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Aprea Therapeutics, Inc. reports developments as a clinical-stage precision medicine oncology company developing targeted therapies for patients with biomarker-defined cancers. Its updates center on small-molecule programs designed to exploit cancer-specific genetic vulnerabilities, including APR-1051, an oral WEE1 kinase inhibitor, and ATRN-119, a small-molecule ATR inhibitor, for solid tumor indications.
Recurring news themes include clinical activity from the ACESOT-1051 study of APR-1051, oncology conference presentations, pipeline and corporate updates, financial results, and financing activity supporting research and development. Company communications also describe biomarker-guided development, safety and tolerability observations, and capital actions tied to its clinical-stage oncology strategy.
Aprea Therapeutics (NASDAQ:APRE), a clinical-stage biopharmaceutical company focused on developing innovative cancer treatments, announced its participation in the upcoming H.C. Wainwright 27th Annual Global Investment Conference.
The presentation is scheduled for Tuesday, September 9, 2025, at 3:30 PM ET at the Lotte New York Palace Hotel in New York. A webcast of the presentation will be accessible for 90 days through the company's investor relations website.
Aprea Therapeutics (Nasdaq: APRE) has reported Q2 2025 financial results and provided updates on its clinical programs. The company's WEE1 inhibitor APR-1051 showed early disease control in three patients during the Phase 1 ACESOT-1051 trial, while their ATR inhibitor ATRN-119 demonstrated activity with seven patients achieving stable disease, including three with tumor shrinkage at 550mg twice daily.
Financially, Aprea reported $16.5 million in cash as of June 30, 2025, expected to fund operations into Q2 2026. The company posted a reduced net loss of $3.2 million ($0.53 per share) compared to $3.5 million in Q2 2024, with decreased R&D expenses of $1.9 million and G&A expenses of $1.6 million.
Aprea Therapeutics (NASDAQ:APRE) has announced promising preclinical and early clinical data for APR-1051, its next-generation oral WEE1 inhibitor, in treating HPV+ head and neck squamous cell carcinoma (HNSCC). The drug demonstrated potent antiproliferative effects with IC₅₀ values between 8.9-230 nM in preclinical studies.
In collaboration with MD Anderson Cancer Center, research showed significant anti-tumor synergy when combining APR-1051 with anti-PD-1 therapies. In the Phase 1 ACESOT-1051 trial, a 62-year-old male patient with advanced HPV+ cancer showed stable disease with 5% tumor reduction at first assessment, with no dose-limiting toxicities reported.
Aprea Therapeutics (NASDAQ: APRE) reported Q1 2025 financial results and provided updates on its clinical programs. The company's ATR inhibitor, ATRN-119, showed promising early anti-tumor activity in the ABOYA-119 trial, with three patients demonstrating tumor shrinkage of 7%, 14%, and 21% in the 550mg twice daily cohort. Their WEE1 inhibitor, APR-1051, is advancing in the ACESOT-1051 Phase 1 trial, now dosing patients at 100mg daily.
Financially, Aprea reported $19.3 million in cash as of March 31, 2025, providing runway into early Q2 2026. The company posted a net loss of $3.9 million ($0.66 per share) for Q1 2025, compared to $2.8 million in Q1 2024. R&D expenses increased to $2.5 million from $1.6 million year-over-year, while G&A expenses slightly decreased to $1.8 million from $1.9 million.
The company expects to report preliminary efficacy data for both clinical programs in the second half of 2025.Adicet Bio (Nasdaq: ACET), a clinical stage biotechnology company focused on allogeneic gamma delta T cell therapies, has appointed Michael Grissinger to its Board of Directors. Grissinger brings over 40 years of pharmaceutical business development and strategic transaction experience, including more than two decades at Johnson & Johnson where he served as Vice President and Head of Worldwide Pharmaceutical Licensing and Corporate Development.
During his tenure at Johnson & Johnson, Grissinger led the Immunology Therapeutic Area Business Development and Licensing Group and was a member of the Immunology R&D/Commercial leadership team. Prior to J&J, he spent 12 years at Ciba-Geigy in finance, marketing, and business development roles. He currently serves on the board of Aprea Therapeutics and three private biotech companies.
Aprea Therapeutics (NASDAQ: APRE) has announced the dosing of the first HPV+ head and neck squamous cell carcinoma (HNSCC) patient in Cohort 5 of the ongoing ACESOT-1051 clinical trial, evaluating APR-1051 at 70mg once daily. The trial is expanding to target populations most likely to benefit from WEE1 inhibition.
The Phase 1 trial is studying APR-1051, a potent and selective small molecule, in patients with advanced solid tumors. Open label data is expected in H2 2025. The study consists of two parts: Part 1 for dose escalation (up to 39 patients) and Part 2 for dose optimization (up to 40 patients).
The trial's significance is highlighted by statistics showing that approximately 70% of the 20,000 annual US cases of oropharyngeal squamous cell carcinoma are HPV-related. The study is being conducted at MD Anderson Cancer Center, with whom Aprea has entered into a Material Transfer Agreement for additional preclinical research.
Aprea Therapeutics (APRE) reported its Q4 and full-year 2024 financial results, highlighting progress in its cancer treatment pipeline. The company ended 2024 with $22.8 million in cash, expected to fund operations into Q1 2026.
Key developments include the ACESOT-1051 trial now enrolling patients in Cohort 5, evaluating WEE1 kinase inhibitor APR-1051, with open-label safety and efficacy data expected H2 2025. The ABOYA-119 trial continues evaluating ATR inhibitor ATRN-119 with both once-daily and twice-daily dosing regimens.
Financial highlights for 2024:
- Full-year operating loss: $14.3 million vs $15.5 million in 2023
- R&D expenses: $9.4 million vs $7.6 million in 2023
- G&A expenses: $6.5 million vs $8.4 million in 2023
- Net loss: $13.0 million ($2.35 per share) vs $14.3 million ($3.95 per share) in 2023
Aprea Therapeutics (NASDAQ: APRE) has entered into a Material Transfer Agreement with MD Anderson Cancer Center to investigate APR-1051 for treating head and neck squamous cell carcinoma (HNSCC). The research will focus on both HPV+ and HPV- HNSCC expressing genomic markers of replication stress.
The collaboration will explore combining APR-1051, Aprea's proprietary WEE1 kinase inhibitor, with immune checkpoint inhibitors. The project is led by Professors Jeffrey N. Myers and Abdullah A. Osman from MD Anderson's Department of Head and Neck Surgery.
Key statistics highlight that approximately 70% of the 20,000 annual OPSCC cases in the US are HPV-related. APR-1051 is currently being evaluated in the ACESOT-1051 Phase 1 clinical trial for advanced solid tumors with cancer-associated gene alterations.
Aprea Therapeutics (NASDAQ: APRE) provided an update on its patent portfolio for DNA Damage Response (DDR) cancer therapeutics. The company's ATR inhibitor program is protected by four granted U.S. patents, one pending U.S. application, and one provisional application, along with 19 granted non-U.S. patents and 16 pending non-U.S. applications. These patents expire between 2035-2037, with pending applications potentially extending exclusivity to 2044.
The company's lead ATR inhibitor, ATRN-119, is being evaluated in the ABOYA-119 clinical trial for advanced solid tumors. Additionally, Aprea's WEE1 kinase inhibitor program includes one pending U.S. patent application and 12 pending non-U.S. applications, set to expire in 2043 if granted. The lead WEE1 inhibitor, APR-1051, is currently in Phase 1 clinical trials (ACESOT-1051) for advanced/metastatic solid tumors.