Adverum Biotechnologies(ADVM) - 2020 Q3 - Quarterly Report

Financial Performance - As of September 30, 2020, the company had an accumulated deficit of $464.9 million and expects to incur substantial expenses and increasing losses from operations in the foreseeable future[48]. - Net loss for the three months ended September 30, 2020, was $27.8 million, compared to a net loss of $16.1 million for the same period in 2019[55]. - Cash and cash equivalents increased to $454.5 million as of September 30, 2020, compared to $166.0 million as of December 31, 2019[61]. - Net cash used in operating activities was $57.1 million for the nine months ended September 30, 2020, compared to $34.3 million for the same period in 2019[64]. - Net cash used in investing activities was $291.7 million for the nine months ended September 30, 2020, primarily for marketable securities purchases[65]. - Net cash provided by financing activities was $355.6 million for the nine months ended September 30, 2020, mainly from the sale of common stock[66]. - The accumulated deficit as of September 30, 2020, was $464.9 million, indicating ongoing financial challenges[61]. Research and Development - The company plans to initiate a pivotal trial for its lead product candidate ADVM-022 in wet AMD in mid-2021 based on promising data from the OPTIC trial[40]. - The OPTIC trial has shown long-term durability beyond 15 months from a single IVT injection of ADVM-022 with zero anti-VEGF rescue injections in the high-dose cohort[40]. - The INFINITY Phase 2 trial is set to enroll approximately 33 patients to evaluate a single IVT injection of ADVM-022 in patients with DME, comparing it to aflibercept[42]. - Future research and development expenses are expected to increase as the company continues to invest in advancing its gene therapy product candidate ADVM-022[57]. Operational Overview - The company has not generated any revenue from product sales to date, relying instead on research, collaboration, and license arrangements with strategic partners[49]. - The company has $454.5 million in cash, cash equivalents, and short-term investments as of September 30, 2020, which is expected to fund operations into mid-2022[48]. - The company is scaling up manufacturing processes from 200L to 1000L to support the future commercial launch of ADVM-022[40]. - The company does not have operational clinical or commercial manufacturing facilities, relying on third-party contractors for clinical manufacturing[48]. - The company has experienced limited impact from the COVID-19 pandemic on its operations and clinical trials to date[43][45]. Revenue and Expenses - Collaboration and license revenue decreased by $250,000 for the three months ended September 30, 2020, compared to the same period in 2019[55]. - Research and development expenses increased by $6.7 million to $16.7 million for the three months ended September 30, 2020, primarily due to higher personnel costs and production costs related to product candidate ADVM-022[57]. - General and administrative expenses rose by $4.0 million to $11.4 million for the three months ended September 30, 2020, mainly driven by increased personnel costs[58].