Risk Factors Update Summary
- Entered into a long-term lease to establish manufacturing capabilities at Bothell facility.
- Reduced investment in ex vivo cell engineering program; focus shifted to Cardiac Program.
- Exposed to unforeseen risks in early stages of testing product candidates in humans.
- Added reliance on EU standard contractual clauses and UK International Data Transfer Agreement for personal data transfers outside EEA and UK. This change might result in increased legal complexity and potential costs.
- Accumulated deficit increased from $1.1 billion to $1.3 billion. This change might indicate financial challenges and impact investor confidence.
- Increased risk of secondary cancers from T cell malignancies in CAR T therapies.
- Limited data in animal models; unexpected differences may require additional time and resources.
- Transitioning manufacturing processes to CDMOs due to insufficient capacity, resources, and capabilities.
- Workforce reductions may lead to unintended consequences, difficulty in retaining and hiring employees.
- Operating losses decreased from $283.3 million to $269.5 million in 2023. This change might suggest improved financial performance and efficiency.
- Development plans may need adjustments due to unexpected differences in product candidates.
- Increased complexity in manufacturing processes, requiring novel technologies and potential delays.
- Increased risk in foreign acquisitions; may impact success of product candidates or technologies.
- Need for comparability studies if switching CDMOs or suppliers, potentially delaying manufacturing.
- Net proceeds raised under the ATM facility increased from approximately $27.6 million to $205.2 million. This change might indicate improved access to capital for operations and growth.
- Gains from changes in fair value of liabilities decreased from $14.7 million to an expense of $9.6 million in 2023. This change might indicate increased financial risk and impact on profitability.
- Reliance on CDMOs for materials may lead to delays if suppliers lack capacity or resources.
- Estimated aggregate fair value of liabilities decreased from $21.0 million to $12.8 million for Cobalt Success Payment. This change might indicate reduced financial obligations and liabilities.
- Risks associated with cybersecurity breaches and incidents, including potential unauthorized access to confidential information.
- Changes in data privacy laws, such as the CPRA, may require additional compliance investment and business process changes.
- Number of outstanding shares increased from 191 million to 197 million. This change might dilute existing shareholders' ownership and impact stock price.
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=1770121&owner=exclude
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