SEC Filings


Form S-1/A
TOCAGEN INC filed this Form S-1/A on 04/03/2017
Document Outline
Entire Document (5142.3 KB)
Subdocument 1 - S-1/A - S-1/A
Page 1 - Registration No. 333-216574
Page 2 - The information in this prospectus is not complete and may be changed. We may not sell these securit
Page 3 - TABLE OF CONTENTS
Page 4 - PROSPECTUS SUMMARY
Page 5 - N/A
Page 6 - Science
Page 7 - Our Pipeline
Page 8 - Risks Associated with Our Business
Page 9 - Corporate and Other 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 - Immunotherapy, gene therapy and biopharmaceutical product development is a highly speculative undert
Page 17 - Our gene therapy product candidates are based on novel technology, which makes it difficult to predi
Page 18 - Failure to successfully develop and obtain approval of our lead product candidate, Toca 511 Toca FC,
Page 19 - The FDA regulatory approval process is lengthy and time-consuming, and we may experience significant
Page 20 - N/A
Page 21 - Our clinical trials may fail to demonstrate safety and efficacy and any of our product candidates co
Page 22 - In third-party clinical trials involving other viral vectors for gene therapy, some patients experie
Page 23 - We may not be successful in our efforts to identify or discover additional product candidates from o
Page 24 - We expect to continue to rely on third parties to distribute, manufacture and perform release testin
Page 25 - Our reliance on third parties may require us to share our trade secrets, which increases the possibi
Page 26 - We face intense competition and rapid technological change and the possibility that our competitors
Page 27 - We are highly dependent on our key personnel, and if we are not successful in attracting and retaini
Page 28 - We may use our financial and human resources to pursue a particular research program or product cand
Page 29 - A variety of risks associated with marketing our product candidates internationally could materially
Page 30 - If product liability lawsuits are brought against us, we may incur substantial liabilities and may b
Page 31 - Negative public opinion and increased regulatory scrutiny of gene therapy and genetic research may d
Page 32 - Obtaining and maintaining regulatory approval of our product candidates in one jurisdiction does not
Page 33 - Additional time may be required to obtain regulatory approval for Toca 511 Toca FC because it is a c
Page 34 - We have Orphan-Drug Designation for Toca 511 Toca FC for the treatment of GBM, but we may be unable
Page 35 - A Fast Track Designation or Breakthrough Therapy Designation by the FDA may not actually lead to a f
Page 36 - We may be subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, fal
Page 37 - N/A
Page 38 - Coverage and reimbursement may be limited or unavailable in certain market segments for our product
Page 39 - N/A
Page 40 - Due to the novel nature of our technology and the small size of our initial target patient populatio
Page 41 - If we fail to comply with environmental, health and safety laws and regulations, we could become sub
Page 42 - Third-party claims of intellectual property infringement may prevent or delay our development and co
Page 43 - We may not be successful in obtaining or maintaining necessary rights to gene therapy product compon
Page 44 - We may be involved in lawsuits to protect or enforce our patents or the patents of our licensors, wh
Page 45 - Obtaining and maintaining our patent protection depends on compliance with various procedural, docum
Page 46 - We may be subject to claims that our employees, consultants or independent contractors have wrongful
Page 47 - We may not be able to protect our intellectual property rights throughout the world.
Page 48 - The market price of our common stock may be highly volatile, and you may not be able to resell your
Page 49 - We do not intend to pay dividends on our common stock so any returns will be limited to the value of
Page 50 - We will incur significant increased costs as a result of operating as a public company, and our mana
Page 51 - Future sales and issuances of our common stock or rights to purchase common stock, including pursuan
Page 52 - Our ability to use our net operating loss carryforwards and certain other tax attributes may be limi
Page 53 - Our amended and restated certificate of incorporation and amended and restated bylaws will provide t
Page 54 - Because we will have an even number of members of our board of directors, deadlocks may occur in our
Page 55 - SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
Page 56 - N/A
Page 57 - USE OF PROCEEDS
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 FINANCIAL DATA
Page 65 - N/A
Page 66 - MANAGEMENT S DISCUSSION AND ANALYSIS OF
Page 67 - Financial Operations Overview
Page 68 - General and Administrative Expenses
Page 69 - Interest Expense
Page 70 - Stock-Based Compensation
Page 71 - Determination of the Fair Value of Common Stock
Page 72 - Audit and Accounting Practice Aid Series: Valuation of Privately Held Company Equity Securities Issu
Page 73 - Methods Used to Allocate Our Enterprise Value to Classes of Securities
Page 74 - Income Taxes
Page 75 - Emerging Growth Company Status
Page 76 - Recent Accounting Pronouncements
Page 77 - Results of Operations
Page 78 - Cash Flows
Page 79 - Investing Activities.
