Skip to main content
 
Print Page    E-mail Page    RSS    E-mail Alerts    Tearsheet 

SEC Filings

Form 10-K
SERES THERAPEUTICS, INC. filed this Form 10-K on 03/06/2019
Document Outline
Entire Document (7178.6 KB)
Subdocument 1 - 10-K - 10-K
Page 1 - UNITED STATES
Page 2 - TABLE OF CONTENTS
Page 3 - FORWARD-LOOKINGSTATEMENTS
Page 4 - N/A
Page 5 - PART I
Page 6 - Clostridium difficileC.difficileC. difficileStaphylococcus aureusLessa , Burden of Clostridium diffi
Page 7 - Other Programs
Page 8 - Our Strategy
Page 9 - Advancing Our Capabilities
Page 10 - Our Microbiome Therapeutics Platform
Page 11 - in vitroin vivo
Page 12 - Current and developing treatment alternatives and their limitations
Page 13 - Further Details of Phase 1b clinical study design.
Page 14 - Phase 1b clinical study results
Page 15 - Phase 2b Clinical Study Design
Page 16 - C. difficileThe Journal of Hospital InfectionAmerican Journal of Infection Control, New Drugs and St
Page 17 - Antibodies. C. difficile
Page 18 - Phase 2 clinical study results.
Page 19 - Phase 3 clinical study design.
Page 20 - SER-262
Page 21 - Material Agreements
Page 22 - Intellectual Property
Page 23 - Trade secrets
Page 24 - Preclinical and Clinical Trials
Page 25 - Clostridium difficile
Page 26 - Expedited Development and Review Programs
Page 27 - Post-Approval Requirements
Page 28 - Biosimilars and Regulatory Exclusivity
Page 29 - Government Regulation Outside of the United States
Page 30 - Other Healthcare Laws
Page 31 - Coverage and Reimbursement
Page 32 - Employees
Page 33 - Our Corporate Information
Page 34 - Presentation of Financial Statements-Going Concern
Page 35 - Our limited operating history may make it difficult to evaluate the success of our business to date
Page 36 - Risks Related to the Discovery, Development and Regulatory Approval of Our Product Candidates
Page 37 - Clinical drug development involves a risky, lengthy and expensive process, with an uncertain outcome
Page 38 - If we experience delays or difficulties in the enrollment of patients in clinical trials, our receip
Page 39 - If we are not able to obtain, or if there are delays in obtaining, required regulatory approvals, we
Page 40 - A Fast Track designation by the FDA may not actually lead to a faster development or regulatory revi
Page 41 - Changes in funding for the FDA and other government agencies could hinder their ability to hire and
Page 42 - We rely, and expect to continue to rely, on third parties to conduct our clinical trials, and those
Page 43 - We have no experience manufacturing our product candidates at commercial scale, and if we decide to
Page 44 - Risks Related to Commercialization of Our Product Candidates and
Page 45 - We face substantial competition, which may result in others discovering, developing or commercializi
Page 46 - Product liability lawsuits against us could cause us to incur substantial liabilities and limit comm
Page 47 - We may face competition from biosimilars, which may have a material adverse impact on the future com
Page 48 - Any product candidate for which we obtain marketing approval could be subject to post- marketing res
Page 49 - Our relationships with customers, physicians and third-party payors are and will be subject to appli
Page 50 - Recently enacted and future legislation may increase the difficulty and cost for us to obtain market
Page 51 - Governments outside the United States tend to impose strict price controls, which may adversely affe
Page 52 - Risks Related to Our Intellectual Property
Page 53 - Third parties may initiate legal proceedings alleging that we are infringing their intellectual prop
Page 54 - If we are unable to protect the confidentiality of our trade secrets and know-how, our business and
Page 55 - Third parties may initiate legal proceedings alleging that we are infringing their intellectual prop
Page 56 - Issued patents covering our product candidates could be found invalid or unenforceable or could be i
Page 57 - Obtaining and maintaining our patent protection depends on compliance with various procedural, docum
