Loading...
•
Dec 31, 2024
Vera Q4 2024 Earnings Report
Vera Therapeutics reported its business highlights and financial results for the fourth quarter and full year ended December 31, 2024.
Key Takeaways
Vera Therapeutics reported a net loss of $152.1 million for the full year ended December 31, 2024, compared to a net loss of $96.0 million for the prior year. The company ended the year with $640.9 million in cash, cash equivalents, and marketable securities, which it believes is sufficient to fund operations through potential approval and U.S. commercial launch of atacicept.
On track to announce primary endpoint results from the atacicept pivotal Phase 3 ORIGIN trial in IgA Nephropathy (IgAN) in 2Q 2025.
BLA submission to the U.S. FDA for accelerated approval of atacicept planned in 2H 2025.
Expanded atacicept clinical development program in multiple autoimmune kidney diseases proceeding in 2025.
Strengthened balance sheet to support clinical pipeline development, planned FDA submission, and potential 2026 commercial launch of atacicept for the treatment of IgAN.
Vera
Vera
Forward Guidance
Vera Therapeutics anticipates key milestones in 2025 and 2026, including full enrollment in the ORIGIN 3 trial, primary endpoint results, BLA submission for atacicept in IgAN, and initiation of new clinical trials.
Positive Outlook
- Anticipate full enrollment in ORIGIN 3 trial in 2Q 2025.
- On track to announce primary endpoint result in ORIGIN 3 trial in 2Q 2025.
- Plan to submit a BLA to the U.S. FDA in 2H 2025 for atacicept in IgAN for accelerated approval.
- Expect a PDUFA date and commercial launch in 2026 for atacicept.
- Plan to initiate the PIONEER trial in 2025 to evaluate atacicept in expanded IgAN populations and anti-PLA2R positive PMN and anti-nephrin positive FSGS and MCD.
Challenges Ahead
- Actual results may differ materially from forward-looking statements due to regulatory approval process risks.
- Results of earlier clinical trials may not be obtained in later clinical trials.
- Preliminary results may not be predictive of topline results.
- Risks and uncertainties associated with Vera's business in general.
- Impact of macroeconomic and geopolitical events could affect outcomes.