Risk Factors Update Summary
- Added "or adequately address" to efforts to prevent cyber incidents, breaches, or compromises.
- Net losses increased from $112 million to $188 million, with a significant jump in accumulated deficit.
- Expanded potential liability to include litigation, regulatory investigations, and enforcement actions.
- The number of product candidates in clinical development increased from two to three.
- Increased focus on artificial intelligence technology and potential regulatory impacts on AI use.
- Increased full-time employees from 46 to 74, indicating potential operational expansion.
- A Phase 1 clinical trial was initiated for DISC-3405 in healthy volunteers.
- Ongoing legislative and enforcement interest in reforming government program reimbursement methodologies for drugs.
- Net operating loss carryforwards increased from $69 million to $88 million.
- Fast track designation granted for DISC-3405 for the treatment of PV and DISC-0974 for anemia.
- Enhanced privacy and data security laws and regulations compliance requirements, especially in the EU and UK.
- Research and development tax credit carryforwards decreased from $2 million to $1.8 million.
- Federal and state research and development tax credit carryforwards decreased from $7 million to $5 million.
- Federal and state net operating loss carryforwards increased from $67 million to $91 million.
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=1816736&owner=exclude
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