Key Highlights

• Updated interim Phase 1 data for oral WEE1 inhibitor APR-1051 to be featured at the ENA 2026 symposium in Barcelona on November 20, 2026

• Phase 1 clinical trial expanded from three to nine active sites, with enrollment expected to reach six to ten patients per month in Q4 2026

• Cash and cash equivalents of $37.8 million as of September 30, 2026, with runway expected into Q1 2028

• Plans to evaluate APR-1051 in combination with pembrolizumab in HPV-positive head and neck squamous cell carcinoma

Aprea Therapeutics, Inc.(NASDAQ:APRE), a clinical-stage precision medicine oncology company, reported its financial results for the third quarter ended September 30, 2026, alongside a Business update on its lead candidate, APR-1051. The company is focused on developing targeted therapies for patients with biomarker-defined cancers, with its WEE1 inhibitor program serving as the centerpiece of its pipeline.

Clinical Development of APR-1051

APR-1051 is a potent and selective oral small molecule WEE1 inhibitor currently being evaluated in ACESOT-1051, a multi-center, open-label Phase 1 study. During the third quarter, the company expanded the clinical site network from three to nine active sites, with enrollment expected to reach six to ten patients per month by the fourth quarter of 2026. The company is concentrating on genetically defined cancers, with particular emphasis on endometrial cancers, including uterine serous carcinoma. This includes tumors characterized by PPP2R1A, CCNE1, CCNE2, or FBXW7 mutations and Cyclin E overexpression. The trial's primary objectives are safety, dose-limiting toxicity, maximum tolerated or administered dose, and recommended Phase 2 dose. Aprea plans to expand ACESOT-1051 to enroll at least 50 patients with uterine serous carcinoma or Cyclin E-overexpressing, platinum-resistant ovarian cancer, with completion of dose escalation and backfill expansion enrollment expected in the second quarter of 2027. The company also intends to evaluate APR-1051 in combination with pembrolizumab in HPV-positive head and neck squamous cell carcinoma.

Upcoming Data Presentations

Updated interim results from ACESOT-1051 will be featured in an oral presentation at the 38th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics (ENA 2026), scheduled for November 20, 2026, in Barcelona, Spain. The presentation will be delivered by Timothy A. Yap, Ph.D., of The University of Texas MD Anderson Cancer Center, and will include updated clinical results beyond the May 6, 2026, data cutoff. The company noted preliminary antitumor activity and manageable tolerability observed to date support the strategy of advancing APR-1051 as a single agent in selected patient populations, while also evaluating rational combination approaches. The dose selection for Part 2 of the study, focused on dose optimization, remains on track for the first half of 2027.

Q3 2026 Financial Results

For the third quarter of 2026, Aprea reported Research and Development expenses that reflected the expansion of the ACESOT-1051 trial and the activation of additional clinical sites. The company expects R&D spending on APR-1051 to increase relative to prior plans as the trial expands. Cash and cash equivalents stood at $37.8 million as of September 30, 2026. The company expects this cash position to provide sufficient runway into the first quarter of 2028, supporting the execution of its clinical development strategy and the achievement of key milestones. On October 20, 2026, Aprea hosted a virtual research and development investor event focused on APR-1051 and its clinical development strategy. The company is positioning APR-1051 as a potentially differentiated, best-in-class WEE1 inhibitor for patients with biomarker-defined cancers.

The Road Ahead

Aprea Therapeutics enters the final stretch of 2026 with several near-term catalysts. The ENA 2026 oral presentation in November will provide the first updated look at ACESOT-1051 clinical data since the May cutoff. Site expansion and enrollment acceleration during Q4 are expected to support faster data generation. The company remains on track to select the Part 2 dose in the first half of 2027, with enrollment in the expansion cohort expected to complete in Q2 2027. With its cash runway extending into early 2028, Aprea has the financial capacity to advance through these milestones.