SEC Filings

Form F-1/A
ERYTECH PHARMA S.A. filed this Form F-1/A on 11/06/2017
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Subdocument 1 - F-1/A - F-1/A
Page 1 - As filed with the United States Securities and Exchange Commission on November 6, 2017.
Page 2 - The information contained in this preliminary prospectus is not complete and may be changed. We may
Page 3 - TABLE OF CONTENTS
Page 4 - EXCHANGE RATE INFORMATION
Page 5 - MARKET, INDUSTRY AND OTHER DATA
Page 6 - PROSPECTUS SUMMARY
Page 7 - Eryaspase Our Lead Cancer Metabolism Targeting Product Candidate
Page 8 - Our Product Development Pipeline
Page 9 - E. coli
Page 10 - Our Additional ERYCAPS Product Candidates
Page 11 - Summary Risk Factors
Page 12 - Implications of Being an Emerging Growth Company
Page 13 - Corporate Information
Page 14 - THE GLOBAL OFFERING
Page 15 - N/A
Page 16 - N/A
Page 17 - SUMMARY CONSOLIDATED FINANCIAL DATA
Page 18 - N/A
Page 19 - RISK FACTORS
Page 20 - We may not be successful in our efforts to use and expand our ERYCAPS platform to develop marketable
Page 21 - Risks Related to our Financial Position and Capital Needs
Page 22 - We may need to raise additional funding, which may not be available on acceptable terms, or at all,
Page 23 - Our product candidates will need to undergo clinical trials that are time-consuming and expensive, t
Page 24 - Delays, suspensions and terminations in our clinical trials could result in increased costs to us an
Page 25 - Changes in regulatory requirements, guidance from regulatory authorities or unanticipated events dur
Page 26 - In the European Union, GRASPA contains a known active substance, which would undermine its data and
Page 27 - We have entered, and may in the future enter into, collaboration agreements with third parties for t
Page 28 - Risks Related to the Commercialization of Our Product Candidates
Page 29 - Even if we successfully complete clinical trials of our product candidates, those candidates may not
Page 30 - Even though we have obtained orphan drug designation from the EMA for eryaspase for the treatment of
Page 31 - Government restrictions on pricing and reimbursement, as well as other healthcare payor cost-contain
Page 32 - Any of our product candidates for which we obtain marketing approval could be subject to post-market
Page 33 - The EMA, FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the
Page 34 - Adverse market and economic conditions may exacerbate certain risks associated with commercializing
Page 35 - Our manufacturing facilities are subject to significant government regulations and approvals. If we
Page 36 - Risks Related to Our Operations
Page 37 - Our business may be exposed to foreign exchange risks.
Page 38 - Our internal computer systems, or those of our third-party contractors or consultants, may fail or s
Page 39 - Our employees may engage in misconduct or other improper activities, including violating applicable
Page 40 - Risks Related to Intellectual Property
Page 41 - Issued patents covering our product candidates could be found invalid or unenforceable if challenged
Page 42 - If we do not obtain protection under the Hatch-Waxman Amendments and similar non-U.S. legislation fo
Page 43 - Third parties may assert ownership or commercial rights to inventions we develop.
Page 44 - Third parties may assert that our employees or consultants have wrongfully used or disclosed confide
Page 45 - Risks Related to the Global Offering, Ownership of our Ordinary Shares and ADSs and Our Status as a
Page 46 - After the completion of the global offering, we may be at an increased risk of securities class acti
Page 47 - We do not currently intend to pay dividends on our securities and, consequently, your ability to ach
Page 48 - The rights of shareholders in companies subject to French corporate law differ in material respects
Page 49 - You may not be able to exercise your right to vote the ordinary shares underlying your ADSs.
Page 50 - Purchasers of ADSs in the U.S. offering may not be directly holding our ordinary shares.
