Risk Factors Update Summary
- Anticipate substantial resources to be expended on future product development programs. This may result in increased expenses.
- Increased data privacy laws complexity and costs due to new foreign regulations and criminal prosecution risks.
- Need for additional financing highlighted due to substantial doubt about continuing as a going concern.
- Addition of new proposed legislation in the EU impacting operations, with a conclusion expected in 2024/2025.
- Potential significant negative impact on revenues and cash flows if BARDA funding is reduced by $423 million.
- Potential limitations on the use of net operating losses and tax attributes, affecting future cash flows.
- FDA clinical hold on Phase 2b CORAL Study may result in delays and additional expenses.
- Increase in outstanding common stock shares from 86 million to 97 million as of December 31, 2023.
- Reorganization of regulatory agencies may impact manufacturing processes and product development.
- Transition from an emerging growth company to a smaller reporting company and non-accelerated filer.
- Potential challenges in patient enrollment and monitoring due to historical issues related to the COVID-19 pandemic.
- Increased focus on cybersecurity measures due to vulnerabilities and potential data breaches.
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=1656634&owner=exclude
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