Adverum Biotechnologies(ADVM) - 2020 Q2 - Quarterly Report

Financial Performance - As of June 30, 2020, the company had an accumulated deficit of $437.1 million and expects to incur substantial expenses and increasing losses in the foreseeable future[42] - The net loss for the six months ended June 30, 2020, was $52.1 million, an increase of $22.7 million compared to a net loss of $29.4 million for the same period in 2019[49] - The accumulated deficit as of June 30, 2020, was $437.1 million, indicating ongoing financial challenges since inception[53] - Net cash used in operating activities for the six months ended June 30, 2020, was $30.5 million, compared to $24.8 million for the same period in 2019[57] - Net cash provided by financing activities for the six months ended June 30, 2020, was $151.4 million, primarily from the sale of common stock[59] 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[44] Cash Position - The company had $280.1 million in cash, cash equivalents, and short-term investments as of June 30, 2020, which is expected to fund operations into 2022[43] - As of June 30, 2020, the company had $280.1 million in cash, cash equivalents, and short-term investments, up from $166.0 million as of December 31, 2019[53] Research and Development - Research and development expenses increased by $10.2 million to $19.2 million for Q2 2020 compared to Q2 2019, primarily due to increased production costs and personnel-related expenses[50] - The company expects research and development expenses to continue increasing as it invests in advancing its gene therapy product candidate ADVM-022 and other research programs[50] Administrative Expenses - General and administrative expenses rose by $3.5 million to $10.6 million for Q2 2020 compared to Q2 2019, driven by higher personnel costs and facility-related expenses[51] - The company anticipates that general and administrative expenses will rise in future periods to support its gene therapy programs and organizational growth[51] Clinical Trials and Product Development - The OPTIC trial for ADVM-022 has shown long-term durability beyond 15 months from a single IVT injection with zero anti-VEGF rescue injections in the high-dose cohort[35] - The INFINITY Phase 2 trial has been initiated to evaluate ADVM-022 in patients with diabetic macular edema, with plans to enroll approximately 33 patients[35] - The company is scaling up manufacturing processes from 200L to 1000L to support the future commercial launch of ADVM-022[35] - The FDA granted Fast Track designation for ADVM-022 for the treatment of wet age-related macular degeneration[35] Manufacturing and Operations - The company does not have operational clinical or commercial manufacturing facilities, relying on third-party contractors for clinical manufacturing[43] - The company has licensed the right to use AAV.7m8 to GenSight Biologics for their product candidate GS030, currently in clinical development[37] - The company has experienced limited impact from the COVID-19 pandemic on its operations and clinical trials to date[39] Internal Controls and Governance - As of June 30, 2020, the company's disclosure controls and procedures were deemed effective by the Chief Executive Officer and Chief Financial Officer[61] - There were no changes in internal control over financial reporting during the three months ended June 30, 2020 that materially affected internal controls[61] - The management acknowledges that disclosure controls and procedures cannot prevent all errors and fraud, providing only reasonable assurance[62] - The design of the control system must consider resource constraints and the cost-benefit ratio of controls[62] - The company recognizes the inherent limitations in all control systems, which may not detect all control issues or instances of fraud[62] Funding and Financial Strategy - The company plans to seek additional funding through equity or debt financings to support its development and commercialization efforts[54]