Generation Bio(GBIO) - 2022 Q2 - Quarterly Report

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].