SEC Filings


Form 424B4
TOCAGEN INC filed this Form 424B4 on 04/13/2017
Document Outline
Entire Document (4198.5 KB)
Subdocument 1 - 424B4 - 424B4
Page 1 - Filed pursuant to Rule 424(b)(4)
Page 2 - TABLE OF CONTENTS
Page 3 - PROSPECTUS SUMMARY
Page 4 - N/A
Page 5 - Science
Page 6 - Our Pipeline
Page 7 - Risks Associated with Our Business
Page 8 - Corporate and Other Information
Page 9 - N/A
Page 10 - The Offering
Page 11 - N/A
Page 12 - Summary Financial Data
Page 13 - N/A
Page 14 - RISK FACTORS
Page 15 - Immunotherapy, gene therapy and biopharmaceutical product development is a highly speculative undert
Page 16 - Our gene therapy product candidates are based on novel technology, which makes it difficult to predi
Page 17 - Failure to successfully develop and obtain approval of our lead product candidate, Toca 511 Toca FC,
Page 18 - The FDA regulatory approval process is lengthy and time-consuming, and we may experience significant
Page 19 - N/A
Page 20 - Our clinical trials may fail to demonstrate safety and efficacy and any of our product candidates co
Page 21 - In third-party clinical trials involving other viral vectors for gene therapy, some patients experie
Page 22 - We may not be successful in our efforts to identify or discover additional product candidates from o
Page 23 - We expect to continue to rely on third parties to distribute, manufacture and perform release testin
Page 24 - Our reliance on third parties may require us to share our trade secrets, which increases the possibi
Page 25 - We face intense competition and rapid technological change and the possibility that our competitors
Page 26 - We are highly dependent on our key personnel, and if we are not successful in attracting and retaini
Page 27 - We may use our financial and human resources to pursue a particular research program or product cand
Page 28 - A variety of risks associated with marketing our product candidates internationally could materially
Page 29 - If product liability lawsuits are brought against us, we may incur substantial liabilities and may b
Page 30 - Negative public opinion and increased regulatory scrutiny of gene therapy and genetic research may d
Page 31 - Obtaining and maintaining regulatory approval of our product candidates in one jurisdiction does not
Page 32 - Additional time may be required to obtain regulatory approval for Toca 511 Toca FC because it is a c
Page 33 - We have Orphan-Drug Designation for Toca 511 Toca FC for the treatment of GBM, but we may be unable
Page 34 - A Fast Track Designation or Breakthrough Therapy Designation by the FDA may not actually lead to a f
Page 35 - We may be subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, fal
Page 36 - N/A
Page 37 - Coverage and reimbursement may be limited or unavailable in certain market segments for our product
Page 38 - N/A
Page 39 - Due to the novel nature of our technology and the small size of our initial target patient populatio
Page 40 - If we fail to comply with environmental, health and safety laws and regulations, we could become sub
Page 41 - Third-party claims of intellectual property infringement may prevent or delay our development and co
Page 42 - We may not be successful in obtaining or maintaining necessary rights to gene therapy product compon
Page 43 - We may be involved in lawsuits to protect or enforce our patents or the patents of our licensors, wh
Page 44 - Obtaining and maintaining our patent protection depends on compliance with various procedural, docum
Page 45 - We may be subject to claims that our employees, consultants or independent contractors have wrongful
Page 46 - We may not be able to protect our intellectual property rights throughout the world.
Page 47 - The market price of our common stock may be highly volatile, and you may not be able to resell your
Page 48 - We do not intend to pay dividends on our common stock so any returns will be limited to the value of
Page 49 - We will incur significant increased costs as a result of operating as a public company, and our mana
Page 50 - Future sales and issuances of our common stock or rights to purchase common stock, including pursuan
Page 51 - Our ability to use our net operating loss carryforwards and certain other tax attributes may be limi
Page 52 - Our amended and restated certificate of incorporation and amended and restated bylaws will provide t
Page 53 - Because we will have an even number of members of our board of directors, deadlocks may occur in our
Page 54 - SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
Page 55 - N/A
Page 56 - USE OF PROCEEDS
Page 57 - DIVIDEND POLICY
Page 58 - CAPITALIZATION
Page 59 - N/A
Page 60 - DILUTION
Page 61 - N/A
Page 62 - SELECTED FINANCIAL DATA
Page 63 - N/A
Page 64 - MANAGEMENT S DISCUSSION AND ANALYSIS OF
Page 65 - Financial Operations Overview
Page 66 - General and Administrative Expenses
Page 67 - Interest Expense
Page 68 - Stock-Based Compensation
Page 69 - Determination of the Fair Value of Common Stock
Page 70 - Audit and Accounting Practice Aid Series: Valuation of Privately Held Company Equity Securities Issu
Page 71 - Methods Used to Allocate Our Enterprise Value to Classes of Securities
Page 72 - Income Taxes
Page 73 - Emerging Growth Company Status
Page 74 - Recent Accounting Pronouncements
Page 75 - Results of Operations
Page 76 - Cash Flows
Page 77 - Investing Activities.
