Adverum Biotechnologies(US:ADVM)2022-11-09 16:00Financial Performance - As of September 30, 2022, the company had an accumulated deficit of $769.9 million and $203.3 million in cash, cash equivalents, and short-term investments[54]. - The net loss for Q3 2022 was $40.1 million, an increase of $1.8 million compared to a net loss of $38.4 million in Q3 2021[62]. - The net loss for the nine months ended September 30, 2022, was $121.8 million, up from $111.1 million in 2021, indicating an increase of approximately 9.5%[72]. - Other income for Q3 2022 was $0.9 million, an increase from $0.2 million in Q3 2021, attributed to higher average yields in investments[66]. - Net cash used in operating activities for the nine months ended September 30, 2022, was $89.6 million, compared to $82.0 million for the same period in 2021, reflecting a 20% increase in cash used[72]. - The company reported $151.1 million in net maturities from marketable securities for the nine months ended September 30, 2022, compared to $65.6 million in 2021[73]. - The company incurred $11.6 million in purchases of property and equipment during the nine months ended September 30, 2022, slightly up from $10.8 million in 2021[73]. - The net cash provided by financing activities for the nine months ended September 30, 2022, was $0.4 million, a decrease from $2.0 million in 2021[74]. - Cash and cash equivalents increased by $50.2 million during the nine months ended September 30, 2022, compared to a decrease of $25.2 million in the same period of 2021[71]. - Non-cash charges for the nine months ended September 30, 2022, included $20.0 million, primarily from stock-based compensation of $14.8 million[72]. Product Development - The lead product candidate, Ixo-vec, is being developed for wet age-related macular degeneration (wet AMD), which affects approximately 20 million individuals worldwide[45]. - The OPTIC trial for Ixo-vec completed enrollment in July 2020, showing strong therapeutic efficacy signals, including stable aflibercept protein levels from 10 weeks to three years[45]. - The company received Fast Track designation from the FDA for Ixo-vec and Priority Medicines (PRIME) designation from the EMA, indicating significant unmet medical need[46][47]. - The LUNA trial, initiated in September 2022, is evaluating two doses of Ixo-vec in up to 72 subjects with wet AMD, focusing on visual acuity and central subfield thickness[46]. - ADVM-062, a second product candidate, received Orphan Drug Designation from the FDA and targets blue cone monochromacy, a rare genetic condition affecting visual acuity[48]. - The company expects research and development expenses to decrease in future periods as it focuses on advancing its gene therapy product candidate Ixo-vec for wet AMD treatment[64]. Expenses and Restructuring - Research and development expenses decreased by $0.2 million to $23.8 million for Q3 2022 from $24.1 million in Q3 2021, primarily due to a $2.0 million decrease in facilities-related expenses and a $1.5 million decrease in salaries following workforce reductions[64]. - Total operating expenses increased by $2.5 million to $41.0 million for Q3 2022 compared to $38.5 million in Q3 2021, with research and development expenses accounting for $23.8 million and general and administrative expenses at $17.2 million[62]. - General and administrative expenses increased by $2.7 million to $17.2 million for Q3 2022, primarily due to a $4.1 million reversal of sublease income and $1.0 million in restructuring costs[65]. - Research and development expenses for the nine months ended September 30, 2022, increased by $10.4 million to $77.1 million from $66.7 million in the same period in 2021, driven by increased clinical trial-related expenses[64]. - General and administrative expenses are anticipated to decrease in future periods due to operational streamlining following restructuring measures[65]. Funding and Financial Strategy - The company plans to seek additional funding through equity or debt financings to support ongoing development and commercialization efforts[69]. - A restructuring in July 2022 aimed to prioritize Ixo-vec's clinical development and extend the cash runway into 2025[49]. - The company expects to incur substantial expenses and continuing losses as it advances its product candidates through development and seeks regulatory approval[54]. - The company has not generated any revenue from product sales to date, relying on research, collaboration, and license arrangements for revenue[55]. - The company has not experienced significant disruptions to its supply chain and manufacturing due to the COVID-19 pandemic, but remains vigilant[53].