Form S-1/A
CHIASMA, INC filed this Form S-1/A on 07/06/2015
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Subdocument 1 - S-1/A - S-1/A
Page 1 - As filed with the Securities and Exchange Commission on July 6, 2015
Page 2 - The information in this preliminary prospectus is not complete and may be changed. We may not sell t
Page 3 - TABLE OF CONTENTS
Page 4 - PROSPECTUS SUMMARY
Page 5 - N/A
Page 6 - Commercialization Strategy
Page 7 - Strategy
Page 8 - Corporate Information
Page 9 - Implications of Being an Emerging Growth Company
Page 10 - THE OFFERING
Page 11 - N/A
Page 12 - SUMMARY CONSOLIDATED FINANCIAL DATA
Page 13 - N/A
Page 14 - RISK FACTORS
Page 15 - If we are not able to obtain required regulatory approvals for oral octreotide, we will not be able
Page 16 - N/A
Page 17 - The FDA may determine that our NDA for oral octreotide for the maintenance therapy of acromegaly is
Page 18 - Our development, regulatory and commercialization strategy for oral octreotide depends, in part, on
Page 19 - Clinical drug development involves a lengthy and expensive process with an uncertain outcome, result
Page 20 - N/A
Page 21 - Changes in regulatory requirements and guidance may also occur and we may need to amend clinical tri
Page 22 - Even if we receive regulatory approval of oral octreotide, we may still face future development and
Page 23 - We face substantial competition from larger companies with considerable resources that already have
Page 24 - The number of patients suffering from acromegaly is small, and has not been established with precisi
Page 25 - Even if we receive regulatory approval of oral octreotide, it may not achieve an adequate level of a
Page 26 - We currently have no sales and marketing organization and, as a company, have not commercialized any
Page 27 - We will need to grow the size of our organization in order to establish our sales and marketing infr
Page 28 - Even if we obtain marketing approval of oral octreotide or any future product candidates we may deve
Page 29 - If we do not achieve our projected development and commercialization goals in the timeframes we anno
Page 30 - Oral octreotide and other products we may develop may not be commercially viable if we fail to obtai
Page 31 - The longer term growth of our business depends on our efforts to leverage our TPE platform to expand
Page 32 - Our ability to develop a viable pipeline of potential future products may require us to enter into l
Page 33 - Our relationships with customers and third-party payors will be subject to applicable anti-kickback,
Page 34 - Legislative or regulatory reform of the health care system in the United States and foreign jurisdic
Page 35 - N/A
Page 36 - We may not be able to maintain our current product liability coverage, and, even if we do, our cover
Page 37 - N/A
Page 38 - If our third-party manufacturers use hazardous and biological materials in a manner that causes inju
Page 39 - We rely, and will rely in the future, on third parties to conduct our nonclinical studies and clinic
Page 40 - We have not generated any revenue from any commercial products and may never be profitable.
Page 41 - We may need additional capital to support our growth, which may be difficult to obtain and restrict
Page 42 - Risks Related to Our Business and Industry
Page 43 - Our employees, independent contractors, consultants, commercial partners, principal investigators, C
Page 44 - Laws and regulations governing conduct of international operations may negatively impact our develop
Page 45 - Risks Related to Our Intellectual Property
Page 46 - inter partes
Page 47 - inter partes
Page 48 - Obtaining and maintaining our patent protection depends on compliance with various procedural, docum
Page 49 - Oral octreotide or any future products we may develop may infringe the intellectual property rights
Page 50 - Changes in either U.S. or foreign patent law or interpretation of such laws could diminish the value
