DOYLESTOWN, PA — Aprea Therapeutics, Inc. (Nasdaq: APRE), a biopharmaceutical company focused on developing novel cancer treatments, reported notable advancements in its first-quarter financial results and clinical trials, including receiving U.S. Food and Drug Administration (FDA) clearance for a new drug trial.
The company announced FDA clearance for its Investigational New Drug (IND) application for APR-1051, marking a significant step forward in its development pipeline. APR-1051 is an oral WEE1 inhibitor, designed to block a specific protein that regulates cell division, and is poised to begin Phase 1 clinical trials in June 2024. This development positions APR-1051 as a highly selective and potentially best-in-class treatment option for cancers expressing high levels of Cyclin E, such as ovarian and breast cancers.
Alongside APR-1051, Aprea’s first-in-class macrocyclic ATR inhibitor, ATRN-119, is advancing through the dose escalation phase of its ABOYA-119 clinical trial. The trial aims to evaluate ATRN-119’s efficacy in treating advanced solid tumors with specific mutations in DNA damage response (DDR) genes, with initial human efficacy data expected in the second half of 2024.
Aprea’s progress was further highlighted at the American Association for Cancer Research (AACR) Annual Meeting, where it presented four posters, including updates on APR-1051 and ATRN-119. These presentations underscore the company’s commitment to addressing the urgent need for new cancer therapies through its innovative research.
Financially, Aprea Therapeutics reported a robust position with $32.4 million in cash and cash equivalents as of March 31, 2024, a significant improvement from $21.6 million at the end of 2023. The company expects its current funds to sustain operations into the third quarter of 2025, reflecting confidence in its financial strategy and the potential of its drug candidates.
For the first quarter of 2024, Aprea recorded an operating loss of $3.1 million, a decrease from $4.6 million in the same period last year, demonstrating improved financial management. Research and Development (R&D) expenses saw a moderate increase due to preparations for the upcoming APR-1051 clinical trials, while General and Administrative (G&A) expenses decreased, primarily due to lower personnel costs.
Overall, Aprea Therapeutics remains optimistic about its future, with President and CEO Dr. Oren Gilad stating, “We believe that our strategic initiatives and pipeline expansion have the potential to drive substantial value for shareholders.” The company’s advancements in clinical trials and favorable financial results indicate a promising direction for its cancer treatment research, offering hope for patients and stakeholders alike.
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