Page 51 - As a foreign private issuer, we are exempt from a number of rules under the U.S. securities laws and
Page 52 - We may lose our foreign private issuer status in the future, which could result in significant addit
Page 53 - We must maintain effective internal control over financial reporting, and if we are unable to do so,
Page 54 - SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
Page 55 - MARKET INFORMATION
Page 56 - USE OF PROCEEDS
Page 57 - N/A
Page 58 - DIVIDEND POLICY
Page 59 - CAPITALIZATION
Page 60 - N/A
Page 61 - DILUTION
Page 62 - N/A
Page 63 - N/A
Page 64 - SELECTED CONSOLIDATED FINANCIAL DATA
Page 65 - N/A
Page 66 - MANAGEMENT S DISCUSSION AND ANALYSIS
Page 67 - Eryaspase - Our Lead Cancer Metabolism-Targeting Product Candidate
Page 68 - Interim Financial Reporting
Page 69 - Financial Operations Overview
Page 70 - Reimbursements from Orphan Europe
Page 71 - Agreement with Orphan Europe
Page 72 - Results of Operations
Page 73 - General and Administrative Expenses
Page 74 - Financial Income (Loss)
Page 75 - Research and Development Expenses
Page 76 - General and Administrative Expenses
Page 77 - Critical Accounting Policies and Estimates
Page 78 - Share-based payment
Page 79 - Liquidity and Capital Resources
Page 80 - Non-refundable Subsidies and Conditional Advances from BPI France
Page 81 - Contractual Obligations
Page 82 - Capital Expenditures
Page 83 - Foreign Currency Exchange Risk
Page 84 - N/A
Page 85 - BUSINESS
Page 86 - Acute Lymphoblastic Leukemia
Page 87 - Our Additional ERYCAPS Product Candidates
Page 88 - Corporate Information
Page 89 - Our ERYCAPS Platform Technology
Page 90 - Our Product Development Pipeline
Page 91 - N/A
Page 92 - Clinical Development of Eryaspase
Page 93 - Background and Potential for L-asparaginase as a Treatment for Pancreatic Cancer
Page 94 - Trial Design
Page 95 - Completed Phase 1 Clinical Trial of Eryaspase for the Treatment of Pancreatic Cancer
Page 96 - Background and Market for ALL
Page 97 - Limitations of Free-Form L-asparaginase Administration
Page 98 - Trial Design
Page 99 - Safety Results
Page 100 - Ongoing Phase 2 Clinical Trial in the Nordic Countries of Europe for Treatment of Patients Allergic
Page 101 - Eryaspase for the Treatment of Acute Myeloid Leukemia (AML)
Page 102 - Other ERYCAPS Development Programs
Page 103 - N/A
Page 104 - Commercialization
Page 105 - Agreement with Teva
Page 106 - Patent License from U.S. Public Health Service
Page 107 - Erwinaze
Page 108 - Government Regulation
Page 109 - N/A
Page 110 - BLA and FDA Review Process
Page 111 - Other U.S. Regulatory Matters
Page 112 - U.S. Patent Term Restoration and Marketing Exclusivity
Page 113 - European Union Drug Development
Page 114 - Orphan Drugs
Page 115 - Commission Nationale de l Informatique et des Libert s
Page 116 - Protection of Clinical Trial Subjects
Page 117 - Reimbursement
Page 118 - Other Healthcare Laws and Compliance Requirements
Page 119 - N/A
Page 120 - Employees
Page 121 - MANAGEMENT
Page 122 - Iman El-Hariry, M.D., Ph.D.
Page 123 - Luc Dochez
Page 124 - Director Independence
Page 125 - Corporate Governance Practices
Page 126 - Remuneration and Appointments Committee
Page 127 - Code of Business Conduct and Ethics
Page 128 - Executive Compensation Arrangements and Change of Control and Severance Benefits
Page 129 - Founder s Share Warrants (BSPCE)
Page 130 - Share Warrants (BSA)
Page 131 - Free Shares (AGA)
Page 132 - Stock Options (SO)
Page 133 - N/A
Page 134 - CERTAIN RELATIONSHIPS AND RELATED PERSON TRANSACTIONS
Page 135 - Profit-Sharing Agreement
Page 136 - Other Arrangements
Page 137 - N/A
Page 138 - PRINCIPAL SHAREHOLDERS
Page 139 - N/A
Page 140 - N/A
Page 141 - DESCRIPTION OF SHARE CAPITAL
Page 142 - Key Provisions of Our Bylaws and French Law Affecting Our Ordinary Shares
Page 143 - Directors Voting Powers on Proposal, Arrangement or Contract in which any Director is Materially Int
Page 144 - Timing of Payment.