Page 51 - If our trademarks are not adequately protected, then we may not be able to build name recognition in
Page 52 - Our research and development and administrative facilities and one of our third-party manufacturers
Page 53 - Our directors, executive officers and principal stockholders exercise significant control over our c
Page 54 - Our amended and restated certificate of incorporation and amended and restated bylaws provide that t
Page 55 - The trading price of our common stock may be volatile, and your investment in our common stock could
Page 56 - We may be subject to securities litigation, which is expensive and could divert our management s att
Page 57 - We have never paid dividends on our capital stock and we do not anticipate paying any dividends in t
Page 58 - If we fail to maintain proper and effective internal controls, our ability to produce accurate finan
Page 59 - If securities or industry analysts do not publish research or publish inaccurate or unfavorable rese
Page 60 - CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
Page 61 - INDUSTRY AND MARKET DATA
Page 62 - USE OF PROCEEDS
Page 63 - DIVIDEND POLICY
Page 64 - CAPITALIZATION
Page 65 - N/A
Page 66 - DILUTION
Page 67 - N/A
Page 68 - SELECTED CONSOLIDATED FINANCIAL DATA
Page 69 - N/A
Page 70 - MANAGEMENT S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Page 71 - Roche License Agreement
Page 72 - Financial Overview
Page 73 - Marketing, General and Administrative
Page 74 - Critical Accounting Policies and Use of Estimates
Page 75 - Stock-based Compensation
Page 76 - Results of Operations for the Three Months Ended March 31, 2014 and 2015
Page 77 - Marketing, General and Administrative
Page 78 - Research and Development
Page 79 - Other Expense, net
Page 80 - Plan of Operations and Future Funding Requirements
Page 81 - Cash Flows
Page 82 - Contractual Obligations and Contingent Liabilities
Page 83 - Common Stock Valuation
Page 84 - Common Stock Valuation Methodologies
Page 85 - Retrospective Valuations
Page 86 - March 16, 2015 Valuation
Page 87 - June 14, 2015 Valuation
Page 88 - Estimated Offering Price
Page 89 - N/A
Page 90 - Stock Option Grants
Page 91 - JOBS Act
Page 92 - BUSINESS
Page 93 - N/A
Page 94 - Strategy
Page 95 - N/A
Page 96 - Our Product Candidate Pipeline
Page 97 - Incidence and Prevalence of Acromegaly and Current Treatment Landscape
Page 98 - Our Solution: Oral Octreotide
Page 99 - Clinical Program for Oral Octreotide in Acromegaly
Page 100 - Phase 3 Clinical Trial Design
Page 101 - Overall Phase 3 Response in mITT Group vs. Baseline
Page 102 - Reduced Number of Acromegaly Symptoms at Conclusion of Oral Octreotide Trial
Page 103 - Planned Phase 3 Clinical Trial
Page 104 - Design of Planned Phase 3 to Support EMA Approval
Page 105 - Suppression of GH Levels in Healthy Volunteers
Page 106 - Our Proprietary Transient Permeability Enhancer Technology Platform
Page 107 - Our TPE Platform
Page 108 - Commercialization Strategy
Page 109 - Competition
Page 110 - Patents
Page 111 - Patent Term
Page 112 - N/A
Page 113 - in vitro
Page 114 - N/A
Page 115 - 505(b)(2) Approval Process
Page 116 - Other Regulatory Matters
Page 117 - U.S. Marketing Exclusivity
Page 118 - Coverage and Reimbursement
Page 119 - Anti-Kickback and False Claims Laws and Other Regulatory Matters
Page 120 - N/A
Page 121 - Affordable Health Care Act and Other Reform Initiatives
Page 122 - European Union Drug Development
Page 123 - European Union Drug Review and Approval
Page 124 - Property and Facilities
Page 125 - MANAGEMENT
Page 126 - Roni Mamluk, Ph.D.
Page 127 - Non-Employee Directors
Page 128 - Vincent Miles, Ph.D.
Page 129 - Board Composition and Election of Directors
Page 130 - Staggered Board
Page 131 - Compensation Committee
Page 132 - Nominating and Corporate Governance Committee
Page 133 - Code of Business Conduct and Ethics
Page 134 - EXECUTIVE COMPENSATION
Page 135 - 2014 Outstanding Equity Awards at Fiscal Year-End
Page 136 - Roni Mamluk, Ph.D.
Page 137 - Chaime Orlev.