Page 78 - Contractual Obligations and Commitments
Page 79 - Quantitative and Qualitative Disclosures about Market Risk
Page 80 - Off-Balance Sheet Arrangements
Page 81 - BUSINESS
Page 82 - Science
Page 83 - Our Proprietary Technology Platform: Harnessing Cancer Immunotherapy and Gene Therapy Together to Fi
Page 84 - Our Pipeline
Page 85 - Immunotherapy and the Emergence of Cancer-Selective Immunotherapy
Page 86 - Our Approach to Immunotherapy
Page 87 - RRV budding from an infected cell
Page 88 - Our RRV Structure
Page 89 - Toca 511 construct optimized for genomic stability
Page 90 - Our Lead Product Candidate: Toca 511 Toca FC
Page 91 - Toca 511 Toca FC is designed to selectively transform cancer cells into chemotherapy factories of 5-
Page 92 - Clinical Development of Toca 511 Toca FC
Page 93 - New England Journal of Medicine
Page 94 - Ongoing Resection Injection Trial
Page 95 - Resection Study: All Responses are in the Higher Dose Cohort
Page 96 - Resection Study: Long-Term Survival in Higher Dose Cohort
Page 97 - N/A
Page 98 - N/A
Page 99 - N/A
Page 100 - Ongoing Intratumoral Injection Trial
Page 101 - Survival By Delivery Univariate Analysis
Page 102 - N/A
Page 103 - Histochemical analysis of serial sections of tumor from a patient stained to show tissue architectur
Page 104 - Adverse Events Related to Toca 511 Pooled Across Studies
Page 105 - Ongoing Intravenous Clinical Trial
Page 106 - Ascending Doses of Toca 511 and 5-FC Increases Survival
Page 107 - In immune deficient mice Toca 511 and 5-FC controlled but did not eliminate human brain cancer cells
Page 108 - Rejection of re-challenge with same tumor in mouse model
Page 109 - Toca 511 and 5-FC reduces tumor burden in mouse glioma
Page 110 - Toca 511 and 5-FC activate Immune System in Tumor Micro-Environment
Page 111 - MDSC level after Toca 511 and one cycle of 5-FC
Page 112 - Preclinical Studies in Other Cancer Types
Page 113 - Survival, cure rates and anti-tumor responses in colorectal cancer model
Page 114 - Systemic 5-FU: significant toxicity but no survival benefit
Page 115 - Manufacturing
Page 116 - in vitro
Page 117 - Grants
Page 118 - Competition
Page 119 - Government Regulation
Page 120 - U.S. Combination Products Development Process
Page 121 - N/A
Page 122 - in vitro
Page 123 - U.S. Review and Approval Processes
Page 124 - N/A
Page 125 - Orphan-Drug Designation
Page 126 - N/A
Page 127 - Post-Approval Requirements
Page 128 - Biosimilars and Exclusivity
Page 129 - Additional U.S. Regulation
Page 130 - N/A
Page 131 - Coverage and Reimbursement
Page 132 - N/A
Page 133 - Environmental Regulation
Page 134 - Legal Proceedings
Page 135 - MANAGEMENT
Page 136 - Dennis N. Berman
Page 137 - Douglas Jolly, Ph.D.
Page 138 - Paul Schimmel, Ph.D.
Page 139 - Board Composition
Page 140 - Role of the Board in Risk Oversight
Page 141 - Compensation Committee
Page 142 - Nominating and Corporate Governance Committee
Page 143 - Limitation of Liability and Indemnification
Page 144 - EXECUTIVE AND DIRECTOR COMPENSATION
Page 145 - Annual Base Salary
Page 146 - N/A
Page 147 - Agreements with Named Executive Officers
Page 148 - Potential Payments and Benefits upon Termination or Change in Control
Page 149 - Option Repricings
Page 150 - Equity Benefit Plans
Page 151 - Administration
Page 152 - Tax Limitations On Incentive Stock Options
Page 153 - N/A
Page 154 - Other Stock Awards
Page 155 - Amendment and Termination
Page 156 - Stock Options
Page 157 - Change in Control
Page 158 - Administration
Page 159 - Plan Amendments, Termination
Page 160 - N/A
Page 161 - CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS
Page 162 - Employment and Consulting Arrangements
Page 163 - Stock Options Granted to Executive Officers and Directors
Page 164 - N/A
Page 165 - PRINCIPAL STOCKHOLDERS
Page 166 - N/A
Page 167 - N/A
Page 168 - DESCRIPTION OF CAPITAL STOCK
Page 169 - Rights and Preferences
Page 170 - Grants
Page 171 - Amended and Restated Certificate of Incorporation and Amended and Restated Bylaws
Page 172 - NASDAQ Global Select Market Listing
Page 173 - SHARES ELIGIBLE FOR FUTURE SALE
Page 174 - Rule 701
Page 175 - Equity Incentive Plans
Page 176 - MATERIAL U.S. FEDERAL INCOME TAX CONSEQUENCES
Page 177 - Distributions on Our Common Stock
Page 178 - Information Reporting Requirements and Backup Withholding
Page 179 - N/A
Page 180 - UNDERWRITING
Page 181 - Option to Purchase Additional Shares
Page 182 - Price Stabilization, Short Positions and Penalty Bids
Page 183 - Other Relationships
Page 184 - N/A
Page 185 - LEGAL MATTERS
Page 186 - Tocagen Inc.
Page 187 - REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
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