Risk Factors Update Summary
- Reduced the number of preclinical programs from five to three, and clinical programs from two to three.
- Announced the completion of enrollment in the Phase 1/2 clinical study evaluating VAX-31 in healthy adults aged 50 and older.
- Increased accumulated deficit from $522 million to $924 million as of December 31, 2023.
- Increased the average price per share from $25 to $27 for the sale of common stock.
- Lonza entered into a Commercial Manufacturing and Supply Agreement to construct a Suite in Switzerland. This could significantly impact production efficiency and costs.
- Raised aggregate gross proceeds from $114 million to $137 million from the sale of common stock.
- Added a Phase 2 study for VAX-24 in healthy adults aged 65 and older.
- Potential delays in drug substance manufacturing campaigns due to insufficient cell-free extract supply. This may lead to increased costs and production delays.
- Expanded the aggregate offering price under the Amended ATM Sales Agreement from $150 million to $400 million.
- Discussions with the FDA regarding Phase 3 regulatory plans and CMC strategy. Disagreements may delay development and regulatory approval.
- Uncertainty regarding the impact of new patent laws on patent expiration dates. This could affect the commercialization of future vaccine candidates.
- Changes in patent law and regulations in Europe may devalue Eurasian patents. This could impact the company's intellectual property rights.
- Increased scrutiny on data privacy laws and regulations, including fines for noncompliance. This may lead to regulatory actions and financial penalties.
- Potential risks associated with banking relationships and access to funds in case of financial institution failures. This could impact short-term liquidity and operations.
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=1649094&owner=exclude
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