Page 80 - Contractual Obligations and Commitments
Page 81 - Quantitative and Qualitative Disclosures about Market Risk
Page 82 - Off-Balance Sheet Arrangements
Page 83 - BUSINESS
Page 84 - Science
Page 85 - Our Proprietary Technology Platform: Harnessing Cancer Immunotherapy and Gene Therapy Together to Fi
Page 86 - Our Pipeline
Page 87 - Immunotherapy and the Emergence of Cancer-Selective Immunotherapy
Page 88 - Our Approach to Immunotherapy
Page 89 - RRV budding from an infected cell
Page 90 - Our RRV Structure
Page 91 - Toca 511 construct optimized for genomic stability
Page 92 - Our Lead Product Candidate: Toca 511 Toca FC
Page 93 - Toca 511 Toca FC is designed to selectively transform cancer cells into chemotherapy factories of 5-
Page 94 - Clinical Development of Toca 511 Toca FC
Page 95 - New England Journal of Medicine
Page 96 - Ongoing Resection Injection Trial
Page 97 - Resection Study: All Responses are in the Higher Dose Cohort
Page 98 - Resection Study: Long-Term Survival in Higher Dose Cohort
Page 99 - N/A
Page 100 - N/A
Page 101 - N/A
Page 102 - Ongoing Intratumoral Injection Trial
Page 103 - Survival By Delivery Univariate Analysis
Page 104 - N/A
Page 105 - Histochemical analysis of serial sections of tumor from a patient stained to show tissue architectur
Page 106 - Adverse Events Related to Toca 511 Pooled Across Studies
Page 107 - Ongoing Intravenous Clinical Trial
Page 108 - Ascending Doses of Toca 511 and 5-FC Increases Survival
Page 109 - In immune deficient mice Toca 511 and 5-FC controlled but did not eliminate human brain cancer cells
Page 110 - Rejection of re-challenge with same tumor in mouse model
Page 111 - Toca 511 and 5-FC reduces tumor burden in mouse glioma
Page 112 - Toca 511 and 5-FC activate Immune System in Tumor Micro-Environment
Page 113 - MDSC level after Toca 511 and one cycle of 5-FC
Page 114 - Preclinical Studies in Other Cancer Types
Page 115 - Survival, cure rates and anti-tumor responses in colorectal cancer model
Page 116 - Systemic 5-FU: significant toxicity but no survival benefit
Page 117 - Manufacturing
Page 118 - in vitro
Page 119 - Grants
Page 120 - Competition
Page 121 - Government Regulation
Page 122 - U.S. Combination Products Development Process
Page 123 - N/A
Page 124 - in vitro
Page 125 - U.S. Review and Approval Processes
Page 126 - N/A
Page 127 - Orphan-Drug Designation
Page 128 - N/A
Page 129 - Post-Approval Requirements
Page 130 - Biosimilars and Exclusivity
Page 131 - Additional U.S. Regulation
Page 132 - N/A
Page 133 - Coverage and Reimbursement
Page 134 - N/A
Page 135 - Environmental Regulation
Page 136 - Legal Proceedings
Page 137 - MANAGEMENT
Page 138 - Dennis N. Berman
Page 139 - Douglas Jolly, Ph.D.
Page 140 - Paul Schimmel, Ph.D.
Page 141 - Board Composition
Page 142 - Role of the Board in Risk Oversight
Page 143 - Compensation Committee
Page 144 - Nominating and Corporate Governance Committee
Page 145 - Limitation of Liability and Indemnification
Page 146 - EXECUTIVE AND DIRECTOR COMPENSATION
Page 147 - Annual Base Salary
Page 148 - N/A
Page 149 - Agreements with Named Executive Officers
Page 150 - Potential Payments and Benefits upon Termination or Change in Control
Page 151 - Option Repricings
Page 152 - Equity Benefit Plans
Page 153 - Administration
Page 154 - Tax Limitations On Incentive Stock Options
Page 155 - N/A
Page 156 - Other Stock Awards
Page 157 - Amendment and Termination
Page 158 - Stock Options
Page 159 - Change in Control
Page 160 - Administration
Page 161 - Plan Amendments, Termination
Page 162 - N/A
Page 163 - CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS
Page 164 - Employment and Consulting Arrangements
Page 165 - Stock Options Granted to Executive Officers and Directors
Page 166 - N/A
Page 167 - PRINCIPAL STOCKHOLDERS
Page 168 - N/A
Page 169 - N/A
Page 170 - DESCRIPTION OF CAPITAL STOCK
Page 171 - Rights and Preferences
Page 172 - Grants
Page 173 - Amended and Restated Certificate of Incorporation and Amended and Restated Bylaws
Page 174 - NASDAQ Global Market Listing
Page 175 - SHARES ELIGIBLE FOR FUTURE SALE
Page 176 - Rule 701
Page 177 - Equity Incentive Plans
Page 178 - MATERIAL U.S. FEDERAL INCOME TAX CONSEQUENCES
Page 179 - Distributions on Our Common Stock
Page 180 - Information Reporting Requirements and Backup Withholding
Page 181 - N/A
Page 182 - UNDERWRITING
Page 183 - Option to Purchase Additional Shares
Page 184 - Price Stabilization, Short Positions and Penalty Bids
Page 185 - Other Relationships
Page 186 - N/A
Page 187 - LEGAL MATTERS
Page 188 - Tocagen Inc.
Page 189 - REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
Page 190 - Tocagen Inc.
