Risk Factors Update Summary
- Seralutinib is in active clinical development, with a registrational Phase 3 trial in PAH starting in Q4 2023.
- Addition of cybersecurity program details and risks, emphasizing protection of Confidential Information.
- Seralutinib was initially targeted for PAH and PH-ILD patients, facing competition from various products.
- The company had federal and state NOLs of approximately $494 million and $1.6 million, respectively, as of December 31, 2023.
- Sales of the product may decrease significantly or become less competitive if undesirable side effects are observed.
- Completing review for ownership change through 2023 due to private placements in 2022 and 2023.
- Failure to enroll sufficient subjects for clinical trials could delay product development and approval timelines.
- The company increased full-time employees from 11 in January 2018 to 178 by February 27, 2024.
- Accumulated deficit increased from $1,032 million to $1,212 million from 2022 to 2023.
- The UK Extension to the Data Privacy Framework came into effect on October 12, 2023.
- Change from predicting investors' reaction to potential material disruption in product development.
- The company had foreign NOLs of approximately $200 million and $89.2 million as of December 31, 2023.
- The California Privacy Rights Act (CPRA) significantly amends the California Consumer Privacy Act (CCPA).
- The Unitary Patent and Unified Patent Court system in Europe may present uncertainties for patent protection.
- The success of product candidates depends on regulatory approvals, commercialization, and ongoing clinical trials.
- Net losses were $179.8 million and $229.4 million for the years ended December 31, 2023 and 2022, respectively.
- Reliance on third parties for manufacturing, clinical trials, and regulatory approvals poses risks to commercialization.
- Transition from reliance on third parties for manufacturing to potential disruptions in clinical supplies.
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=1728117&owner=exclude
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