- Tyme Technologies (NASDAQ:TYME) has risen ~13.2% in extended trading after announcing Q4 and full-year financials for fiscal 2021 today.
- The basic and diluted loss per share has increased ~15.7% YoY to ~$0.22 in FY21 while cash and cash equivalents reached ~$107.5M more than a fourfold rise from $26.7M in the previous year.
- The company also gave an update on its clinical development program following a strategic review. It has launched a Phase 2 breast cancer trial named OASIS in partnership with Georgetown University.
- The investigator-initiated prospective open-label study is designed to evaluate SM-88 in metastatic hormone receptor-positive, human epidermal growth factor receptor 2 negative (HR+/HER2-) breast cancer after treatment with a CDK4/6 inhibitor, the company said.
- The trial targeting the commonest form of breast cancer in the U.S. is expected to enroll 30 patients with potential expansion up to a total of 50 patients.
- As a result of the strategic review, Tyme has also decided to halt the TYME-88-Panc (Part 2) clinical trial evaluating SM-88 as third-line therapy in pancreatic cancer.
- Precision Promise, the Pancreatic Cancer Network-sponsored trial which is evaluating SM-88 as a second-line therapy will continue, the company said.
- In November, Tyme Technologies named Richie Cunningham as its new CEO.