies and Significant Judgments and Estimates
Page 73 - Derivative Instruments
Page 74 - Compensation Stock Compensation
Page 75 - Determination of the Fair Value of Common Stock on Grant Dates
Page 76 - Methods Used to Allocate Our Enterprise Value to Classes of Securities
Page 77 - Research and Development Expenses.
Page 78 - Research and Development Expenses.
Page 79 - Series D Financing
Page 80 - Cash Flows
Page 81 - Off-Balance Sheet Arrangements
Page 82 - Contractual Obligations
Page 83 - BUSINESS
Page 84 - Our Strengths
Page 85 - Safety profile supports approval.
Page 86 - Commercialize PRT-201 directly in the United States.
Page 87 - N/A
Page 88 - Established Medical Need
Page 89 - The procedures are not always successful in restoring patency.
Page 90 - PRT-201
Page 91 - PRT-201 Treatment Inhibits Stenosis Formation
Page 92 - Primary Unassisted Patency All AVFs
Page 93 - Primary Unassisted Patency Radiocephalic AVFs
Page 94 - Reduction in Risk of Primary Unassisted Patency Loss vs. Placebo Brachiocephalic AVFs
Page 95 - Secondary and other endpoints
Page 96 - Unassisted Maturation Radiocephalic AVFs
Page 97 - Average Procedure Rate to Restore/Maintain Patency Including Registry Data (p-Value vs. Placebo)
Page 98 - Use for hemodialysis.
Page 99 - Phase 1/2 AVF Clinical Trial
Page 100 - Preclinical Development
Page 101 - Peripheral Artery Disease
Page 102 - Sales and Marketing
Page 103 - Patents
Page 104 - Competition
Page 105 - Approval process
Page 106 - N/A
Page 107 - U.S. Patent Term Restoration
Page 108 - Post-approval requirements
Page 109 - Fast track designation and accelerated approval
Page 110 - Biosmilars
Page 111 - European Union EMA process
Page 112 - Data and market exclusivity
Page 113 - Sales and marketing
Page 114 - Other laws and regulatory processes
Page 115 - Legal Proceedings
Page 116 - MANAGEMENT
Page 117 - George A. Eldridge
Page 118 - Todd Foley
Page 119 - Dmitry Kobyzev, Ph.D.
Page 120 - Board Committees
Page 121 - Compensation Committee
Page 122 - Compensation Committee Interlocks and Insider Participation
Page 123 - EXECUTIVE AND DIRECTOR COMPENSATION
Page 124 - Base Salary
Page 125 - Timothy P. Noyes
Page 126 - Daniel P. Gottlieb
Page 127 - Outstanding Equity Awards at Fiscal Year End
Page 128 - Employee Benefit and Stock Plans
Page 129 - Amendment and Termination
Page 130 - Available Shares
Page 131 - Stock Appreciation Rights
Page 132 - Qualified Performance-Based Awards
Page 133 - Change of Control
Page 134 - Allocation of Awards; Plan Benefits.
Page 135 - Withdrawal
Page 136 - Amount of Benefits
Page 137 - N/A
Page 138 - CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS
Page 139 - Series D Preferred Stock Financing
Page 140 - Voting Agreement
Page 141 - PRINCIPAL STOCKHOLDERS
Page 142 - N/A
Page 143 - N/A
Page 144 - N/A
Page 145 - DESCRIPTION OF CAPITAL STOCK
Page 146 - Warrants
Page 147 - Action by Written Consent; Special Meetings of Stockholders.
Page 148 - Authorized but Unissued Shares.
Page 149 - Transfer Agent and Registrar
Page 150 - SHARES ELIGIBLE FOR FUTURE SALE
Page 151 - Rule 144
Page 152 - Rule 701
Page 153 - MATERIAL UNITED STATES FEDERAL INCOME TAX CONSEQUENCES TO
Page 154 - Distributions on Common Stock
Page 155 - Gain on Disposition of Common Stock
Page 156 - Foreign Account Tax Compliance Act
Page 157 - UNDERWRITING
Page 158 - Commissions and Discounts
Page 159 - NASDAQ Market Listing
Page 160 - Electronic Distribution
Page 161 - Notice to Prospective Investors in the United Kingdom
Page 162 - Notice to Prospective Investors in the Netherlands
Page 163 - N/A
Page 164 - LEGAL MATTERS
Page 165 - Proteon Therapeutics, Inc.
Page 166 - Proteon Therapeutics, Inc.
Page 167 - N/A
Page 168 - N/A
Page 169 - Proteon Therapeutics, Inc.
