Item 8.01 Other Events.



On August 4, 2021, Aprea Therapeutics, Inc. ("Aprea") was notified by the U.S. Food and Drug Administration (FDA) that it had placed a partial clinical hold on its clinical trials of eprenetapopt in combination with azacitidine in its myeloid malignancy programs. The partial clinical hold does not apply to Aprea's ongoing clinical trials in lymphoid malignancies and solid tumors, or the APR-548 clinical trial. There are approximately 20 patients currently receiving eprenetapopt in combination with azacitidine in Aprea's myeloid malignancy programs, which includes myelodysplastic syndromes (MDS), acute myeloid leukemia (AML), and post-transplant maintenance trials, all of which have completed enrollment. Patients who are benefiting from treatment can continue to receive study treatment. As part of the clinical hold, no additional patients can be enrolled to these trials until the partial clinical hold is resolved. Aprea intends to work closely with the FDA to analyze the data, address the specific questions raised, and seek to resolve the partial clinical hold as soon as possible.

On August 5, 2021, the Company issued a press release announcing the partial clinical hold. A copy of this press release is filed herewith as Exhibit 99.1 to this Current Report.





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Item 9.01. Financial Statements and Exhibits.






(d)    Exhibits.



Exhibit
 Number                                   Description
  99.1       Press release issued by Aprea Therapeutics, Inc. dated August 5, 2021.

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