Risk Factors Update Summary
- Accumulated deficit increased from $542 million to $849 million, impacting future profitability and funding.
- New and emerging data privacy regimes, such as China's PIPL, may impact operations globally.
- Cash, cash equivalents, and marketable securities decreased from $866 million to $1.14 billion.
- Clinical trials' timing and cost impacted by geopolitical instability, public health epidemics, and competition.
- Potential legal challenges to mechanisms for transferring personal data could disrupt operations.
- Anticipated cash position to fund operations extended from 2026 to 2027, but uncertain additional capital.
- Preliminary and interim data subject to audit, with potential material changes affecting business prospects.
- Phase 3 trials initiated by competitors may affect development programs and stock price fluctuation.
- Increased scrutiny on data privacy could lead to regulatory actions, fines, and penalties.
- Future capital requirements dependent on various factors, including regulatory review costs and commercialization expenses.
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.
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