SEC Filings

Form 10-K
CATABASIS PHARMACEUTICALS INC filed this Form 10-K on 03/16/2017
Document Outline
Entire Document (4363.3 KB)
Subdocument 1 - 10-K - 10-K
Page 1 - UNITED STATES
Page 2 - TABLE OF CONTENTS
Page 3 - SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS AND INDUSTRY DATA
Page 4 - REFERENCES TO CATABASIS
Page 5 - PART I
Page 6 - Pseudomonas aeruginosa
Page 7 - SMART Linker Drug Discovery Platform
Page 8 - Our Product Candidates
Page 9 - Overview of DMD
Page 10 - Edasalonexent Clinical Development
Page 11 - N/A
Page 12 - Completed Clinical Trials
Page 13 - Edasalonexent Completed Phase 1 Clinical Trials
Page 14 - ex vivo
Page 15 - mdx Mouse Model.
Page 16 - CAT-5571
Page 17 - CAT-4001
Page 18 - CAT-2000 Series
Page 19 - Edasalonexent for Duchenne Muscular Dystrophy
Page 20 - Intellectual Property
Page 21 - Government Regulation and Product Approvals
Page 22 - Review and Approval of Drugs in the United States
Page 23 - The IND and IRB Processes
Page 24 - Human Clinical Trials in Support of an NDA
Page 25 - in vitro
Page 26 - Fast Track, Breakthrough Therapy, Priority Review and Regenerative Advanced Therapy Designations
Page 27 - Accelerated Approval Pathway
Page 28 - The FDA's Decision on an NDA
Page 29 - Abbreviated New Drug Applications for Generic Drugs
Page 30 - Hatch-Waxman Patent Certification and the 30-Month Stay
Page 31 - Pediatric Studies and Exclusivity
Page 32 - Patent Term Restoration and Extension
Page 33 - The 21st Century Cures Act
Page 34 - Clinical Trial Approval
Page 35 - Data and Market Exclusivity in the European Union
Page 36 - Periods of Authorization and Renewals
Page 37 - Pharmaceutical Coverage, Pricing and Reimbursement
Page 38 - Healthcare Law and Regulation
Page 39 - N/A
Page 40 - Employees
Page 41 - Item 1A. Risk Factors
Page 42 - We have a limited operating history and no history of commercializing pharmaceutical products, which
Page 43 - N/A
Page 44 - Raising additional capital may cause dilution to our stockholders, restrict our operations or requir
Page 45 - Risks Related to the Discovery, Development and Commercialization of Our Product Candidates
Page 46 - Our SMART linker drug discovery platform may fail to help us discover and develop additional potenti
Page 47 - We have never obtained marketing approval for a product candidate and we may be unable to obtain, or
Page 48 - Because we are developing edasalonexent for the treatment of DMD, a disease for which regulatory aut
Page 49 - Clinical drug development involves a lengthy and expensive process with an uncertain outcome.
Page 50 - Adverse events or undesirable side effects caused by, or other unexpected properties of, any of our
Page 51 - N/A
Page 52 - If we, or any future collaborators, experience delays or difficulties in the enrollment of patients
Page 53 - If any of our product candidates receives marketing approval and we, or others, later discover that
Page 54 - If we are unable to establish sales, marketing and distribution capabilities or enter into sales, ma
Page 55 - We face substantial competition from other pharmaceutical and biotechnology companies, and our opera
Page 56 - If the FDA or comparable foreign regulatory authorities approve generic versions of any of our produ
Page 57 - Even if we, or any future collaborators, are able to commercialize any product candidate that we, or
Page 58 - Product liability lawsuits against us could divert our resources, cause us to incur substantial liab
Page 59 - Risks Related to Our Dependence on Third Parties
Page 60 - We rely on third parties to conduct our clinical trials. If they do not perform satisfactorily, our
Page 61 - We contract with third parties for the manufacture and distribution of our product candidates for cl
Page 62 - N/A
Page 63 - Risks Related to Our Intellectual Property
Page 64 - If we are unable to protect the confidentiality of our trade secrets, the value of our technology co
Page 65 - If we are sued for infringing intellectual property rights of third parties, such litigation could b
Page 66 - Changes to the patent law in the United States and other jurisdictions could diminish the value of p
Page 67 - Obtaining and maintaining our patent protection depends on compliance with various procedural, docum
Page 68 - Patent term may be inadequate to protect our competitive position on our products for an adequate am
Page 69 - Failure to obtain marketing approval in foreign jurisdictions would prevent our product candidates f
Page 70 - Even if we, or any future collaborators, obtain marketing approvals for our product candidates, the
Page 71 - Any of our product candidates for which we, or any future collaborators, obtain marketing approval i
Page 72 - Recently enacted and future legislation may increase the difficulty and cost for us and any future c
Page 73 - Our relationships with customers and third-party payors, among others, will be subject to applicable
Page 74 - Anti-Kickback Statute.