Page 170 - N/A
Page 171 - 1. Organization and operations
Page 172 - Notes to Financial Statements (Continued)
Page 173 - Notes to Financial Statements (Continued)
Page 174 - Notes to Financial Statements (Continued)
Page 175 - Notes to Financial Statements (Continued)
Page 176 - Notes to Financial Statements (Continued)
Page 177 - Notes to Financial Statements (Continued)
Page 178 - Notes to Financial Statements (Continued)
Page 179 - Notes to Financial Statements (Continued)
Page 180 - Notes to Financial Statements (Continued)
Page 181 - Notes to Financial Statements (Continued)
Page 182 - Notes to Financial Statements (Continued)
Page 183 - Notes to Financial Statements (Continued)
Page 184 - Notes to Financial Statements (Continued)
Page 185 - Notes to Financial Statements (Continued)
Page 186 - Notes to Financial Statements (Continued)
Page 187 - Notes to Financial Statements (Continued)
Page 188 - Notes to Financial Statements (Continued)
Page 189 - Notes to Financial Statements (Continued)
Page 190 - Notes to Financial Statements (Continued)
Page 191 - Notes to Financial Statements (Continued)
Page 192 - Notes to Financial Statements (Continued)
Page 193 - Notes to Financial Statements (Continued)
Page 194 - Notes to Financial Statements (Continued)
Page 195 - Notes to Financial Statements (Continued)
Page 196 - Notes to Financial Statements (Continued)
Page 197 - Notes to Financial Statements (Continued)
Page 198 - 4,700,000 Shares
Page 199 - PART II
Page 200 - Item 15. Recent Sales of Unregistered Securities
Page 201 - Item 16. Exhibits and Financial Statement Schedules.
Page 202 - N/A
Page 203 - (b) Financial Statement Schedules
Page 204 - bona fide
Page 205 - SIGNATURES
Page 206 - EXHIBIT INDEX
Page 207 - N/A
Page 208 - N/A
Subdocument 2 - EX-1.1 - EX-1.1
Page 1 - Exhibit 1.1
Page 2 - N/A
Page 3 - N/A
Page 4 - N/A
Page 5 - N/A
Page 6 - N/A
Page 7 - N/A
Page 8 - N/A
Page 9 - N/A
Page 10 - N/A
Page 11 - N/A
Page 12 - N/A
Page 13 - N/A
Page 14 - N/A
Page 15 - N/A
Page 16 - N/A
Page 17 - N/A
Page 18 - N/A
Page 19 - N/A
Page 20 - N/A
Page 21 - N/A
Page 22 - N/A
Page 23 - N/A
Page 24 - N/A
Page 25 - N/A
Page 26 - N/A
Page 27 - N/A
Page 28 - Signature Page Follows
Page 29 - N/A
Page 30 - Free Writing Prospectuses
Page 31 - OPINION OF COUNSEL TO THE COMPANY
Page 32 - OPINION OF BIOSPARK INTELLECTUAL PROPERTY LAW
Page 33 - OPINION OF HUGHES, HUBBARD REED LLP
Page 34 - LOCK-UP AGREEMENT
Page 35 - bona fide
Page 36 - provided that
Page 37 - N/A
Page 38 - [Form of Press Release]
Subdocument 3 - EX-3.2 - EX-3.2
Page 1 - Exhibit 3.2
Page 2 - Common Stock
Page 3 - ARTICLE FIVE
Page 4 - Removal
Page 5 - ARTICLE EIGHT
Page 6 - Merger or Consolidation
Page 7 - ARTICLE TWELVE
Page 8 - IN WITNESS WHEREOF
Subdocument 4 - EX-3.4 - EX-3.4
Page 1 - Exhibit 3.4
Page 2 - DGCL
Page 3 - 2.10. Inspectors of Elections; Opening and Closing the Polls.
Page 4 - Exchange Act
Page 5 - Other Stockholder Proposals
Page 6 - Article III. - Directors
Page 7 - 3.2. Resignation.
Page 8 - 3.8. Substitute Committee Member.
Page 9 - 4.8. Vice-Presidents.
Page 10 - 4.15. Removal.
Page 11 - 5.4. Record Date.
Page 12 - Reserves
Page 13 - 6.4. Voting of Securities owned by the Company.
Page 14 - Advancement of Expenses
Page 15 - Article VIII. - Amendments
Subdocument 5 - EX-3.5 - EX-3.5
Page 1 - Exhibit 3.5
Page 2 - SIGNATURE PAGE TO AMENDMENT NO. 1 TO
Subdocument 6 - EX-3.6 - EX-3.6
Page 1 - Exhibit 3.6
Page 2 - N/A
Page 3 - SIGNATURE PAGE TO AMENDMENT NO. 2 TO
Subdocument 7 - EX-4.1 - EX-4.1
Page 1 - Exhibit 4.1
Subdocument 8 - EX-5.1 - EX-5.1
Page 1 - Exhibit 5.1
Page 2 - to be issued and sold by the Company under the Underwriting Agreement will have been duly authorized
Subdocument 9 - EX-10.1 - EX-10.1
Page 1 - Exhibit 10.1
Page 2 - (iii)
Page 3 - (j)
Page 4 - (o)
Page 5 - (aa)
Page 6 - (i)
Page 7 - provided, however,
Page 8 - (ii)
Page 9 - (c)
Page 10 - (g)
Page 11 - (k)
Page 12 - (iv)
Page 13 - (iv)
Page 14 - (v)
Page 15 - provided, however,
Page 16 - (f)
Page 17 - (ii)
Page 18 - (d)
Page 19 - (d)
Subdocument 10 - EX-10.2 - EX-10.2
Page 1 - Exhibit 10.2
Page 2 - TABLE OF CONTENTS
Page 3 - PROTEON THERAPEUTICS, INC.
