Aprea Therapeutics Reports Second Quarter 2024 Financial Results and Progress in Clinical Trials

Aprea Therapeutics

DOYLESTOWN, PAAprea Therapeutics, Inc. (Nasdaq: APRE) has released its financial results for the second quarter ending June 30, 2024, alongside significant business updates that highlight the company’s strategic advancements in synthetic lethality drug development.

Financial Highlights

Aprea reported $28.7 million in cash and cash equivalents as of June 30, 2024, up from $21.6 million at the end of 2023. This financial status extends the company’s cash runway into the fourth quarter of 2025, providing a solid foundation for ongoing and future clinical initiatives.

For the second quarter, the company reported an operating loss of $3.8 million, a slight increase from the $3.7 million operational loss in the same period in 2023. Research and development expenses rose to $2.6 million, reflecting increased costs related to the initiation of the ACESOT-1051 Phase 1 study. General and administrative expenses also saw a rise to $1.9 million, primarily driven by higher personnel costs.

ACESOT-1051 Phase 1 Trial Commences

A notable milestone for Aprea is the commencement of the ACESOT-1051 Phase 1 trial, which evaluates APR-1051 as a monotherapy for advanced solid tumors with cancer-associated gene alterations. APR-1051, a next-generation WEE1 kinase inhibitor, has shown promise in preclinical studies for its potential to limit toxicity. The first patient dosed at NEXT Oncology in San Antonio, Texas, exhibited no dose-limiting toxicities. A second patient has begun treatment at The University of Texas MD Anderson Cancer Center.

The primary goals of the Phase 1 study include assessing safety, dose-limiting toxicities, and determining the maximum tolerated dose. Secondary objectives focus on pharmacokinetics and preliminary efficacy, with pharmacodynamics as an exploratory objective. The company plans to provide an update on this study by the end of the year, with open-label safety and efficacy data expected in the first half of 2025.

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Ongoing ABOYA-119 Trial for ATR Inhibitor

Aprea continues to advance its ABOYA-119 Phase 1/2a trial, evaluating ATRN-119, a first-in-class macrocyclic ATR inhibitor. Designed for patients with mutations in DDR-related genes, ATRN-119 is currently being tested in multiple dose cohorts. The trial aims to determine the tolerability and pharmacokinetics of ATRN-119, with amendments planned to explore twice-daily dosing and the effects of food on drug absorption. Results from this study are anticipated in the first half of 2025.

Strategic Focus and Leadership Enhancement

Aprea remains committed to the development of treatments that can significantly impact cancer patients’ lives. The company’s focus on synthetic lethality, a strategy that targets cancer cells with specific genetic vulnerabilities, positions it at the forefront of innovative cancer therapy development.

In a strategic move to bolster its leadership, Aprea appointed Nadeem Q. Mirza, M.D., M.P.H., as Chief Medical Officer effective May 1, 2024. Dr. Mirza has been a consultant to Aprea since February 2023 and now takes on a central role in guiding the company’s clinical pipeline.

Conclusion

Aprea Therapeutics is making substantial strides in its clinical programs and financial stability, reflecting its commitment to innovation in cancer treatment. With an extended cash runway and ongoing progress in key clinical trials, the company is well-positioned to deliver on its promise of developing groundbreaking therapies for cancer patients.

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