Aprea Therapeutics, Inc.'s lymphoid malignancy program includes a clinical trial evaluating eprenetapopt in patients with non-Hodgkin lymphomas (NHL). In August 2021, FDA placed a clinical hold on this trial. In October 2021, the Company discussed with FDA the requested data and analyses from the Phase 3 frontline MDS clinical trial and proposed amendments for clinical trials to proceed in its lymphoid malignancy program.

Following interaction with the FDA, the clinical hold was lifted in December 2021. The Company is in the planning phase for new clinical trials in both myeloid and lymphoid malignancies and is continuing to evaluate other development opportunities. The Company plans to provide updates on progress on all programs throughout 2022.

APR-548 Phase I Trial: The Company's second product candidate, APR-548, is a next generation p53 reactivator that is being developed in an oral dosage form. The Company initiated a Phase 1 clinical trial testing APR-548 in relapsed/refractory MDS and AML. Enrollment in the first dosing cohort was completed and pharmacokinetic and adverse event data will be collected and analyzed.

The Company does not plan to enroll additional patients into the trial. Solid Tumor Program: The Company's solid tumor program includes its clinical trial evaluating eprenetapopt with anti-PD-1 therapy in advanced solid tumors. The Company completed enrollment in its Phase 1/2 clinical trial in relapsed/refractory gastric, bladder and non-small cell lung cancers assessing eprenetapopt with anti-PD-1 therapy.

The Company is in the planning phase for a future clinical trial to further evaluate orally-administered eprenetapopt with immunotherapy checkpoint inhibitors.