Risk Factors Update Summary
- The company generated net product sales of $24.4 million for FYARRO in 2023, compared to $15.2 million in 2022.
- Increased costs and efforts to comply with evolving laws and regulations may be costly. This could materially affect business operations.
- The company had cash, cash equivalents, and short-term investments of $108.6 million as of December 31, 2023, compared to $172 million as of December 31, 2022.
- The company announced results from an interim analysis on the first third of participants in the PRECISION1 trial, with the trial expected to be completed by the end of 2024.
- Negotiating an extension to the Fresenius Agreement effective through March 31, 2024, with ongoing dependency on a single-source supplier.
- The company incurred net losses of $65.8 million for the year ended December 31, 2023, compared to $60.5 million for the year ended December 31, 2022.
- The company entered into a collaboration and supply agreement in October 2022 for the combination of Mirati's adagrasib and FYARRO in KRAS G12C mutant NSCLC and other solid tumors.
- Federal NOL carryforwards increased from $167 million to $187 million, with state NOL carryforwards increasing from $72 million to $92 million.
- The company had an accumulated deficit of $269.0 million as of December 31, 2023, compared to $203.2 million as of December 31, 2022.
- The company incurred net losses of $110.1 million for the year ended December 31, 2021, compared to $60.5 million for the year ended December 31, 2022.
- Leadership transitions occurred, with David Lennon appointed as President and CEO effective October 2, 2023.
- Market closing price for common stock ranged from a low of $1 to a high of $33.00 per share.
- Cash, cash equivalents, and short-term investments decreased from $172 million to $108 million.
- The company is a smaller reporting company with specific criteria related to market value, revenue, and public float.
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=1422142&owner=exclude
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