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 ...

Table of Contents (Exact name of registrant as specified in its charter) 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 June 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. Delaware 81-4301284 (State or other juris ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Table of Contents 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, 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 juri ...

Financial Performance - The company incurred net losses of $136.6 million, $119.2 million, and $80.5 million for the years ended December 31, 2022, 2021, and 2020, respectively, with an accumulated deficit of $444.8 million as of December 31, 2022[307]. - The company has never generated revenue from product sales and does not expect to achieve profitability for many years, if at all[312]. - The company anticipates significant increases in operating expenses as it establishes manufacturing sources, sales infrastructure, and expands its research programs[308]. - The company expects to need substantial additional funding to support ongoing operations and product development efforts[314]. Research and Development Challenges - The company has devoted substantially all financial resources to research and development, with no products approved for sale[307]. - The company has not identified any product candidates for Investigational New Drug (IND)-enabling studies or clinical development, indicating a long timeline before potential commercialization[330]. - The risk of failure for product candidates is high, with significant uncertainties regarding their effectiveness and safety in humans[337]. - The company has not previously conducted any IND-enabling studies or clinical trials, which may limit its ability to successfully develop genetic medicine programs[351]. - The non-viral genetic medicine platform relies on unproven technologies, making it difficult to predict development timelines and costs[357]. Regulatory and Approval Processes - The commencement of clinical trials in the United States is contingent upon FDA acceptance of an IND application and finalizing trial design, which may lead to delays if additional preclinical studies are required[332]. - Regulatory approvals from authorities such as the FDA and EMA are critical for the commercialization of product candidates, and any delays in obtaining these approvals could materially impact the business[336]. - The regulatory approval process for novel product candidates can be more expensive and time-consuming compared to established therapies, particularly for indications like hemophilia A and PKU, where approved therapies exist[360]. - The company must establish and maintain healthcare insurance coverage and adequate reimbursement by payers to ensure the commercial success of its product candidates[335]. Manufacturing and Supply Chain Risks - The company has entered into a lease for a cGMP-compliant manufacturing facility in Waltham, Massachusetts, but may incur ongoing costs if unable to sublease the property[383]. - The actual cost of manufacturing and processing product candidates is currently unknown, which could adversely affect their commercial viability[386]. - The company relies on a limited number of third-party suppliers for raw materials, which poses risks related to pricing, availability, and quality, potentially impacting the ability to manufacture product candidates[415]. - Any supply interruption of sole-sourced raw materials could materially harm the company's ability to manufacture product candidates, delaying development and commercialization[416]. Competition and Market Dynamics - The competitive landscape includes numerous companies developing genetic medicines, posing significant competition for the company's product candidates[443]. - The company faces significant competition from rivals with greater financial resources and expertise in R&D, manufacturing, and marketing, which could hinder its market position[447]. - Mergers and acquisitions in the pharmaceutical industry may concentrate resources among fewer competitors, increasing competitive pressures[448]. Intellectual Property and Licensing - The company’s ability to protect its intellectual property is crucial; failure to do so could allow competitors to develop similar products, adversely affecting its market position[471]. - The patent prosecution process is complex and costly, with potential risks of failing to file necessary applications on time, which could jeopardize patent protection[474]. - The company may face challenges in obtaining and maintaining patent rights due to prior work in the public domain, which could affect its ability to secure competitive advantages[474]. - The company may lose intellectual property rights if it fails to comply with obligations under its license agreements, which could hinder its ability to develop and commercialize products[482]. Collaboration and Partnership Challenges - Collaborations with third parties for research and commercialization may limit the company's control over resources and timelines, impacting revenue generation[429]. - Collaborators may not commit sufficient resources or may abandon product candidates, which could delay development and commercialization efforts[430]. - The company faces challenges in negotiating collaborations due to recent business combinations among large pharmaceutical companies, reducing potential partners[441].

