Aprea Therapeutics Inc (APRE) News & EventsAPREAprea Therapeutics Inc

Aprea CEO: Significant Progress on APR-1051, Expecting 6-10 Patients Monthly Enrollment in Q4 2026

"We continue to make meaningful progress in advancing APR-1051 towards our goal of developing a differentiated, potentially best-in-class WEE1 inhibitor for patients with biomarker defined cancers," said Oren Gilad, President and Chief Executive Officer of Aprea. "We have expanded our clinical site network from three to nine active sites and expect enrollment in ACESOT-1051 to reach six to ten patients per month during the fourth quarter of 2026, positioning us to accelerate clinical development. Our strategy is focused on biomarker defined endometrial cancers, including uterine serous carcinoma, building on the encouraging early clinical activity observed in these patients. The preliminary antitumor activity and manageable tolerability observed to date support our strategy to advance APR-1051 as a single agent in selected patient populations, while evaluating rational combination approaches to expand its therapeutic potential across multiple tumor types. We look forward to presenting updated Phase 1 clinical results at the upcoming EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics and remain on track to select the dose for Part 2 of the study, focused on dose optimization, in the first half of 2027. With $37.8 million in cash and cash equivalents as of September 30, 2026, and an expected cash runway into the first quarter of 2028, we believe we are well positioned to execute our clinical development strategy, achieve meaningful milestones, and create long-term value for patients and shareholders."

Aprea Provides Update on Patent Portfolio

Aprea Therapeutics provided an update on its existing patent portfolio. The intellectual property covering Aprea's WEE1 kinase inhibitor program includes two pending U.S. patent applications, one pending U.S. provisional application, two granted non-U.S. patents, and 12 pending non-U.S. patent applications. The WEE1 family of applications, if granted, will expire in 2047, not including any regulatory exclusivities that may be awarded. The WEE1-portfolio covers key aspects of the program, including proprietary compounds, pharmaceutical compositions, and methods of use. The Company's lead WEE1 inhibitor, APR-1051, is currently being evaluated in the ACESOT-1051 Phase 1 clinical trial in advanced/metastatic solid tumors harboring certain cancer-associated gene alterations. Aprea's ATR inhibitor program is protected by four granted U.S. patents, one pending U.S. application, and one pending international application. There are 22 granted non-U.S. patents and 13 pending non-U.S. patent applications. The granted patents will expire 2035-2037 and the pending applications, if granted, could extend exclusivity into 2045. Additional regulatory exclusivities up to five years may also be available. This portfolio comprehensively covers the program's proprietary compounds, pharmaceutical compositions, and methods of use. During 2025, Aprea determined the recommended Phase 2 monotherapy dose of 1,100 mg once daily for ATRN-119 in the ABOYA-119 Phase 1/2a dose-escalation study and subsequently closed this study to focus resources on the clinical development of APR-1051. Building on the completion of dose escalation, the Company is considering further ATRN-119 development in combination approaches that could expand its therapeutic potential. Aprea believes ATRN-119's mechanism of action, potentially favorable safety profile, and pharmacologic characteristics could make it an ideal candidate for combination with other anti-cancer therapies, including radiation therapy, chemotherapy, antibody-drug conjugates and immune checkpoint inhibitors.

Aprea Expands APR-1051 Clinical Trial

"Having observed early signs of clinical activity for APR-1051, we are now expanding the ongoing ACESOT-1051 trial," said Oren Gilad, President and Chief Executive Officer of Aprea. "We are accelerating enrollment, advancing dose escalation to inform dose selection, and preparing to evaluate APR-1051 both as a single agent in uterine serous carcinoma and Cyclin E-overexpressing platinum-resistant ovarian cancer and also in combination with standard of care in HPV-positive head and neck cancer and colorectal cancer. We look forward to sharing our next clinical data update at a medical meeting in the fourth quarter of 2026. This ongoing progress reflects our commitment to developing targeted cancer therapies that have the potential to improve outcomes and quality of life for patients, while also creating value for our shareholders."