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Page 218 - Tocagen Inc.
Page 219 - Tocagen Inc.
Page 220 - 7,250,000 Shares
Page 221 - PART II
Page 222 - N/A
Page 223 - Item 15. Recent sales of unregistered securities.
Page 224 - Item 16. Exhibits and financial statement schedules.
Page 225 - SIGNATURES
Page 226 - EXHIBIT INDEX
Subdocument 2 - EX-3.1 - EX-3.1
Page 1 - Exhibit 3.1
Page 2 - C.
Page 3 - L.
Page 4 - (e)
Page 5 - (a)
Page 6 - (c)
Page 7 - (c)
Page 8 - (A)
Page 9 - Qualifying Series H Dilutive Issuance
Page 10 - (A)
Page 11 - (A)
Page 12 - (vi)
Page 13 - (k)
Page 14 - (l)
Page 15 - C.
Page 16 - FOUR:
Page 17 - IN WITNESS WHEREOF
Page 18 - CERTIFICATE OF AMENDMENT TO
Page 19 - IN WITNESS WHEREOF
Subdocument 3 - EX-4.1 - EX-4.1
Page 1 - Exhibit 4.1
Page 2 - N/A
Subdocument 4 - EX-5.1 - EX-5.1
Page 1 - Exhibit 5.1
Page 2 - COOLEY LLP
Subdocument 5 - EX-10.3 - EX-10.3
Page 1 - Exhibit 10.3
Page 2 - 2. ADMINISTRATION.
Page 3 - (vii)
Page 4 - (c) Delegation to Committee.
Page 5 - (b) Reversion of Shares to the Share Reserve.
Page 6 - (ii)
Page 7 - 5. PROVISIONS RELATING TO OPTIONS AND STOCK APPRECIATION RIGHTS.
Page 8 - provided, however
Page 9 - (f) Vesting Generally.
Page 10 - (i) Disability of Participant.
Page 11 - 6. PROVISIONS OF STOCK AWARDS OTHER THAN OPTIONS AND SARS.
Page 12 - (i) Consideration.
Page 13 - (ii) Performance Cash Awards
Page 14 - 7. COVENANTS OF THE COMPANY.
Page 15 - (c) Stockholder Rights.
Page 16 - (h) Withholding Obligations.
Page 17 - (l) Clawback/Recovery
Page 18 - provided, however
Page 19 - (d) Change in Control.
Page 20 - (d)
Page 21 - IPO Entities
Page 22 - (v)
Page 23 - (o)
Page 24 - (u)
Page 25 - Regulation S-K
Page 26 - (ll)
Page 27 - (oo)
Page 28 - (tt)
Page 29 - TOCAGEN INC.
Page 30 - Additional Terms/Acknowledgements:
Page 31 - ATTACHMENT I
Page 32 - (a)
Page 33 - 6. WHOLE SHARES.
Page 34 - (d)
Page 35 - Lock-Up Period
Page 36 - 12. WITHHOLDING OBLIGATIONS.
Page 37 - 14. NOTICES.
Page 38 - 20. MISCELLANEOUS
Page 39 - ATTACHMENT II
Page 40 - ATTACHMENT III
Page 41 - N/A
Page 42 - TOCAGEN INC.
Page 43 - Additional Terms/Acknowledgements:
Page 44 - ATTACHMENT I
Page 45 - (b)
Page 46 - 2. NUMBER OF SHARES AND EXERCISE PRICE.
Page 47 - (d)
Page 48 - 8. TERM.
Page 49 - 9. EXERCISE.
Page 50 - 10. TRANSFERABILITY.
Page 51 - (b)
Page 52 - 15. GOVERNING PLAN DOCUMENT.
Page 53 - (c)
Page 54 - ATTACHMENT II
Page 55 - ATTACHMENT III
Page 56 - N/A
Page 57 - TOCAGEN INC.
Page 58 - Additional Terms/Acknowledgements:
Page 59 - ATTACHMENT I
Page 60 - 2. NUMBER OF SHARES AND EXERCISE PRICE.
Page 61 - 4. EXERCISE PRIOR TO VESTING ( EARLY EXERCISE ).
Page 62 - (c)
Page 63 - 9. EXERCISE.
Page 64 - 10. TRANSFERABILITY.
Page 65 - 12. WITHHOLDING OBLIGATIONS.
Page 66 - 15. GOVERNING PLAN DOCUMENT.
Page 67 - 20. MISCELLANEOUS
Page 68 - ATTACHMENT II
Page 69 - ATTACHMENT III
Page 70 - N/A
Subdocument 6 - EX-10.4 - EX-10.4
Page 1 - Exhibit 10.4
Page 2 - (viii)
Page 3 - (b)
Page 4 - (i)
Page 5 - (c)
Page 6 - (c)
Page 7 - (a)
Page 8 - (a)
Page 9 - (c)
Page 10 - (i)
Page 11 - (ii)
Page 12 - (aa)
Subdocument 7 - EX-10.5 - EX-10.5
Page 1 - Exhibit 10.5
Page 2 - Initial Grant
Subdocument 8 - EX-23.1 - EX-23.1
Page 1 - N/A