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 Commission File Number: 001-39319 GENERATION BIO CO. (Exact name of registrant as specified in its charter) Delaware 81-4301284 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification Number) 301 Binney Street Cambridge, Massachusetts 02142 (Address of principal executive offices) (Zip Code) FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE AC ...

Financial Performance - The company reported net losses of $72.9 million and $56.4 million for the six months ended June 30, 2022 and 2021, respectively, with an accumulated deficit of $381.1 million as of June 30, 2022[67]. - The net loss for the three months ended June 30, 2022, was $37.9 million, compared to a net loss of $30.8 million for the same period in 2021, reflecting a 23.2% increase in losses[87]. - Research and development expenses increased to $28.4 million for the three months ended June 30, 2022, up from $22.7 million in the same period of 2021, representing a 25.2% increase[88]. - General and administrative expenses rose to $10.1 million for the three months ended June 30, 2022, compared to $8.2 million in the same period of 2021, marking a 23.6% increase[90]. - Net cash used in operating activities was $59.0 million for the six months ended June 30, 2022, compared to $48.5 million for the same period in 2021, representing a 21.0% increase[94]. - Net cash used in investing activities was $161.5 million for the six months ended June 30, 2022, primarily due to an increase in purchases of marketable securities[98]. - Net cash provided by financing activities was $3.6 million for the six months ended June 30, 2022, a significant decrease from $213.9 million in the same period of 2021[100]. - The company expects to incur significant expenses and operating losses for the foreseeable future as it continues its research activities and development of programs[93]. - The company believes its existing cash and marketable securities will fund operations into 2025, but additional financing may be required sooner than expected[102]. Capital and Financing - The company completed its IPO in June 2020, issuing 12,105,263 shares of common stock and receiving net proceeds of $210.7 million[66]. - The company had marketable securities amounting to $153.9 million as of June 30, 2022, with no impairment charges recorded during the first half of 2022[109]. - The company is exposed to interest rate market risk, primarily due to investments in short-term securities, but does not currently hedge this exposure[109]. - The company prohibits investment in auction rate securities and does not have direct exposure to losses from mortgage-based securities or related derivatives[110]. - The company may need to significantly curtail or delay research and development programs if sufficient capital is not raised[103]. - The company may have to relinquish valuable rights to future revenue streams if additional funds are raised through collaborations or licensing arrangements[105]. - The company faces risks associated with substantial capital requirements, as detailed in the "Risk Factors" section of its Quarterly Report[106]. Research and Development - The company has focused on building its non-viral genetic medicine platform since its inception in October 2016, with no products approved for sale and no revenue generated from product sales[66]. - The company plans to expand its portfolio to include therapies for rare and prevalent diseases of the skeletal muscle, central nervous system, and oncology[63]. - The company is exploring the development of mRNA-ctLNP and ceDNA-ctLNP vaccines, which could offer more durable antigen expression and greater shelf stability compared to current mRNA-LNP vaccines[62]. - The company achieved a significant increase in scale for ceDNA manufacturing while maintaining high productivity and purity, leading to underutilization of its planned cGMP facility[64]. - The company believes its non-viral genetic medicine platform can deliver antibody genes for long-term production of antibody therapies from a single dose[61]. - The costs and timing of clinical and commercial-scale manufacturing activities are critical to the company's future commercialization efforts[103]. - The company is focused on the continued development of its non-viral genetic medicine platform, which involves significant costs[103]. Administrative and Operational Expenses - The company anticipates that general and administrative expenses will increase as it expands its headcount and incurs costs associated with operating as a public company[85]. - Other income and interest income increased to $0.6 million for the three months ended June 30, 2022, compared to $0.1 million in the same period of 2021, indicating a significant increase[92]. - The company evaluates its estimates and assumptions regarding financial statements on an ongoing basis, which may lead to significant differences in actual results[107]. - The company considers accrued research and development expenses and stock-based compensation as critical accounting policies affecting financial statement preparation[108].