DOYLESTOWN, PA — Aprea Therapeutics Inc. (Nasdaq: APRE) reported its fourth-quarter and full-year 2025 financial results and said early clinical data from its ongoing Phase 1 trial of APR-1051 showed initial tumor responses in patients with endometrial cancer.
The company announced the update alongside business developments, including leadership changes and financing activities.
Aprea said two patients with PPP2R1A-mutated endometrial cancer achieved unconfirmed partial responses at their first imaging assessment in the ACESOT-1051 trial, each showing a 50% reduction in target lesion size.
The company reported that one patient treated at 150 mg also saw cancer antigen 125 levels decline from 732 to 70 U/mL, while a second patient treated at 220 mg saw levels decrease from 362 to 47 U/mL.
Five additional patients in the study achieved stable disease across multiple cancer types, including head and neck, colorectal and endometrial cancers, according to the company.
APR-1051 is being evaluated as an oral WEE1 inhibitor in a dose-escalation Phase 1 trial targeting cancers with specific genetic mutations.
Aprea said the treatment has been “safe and well tolerated,” with the most common adverse events reported as low-grade nausea and fatigue.
Dose escalation is ongoing, with patients currently receiving 220 mg once daily, and the company said it plans to enroll additional patients in selected tumor types.
A further update from the trial is expected in the second quarter of 2026.
“The most recent data … provide early proof of clinical concept for APR-1051,” CEO Oren Gilad said, citing initial responses observed in the study.
In a separate program, Aprea said it determined a recommended Phase 2 dose of 1,100 mg for its ATR inhibitor ATRN-119 in late 2025.
The company has paused enrollment in parts of that trial while evaluating potential combination approaches, including studies with radiation and immunotherapy.
Aprea also said it appointed Eugene Kennedy as chief medical advisor in February 2026 to support clinical development.
The company raised about $8.7 million in gross proceeds through private placements completed in December 2025 and January 2026.
As of December 31, 2025, Aprea reported cash and cash equivalents of $14.6 million, compared with $22.8 million a year earlier.
The company said its cash position, including proceeds from its January financing, is expected to fund operations into the first quarter of 2027.
For the fourth quarter, Aprea reported an operating loss of $2.6 million, compared with $3.2 million in the same period a year earlier.
Net loss for the quarter was $2.5 million, or $0.32 per share, compared with $2.9 million, or $0.49 per share, in the fourth quarter of 2024.
For the full year, the company reported an operating loss of $13.2 million, compared with $14.3 million in 2024.
Net loss for 2025 was $12.6 million, or $1.93 per share, compared with $13.0 million, or $2.35 per share, the prior year.
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