
Financial Performance - For the three months ended September 30, 2022, total operating expenses decreased by 12% to $13.6 million from $15.5 million in the same period of 2021[82]. - Operating expenses for the nine months ended September 30, 2022, were $44.8 million, a slight decrease of 1% from $45.5 million in the same period of 2021[82]. - The net loss for the nine months ended September 30, 2022, was $44.1 million, adjusted for non-cash items including stock-based compensation expense of $8.8 million[95]. - The company has not generated product revenue or achieved profitability since inception and anticipates continued net losses for the foreseeable future[98]. Research and Development - Research and development expenses for the three months ended September 30, 2022, were $9.5 million, a decrease of 4% compared to $9.9 million for the same period in 2021[82]. - Research and development expenses for the nine months ended September 30, 2022, were $31.1 million, an increase from $29.4 million in the same period of 2021, primarily due to costs related to the Phase 1 clinical trial of NL-201[85]. - The decision to discontinue NL-201 was based on a review of preliminary data and the expected benefit-to-risk ratio for patients[66]. - The company is exploring additional therapeutic candidates beyond NL-201, including a targeted activator of T-regulatory cells for inflammation and autoimmune diseases[73]. - The company is focusing on the next generation of immunotherapies using de novo protein design and advanced machine learning[65]. Cost Management - General and administrative expenses decreased by 26% to $4.1 million for the three months ended September 30, 2022, compared to $5.6 million in the same period of 2021[82]. - General and administrative expenses for the three months ended September 30, 2022, were $4.1 million, down from $5.6 million in the same period of 2021, mainly due to a decrease in personnel-related costs[87]. - For the nine months ended September 30, 2022, general and administrative expenses totaled $13.7 million, compared to $16.1 million for the same period in 2021, reflecting decreases in personnel-related and facility-related costs[88]. - The company expects cost savings from a 40% reduction in workforce and the discontinuation of NL-201 development to extend its cash runway into the second half of 2025[67]. Cash Flow and Investments - Net cash used in operating activities for the nine months ended September 30, 2022, was $34.7 million, slightly lower than $35.4 million in the same period of 2021[92]. - Cash used in investing activities for the nine months ended September 30, 2022, was $67.6 million, significantly higher than $2.9 million in the same period of 2021[94]. - As of September 30, 2022, the company had an accumulated deficit of $437.6 million and cash, cash equivalents, and short-term investments of $106.9 million[92]. - The company expects its existing cash resources to fund operations into the second half of 2025, but may need to seek additional funds sooner than planned[98]. Capital Raising - The company plans to raise substantial additional capital to support operations and growth strategy, relying on equity sales, debt financing, or collaborations[77]. Interest Income - Interest income for the three months ended September 30, 2022, was $559,000, an increase from $6,000 in the same period of 2021, attributed to higher interest rates and U.S. treasury securities purchases[91]. Work Environment - The company has transitioned to a work-from-home policy during the COVID-19 pandemic but has returned to in-office work with hybrid schedules as of the end of Q3 2022[80].