Financial Performance - The company reported a net loss of $31.0 million for the six months ended June 30, 2022, compared to a net loss of $30.1 million for the same period in 2021[88]. - Cash used in operating activities was $25.4 million for the six months ended June 30, 2022, a slight decrease from $26.6 million in the same period in 2021[85]. - As of June 30, 2022, the company had an accumulated deficit of $424.5 million and working capital of $109.2 million[85]. - The net change in cash, cash equivalents, and restricted cash was a decrease of $64.9 million for the six months ended June 30, 2022, compared to a decrease of $28.3 million in the same period in 2021[87]. - The company has not generated product revenue or achieved profitability since inception and anticipates continued net losses[92]. Research and Development - Research and development expenses for Q2 2022 were $11.0 million, an increase of 12% from $9.8 million in Q2 2021[81]. - The company reported a 12% increase in research and development expenses for the first half of 2022, primarily due to increased clinical trial expenses for NL-201[81]. - The Phase 1 clinical trial of NL-201 is planned to enroll up to 252 patients, with approximately 120 patients receiving NL-201 as monotherapy[67]. - The trial is evaluating doses escalating from 0.1 μg/kg to 24 μg/kg, with interim data expected to be disclosed in 2023[68]. - The company plans to initiate a Phase 1 clinical trial in hematological malignancies, dependent on data from the ongoing solid tumor trial[69]. - The company has incorporated machine learning into its de novo protein design methods to accelerate the development of potential therapeutics[71]. Capital and Financing - The company needs to raise substantial additional capital to support operations and growth strategy, with no assurances of obtaining adequate financing[74]. - Cash, cash equivalents, and short-term investments totaled $116.5 million as of June 30, 2022, which is expected to fund operations through 2023[92]. - The company incurred $39.8 million in cash used for investing activities during the six months ended June 30, 2022, compared to $2.3 million in the same period in 2021[87]. - The company entered into an ATM Equity Offering Sales Agreement with BofA for an aggregate offering price of up to $40.0 million, but no sales have been made to date[86]. - The company expects future capital requirements to vary significantly and may need to seek additional funds sooner than planned[92]. Operating Expenses - Total operating expenses for the first half of 2022 were $31.2 million, a 4% increase from $30.1 million in the same period of 2021[79]. - General and administrative expenses for Q2 2022 were $4.9 million, a decrease of 7% from $5.3 million in Q2 2021[83]. - Interest income increased significantly to $194,000 for the three months ended June 30, 2022, compared to $5,000 in the same period in 2021, reflecting a 3780% increase[84].
Neurogene(NGNE) - 2022 Q2 - Quarterly Report