Core Insights - Generation Bio Co. presented new 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, highlighting advancements in genetic medicines for rare and prevalent diseases [1][2] Group 1: ctLNP Platform - A single intravenous dose of ctLNP successfully delivered mRNA encoding a reporter protein to a majority of circulating T cells in non-human primates, with a dose of 1 mg/kg transducing most T cells and showing balanced distribution to CD4+ and CD8+ cells [2] - Untargeted lipid nanoparticles (LNPs) did not achieve T cell transduction, indicating the specificity of the ctLNP platform [2] - The biodistribution of ctLNP-mRNA to other organs such as the liver, spleen, and lung was minimal, confirming improved results over previous murine studies [2] Group 2: iqDNA Platform - The iqDNA platform is a partially single-stranded DNA molecule designed to evade recognition by primary DNA sensors in both mice and non-human primates [3] - Recent research has focused on enhancing protein expression through methods such as encoding the promoter region as double-stranded and stabilizing iqDNA against degradation by exonucleases [3] - The company is pursuing targeted research areas to prepare iqDNA for the development of novel genetic medicines [3] Group 3: Company Overview - Generation Bio is focused on innovating non-viral genetic medicines aimed at providing durable and redosable treatments for patients with rare and prevalent diseases [5] - The company is developing two complementary platforms: the highly selective ctLNP delivery system and the novel iqDNA cargo produced through a scalable capsid-free manufacturing process [5] - The mission of Generation Bio is to extend the reach of genetic medicine to a broader patient population globally [5]

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 ...

CAMBRIDGE, Mass., April 22, 2024 (GLOBE NEWSWIRE) -- Generation Bio Co. (NASDAQ:GBIO) a biotechnology company innovating genetic medicines for people living with rare and prevalent diseases, today announced that six abstracts highlighting preclinical data from its cell-targeted lipid nanoparticle (ctLNP) and immune-quiet DNA (iqDNA) platforms have been accepted for presentation, including one oral presentation, at the American Society of Gene and Cell Therapy (ASGCT) 27th Annual Meeting taking place May 7-1 ...

Generation Bio Co. (GBIO) came out with a quarterly loss of $0.53 per share versus the Zacks Consensus Estimate of a loss of $0.41. This compares to loss of $0.55 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -29.27%. A quarter ago, it was expected that this company would post a loss of $0.51 per share when it actually produced a loss of $0.43, delivering a surprise of 15.69%.Over the last four quarters, the company has surp ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 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 othe ...

CAMBRIDGE, Mass., Feb. 27, 2024 (GLOBE NEWSWIRE) -- Generation Bio Co. (Nasdaq:GBIO) a biotechnology company innovating genetic medicines for people living with rare and prevalent diseases, announced that Geoff McDonough, M.D., president and chief executive officer, will present at the 2024 TD Cowen Health Care Conference on Tuesday, March 5, 2024 at 9:10 a.m. ET in Boston. A live webcast of the presentation will be available on the investor section of the company’s website at investors.generationbio.com. A ...

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, 2023 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 ...