Risk Factors Update Summary
- Issuances of common stock could result in significant dilution and cause stock price to fall.
- The company deprioritized the IgAN program, discontinuing all IgAN clinical development activities in 2023.
- The company received regulatory approval for a Phase 1b clinical trial of tegoprubart in up to 24 subjects.
- Future issuances of shares of common stock were added to the risk factors.
- Plans to focus resources on kidney transplantation programs, discontinuing islet cell transplantation and deprioritizing IgAN.
- The text regarding period-to-period fluctuations in financial results was replaced with future issuances of shares of common stock.
- The company plans to evaluate tegoprubart for the treatment of IgAN, with a Phase 2 global study in twelve countries.
- The risk factor now includes the impact on insurance coverage and reimbursement of newly approved products.
- Received IND clearance for a Phase 2 BESTOW trial of tegoprubart for prevention of transplant rejection in kidney transplant recipients.
- The company entered into a collaborative research agreement with eGenesis for xenotransplantation studies.
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=1404281&owner=exclude
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