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Mar 31, 2023
Viridian Therapeutics Q1 2023 Earnings Report
Viridian Therapeutics reported financial results for Q1 2023 and provided a corporate update.
Key Takeaways
Viridian Therapeutics reported a net loss of $68.2 million for the first quarter of 2023, compared to a net loss of $25.7 million for the same period last year. Research and development expenses were $50.7 million, including a one-time $15.0 million upfront payment to Enable Injections. Cash, cash equivalents, and short-term investments were $373.9 million as of March 31, 2023.
Topline data from proof-of-concept study of VRDN-001 in patients with chronic thyroid eye disease (TED) expected in June/July 2023.
Selection of lead subcutaneous (SC) program in TED planned for year-end 2023.
Company added multiple senior executives to its leadership team, including its first Chief Commercial Officer.
Initiation of the THRIVE-2 Phase 3 trial evaluating the efficacy and safety of VRDN-001 in patients with chronic TED is planned for the middle of 2023, with topline results expected by year-end 2024.
Viridian Therapeutics
Viridian Therapeutics
Viridian Therapeutics Revenue by Segment
Revenue by Segment
Collaboration Revenue - related party Revenue
CapyFin.com Forward Guidance
Viridian expects topline results from Phase 1 trials evaluating VRDN-003 and VRDN-001 SC in healthy volunteers in the fourth quarter of 2023. The Company expects to select its lead SC program based on the preclinical and clinical data available across all three programs by year-end 2023, and plans to advance the selected SC program into a pivotal trial in the middle of 2024.
Positive Outlook
- Topline data from proof-of-concept study of VRDN-001 in patients with chronic TED expected in June/July 2023.
- Initiation of the THRIVE-2 Phase 3 trial evaluating the efficacy and safety of VRDN-001 in patients with chronic TED is planned for the middle of 2023, with topline results expected by year-end 2024.
- The THRIVE Phase 3 trial evaluating the efficacy and safety of VRDN-001 in patients with active TED remains ongoing, with topline results expected in the middle of 2024.
- Viridian plans to file the investigational new drug application (IND) for VRDN-003 with the US Food and Drug Administration (FDA) in the second quarter of 2023.
- The Company expects to select its lead SC program based on the preclinical and clinical data available across all three programs by year-end 2023, and plans to advance the selected SC program into a pivotal trial in the middle of 2024.
Challenges Ahead
- Uncertainty and potential delays related to clinical drug development.
- The duration and impact of regulatory delays in the Company’s clinical programs.
- Manufacturing risks.
- Competition from other therapies or products.
- Other matters that could affect the sufficiency of existing cash, cash equivalents and short-term investments to fund operations.