Adverum Biotechnologies(ADVM) - 2021 Q2 - Quarterly Report

Financial Position - As of June 30, 2021, the company had an accumulated deficit of $575.3 million and expects to incur substantial expenses and increasing losses from operations in the foreseeable future [66]. - The company had $363.8 million in cash, cash equivalents, and short-term investments as of June 30, 2021 [71]. - As of June 30, 2021, the company had $363.8 million in cash, cash equivalents, and short-term investments, down from $429.7 million as of December 31, 2020 [95]. - Net cash provided by financing activities for the six months ended June 30, 2021, was $2.0 million, primarily from the sale of common stock [105]. - The accumulated deficit as of June 30, 2021, was $575.3 million, indicating ongoing financial challenges [95]. Revenue Generation - The company has not generated any revenue from product sales to date, relying instead on research, collaboration, and license arrangements with strategic partners [72]. - License revenue for the six months ended June 30, 2021, was $7.5 million, related to an upfront payment from Lexeo Therapeutics [87]. Research and Development - The OPTIC trial for ADVM-022, targeting wet age-related macular degeneration (wet AMD), completed enrollment in July 2020 and is designed to evaluate safety in treatment-experienced patients [57]. - The FDA granted Fast Track designation for ADVM-022 for the treatment of wet AMD, recognizing the need for new treatment options [56]. - The INFINITY trial for ADVM-022 in diabetic macular edema (DME) was initiated but development for DME has been halted due to observed dose-limiting toxicity [58]. - The company plans to leverage existing contract manufacturing organization partners for ongoing supply of ADVM-022 after reevaluating in-house manufacturing capabilities [59]. - The company expects research and development expenses to increase in future periods as it continues to invest in advancing its gene therapy product candidate ADVM-022 [90]. - Research and development expenses include personnel-related costs, laboratory supplies, and external contract research expenses, which are central to the company's business model [73]. - Research and development expenses increased by $8.7 million to $42.6 million for the six months ended June 30, 2021, primarily due to a $6.9 million increase in personnel-associated costs [89]. Operating Expenses - The company anticipates increased general and administrative expenses as it invests in infrastructure to support ongoing research and potential commercialization of product candidates [77]. - General and administrative expenses rose by $18.5 million to $38.1 million for the six months ended June 30, 2021, driven by a $9.4 million increase in personnel-associated costs and a $6.5 million increase in professional services [92]. - The company anticipates that general and administrative expenses will also increase to support its organizational growth and gene therapy programs [93]. Losses and Cash Flow - Net loss for the six months ended June 30, 2021, was $72.8 million, compared to a net loss of $52.1 million for the same period in 2020 [101]. - Cash used in operating activities for the six months ended June 30, 2021, was $56.2 million, primarily due to the net loss and a decrease in operating assets and liabilities [101]. - The company has experienced limited impact from the COVID-19 pandemic on its operations and clinical trials to date [60].