Aprea Therapeutics(US:APRE)2025-07-07 08:25Pipeline and Milestones - Aprea Therapeutics' WEE1 inhibitor (APR-1051) ACESOT-1051 Phase 1 study expects safety/efficacy data in H2 2025 and complete dose escalation in H1 2026 [7, 43] - Aprea Therapeutics' ATR inhibitor (ATRN-119) ABOYA-119 Phase 1/2a study expects safety/efficacy data in H2 2025 and Recommended Phase 2 Dose (RP2D) in H1 2026 [8, 68] - Six patients in the ATRN-119 dose escalation cohorts achieved stable disease, with three patients (50%) in the 550mg BID cohort demonstrating measurable tumor shrinkage of 7%, 14%, and 21% [53] APR-1051 (WEE1 Inhibitor) - APR-1051 is a potent WEE1 inhibitor with high selectivity, showing >150-fold, >50-fold, and >600-fold difference in IC50 compared to PLK1, PLK2, and PLK3 inhibition, respectively [31] - Clinical data cutoff on March 4, 2025, for APR-1051 (N=9) showed treatment-related adverse events, including alanine aminotransferase increased (2 patients), aspartate aminotransferase increased (2 patients), and lymphocyte count decreased (1 patient) [26] ATRN-119 (ATR Inhibitor) - ATRN-119 exhibits near-dose proportional exposure following oral administration, with AUC 0-24hr ranging from 180 ngh/mL at 50mg to 6899 ngh/mL at 550mg [55] - Clinical data cutoff on May 1, 2025, for ATRN-119 (N=32) showed treatment-related adverse events, including nausea (13 patients), diarrhea (12 patients), and fatigue (10 patients) [57] - ATRN-119 is the first and only macrocyclic ATR inhibitor, potentially offering increased selectivity and improved tolerability compared to first-generation acyclic structures [59, 66] Financials and Capitalization - As of March 31, 2025, Aprea Therapeutics had approximately $19.3 million in cash and equivalents [73] - Aprea Therapeutics has 5,531,373 common stock, 2,701,864 warrants, 782,243 options, and 30,607 restricted stock units outstanding as of May 14, 2025, resulting in 9,061,683 fully diluted equivalents [73]