Adverum Q2 2021 Earnings Report
Key Takeaways
Adverum Biotechnologies reported a net loss of $44.3 million for the second quarter of 2021. The company's cash, cash equivalents, and short-term investments were $363.8 million as of June 30, 2021, which is expected to fund operations into 2024.
Adverum is prioritizing the development of ADVM-022 in wet age-related macular degeneration.
Cash runway is extended into 2024 based on current development and manufacturing plans for ADVM-022.
Long-term OPTIC data shows the potential for the low dose of ADVM-022 to offer durable treatment for wet AMD.
Adverum is in active discussions to sublease its GMP commercial manufacturing facility in Research Triangle Park, NC.
Adverum
Adverum
Forward Guidance
Adverum anticipates presenting long-term OPTIC data in wet AMD and INFINITY data in DME in 2H21. They also plan to complete data analysis by YE21 to develop a protocol and seek feedback on a Phase 2 clinical trial in wet AMD.
Positive Outlook
- Plan to present long-term OPTIC data in wet AMD in 2H21, including 52-week data from Cohort 4 at a medical conference
- Plan to present INFINITY data in DME in 2H21 at a medical conference
- Plan to complete data analysis by YE21 to develop a protocol
- Seek investigator and regulatory feedback on a Phase 2 clinical trial in wet AMD
- Evaluate low doses of ADVM-022 and alternative prophylactic regimens
Challenges Ahead
- Adverum’s novel technology, which makes it difficult to predict the time and cost of product candidate development and obtaining regulatory approval
- The results of early clinical trials not always being predictive of future results
- The potential for Adverum’s recent announcement of a dose-limiting toxicity at the high dose in DME patients in our INFINITY trial
- Any future complications or side effects in connection with use of ADVM-022
- May delay or prevent regulatory advancement or approval for ADVM-022