Page 75 - If we fail to comply with environmental, health and safety laws and regulations, we could become sub
Page 76 - We are subject to anti-corruption laws, as well as export control laws, customs laws, sanctions laws
Page 77 - We expect to grow our organization, and as a result, we may encounter difficulties in managing our g
Page 78 - If we were to be delisted from The NASDAQ Stock Market, it could make trading in our stock more diff
Page 79 - We are an "emerging growth company," and the reduced disclosure requirements applicable to emerging
Page 80 - A significant portion of our total outstanding shares may be sold into the market in the near future
Page 81 - Our executive officers, directors and principal stockholders, if they choose to act together, have t
Page 82 - Our certificate of incorporation designates the state courts in the State of Delaware or, if no stat
Page 83 - PART II
Page 84 - COMPARISON OF CUMULATIVE TOTAL RETURN*
Page 85 - Recent Sales of Unregistered Securities
Page 86 - Item 6. Selected Financial Data
Page 87 - Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations
Page 88 - Pseudomonas aeruginosa
Page 89 - Financial Overview
Page 90 - CAT-4001
Page 91 - General and Administrative Expenses
Page 92 - Critical Accounting Policies and Significant Estimates
Page 93 - Stock-Based Compensation
Page 94 - Technical Practice Aid, Valuation of Privately-Held-Company Equity Securities Issued as Compensation
Page 95 - Research and Development Expenses
Page 96 - General and Administrative Expenses
Page 97 - Initial Public Offering
Page 98 - Funding Requirements
Page 99 - N/A
Page 100 - Cash Flows
Page 101 - Comparison of the Years Ended December 31, 2015 and 2014
Page 102 - Contractual Obligations
Page 103 - Item 7A. Quantitative and Qualitative Disclosures about Market Risk
Page 104 - Management's Annual Report on Internal Control over Financial Reporting
Page 105 - PART III
Page 106 - PART IV
Page 107 - REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
Page 108 - Consolidated Balance Sheets
Page 109 - Consolidated Statements of Operations
Page 110 - Consolidated Statements Comprehensive Loss
Page 111 - Catabasis Pharmaceuticals, Inc.
Page 112 - Consolidated Statements of Cash Flows
Page 113 - 1. Organization and Operations
Page 114 - Notes to Consolidated Financial Statements (Continued)
Page 115 - Notes to Consolidated Financial Statements (Continued)
Page 116 - Notes to Consolidated Financial Statements (Continued)
Page 117 - Notes to Consolidated Financial Statements (Continued)
Page 118 - Notes to Consolidated Financial Statements (Continued)
Page 119 - Notes to Consolidated Financial Statements (Continued)
Page 120 - Notes to Consolidated Financial Statements (Continued)
Page 121 - Notes to Consolidated Financial Statements (Continued)
Page 122 - Notes to Consolidated Financial Statements (Continued)
Page 123 - Notes to Consolidated Financial Statements (Continued)
Page 124 - Notes to Consolidated Financial Statements (Continued)
Page 125 - Notes to Consolidated Financial Statements (Continued)
Page 126 - Notes to Consolidated Financial Statements (Continued)
Page 127 - Notes to Consolidated Financial Statements (Continued)
Page 128 - Notes to Consolidated Financial Statements (Continued)
Page 129 - Notes to Consolidated Financial Statements (Continued)
Page 130 - Notes to Consolidated Financial Statements (Continued)
Page 131 - Notes to Consolidated Financial Statements (Continued)
Page 132 - SIGNATURES
Page 133 - EXHIBIT INDEX
Page 134 - N/A
Page 135 - N/A
Subdocument 2 - EX-23.1 - EX-23.1
Page 1 - Exhibit 23.1
Page 2 - N/A
Subdocument 3 - EX-31.1 - EX-31.1
Page 1 - Exhibit 31.1
Page 2 - N/A
Subdocument 4 - EX-31.2 - EX-31.2
Page 1 - Exhibit 31.2
Page 2 - N/A
Subdocument 5 - EX-32.1 - EX-32.1
Page 1 - Exhibit 32.1
Page 2 - N/A
Subdocument 6 - EX-32.2 - EX-32.2
Page 1 - Exhibit 32.2
Page 2 - N/A
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