Page 138 - 2014 Director Compensation
Page 139 - Compensation Risk Assessment
Page 140 - 2008 Stock Incentive Plan
Page 141 - 2015 Stock Option and Incentive Plan
Page 142 - N/A
Page 143 - Employee Stock Purchase Plan
Page 144 - Senior Executive Cash Incentive Bonus Plan
Page 145 - 401(k) Plan
Page 146 - CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS
Page 147 - Series D Financing
Page 148 - Exchange of Previously Outstanding Preferred Stock
Page 149 - Indemnification Agreements
Page 150 - Services and Consulting Agreement
Page 151 - N/A
Page 152 - PRINCIPAL STOCKHOLDERS
Page 153 - N/A
Page 154 - N/A
Page 155 - N/A
Page 156 - DESCRIPTION OF CAPITAL STOCK
Page 157 - Registration Rights
Page 158 - Expiration of Registration Rights
Page 159 - Authorized but Unissued Shares
Page 160 - Transfer Agent and Registrar
Page 161 - SHARES ELIGIBLE FOR FUTURE SALE
Page 162 - Lock-up Agreements
Page 163 - MATERIAL UNITED STATES FEDERAL INCOME TAX CONSIDERATIONS
Page 164 - This discussion is for general information only and is not tax advice. Accordingly, all prospective
Page 165 - Gain on Sale, Exchange or Other Disposition of Our Common Stock
Page 166 - Withholding and Information Reporting Requirements FATCA
Page 167 - UNDERWRITING
Page 168 - Option to Purchase Additional Shares
Page 169 - Offering Price Determination
Page 170 - Stabilization, Short Positions and Penalty Bids
Page 171 - Listing on The NASDAQ Global Market
Page 172 - European Economic Area
Page 173 - Notice to Investors in Israel
Page 174 - LEGAL MATTERS
Page 175 - INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
Page 176 - CHIASMA, INC.
Page 177 - CHIASMA, INC.
Page 178 - CHIASMA, INC.
Page 179 - CHIASMA, INC.
Page 180 - CHIASMA, INC.
Page 181 - Use of Estimates
Page 182 - N/A
Page 183 - 3. Accrued Expenses and Other Current Liabilities
Page 184 - 6. Warrants
Page 185 - 9. Subsequent events
Page 186 - REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
Page 187 - CHIASMA, INC.
Page 188 - CHIASMA, INC.
Page 189 - CHIASMA, INC.
Page 190 - CHIASMA, INC.
Page 191 - CHIASMA, INC.
Page 192 - CHIASMA, INC.
Page 193 - Use of estimates
Page 194 - Concentrations of credit risk
Page 195 - Employment termination costs
Page 196 - Long-term purchase obligation
Page 197 - Warrants
Page 198 - Contingent liabilities
Page 199 - 3. Net Loss Per Share Attributable to Common Stockholders
Page 200 - 5. Accrued Expenses and Other Current Liabilities
Page 201 - 6. License Agreement
Page 202 - 8. Warrants
Page 203 - 9. Redeemable Convertible Preferred Stock
Page 204 - Optional conversion
Page 205 - 10. Common Stock
Page 206 - Stock options
Page 207 - 12. Income Taxes
Page 208 - N/A
Page 209 - N/A
Page 210 - 13. Commitments and Contingencies
Page 211 - 15. Employee Benefit Plan
Page 212 - 5,360,000 Shares
Page 213 - Part II
Page 214 - Item 15. Recent Sales of Unregistered Securities
Page 215 - Item 16. Exhibits and financial statement schedules
Page 216 - N/A
Page 217 - SIGNATURES
Page 218 - EXHIBIT INDEX
Subdocument 2 - EX-1.1 - EX-1.1
Page 1 - Exhibit 1.1
Page 2 - Effective Date
Page 3 - Statement
Page 4 - provided
Page 5 - Subsidiary
Page 6 - FINRA
Page 7 - Critical Accounting Policies
Page 8 - Permits
Page 9 - Intellectual Property
Page 10 - N/A
Page 11 - Environmental Laws
Page 12 - ERISA
Page 13 - FCPA
Page 14 - Money Laundering Laws
Page 15 - Applicable Laws
Page 16 - Regulatory Authorities
Page 17 - Offering of Stock by the Underwriters
Page 18 - Further Agreements of the Company and the Underwriters
Page 19 - EDGAR
Page 20 - Lock-Up Period
Page 21 - N/A
Page 22 - Permitted Issuer Information
Page 23 - provided
Page 24 - initial letter
Page 25 - provided
Page 26 - N/A
Page 27 - Indemnification and Contribution.
