DOYLESTOWN, PA — Aprea Therapeutics, Inc. (Nasdaq: APRE) reported third-quarter 2025 financial results and highlighted steady progress across its two clinical-stage DNA damage response (DDR) programs, citing emerging signs of anti-tumor activity and a cash runway that extends into late 2026.
The company’s WEE1 inhibitor, APR-1051, continues to move through dose escalation in the Phase 1 ACESOT-1051 study. At the 100 mg once-daily dose level, three of four heavily pretreated patients achieved stable disease per RECIST criteria, including individuals with FBXW7, CCNE1, and KRAS/TP53 alterations — genetic profiles associated with replicative stress and WEE1 dependency. Aprea has now advanced to a 150 mg daily dose and reported that the therapy remains manageable, with mostly low-grade gastrointestinal events and fatigue.
Complementing this effort, Aprea’s ATR inhibitor ATRN-119 reached a recommended Phase 2 dose of 1,100 mg once daily in the ongoing Phase 1/2a ABOYA-119 trial. The company is pausing additional enrollment to prioritize future combination strategies, including potential studies pairing ATRN-119 with radiation for HPV-positive head and neck cancer and investigator-led trials combining the agent with immunotherapies or ADCs.
Posters for both programs were featured at the AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics Conference in October, underscoring the company’s emphasis on mechanism-driven oncology development.
Financially, Aprea ended the quarter with $13.7 million in cash and equivalents, down from $22.8 million at year-end 2024. R&D expenses fell to $1.6 million from $2.8 million a year earlier, reflecting higher start-up costs in 2024 and reduced activity on the ATRN-119 trial in 2025. General and administrative expenses edged down to $1.5 million. Net loss improved to $3.0 million, or $0.47 per share, compared with $3.8 million, or $0.64 per share, in the prior-year quarter.
CEO Oren Gilad said the data emerging from both clinical assets “reinforce Aprea’s differentiated DDR approach,” with several potential catalysts expected in 2026 as dose escalation continues and combination-development paths mature.
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