Risk Factors Update Summary
- Ex-US regulatory requirements, including new EU-specific regulations like IVDR and GDPR, may delay clinical studies.
- Accumulated deficit increased from $452 million to $559 million, a significant rise of $107 million.
- Legislative changes, such as the Infrastructure Investment and Jobs Act, impact manufacturers' obligations.
- Net loss decreased from $119.2 million to $106.8 million, a reduction of $12.4 million.
- The enactment of the IRA in August 2022 allows HHS to negotiate drug prices.
- Cash, cash equivalents, and marketable securities increased from $302 million to $333 million, a rise of $31 million.
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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