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Note 11 - Subsequent Events
6 Months Ended
Jun. 30, 2023
Notes to Financial Statements  
Subsequent Events [Text Block]

11. Subsequent Events

 

In August 2023, the Company announced that its Phase 3 AXLerate-OC trial evaluating the safety and efficacy of batiraxcept in platinum-resistant ovarian cancer did not meet its primary endpoint of progression-free survival (PFS) in the pre-specified subset of patients naïve to prior bevacizumab treatment. The trial also did not show any difference between the two arms in the overall population (which included patients previously treated with bevacizumab). No new safety signals were identified. Based on the efficacy results, the Company has terminated the PROC trial and program. In order to preserve cash, the Company has also terminated the P1b/P2 studies in clear cell renal cell cancer and pancreatic adenocarcinoma and will not continue either the renal or pancreatic programs unless the Company raises additional capital. Although the Company is currently exploring various strategic alternatives, including strategic partners and financing opportunities, these strategic alternatives may not be successful in the next several weeks prior to its cash position getting to the point that it will need to pursue the winding down and dissolution of the Company. If the Company does not raise capital or successfully engage a strategic partner in the next several weeks, it will be forced to cease operations, liquidate assets and possibly seek bankruptcy protection or engage in a similar process.

 

On August 18, 2023, our Board of Directors approved a workforce reduction of approximately 70% of our current employee base.  The decision was based on our cash position and decision to terminate all clinical trials and conserve cash following our announcement that the Phase 3 clinical trial of batiraxcept for the treatment of PROC failed to meet its primary endpoint.

 

As a result of the expense reduction, we estimate that we will incur approximately $900,000 in costs resulting from severance payments and an additional $300,000 for previously accrued paid time off. We expect to make cash payments of approximately $1.2 million for the employee reduction, most of which is expected to be paid in the third quarter of fiscal year 2023. The estimate of costs that we expect to incur and the expected timing to complete the expense reduction measures are subject to a number of assumptions, and actual results may differ. We may also incur other cash or non-cash charges or cash expenditures not currently contemplated due to events that may occur as a result of, or in association with, the cost reduction measures.