Business and Clinical Update Aprea Therapeutics reported positive progress in its two lead clinical programs, APR-1051 and ATRN-119, showing early clinical activity and disease control in Phase 1 trials - CEO Oren Gilad highlighted emerging data from both lead programs (APR-1051 and ATRN-119) showing evidence of clinical activity, strengthening confidence in the company's DDR (DNA Damage Response) assets2 ACESOT-1051: WEE1 inhibitor, APR-1051 The Phase 1 trial for oral WEE1 inhibitor APR-1051 shows early disease control, with three patients achieving stable disease, expanded enrollment for HPV+ tumors, and further data expected in H2 2025 - Three patients achieved stable disease: one in the 70mg cohort and two in the 100mg cohort, including patients with HPV+ head and neck, rectal, and uterine cancers12 - The trial is currently enrolling patients at a 100 mg once-daily dose, with plans to escalate to 150 mg, following a 2025 revision to optimize the therapeutic window4 - Enrollment criteria expanded to include HPV+ tumors after a patient with HPV+ HNSCC showed stable disease with a 5% tumor reduction at a 70 mg dose4 - A collaboration with MD Anderson Cancer Center demonstrated potent single-agent activity of APR-1051 in head and neck cancer cell lines and significant synergy with anti-PD-1 therapies in preclinical models5 - Future plans include releasing additional data in H2 2025, completing dose-escalation in H1 2026, and potentially evaluating APR-1051 in combination with checkpoint inhibitors8 ABOYA-119: ATR inhibitor, ATRN-119 The Phase 1/2a trial for ATR inhibitor ATRN-119 shows early activity with seven patients achieving stable disease, and three patients at 550 mg showing tumor shrinkage, leading to a dose reduction to 400 mg due to toxicity - In the ongoing Phase 1/2a trial, seven patients with advanced solid tumors demonstrated stable disease29 - Three patients in the 550 mg twice-daily cohort showed meaningful tumor shrinkage of 7%, 14%, and 21%9 - Dose-limiting toxicity observed in two patients at the 550 mg level led to a dose reduction to 400 mg twice daily to optimize the therapeutic profile9 - Additional safety and efficacy data are expected in H2 2025, with the recommended Phase 2 dose anticipated in H1 20269 Second Quarter 2025 Financial Results Aprea reported a net loss of $3.2 million for Q2 2025, an improvement from Q2 2024, driven by decreased operating expenses, with $16.5 million in cash expected to fund operations into Q2 2026 Financial Performance The company's Q2 2025 operating loss narrowed to $3.4 million from $3.8 million year-over-year, driven by reduced R&D and G&A expenses, with net loss per share improving to $0.53 Q2 2025 vs. Q2 2024 Statement of Operations | Metric | Q2 2025 | Q2 2024 | Change | | :--- | :--- | :--- | :--- | | Operating Loss | $3.4 million | $3.8 million | Decreased | | Net Loss | $3.2 million | $3.5 million | Decreased | | Net Loss Per Share | $0.53 | $0.58 | Improved | | R&D Expenses | $1.9 million | $2.6 million | Decreased | | G&A Expenses | $1.6 million | $1.9 million | Decreased | - The decrease in R&D expenses was mainly due to higher study start-up costs in 2024 for the ACESOT-1051 trial and lower personnel costs in 20259 - The decrease in G&A expenses was primarily driven by lower professional fees, particularly legal expenses, and a reduction in personnel costs910 Financial Position and Cash Runway As of June 30, 2025, Aprea held $16.5 million in cash and cash equivalents, projected to fund operations into Q2 2026 Cash and Cash Equivalents | Date | Amount | | :--- | :--- | | June 30, 2025 | $16.5 million | | December 31, 2024 | $22.8 million | - The company believes its current cash and cash equivalents are sufficient to meet operating and capital expenditure requirements into Q2 20269 Corporate Information and Forward-Looking Statements Aprea is a clinical-stage biopharmaceutical company focused on cancer treatment through targeted therapies like APR-1051 and ATRN-119, with the report including standard forward-looking statement disclaimers - Aprea's strategy is to develop treatments that exploit vulnerabilities in cancer cell mutations to kill tumors while minimizing effects on healthy cells11 - The company's lead programs, APR-1051 (WEE1 inhibitor) and ATRN-119 (ATR inhibitor), are in clinical development for solid tumor indications11 - The press release contains forward-looking statements concerning clinical trials, regulatory submissions, and financial projections, which are subject to inherent risks and uncertainties, cautioning readers against undue reliance1314
Aprea Therapeutics(APRE) - 2025 Q2 - Quarterly Results