Company Overview - Generation Bio is a biotechnology company focused on developing therapeutics for T cell-driven autoimmune diseases [3] - The company utilizes a novel approach with T cell-selective cell-targeted lipid nanoparticles (ctLNP) to deliver siRNA in vivo, aiming to modulate T cell activity responsible for inflammation and tissue destruction [3] - This new modality is designed to effectively target areas that are challenging to address with existing therapies, potentially expanding treatment options for various autoimmune diseases [3] Upcoming Event - Geoff McDonough, M.D., the president and CEO of Generation Bio, will present at the TD Cowen 45th Annual Health Care Conference on March 3, 2025, at 9:10 a.m. ET in Boston [1] - A live webcast of the presentation will be accessible on the investor section of the company's website, with a replay available for 30 days post-event [2]

Core Viewpoint - Generation Bio is advancing its T cell-directed lipid nanoparticle (ctLNP) technology to develop siRNA therapeutics aimed at treating T cell-driven autoimmune diseases, with plans to submit its first Investigational New Drug (IND) application in the second half of 2026 [1][3][7]. Group 1: Technology and Development - The company is utilizing its validated ctLNP to deliver siRNA specifically to T cells, aiming to silence disease-driving targets without affecting other immune cell types [2][9]. - Generation Bio's ctLNP technology has shown strong selectivity for CD8+ and CD4+ effector T cells and NK cells, which are involved in auto-reactive tissue damage in autoimmune diseases [2][3]. - The ctLNP-siRNA approach is designed to modulate T cell functions that lead to inflammation and tissue damage, potentially addressing high-value, currently undruggable targets [3][7]. Group 2: Clinical Plans and Timeline - The company plans to enter clinical trials within its cash runway, which extends into the second half of 2027, following the submission of its first IND in late 2026 [2][3]. - Generation Bio is reorganizing to support the clinical development of its T cell-directed therapies, indicating a strategic shift towards clinical capabilities [3][7]. Group 3: Leadership Changes - The company announced changes in its executive leadership team, with Phillip Samayoa, Ph.D., becoming the new chief scientific officer, and Kevin Conway being appointed as chief financial officer [4][5]. - Matthew Stanton, the outgoing chief scientific officer, will transition to the Scientific Advisory Board, while Matthew Norkunas, M.D., will remain until mid-2025 [4][5].

Group 1 - Generation Bio Co. reported a quarterly loss of $0.23 per share, better than the Zacks Consensus Estimate of a loss of $0.28, and improved from a loss of $0.43 per share a year ago, representing an earnings surprise of 17.86% [1] - The company posted revenues of $7.55 million for the quarter ended September 2024, surpassing the Zacks Consensus Estimate by 249.24%, compared to year-ago revenues of $2.15 million [2] - Generation Bio shares have increased approximately 32.7% since the beginning of the year, outperforming the S&P 500's gain of 21.2% [3] Group 2 - The current consensus EPS estimate for the coming quarter is -$0.24 on revenues of $2.16 million, and for the current fiscal year, it is -$1.80 on revenues of $12.48 million [7] - The Medical - Biomedical and Genetics industry, to which Generation Bio belongs, is currently ranked in the top 38% of over 250 Zacks industries, indicating a favorable outlook for the sector [8]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to | --- | --- | |---------------------------------------------------------------------------------------|----------------------------------------- ...

Generation Bio Reports Recent Business Highlights and Third Quarter 2024 Financial Results ● Non-human primate data presented at ESGCT demonstrated selective in vivo delivery of mRNA with T cell-targeted lipid nanoparticle (ctLNP) ● Cash balance of $199.8 million expected to fund operations into 2H 2027 CAMBRIDGE, MASS., Nov. 6, 2024 -- Generation Bio Co. (Nasdaq:GBIO), a biotechnology company innovating genetic medicines for people living with rare and prevalent diseases, reported business highlights and t ...

New non-human primate data show highly selective in vivo delivery of mRNA to T cells with a cell-targeted lipid nanoparticle (ctLNP) CAMBRIDGE, Mass., Oct. 22, 2024 (GLOBE NEWSWIRE) -- Generation Bio Co. (Nasdaq:GBIO) a biotechnology company innovating genetic medicines for people living with rare and prevalent diseases, today presented data on its cell-targeted lipid nanoparticle (ctLNP) and immune-quiet DNA (iqDNA) platforms at the European Society of Gene and Cell Therapy (ESGCT) 31st Annual Congress. Th ...

Financial Performance - Cash, cash equivalents, and marketable securities were $216.9 million as of June 30, 2024, down from $264.4 million as of December 31, 2023[2] - Net loss for Q2 2024 was $20.4 million, or $0.31 per share, compared to a net loss of $31.1 million, or $0.47 per share, in Q2 2023, indicating an improvement of approximately 34%[2] - Total operating expenses for Q2 2024 were $27.4 million, down from $34.8 million in Q2 2023, reflecting a decrease of about 21%[7] Research and Development - Research and development (R&D) expenses decreased to $16.4 million for Q2 2024 from $21.8 million in Q2 2023, representing a reduction of approximately 25%[2] - The company is developing a novel immune-quiet DNA (iqDNA) cargo designed to express or replace large genes for long-term therapeutic protein expression[3] Administrative Expenses - General and administrative (G&A) expenses were $9.5 million for Q2 2024, down from $13.0 million in Q2 2023, a decrease of about 27%[2] Revenue Growth - Collaboration revenue increased to $4.1 million in Q2 2024 from $0.88 million in Q2 2023, showing a significant growth[7] Future Outlook - The company expects its cash resources to fund operations into the second half of 2027[2] Product Development Focus - Generation Bio is focused on developing in vivo T cell therapies for autoimmune indications and therapies for sickle cell disease and beta-thalassemia[1] - The proprietary cell-targeted lipid nanoparticle (ctLNP) delivery system aims to create differentiated in vivo therapeutics that are redosable and scalable at low cost[1]

While Generation Bio has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movement ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39319 GENERATION BIO CO. (Exact name of registrant as specified in its charter) Delaware 81-4301284 (State or other juri ...

Generation Bio Announces Recent Business Highlights and First Quarter 2024 Financial Results CAMBRIDGE, MASS., May 13, 2024 -- Generation Bio Co. (Nasdaq: GBIO), a biotechnology company innovating genetic medicines for people living with rare and prevalent diseases, reported additional data on its cell-targeted lipid nanoparticle (ctLNP) platform presented at the American Society of Gene and Cell Therapy (ASGCT) 27th Annual Meeting as well as first quarter 2024 financial results. "The data presented on our ...