Risk Factors Update Summary
- Added risks related to inflation, interest rates, natural disasters, political crises, and geopolitical events.
- Mentioned the need for additional capital for commercialization and development, with $7 million increase in NOL carryforwards.
- Highlighted challenges in patient enrollment, especially for cirrhosis patients, potentially leading to delays.
- Disclosed reliance on third-party manufacturers and the need to identify new suppliers by the end of 2023.
- Noted potential impact of tax assessment by Israeli Tax Authorities on NOL carryforwards and financial condition.
- Discussed risks associated with litigation costs and outcomes, impacting business operations and financials.
- Mentioned the uncertainty surrounding the impact of the BPCIA on the approval of biosimilar and interchangeable biological products.
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=1785173&owner=exclude
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