Risk Factors Update Summary
- Cash and cash equivalents increased from $129.3 million to $134 million as of December 31, 2023.
- The company may face delays due to complications associated with public health crises.
- Certain states have submitted Section 804 Importation Program proposals and are awaiting FDA approval. On January 5, 2023, the FDA approved Florida’s plan for Canadian drug importation.
- Failure to comply with privacy and security laws could expose the company to fines and penalties.
- Net loss decreased from $53 million to $37 million for the year ended December 31, 2022.
- Federal and state net operating loss carryforwards increased from $92 million to $96 million and $86 million to $44 million, respectively.
- A new regulation removes safe harbor protection for price reductions reflected at the point-of-sale from pharmaceutical manufacturers to plan sponsors under Part D.
- Merck & Co. filed a lawsuit against HHS and CMS regarding the IRA's Drug Price Negotiation Program for Medicare.
- Accumulated deficit increased from $306 million to $344 million as of December 31, 2022.
- The company is developing WTX-124 and WTX-330 and other future product candidates.
- The Inflation Reduction Act implementation has been delayed until January 1, 2032.
- Changes in privacy laws at state and federal levels may impact the processing of personal information and increase compliance efforts.
- Gross proceeds of $17.7 million were received under the at-the-market sales facility from January 1, 2024, through March 1, 2024.
- Various parties, including U.S. Chamber of Commerce, filed lawsuits against HHS and CMS regarding the IRA.
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=1785530&owner=exclude
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