Page 28 - provided
Page 29 - provided, however
Page 30 - N/A
Page 31 - Defaulting Underwriters
Page 32 - provided
Page 33 - Notices, etc.
Page 34 - business day
Page 35 - N/A
Page 36 - N/A
Page 37 - SCHEDULE I
Page 38 - SCHEDULE II
Page 39 - N/A
Page 40 - N/A
Page 41 - SCHEDULE III
Page 42 - SCHEDULE IV
Page 43 - SCHEDULE V
Page 44 - SCHEDULE VI
Page 45 - EXHIBIT A
Page 46 - Securities Act
Page 47 - Exchange Act
Page 48 - N/A
Page 49 - EXHIBIT B
Subdocument 3 - EX-3.1 - EX-3.1
Page 1 - Exhibit 3.1
Page 2 - ARTICLE IV
Page 3 - Series E Original Issue Price
Page 4 - Series E Liquidation Amount
Page 5 - Series C Liquidation Amount
Page 6 - Deemed Liquidation Events
Page 7 - Available Proceeds
Page 8 - Initial Consideration
Page 9 - Fractional Shares
Page 10 - Effect of Conversion
Page 11 - Certain Dividends and Distributions
Page 12 - Adjustments to Conversion Price for Dilutive Issues
Page 13 - Series E Purchase Agreement
Page 14 - N/A
Page 15 - Adjustment of Conversion Price Upon Issuance of Additional Shares of Common Stock
Page 16 - Determination of Consideration
Page 17 - Certificate as to Adjustments
Page 18 - Mandatory Conversion Time
Page 19 - Election of Directors
Page 20 - N/A
Page 21 - Status of Converted Preferred Stock
Page 22 - Series B1 Call Redemption Date
Page 23 - Rights Subsequent to Redemption
Page 24 - Notices
Page 25 - ARTICLE V
Page 26 - Covered Persons
Page 27 - N/A
Page 28 - IN WITNESS WHEREOF
Subdocument 4 - EX-4.1 - EX-4.1
Page 1 - Exhibit 4.1
Page 2 - N/A
Subdocument 5 - EX-5.1 - EX-5.1
Page 1 - Exhibit 5.1
Page 2 - N/A
Subdocument 6 - EX-10.3 - EX-10.3
Page 1 - Exhibit 10.3
Page 2 - Covered Employee
Page 3 - Performance Criteria
Page 4 - Sale Event
Page 5 - Delegation of Authority to Grant Awards
Page 6 - Foreign Award Recipients
Page 7 - Changes in Stock
Page 8 - Award of Stock Options
Page 9 - Option Term
Page 10 - Annual Limit on Incentive Stock Options
Page 11 - Restrictions
Page 12 - Election to Receive Restricted Stock Units in Lieu of Compensation
Page 13 - Nature of Performance Share Awards
Page 14 - Payment of Performance-Based Awards
Page 15 - Administrator Action
Page 16 - Termination of Employment
Page 17 - No Distribution
Page 18 - Stockholder Rights
Page 19 - CHIASMA, INC.
Page 20 - N/A
Page 21 - N/A
Page 22 - N/A
Page 23 - N/A
Page 24 - INCENTIVE STOCK OPTION AGREEMENT
Page 25 - Manner of Exercise
Page 26 - Termination of Employment
Page 27 - Incorporation of Plan
Page 28 - Integration
Page 29 - Notices
Page 30 - NON-QUALIFIED STOCK OPTION AGREEMENT
Page 31 - Manner of Exercise
Page 32 - Termination of Employment
Page 33 - Incorporation of Plan
Page 34 - Notices
Page 35 - NON-QUALIFIED STOCK OPTION AGREEMENT
Page 36 - Manner of Exercise
Page 37 - Termination as Director
Page 38 - No Obligation to Continue as a Director
Page 39 - Notices
Page 40 - NON-QUALIFIED STOCK OPTION AGREEMENT
Page 41 - Manner of Exercise
Page 42 - Termination as Consultant
Page 43 - Notices
Page 44 - RESTRICTED STOCK UNIT AWARD AGREEMENT
Page 45 - Issuance of Shares of Stock
Page 46 - Notices
Page 47 - RESTRICTED STOCK UNIT AWARD AGREEMENT
Page 48 - Issuance of Shares of Stock
Page 49 - Notices
Page 50 - RESTRICTED STOCK AWARD AGREEMENT
Page 51 - Dividends
Page 52 - No Obligation to Continue Employment
Page 53 - Notices
Page 54 - CHIASMA, INC.