Page 145 - Sinking Fund Provisions.
Page 146 - Notice of Annual Shareholders Meetings.
Page 147 - Extraordinary Shareholders Meeting.
Page 148 - Declaration of Crossing of Ownership Thresholds (Article 9 of the Bylaws)
Page 149 - Reduction in Share Capital.
Page 150 - Holding of Shares.
Page 151 - N/A
Page 152 - N/A
Page 153 - N/A
Page 154 - N/A
Page 155 - N/A
Page 156 - N/A
Page 157 - N/A
Page 158 - N/A
Page 159 - Listing
Page 160 - LIMITATIONS AFFECTING SHAREHOLDERS OF A FRENCH COMPANY
Page 161 - DESCRIPTION OF AMERICAN DEPOSITARY SHARES
Page 162 - If the exchange rates fluctuate during a time when the depositary cannot convert the foreign currenc
Page 163 - How can ADS holders interchange between certificated ADSs and uncertificated ADSs?
Page 164 - N/A
Page 165 - Payment of Taxes
Page 166 - pro rata
Page 167 - Your Right to Receive the Ordinary Shares Underlying Your ADSs
Page 168 - Shareholder Communications; Inspection of Register of Holders of ADSs; ADS Holder Information
Page 169 - SHARES AND ADSs ELIGIBLE FOR FUTURE SALE
Page 170 - Lock-up Agreements
Page 171 - MATERIAL UNITED STATES FEDERAL INCOME AND FRENCH TAX CONSIDERATIONS
Page 172 - Material French Tax Considerations
Page 173 - Tax on Sale or Other Disposition
Page 174 - Wealth Tax
Page 175 - Distributions.
Page 176 - Sale, Exchange or Other Taxable Disposition of the ADSs.
Page 177 - The U.S. federal income tax rules relating to PFICs are complex. Prospective U.S. investors are urge
Page 178 - of an investment in a PFIC, any elections available with respect to the ADSs and the IRS information
Page 179 - ENFORCEMENT OF CIVIL LIABILITIES
Page 180 - UNDERWRITING
Page 181 - Commission and Expenses
Page 182 - No Sales of Similar Securities
Page 183 - Electronic Distribution
Page 184 - N/A
Page 185 - NOTICE TO INVESTORS
Page 186 - Taxation and Eligibility for Investment
Page 187 - Code mon taire et financier
Page 188 - Singapore
Page 189 - N/A
Page 190 - EXPENSES RELATING TO THE GLOBAL OFFERING
Page 191 - LEGAL MATTERS
Page 192 - WHERE YOU CAN FIND MORE INFORMATION
Page 193 - INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
Page 194 - REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
Page 195 - CONSOLIDATED STATEMENTS OF INCOME (LOSS)
Page 196 - CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
Page 197 - CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
Page 198 - CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS EQUITY
Page 199 - CONSOLIDATED STATEMENTS OF CASH FLOWS
Page 200 - NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
Page 201 - 3. STATEMENT OF COMPLIANCE
Page 202 - 4. SIGNIFICANT ACCOUNTING POLICIES
Page 203 - 4.5 Use of estimates and judgments
Page 204 - 4.8 Impairment tests
Page 205 - Financial liabilities at the amortized cost
Page 206 - Provisions for risks
Page 207 - Accounting for Government Grants and Disclosure of Government Assistance
Page 208 - Partnership with Orphan Europe
Page 209 - 4.19 Earnings per share
Page 210 - 5. NOTES RELATED TO THE CONSOLIDATED STATEMENT OF INCOME (LOSS)
Page 211 - 5.3 Personnel expenses
Page 212 - Allocation of 3,585 BSA on August 31, 2015.
