Revenue Performance - Collaboration revenue for Q3 2025 was $1.6 million, down from $7.6 million in Q3 2024, a decrease of approximately 79.3%[108] - For the nine months ended September 30, 2025, collaboration revenue totaled $11.1 million, compared to $15.7 million in the same period of 2024, reflecting a decline of about 29.3%[108] Expenses - Research and development expenses increased to $21.6 million in Q3 2025 from $15.1 million in Q3 2024, marking a rise of approximately 43.4%[107] - General and administrative expenses rose to $12.2 million in Q3 2025, up from $9.2 million in Q3 2024, an increase of about 32.4%[107] - The total operating expenses for Q3 2025 were $8.3 million, down from $25.4 million in Q3 2024, a decrease of approximately 67.4%[107] - Research and development expenses for Q3 2025 were $21.6 million, up from $15.1 million in Q3 2024, representing a 43.3% increase[109] - For the nine months ended September 30, 2025, research and development expenses totaled $52.5 million, compared to $45.8 million in the same period of 2024, marking a 14.7% increase[110] - General and administrative expenses for Q3 2025 were $12.2 million, an increase of 32.4% from $9.2 million in Q3 2024[113] - For the nine months ended September 30, 2025, general and administrative expenses were $28.7 million, slightly down from $29.1 million in the same period of 2024, a decrease of 1.4%[114] Net Loss and Gains - The net loss for Q3 2025 was $5.5 million, compared to a net loss of $15.3 million in Q3 2024, an improvement of about 63.9%[107] - The company reported a gain of $26.2 million on lease termination for Q3 2025, resulting from a settlement agreement with the landlord[115] Cash Flow and Investments - Net cash used in operating activities for the nine months ended September 30, 2025 was $97.9 million, compared to $72.8 million in the same period of 2024, an increase of 34.5%[119] - As of September 30, 2025, the company had cash, cash equivalents, and marketable securities totaling $89.6 million[117] - Net cash provided by investing activities for the nine months ended September 30, 2025 was $43.4 million, compared to $24.2 million in the same period of 2024, an increase of 79.2%[122] - As of September 30, 2025, the company had marketable securities valued at $67.7 million[126] - The company has an "at-the-market" sales agreement allowing for the sale of up to $237.0 million in common stock, but has not yet issued any shares under this agreement as of the report date[117] Strategic Initiatives - The company expects to incur costs of approximately $12.0 million to $15.0 million related to a strategic restructuring, which will result in a workforce reduction of approximately 90% by the end of October 2025[92] - A settlement agreement with the landlord resulted in a payment of $31.0 million, concluding litigation related to the Seyon Lease[93] - The company is exploring strategic alternatives, including potential acquisitions or mergers, with TD Cowen acting as the financial advisor[91] - Moderna made an upfront payment of $40.0 million under a collaboration agreement, with potential milestone payments of up to $1.8 billion[98] Market Risk - The company's primary exposure to market risk is interest rate sensitivity, particularly due to investments in short-term securities[126] - A hypothetical increase in interest rates of 100 basis points would result in a $0.1 million decrease in the fair value of the company's holdings[126] - The company does not currently seek to hedge its exposure to fluctuations in interest rates[126] - There have been no material risks anticipated due to changes in interest rates[126] Other Income - Other income and interest income, net for Q3 2025 was $1.2 million, down from $2.6 million in Q3 2024, a decrease of 53.8%[116] - No impairment charges were recorded for marketable securities during the three or nine months ended September 30, 2025[126]

For more information, please visit www.generationbio.com. Exhibit 99.1 Generation Bio Announces Third Quarter 2025 Financial Results CAMBRIDGE, MASS., November 5, 2025 -- Generation Bio Co. (Nasdaq: GBIO), a biotechnology company, today reported third quarter financial results. Third Quarter 2025 Financial Results About Generation Bio Generation Bio is a biotechnology company that was historically working to change what's possible for people living with T cell-driven autoimmune diseases. In August 2025, the ...

Core Viewpoint - Generation Bio Co. reported its third quarter financial results for 2025, highlighting a significant decrease in cash reserves and a reduction in net loss compared to the same quarter in the previous year [1][2]. Financial Performance - Cash Position: As of September 30, 2025, cash, cash equivalents, and marketable securities totaled $89.6 million, down from $185.2 million as of December 31, 2024 [7]. - R&D Expenses: Research and development expenses increased to $21.7 million for the quarter ended September 30, 2025, compared to $15.1 million for the same quarter in 2024 [7]. - G&A Expenses: General and administrative expenses rose to $12.2 million for the quarter ended September 30, 2025, up from $9.2 million in the same quarter of 2024 [7]. - Net Loss: The net loss for the quarter was $5.5 million, or $0.82 per share, an improvement from a net loss of $15.3 million, or $2.29 per share, for the same quarter in 2024 [7][11]. Strategic Developments - Strategic Alternatives: In August 2025, the company initiated a process to evaluate strategic alternatives aimed at maximizing shareholder value, with no assurance that this will lead to a transaction [3].

