Loading...
•
Jun 30, 2022
Tectonic Q2 2022 Earnings Report
AVROBIO reported a net loss for the second quarter of 2022, driven by a reduction in research and development expenses, while highlighting pipeline advancements and upcoming milestones.
Key Takeaways
AVROBIO reported a net loss of $28.1 million for Q2 2022, with reduced research and development expenses. The company is advancing its gene therapy pipeline, with key milestones expected in the second half of the year, including regulatory interactions and clinical data updates for cystinosis and Gaucher disease programs.
Presented positive data from Phase 1/2 cystinosis trial, showing systemic gene therapy effect.
Comprehensive Gaucher disease franchise update planned for Q4 2022.
Regulatory interactions planned in 2H 2022 to inform clinical development strategies for cystinosis and Gaucher disease type 3.
Cash runway extended into Q1 2024.
Tectonic
Tectonic
Forward Guidance
AVROBIO plans to engage with regulatory agencies in the second half of 2022 to discuss clinical development and regulatory strategies for cystinosis and Gaucher disease, with the aim of initiating company-sponsored clinical trials in 2023. Additionally, a clinical trial application authorization is expected for Hunter syndrome, with plans to initiate a collaborator-sponsored Phase 1/2 clinical trial in 2023.
Positive Outlook
- Plan to engage with regulatory agencies in 2H 2022 to discuss clinical development and regulatory strategy for cystinosis.
- Aim to initiate a company-sponsored clinical trial in 2023 for cystinosis, subject to regulatory alignment.
- Plan to provide interim clinical data update for Gaucher disease type 1 in 2H 2022.
- Aim to initiate a trial in 2023 for Gaucher disease type 3, subject to regulatory alignment.
- Clinical Trial Application (CTA) authorization expected 2H 2022 for Hunter syndrome.
Challenges Ahead
- Initiation of clinical trials is subject to regulatory alignment.
- Clinical trial plans are dependent on collaborator progress.
- Future results may differ materially and adversely from forward-looking statements.
- Success of product candidates is subject to risks and uncertainties.
- Dependence on third-party suppliers and manufacturers poses risks.