Page 213 - 2016 Plan
Page 214 - Allocation of 111,261 free shares (AGA2016) on October 3, 2016
Page 215 - Allocation of 45,000 share subscription warrants (BSA2016) on October 3, 2016
Page 216 - 5.6 Income tax
Page 217 - 6.2 Property, plant and equipment
Page 218 - 6.4 Inventories
Page 219 - 6.8 Shareholders equity
Page 220 - 6.9 Provisions
Page 221 - 6.10 Financial liabilities
Page 222 - BPI France / Pancreas
Page 223 - BPI France / GR-SIL
Page 224 - 6.11 Other current liabilities
Page 225 - 6.13 Financial instruments recognized in the consolidated statement of financial position and effect
Page 226 - Liquidity risk
Page 227 - Interest rate risk
Page 228 - Agreement with the Teva Group
Page 229 - UNAUDITED INTERIM CONDENSED CONSOLIDATED STATEMENTS OF INCOME (LOSS)
Page 230 - UNAUDITED INTERIM CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
Page 231 - UNAUDITED INTERIM CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
Page 232 - UNAUDITED INTERIM CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS EQUITY
Page 233 - UNAUDITED INTERIM CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
Page 234 - NOTES TO THE UNAUDITED INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Page 235 - 2. BASIS OF PREPARATION AND STATEMENT OF COMPLIANCE
Page 236 - Use of judgments and estimates
Page 237 - 5.2 Operating expenses by nature
Page 238 - Share-based payments (IFRS 2)
Page 239 - Allocation of 55,000 share subscription warrants (BSA2017) on June 27, 2017
Page 240 - 6 NOTES RELATED TO THE UNAUDITED INTERIM CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
Page 241 - Other non-current financial assets
Page 242 - Research Tax Credit
Page 243 - 6.7 Financial liabilities
Page 244 - 6.8 Other current liabilities
Page 245 - 7 OFF-BALANCE SHEET COMMITMENTS
Page 246 - ERYTECH Pharma S.A.
Page 247 - PART II
Page 248 - N/A
Page 249 - N/A
Page 250 - SIGNATURES
Page 251 - POWER OF ATTORNEY
Page 252 - SIGNATURE OF AUTHORIZED U.S. REPRESENTATIVE OF REGISTRANT
Subdocument 2 - EX-3.1 - EX-3.1
Page 1 - Exhibit 3.1
Page 2 - SECTION I
Page 3 - SECTION II
Page 4 - N/A
Page 5 - ARTICLE 7. CAPITAL STOCK
Page 6 - ARTICLE 10. INCREASES IN SHARE CAPITAL
Page 7 - ARTICLE 13. SHARE TYPES
Page 8 - ARTICLE 16. RIGHTS AND OBLIGATIONS ATTACHED TO THE SHARES
Page 9 - III. Vacancy, death, resignation
Page 10 - ARTICLE 20. POWERS OF THE BOARD OF DIRECTORS
Page 11 - 3 - Deputy Managing Director
Page 12 - ARTICLE 23. PLURALITY OF TERMS OF OFFICE
Page 13 - ARTICLE 27. SUMMONSES AND MEETINGS OF THE GENERAL SHAREHOLDERS
Page 14 - ARTICLE 28. AGENDA
Page 15 - SECTION V
Page 16 - ARTICLE 34. PAYMENT OF DIVIDENDS
Page 17 - ARTICLE 37. DISPUTES
Subdocument 3 - EX-5.1 - EX-5.1
Page 1 - Exhibit 5.1
Subdocument 4 - EX-8.1 - EX-8.1
Page 1 - Exhibit 8.1
Page 2 - Code G n ral des Imp ts
Subdocument 5 - EX-23.1 - EX-23.1
Page 1 - Exhibit 23.1
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