Current Report · Items 2.02, 9.01 · 8-K

Generation Bio Co.

Results of Operations and Financial Condition

Filed Aug 12, 2025Accepted Aug 12, 2025, 4:10 PM EDTCIK 1733294Accession 0001558370-25-011223

Company context

Generation Bio is a biotechnology company working to change what’s possible for people living with T cell-driven autoimmune diseases. The company is developing redosable therapeutics that reprogram T cells in vivo to reduce or eliminate the production and persistence of autoreactive T cells, which erroneously recognize and attack the body’s own tissues, causing autoimmune diseases. Generation Bio’s innovative approach leverages cell-targeted lipid nanoparticles (ctLNP) to selectively deliver small interfering RNA (siRNA) to T cells. This combination of selective delivery and an intracellular, genetically precise mechanism of target engagement could unlock a series of high-value, historically undruggable disease-driving genes in autoimmunity.

Recent company filings

Disclosure sections

Items 2.02, 9.01

Select an item to read the extracted section. The as-filed document remains the primary evidence.

Item 2.02Item 2.02 - Results of Operations

Item 2.02 Results of Operations and Financial Condition. On August 12, 2025, Generation Bio Co. (the “Company”) issued a press release announcing the Company’s financial results for the quarter ended June 30, 2025. A copy of this press release is furnished as Exhibit 99.1 and is incorporated herein by reference. The information in this Item 2.02 on Form 8-K (including Exhibit 99.1 attached hereto) is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any filing by the Company, under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filling.

Filed exhibits (1)

EX-99.1 (by filename) gbio-20250812xex99d1.htm

EX-99.1 2 gbio-20250812xex99d1.htm EX-99.1 Exhibit 99.1 CONFIDENTIAL Generation Bio Announces New Data for Its Novel ctLNP Delivery System and Early T Cell Programs and Reports Second Quarter 2025 Financial Results New data confirm highly selective profile of cell-targeted lipid nanoparticle (ctLNP) and first-ever siRNA delivery to T cells in non-human primates Lead siRNA candidates show potent knockdown of LAT1 and VAV1, targets potentially relevant to T cell-driven autoimmune diseases Company is evaluating strategic alternatives to maximize value of its delivery system and potential therapeutics for T cell-driven autoimmune diseases for shareholders Cash balance of $141.4M as of June 30, 2025 Recent litigation settlement extinguishes lease liability CAMBRIDGE, MASS., August 12, 2025 -- Generation Bio Co. (Nasdaq: GBIO), a biotechnology company working to change what’s possible for people living with T cell-driven autoimmune diseases, today announced new data demonstrating that its cell-targeted lipid nanoparticle (ctLNP) system selectively delivered siRNA to T cells in non-human primates, reinforcing the company’s belief that its ctLNP has the ability to del…

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