Group 1 - The article does not provide any relevant content regarding company or industry insights [1]

Core Points - Geoff McDonough, MD will step down as CEO & President and transition to Chair of the Board of Directors, effective October 31, 2025 [1] - Yalonda Howze, JD, currently the Chief Legal Officer, has been appointed as Interim CEO & President [1] - Jason Rhodes will step down as Chair of the Board but will remain a Board Director [1] Company Overview - Generation Bio is a biotechnology company focused on developing redosable therapeutics for T cell-driven autoimmune diseases [2] - The company aims to reprogram T cells in vivo to reduce or eliminate autoreactive T cells that attack the body's own tissues [2] - Generation Bio utilizes cell-targeted lipid nanoparticles (ctLNP) for selective delivery of small interfering RNA (siRNA) to T cells, potentially addressing previously undruggable disease-driving genes in autoimmunity [2]

Financial Performance - Generation Bio reported a quarterly loss of $3.12 per share, which was worse than the Zacks Consensus Estimate of a loss of $2.8, representing an earnings surprise of -11.43% [1] - The company posted revenues of $0.77 million for the quarter ended June 2025, missing the Zacks Consensus Estimate by 51.58%, compared to year-ago revenues of $4.09 million [2] - The current consensus EPS estimate for the upcoming quarter is -$2.62 on revenues of $1.58 million, and for the current fiscal year, it is -$11.10 on revenues of $13.46 million [7] Stock Performance - Generation Bio shares have declined approximately 61.9% since the beginning of the year, contrasting with the S&P 500's gain of 8.4% [3] - The company has surpassed consensus EPS estimates two times over the last four quarters [2] Industry Outlook - The Medical - Biomedical and Genetics industry, to which Generation Bio belongs, is currently ranked in the bottom 43% of over 250 Zacks industries, indicating potential challenges ahead [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which could impact Generation Bio's stock performance [5] Future Expectations - The earnings outlook for Generation Bio will depend on management's commentary during the earnings call and how earnings expectations may change following the recent report [4][6] - The estimate revisions trend for Generation Bio was favorable ahead of the earnings release, resulting in a Zacks Rank 2 (Buy) for the stock, suggesting it may outperform the market in the near future [6]

Financial Performance - Collaboration revenue for Q2 2025 was $765,000, a decrease of $3.33 million compared to $4.09 million in Q2 2024[117] - Net loss for Q2 2025 was $20.92 million, slightly higher than the net loss of $20.43 million in Q2 2024[117] - Collaboration revenue for Q2 2025 was $0.8 million, down from $4.1 million in Q2 2024, while total collaboration revenue for the first half of 2025 increased to $9.5 million from $8.2 million in the same period of 2024[118] - Other income and interest income, net for Q2 2025 was $2.0 million, down from $2.9 million in Q2 2024, primarily due to decreases in interest yields and invested cash balances[125] Operating Expenses - Total operating expenses for Q2 2025 were $23.68 million, down $3.72 million from $27.4 million in Q2 2024[117] - Research and development expenses for Q2 2025 were $15.5 million, a decrease of $889,000 from $16.39 million in Q2 2024[117] - General and administrative expenses for Q2 2025 were $7.67 million, down $1.85 million from $9.52 million in Q2 2024[117] - General and administrative expenses for Q2 2025 were $7.7 million, down from $9.5 million in Q2 2024, primarily due to a $1.3 million decrease in stock-based compensation costs[122] Strategic Actions - The company plans to implement a strategic restructuring resulting in approximately 90% reduction in workforce, incurring costs of $12 million to $15 million[97] - The company is exploring strategic alternatives, including potential acquisitions or mergers, to maximize shareholder value[96] - A reverse stock split of 1-for-10 was executed on July 21, 2025, to regain compliance with Nasdaq listing requirements[98][99] Cash Flow and Liquidity - The company reported a net cash used in operating activities of $45.2 million for the first half of 2025, compared to $53.2 million in the same period of 2024[128] - Cash, cash equivalents, and marketable securities totaled $141.4 million as of June 30, 2025[127] - Net cash provided by investing activities was $17.9 million for the first half of 2025, compared to $11.5 million in the same period of 2024, driven by $70.0 million in maturities of marketable securities[132] Legal and Settlement Matters - The company entered into a settlement agreement with the landlord for $31 million related to the Seyon Lease litigation[100] - A lump sum payment of $31.0 million is expected to be made in August 2025 to settle litigation related to the Seyon Lease[134] Market Risks and Funding Needs - The company may need to obtain additional funding through public or private equity offerings, debt financings, or collaborations if it does not complete a strategic transaction[135] - Future debt financing may impose fixed payment obligations and restrictive covenants that could limit the company's operational flexibility[138] - The company is exposed to market risks related to changes in interest rates, primarily due to its investments in short-term securities[142] - The company has no committed external source of funds and may need to relinquish rights to future revenue streams if it raises funds through collaborations[139] Accounting and Financial Reporting - The company’s financial statements are prepared in accordance with GAAP, requiring estimates and judgments that may differ from actual results[141] - There have been no material changes to the company's critical accounting policies and estimates from those disclosed in the 2024 Annual Report[141] - The company does not currently seek to hedge its exposure to fluctuations in interest rates[142] Research and Development Outlook - The company expects to incur significant operating losses for the foreseeable future as it continues its research and development activities[126] - The company may be required to significantly curtail or discontinue research or development programs if it cannot raise sufficient capital[139] - The company recognized a non-cash charge of $0.5 million related to the termination of the Seyon Lease in Q2 2025, significantly lower than the $1.5 million charge in Q2 2024[124]

