Monday, Aprea Therapeutics Inc ( APRE ) announced that the FDA has cleared its Investigational New Drug (IND) application for APR-1051.

“APR-1051 is a next-generation inhibitor of WEE1 kinase, and based on its unique characteristics, we believe it will be best in class,” said Oren Gilad, President and CEO of Aprea.

“We look forward to evaluating therapeutic activity in patients, focusing on Cyclin E overexpressing cancers, including ovarian and breast cancers,” Gilad added.

Clearance of the IND application will allow Aprea to initiate the Phase 1 ACESOT-1051 dose escalation trial to evaluate the safety, tolerability, and preliminary efficacy of APR-1051. 

Enrollment of the first patient in this study is expected in the first half of 2024, with an update expected in the fourth quarter of the year.

Concurrently, Aprea Therapeutics ( APRE ) has announced a private placement of up to $34 million, including initial upfront funding of $16.0 million and up to an additional $18.0 million upon cash exercise of accompanying warrants at the election of the investors.

Aprea will use the net proceeds from the private placement for general corporate purposes and to fund the clinical development of APR-1051, the Company’s WEE1 inhibitor product candidate. 

The aggregate net proceeds (assuming the cash exercise of all accompanying warrants) are expected to be sufficient to fund the company into 2026.

Price Action: APRE shares are up 6.17% at $7.57 on the last check Monday.

Illustration of Phrama lab worker created with MidJourney.