Aprea Shares Slump After Cancer-Drug Trial Misses Key Goal

Aprea Therapeutics shares slumped after the biopharma said that a Phase 3 trial of an MDS treatment missed its primary endpoint.
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Shares of Aprea Therapeutics Inc.  (APRE) - Get Report lost three-quarters of their market value in Monday trading after the biopharmaceutical company said that a Phase 3 clinical trial of an MDS treatment failed to meet its primary endpoint of complete remission rate.

At last check Aprea shares gave up 78% to $5.61. Last Dec. 30 the stock touched a 52-week high above $53.

Myelodysplastic syndromes, or MDS, are considered a type of cancer with conditions that occur when blood-forming cells in the bone marrow become abnormal.

Aprea focuses on developing cancer therapeutics that reactivate the mutant tumor suppressor protein p53.

The Boston company said the Phase 3 trial was meant to evaluate the safety and efficacy of a mix of eprenetapopt and azacitidine versus azacitidine alone. The effort “didn’t reach statistical significance,” the company said.

The combination appeared well-tolerated with an adverse-event profile that was similar to Phase II clinical trials, according to the company’s statement.

“Though we are disappointed the top-line results did not reach statistical significance, we continue to believe that eprenetapopt can offer clinical benefit to patients with TP53 mutant malignancies,” said Eyal Attar, a physician who is chief medical officer of Aprea.

Aprea Therapeutics said it would analyze data from the clinical trials and follow up with patients who are still receiving study treatment.

The company’s Phase 3 trial enrolled 154 mutant-MDS patients. 

In November, Aprea Therapeutics reported a third quarter net loss of $12.3 million, or 58 cents a share, compared with a loss of $6.2 million, or $5.29 a share, in the year-earlier quarter. The company went public in October 2019.

At Sept. 30, 2020, the company had $101.1 million of cash and equivalents.

"Our other clinical trials continue to progress and we remain committed to pursuing our clinical development programs,” Attar said.