Page 55 - N/A
Page 56 - N/A
Page 57 - TRUST AND SERVICES AGREEMENT ( Agreement )
Page 58 - NOW THEREFORE the parties hereby agree as follows:
Page 59 - N/A
Page 60 - N/A
Page 61 - N/A
Page 62 - N/A
Page 63 - Company s Account
Page 64 - Terminated Employee
Page 65 - N/A
Page 66 - Exhibit 15
Page 67 - Chiasma, Inc.
Page 68 - Chiasma (Israel) Ltd.
Page 69 - IN WITNESS WHEREOF
Page 70 - Exhibit 8.1
Page 71 - Annex 1
Page 72 - Exhibit 8.2
Page 73 - Annex 2
Page 74 - Exhibit 8.3
Page 75 - Exhibit 8.4
Page 76 - Annex 4
Page 77 - Exhibit 8.5
Page 78 - Annex 5
Page 79 - Exhibit 10.7
Page 80 - Employee s details:
Page 81 - Exhibit 15
Subdocument 7 - EX-10.4 - EX-10.4
Page 1 - Exhibit 10.4
Page 2 - Offerings
Page 3 - Participation
Page 4 - Employee Contributions
Page 5 - Grant of Options
Page 6 - Exercise of Option and Purchase of Shares
Page 7 - Rights on Termination of Employment
Page 8 - Special Rules
Page 9 - Rights Not Transferable
Page 10 - Termination of the Plan
Page 11 - APPENDIX A
Page 12 - CHIASMA, INC.
Page 13 - N/A
Page 14 - N/A
Page 15 - N/A
Page 16 - N/A
Page 17 - CHIASMA, INC.
Page 18 - N/A
Page 19 - 2015 Employee Stock Purchase Plan
Page 20 - TRUST AND SERVICES AGREEMENT ( Agreement )
Page 21 - NOW THEREFORE the parties hereby agree as follows:
Page 22 - N/A
Page 23 - N/A
Page 24 - N/A
Page 25 - N/A
Page 26 - Company s Account
Page 27 - Terminated Employee
Page 28 - N/A
Page 29 - Exhibit 15
Page 30 - Chiasma, Inc.
Page 31 - Chiasma (Israel) Ltd.
Page 32 - IN WITNESS WHEREOF
Page 33 - Exhibit 8.1
Page 34 - Annex 1
Page 35 - Exhibit 8.2
Page 36 - Annex 2
Page 37 - Exhibit 8.3
Page 38 - Exhibit 8.4
Page 39 - Annex 4
Page 40 - Exhibit 8.5
Page 41 - Annex 5
Page 42 - Exhibit 10.7
Page 43 - Employee s details:
Page 44 - Exhibit 15
Subdocument 8 - EX-10.10 - EX-10.10
Page 1 - Exhibit 10.10
Page 2 - Services to the Company
Page 3 - Corporate Status
Page 4 - Proceeding
Page 5 - Indemnification for Expenses of a Party Who is Wholly or Partly Successful
Page 6 - Advancement of Expenses
Page 7 - Procedure Upon Application for Indemnification
Page 8 - Presumptions and Effect of Certain Proceedings
Page 9 - N/A
Page 10 - Non-exclusivity; Survival of Rights; Insurance; [Primacy of Indemnification;]3 Subrogation
Page 11 - Fund Indemnitors
Page 12 - Severability
Page 13 - Notices
Page 14 - Headings
Page 15 - N/A
Page 16 - Exhibit A
Subdocument 9 - EX-10.13 - EX-10.13
Page 1 - Exhibit 10.13
Page 2 - Expenses
Subdocument 10 - EX-23.1 - EX-23.1
Page 1 - Exhibit 23.1