- Aprea Therapeutics Inc (NASDAQ:APRE) can resume testing its eprenetapopt after a string of clinical holds on the therapy in August 2021.
- The Company plans to study the drug in new trials across various myeloid and lymphoid malignancies.
- Aprea Therapeutics will initiate a new study of eprenetapopt in patients with relapsed/refractory Myelodysplastic syndrome (MDS), it said in its Q4 earnings release.
- The trial adjustments come after the FDA told Aprea to hold off on multiple clinical trials last summer.
- The agency placed a clinical hold on Aprea's NHL study and partial holds on a phase 3 MDS study, midstage MDS/AML post-transplant trial, and a phase 1/2 AML study.
- The NHL trial hold was lifted in December 2021, and Aprea received the FDA green light to proceed with a new MDS and AML study in Q1 of 2022.
- Aprea "is in the planning phase for new clinical trials in both myeloid and lymphoid malignancies and is continuing to evaluate other development opportunities," Aprea said.
- It held cash and cash equivalents of $53.1 million at the end of 2021, sufficient to meet its operating requirements into 2023.
- Aprea expects an FY 22 cash burn of $25 million - $30 million.
- Price Action: APRE shares are up 1.15% at $1.76 during the market session on the last check Wednesday.
