Risk Factors Update Summary
- Congress amended the FDCA to require a diversity action plan for Phase 3 trials.
- Potential milestone payments of $30.0 million and $95.0 million were added to agreements.
- Cash runway extended from late 2024 to late 2025 based on current operating plans.
- Potential dilution from raising additional capital through Sales Agreement with Cantor Fitzgerald & Co.
- Ownership changes may limit the utilization of remaining NOLs, impacting future tax obligations.
- Potential impact of European Commission's proposal to revise pharmaceutical legislation in April 2023.
- Increased compliance complexity and risks due to new privacy laws in various U.S. states.
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=1701108&owner=exclude
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