Page 4 - Code
Page 5 - Market Value
Page 6 - Stock
Page 7 - Application
Page 8 - Eligibility
Page 9 - provided, however
Page 10 - Stock Appreciation Rights
Page 11 - Escrow of Shares
Page 12 - Character
Page 13 - Discretion of Committee with Respect to Qualified Performance-Based Awards
Page 14 - Performance Goals
Page 15 - Adjustment for Corporate Actions
Page 16 - Definition of Transaction
Page 17 - provided, however
Page 18 - Related Matters
Page 19 - Placement of Legends; Stop Orders; etc.
Page 20 - provided
Page 21 - provided, however
Page 22 - Limitations on Amendments, Etc.
Page 23 - [End of document.]
Page 24 - Vested Shares
Page 25 - [Signature page follows]
Page 26 - IN WITNESS WHEREOF
Page 27 - PROTEON THERAPEUTICS, INC.
Subdocument 11 - EX-10.25 - EX-10.25
Page 1 - Exhibit 10.25
Page 2 - PROTEON THERAPEUTICS, INC.
Page 3 - Contributions
Page 4 - Purchase Price
Page 5 - Plan Periods
Page 6 - Shares
Page 7 - Exercise
Page 8 - N/A
Page 9 - Adjustment in General
Page 10 - Related Matters
Page 11 - N/A
Page 12 - N/A
Page 13 - SAMPLE
Page 14 - I hereby agree to notify the Company in writing within five (5) business days after the date of any
Page 15 - N/A
Page 16 - SAMPLE
Subdocument 12 - EX-10.26 - EX-10.26
Page 1 - Exhibit 10.26
Page 2 - Benefits
Page 3 - By Reason of Constructive Termination
Page 4 - e.g.
Page 5 - provided, however, that
Page 6 - Corporate Transaction
Page 7 - Indemnification
Page 8 - The remainder of this page is intentionally left blank.
Page 9 - N/A
Page 10 - EXHIBIT A
Page 11 - IN WITNESS WHEREOF
Subdocument 13 - EX-10.27 - EX-10.27
Page 1 - Exhibit 10.27
Page 2 - Benefits
Page 3 - provided
Page 4 - By the Company Without Cause
Page 5 - Payment
Page 6 - Person
Page 7 - Noncompetition Covenant
Page 8 - Severability
Page 9 - PROTEON THERAPEUTICS, INC.
Page 10 - EXHIBIT A
Page 11 - IN WITNESS WHEREOF
Subdocument 14 - EX-10.28 - EX-10.28
Page 1 - Exhibit 10.28
Page 2 - Benefits
Page 3 - Earned and Unpaid Bonus
Page 4 - By the Company Without Cause
Page 5 - Section 280G
Page 6 - Person
Page 7 - Noncompetition Covenant
Page 8 - Severability
Page 9 - PROTEON THERAPEUTICS, INC.
Page 10 - EXHIBIT A
Page 11 - IN WITNESS WHEREOF
Subdocument 15 - EX-10.29 - EX-10.29
Page 1 - Exhibit 10.29
Page 2 - Benefits
Page 3 - Earned and Unpaid Bonus
Page 4 - By the Company Without Cause
Page 5 - Section 280G
Page 6 - Person
Page 7 - Noncompetition Covenant
Page 8 - Severability
Page 9 - PROTEON THERAPEUTICS, INC.
Page 10 - EXHIBIT A
Page 11 - IN WITNESS WHEREOF
Subdocument 16 - EX-10.30 - EX-10.30
Page 1 - Exhibit 10.30
Page 2 - AMENDED AND RESTATED INDEMNIFICATION AGREEMENT
Page 3 - Indemnity of Indemnitee
Page 4 - Additional Indemnity
Page 5 - Indemnification for Expenses of a Witness
Page 6 - Section 6(a)
Page 7 - Section 6(e)
Page 8 - Remedies of Indemnitee
Page 9 - Section 7
Page 10 - Exception to Right of Indemnification
Page 11 - Independent Counsel
Page 12 - Modification and Waiver
Page 13 - SIGNATURE PAGE TO FOLLOW
Page 14 - SIGNATURE PAGE TO INDEMNIFICATION AGREEMENT
Subdocument 17 - EX-23.2 - EX-23.2
Page 1 - Exhibit 23.2
Page 2 - N/A