DOYLESTOWN, PA — Aprea Therapeutics, Inc. (Nasdaq: APRE) reported encouraging early clinical results from its two lead oncology programs while narrowing its quarterly loss, according to second-quarter 2025 financial results released this week.
The company’s oral WEE1 inhibitor, APR-1051, showed early signs of disease control in the ongoing Phase 1 ACESOT-1051 trial. Three patients — one at 70 mg and two at 100 mg — achieved stable disease, including cases of HPV-positive head and neck squamous cell carcinoma, rectal cancer, and uterine cancer. Based on its safety and tolerability profile to date, Aprea plans to escalate dosing to 150 mg and anticipates more safety and efficacy data in the second half of 2025.
Aprea also advanced its macrocyclic ATR inhibitor, ATRN-119, which is in a Phase 1/2a trial targeting cancers with mutations in DNA damage response (DDR)-related genes. Seven patients have achieved stable disease, and three in the 550 mg twice-daily cohort showed tumor shrinkage of up to 21%. Due to dose-limiting toxicities at the higher level, dosing has shifted to 400 mg twice daily. Additional trial data are expected later this year, with a recommended Phase 2 dose to be determined in early 2026.
The company deepened its research capabilities earlier this year through a collaboration with MD Anderson Cancer Center, which demonstrated APR-1051’s strong single-agent activity and synergy with anti–PD-1 therapies in HPV-positive head and neck cancer models. This positions the drug as a candidate for future combination trials.
Financially, Aprea ended the quarter with $16.5 million in cash and cash equivalents, compared to $22.8 million at year-end 2024, and expects its resources to fund operations into the second quarter of 2026. Second-quarter net loss narrowed to $3.2 million, down from $3.5 million a year earlier, on lower research, administrative, and legal costs.
With both programs producing early signs of clinical activity and key data milestones ahead, Aprea is aiming to validate its targeted cancer therapies while maintaining a disciplined financial approach.
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