Financial Performance - Generation Bio reported a net loss of $20.9 million, or $3.12 per share, for Q2 2025, compared to a net loss of $20.4 million, or $3.07 per share, in Q2 2024[17]. - Cash, cash equivalents, and marketable securities decreased to $141.4 million as of June 30, 2025, down from $185.2 million as of December 31, 2024[11]. - Total operating expenses for Q2 2025 were $23.7 million, down from $27.4 million in Q2 2024[23]. Research and Development - Research and development expenses for Q2 2025 were $15.5 million, a decrease from $16.4 million in Q2 2024[11]. - The company achieved significant knockdown of beta-2 microglobulin in T cells using a 0.5 mg/kg dose of ctLNP-siRNA in a non-human primate study[5]. - Generation Bio's lead siRNA candidates demonstrated potent knockdown of LAT1 and VAV1, which are relevant to T cell-driven autoimmune diseases[7]. Strategic Initiatives - The company is exploring strategic alternatives, including potential acquisitions or mergers, to maximize shareholder value[9]. - A recent litigation settlement will extinguish a lease liability of $58 million, with a lump sum payment of $31 million to the landlord[17]. - The company anticipates a workforce reduction of approximately 90% as part of a strategic restructuring process[10]. Operating Expenses - General and administrative expenses were $7.7 million for Q2 2025, down from $9.5 million in Q2 2024[11].

Core Insights - Generation Bio Co. has demonstrated the ability of its cell-targeted lipid nanoparticle (ctLNP) system to selectively deliver siRNA to T cells in non-human primates, marking a significant advancement in genetic medicine for T cell-driven autoimmune diseases [1][2][3] Financial Position - As of June 30, 2025, the company reported a cash balance of $141.4 million, down from $185.2 million at the end of 2024 [11][14] - Research and development (R&D) expenses for Q2 2025 were $15.5 million, a decrease from $16.4 million in Q2 2024 [11][16] - General and administrative (G&A) expenses were $7.7 million for Q2 2025, down from $9.5 million in the same quarter of the previous year [11][16] - The net loss for Q2 2025 was $20.9 million, or $3.12 per share, compared to a net loss of $20.4 million, or $3.07 per share, in Q2 2024 [11][16] Strategic Developments - The company is exploring strategic alternatives to maximize the value of its delivery system and potential therapeutics, including options such as acquisition, merger, or sale of assets [5][6] - A significant workforce reduction of approximately 90% is planned as part of a strategic restructuring process, expected to begin in mid-August 2025 and conclude by the end of October 2025 [7][6] Research and Development Highlights - The ctLNP system has shown significant knockdown of beta-2 microglobulin in T cells over three weeks in a non-human primate study, indicating its selective and potent delivery capabilities [3][4] - Lead siRNA candidates have demonstrated effective knockdown of LAT1 and VAV1, which are relevant targets for T cell-driven autoimmune diseases [4][6]

Core Viewpoint - Generation Bio Co. announced a 1-for-10 reverse stock split to increase the per-share market price and regain compliance with Nasdaq listing requirements [1][3]. Group 1: Reverse Stock Split Details - The reverse stock split will be effective at 5:00 pm Eastern Time on July 21, 2025, and trading on a split-adjusted basis will begin on July 22, 2025 [1][2]. - The number of issued and outstanding shares will decrease from approximately 67.3 million to approximately 6.7 million [3]. - No fractional shares will be issued; instead, stockholders will receive cash payments for any fractional shares [4]. Group 2: Company Background - Generation Bio is focused on developing therapeutics for T cell-driven autoimmune diseases using cell-targeted lipid nanoparticles to deliver small interfering RNA to T cells [7]. - The company's innovative approach aims to address historically undruggable disease-driving genes in autoimmunity [7].