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Sep 30, 2020
Adverum Q3 2020 Earnings Report
Adverum Biotechnologies reported its Q3 2020 financial results and recent business progress.
Key Takeaways
Adverum Biotechnologies reported a net loss of $27.8 million for the third quarter ended September 30, 2020. The FDA removed the partial clinical hold on ADVM-022, and the company raised approximately $203.4 million in net proceeds from an underwritten public offering in August 2020.
FDA removed partial clinical hold on ADVM-022.
Planning to start a pivotal trial for ADVM-022 in wet AMD mid-2021.
INFINITY Phase 2 trial for ADVM-022 enrolling patients with DME; Data expected 2H21.
Raised approximately $203.4 million in net proceeds from an underwritten public offering in August 2020.
Adverum
Adverum
Forward Guidance
Adverum provided forward-looking statements regarding the potential of ADVM-022, clinical trial plans, and expectations for data presentation and regulatory interactions.
Positive Outlook
- Potential for ADVM-022 in treating patients with wet AMD and DME.
- Expectations to present additional data from all four cohorts of the OPTIC Phase 1 trial for ADVM-022 in wet AMD in November 2020.
- Plans to advance ADVM-022 in wet AMD by initiating a pivotal trial mid-2021 and in DME by continuing to enroll patients in the INFINITY trial.
- Expectations to present data from the INFINITY trial in the second half of 2021.
- Expectations to accelerate its development, manufacturing, and commercial launch plans for ADVM-022.
Challenges Ahead
- Novel technology makes it difficult to predict the time and cost of product candidate development and obtaining regulatory approval.
- Early clinical trials not always being predictive of future results.
- Potential for preliminary or interim results of clinical trials to change.
- Potential for future complications or side effects in connection with use of ADVM-022.
- Effects of the COVID-19 pandemic on the company’s operations and ongoing clinical trials.