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Mar 31, 2025
Vera Q1 2025 Earnings Report
Vera Therapeutics reported its business highlights and financial results for the first quarter ended March 31, 2025.
Key Takeaways
Vera Therapeutics reported a net loss of $51.7 million for the first quarter of 2025, a significant increase compared to the net loss of $28.4 million in the same period last year. The company is on track to announce pivotal Phase 3 trial results for atacicept in IgAN in Q2 2025 and plans for a BLA submission in Q4 2025.
Net loss for Q1 2025 was $51.7 million, a substantial increase from $28.4 million in Q1 2024.
Net loss per share for Q1 2025 was $0.81 compared to $0.56 in Q1 2024.
Cash, cash equivalents, and marketable securities totaled $589.8 million as of March 31, 2025.
The company expects cash on hand to fund operations through potential approval and U.S. commercial launch of atacicept.
Forward Guidance
Vera Therapeutics anticipates key milestones in 2025 and 2026, including announcing Phase 3 trial results, submitting a BLA for atacicept, and potentially achieving FDA approval and commercial launch.
Positive Outlook
- Anticipated announcement of primary endpoint results from pivotal ORIGIN 3 trial in 2Q 2025.
- Plan to submit a Biologics License Application (BLA) for atacicept in IgAN to the U.S. FDA in 4Q 2025 for accelerated approval.
- Potential PDUFA date and commercial launch of atacicept in 2026.
- Believes atacicept has the potential to advance the standard of care in IgA nephropathy if approved.
- Expanded atacicept development program across multiple autoimmune kidney diseases is underway.
Challenges Ahead
- Regulatory approval process for atacicept is subject to risks and uncertainties.
- Results of earlier clinical trials may not be obtained in later clinical trials.
- Preliminary results may not be predictive of topline results.
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