Page 58 - If our trademarks and trade names are not adequately protected, then we may not be able to build nam
Page 59 - Risks Related to Our Operations
Page 60 - We may expand our operational capabilities, and as a result, we may encounter difficulties in managi
Page 61 - Our business and operations would suffer in the event of information technology and other system fai
Page 62 - We have in the past been subject to securities class action litigation and may be subject to similar
Page 63 - Risks Related to Our Common Stock
Page 64 - A significant portion of our total outstanding shares are eligible to be sold into the market, which
Page 65 - Provisions in our restated certificate of incorporation and amended and restated bylaws and under De
Page 66 - Because we do not anticipate paying any cash dividends on our capital stock in the foreseeable futur
Page 67 - Dennis A. Ausiello, M.D.
Page 68 - Roger J. Pomerantz, M.D.
Page 69 - Matthew Henn, Ph.D.
Page 70 - PART II
Page 71 - Item 6. Selected Consolidated Financial Data
Page 72 - Item 7. Management s Discussion and Analysis of Financial Condition and Results of Operations
Page 73 - C. difficile C. difficile
Page 74 - Financial Operations Overview
Page 75 - Research and Development Expenses
Page 76 - General and Administrative Expenses
Page 77 - Adoption of ASC 606
Page 78 - Collaboration revenue
Page 79 - Milestone Payments
Page 80 - Stock-Based Compensation
Page 81 - Emerging Growth Company Status
Page 82 - General and Administrative Expenses
Page 83 - Comparison of Years Ended December 31, 2017 and 2016
Page 84 - General and Administrative Expenses
Page 85 - Cash Flows
Page 86 - Investing Activities
Page 87 - N/A
Page 88 - Contractual Obligations and Commitments
Page 89 - Item 9A. Controls and Procedures
Page 90 - PART III
Page 91 - PART IV
Page 92 - Item 16. Form 10-K Summary
Page 93 - INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
Page 94 - REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
Page 95 - SERES THERAPEUTICS, INC.
Page 96 - SERES THERAPEUTICS, INC.
Page 97 - SERES THERAPEUTICS, INC.
Page 98 - SERES THERAPEUTICS, INC.
Page 99 - SERES THERAPEUTICS, INC.
Page 100 - SERES THERAPEUTICS, INC.
Page 101 - SERES THERAPEUTICS, INC.
Page 102 - SERES THERAPEUTICS, INC.
Page 103 - SERES THERAPEUTICS, INC.
Page 104 - SERES THERAPEUTICS, INC.
Page 105 - SERES THERAPEUTICS, INC.
Page 106 - SERES THERAPEUTICS, INC.
Page 107 - SERES THERAPEUTICS, INC.
Page 108 - SERES THERAPEUTICS, INC.
Page 109 - SERES THERAPEUTICS, INC.
Page 110 - SERES THERAPEUTICS, INC.
Page 111 - SERES THERAPEUTICS, INC.
Page 112 - SERES THERAPEUTICS, INC.
Page 113 - SERES THERAPEUTICS, INC.
Page 114 - SERES THERAPEUTICS, INC.
Page 115 - SERES THERAPEUTICS, INC.
Page 116 - SERES THERAPEUTICS, INC.
Page 117 - SERES THERAPEUTICS, INC.
Page 118 - SERES THERAPEUTICS, INC.
Page 119 - SERES THERAPEUTICS, INC.
Page 120 - SERES THERAPEUTICS, INC.
Page 121 - SERES THERAPEUTICS, INC.
Page 122 - SERES THERAPEUTICS, INC.
Page 123 - SERES THERAPEUTICS, INC.
Page 124 - SIGNATURES
Subdocument 2 - EX-10.22 - EX-10.22
Page 1 - N/A
Page 2 - N/A
Subdocument 3 - EX-10.23 - EX-10.23
Page 1 - EXHIBIT
Page 2 - *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH
Page 3 - *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH
Page 4 - Signature Page Follows
Page 5 - *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH
Subdocument 4 - EX-21.1 - EX-21.1
Page 1 - N/A
Subdocument 5 - EX-23.1 - EX-23.1
Page 1 - N/A
Subdocument 6 - EX-31.1 - EX-31.1
Page 1 - N/A
Subdocument 7 - EX-32.1 - EX-32.1
Page 1 - N/A
XBRL Item - EX-101.INS - XBRL INSTANCE DOCUMENT (What's this?)
XBRL Item - EX-101.SCH - XBRL TAXONOMY EXTENSION SCHEMA (What's this?)
XBRL Item - EX-101.CAL - XBRL TAXONOMY EXTENSION CALCULATION LINKBASE (What's this?)
XBRL Item - EX-101.DEF - XBRL TAXONOMY EXTENSION DEFINITION LINKBASE (What's this?)
XBRL Item - EX-101.LAB - XBRL TAXONOMY EXTENSION LABEL LINKBASE (What's this?)
XBRL Item - EX-101.PRE - XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE (What's this?)
XBRL Viewer