Risk Factors Update Summary
- Numerous U.S. states have enacted privacy laws impacting business operations, including fines for noncompliance.
- The company increased its borrowing capacity from $25.0 million to $50.0 million.
- California Consumer Privacy Act (CCPA) amended by CPRA imposes fines of up to $7,500 per violation.
- The company's cash, cash equivalents, and marketable securities increased from $114.7 million to $160.7 million.
- Stricter state laws require processing sensitive data, impacting compliance efforts and increasing costs.
- The company incurred net losses of $96.0 million in 2023, up from $32.6 million in 2022.
- The company delayed enrollment in the pivotal Phase 3 trial for LN and committed resources to the MAU868 program.
- The company announced plans to prioritize the advancement of atacicept in IgAN into a pivotal Phase 3 trial.
- The company may seek accelerated approval based on a reduction in the rate of change in eGFR.
- The company faces significant competition in the biotechnology industry, with various companies advancing programs in clinical development.
Full Text Changes in Most Recent 10-K
Intended use: review the highlighted statements. These are additions to the risk factors disclosure in the most recent 10-K filing compared to the previous 10-K filing. Deleted and moved text is less important and is shown for context.
To view the full company filings, click on the following link to be taken to the SEC EDGAR database landing page for the company: https://www.sec.gov/edgar/browse/?CIK=1831828&owner=exclude
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