Generation Bio Co 2024年度报告

Indicate by check mark whether the registrant (1)has filed all reports required to be filed by Section13 or 15(d)of the Securities Exchange Act of 1934 during the preceding 12months(or for such shorter period that the registrant was required to file such reports), and (2)has been subject to such filing requirements for the past 90days.Yes☒No☐ Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule405 of Regulation S-T (§232.405 of thischapter) during the preceding 12months (or for such shorter period that the registrant was required to submit such files).Yes☒No☐Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule12b-2 of the Exchange Act. Acceleratedfiler☐Smallerreportingcompany☒Emerginggrowthcompany☐ Largeacceleratedfiler☐Non-accelerated filer☒ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accountingstandards provided pursuant to Section13(a)of the Exchange Act.☐ Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting underSection404(b)of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report.☐ If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the fi ling reflect the correction of anerror to previously issued financial statements.☐ The aggregate market value of Common Stock held bynon-affiliatesof the registrant computed by reference to the price of the registrant’s Common Stock as of June28, 2024, the lastbusiness day of the registrant’s most recently completed second fiscal quarter, was approximately $155.2million (based on the last reported sale price on the Nasdaq Global Select Market as ofsuch date). For this computation, the registrant has excluded the market value of all shares of Common Stock reported as beneficially owned by its executive officer and directors; such exclusionshall not be deemed to constitute an admission that any such person is an affiliate of the registrant.As of February28, 2025, there were67,007,864shares of the registrant’s Common Stock, $0.0001 par value per share, outstanding. DOCUMENTS INCORPORATED BY REFERENCE Portions of the registrant’s Proxy Statement for its 2025 Annual Meeting of Stockholders, which the registrant intends to file with the Securities and Exchange Commission not later than120days after the registrant’s fiscalyear ended December31, 2024, are incorporated by reference into PartIII of this Annual Report on Form10-K.. Generation Bio Co.Index PARTI Item1.Business7Item1A.Risk Factors45Item1B.Unresolved Staff Comments106Item 1C.Cybersecurity106Item2.Properties107Item3.Legal Proceedings107Item4.Mine Safety Disclosures108PARTIIItem5.Market for Registrant’s Common Equity, Related Stockholder Matters and IssuerPurchases of Equity Securities109Item6.[Reserved]110Item7.Management’s Discussion and Analysis of Financial Condition and Results ofOperations111Item7A.Quantitative and Qualitative Disclosures About Market Risk123Item8.Financial Statements and Supplementary Data123Item9.Changes in and Disagreements With Accountants on Accounting and FinancialDisclosure123Item9A.Controls and Procedures123Item9B.Other Information124Item9C.Disclosure Regarding Foreign Jurisdictions that Prevent Inspections124PARTIIIItem10.Directors, Executive Officers and Corporate Governance125Item11.Executive Compensation125Item12.Security Ownership of Certain Beneficial Owners and Management and RelatedStockholder Matters125Item13.Certain Relationships and Related Transactions, and Director Independence125Item14.Principal Accounting Fees and Services125PARTIVItem15.Exhibits, Financial Statement Schedules126Item16.Form10-K Summary129Signatures160 CAUTIONARY NOTEREGARDING FORWARD-LOOKING STATEMENTS This Annual Report on Form10-K, or this Annual Report, of Generation Bio Co. contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act andSection21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act, that involvesubstantial risks and uncertainties. All statements, other than statements of historical fact, contained inthis Annual Report, including statements regarding our strategy, future operations, future financialposition, future revenue, projected costs, prospects, plans and objectives of management, are forward-lookingstatements.The words“