Aprea Therapeutics Q2 2024 Financial Results and Business Update

16 August 2024

Aprea Therapeutics, Inc., a clinical-stage biopharmaceutical company focusing on precision oncology, has reported significant progress in its clinical pipeline and financial results for the second quarter ending June 30, 2024. The company announced the initiation of patient enrollment in the ACESOT-1051 Phase 1 trial for APR-1051, a next-generation WEE1 kinase inhibitor designed to limit toxicity. This marks a significant milestone as APR-1051 moves forward in clinical development, with no myelosuppression observed in the initial cohort.

APR-1051 is being evaluated in advanced solid tumors that exhibit cancer-associated gene alterations. The trial, conducted at multiple centers, aims to determine the safety, dose-limiting toxicities, and recommended Phase 2 dose of APR-1051. Early results from the first cohort indicate no dose-limiting toxicities, including myelosuppression, which is promising for the drug's safety profile. Aprea plans to provide further updates on the trial's progress by the end of the year, with open-label safety and efficacy data expected in the first half of 2025.

In addition to APR-1051, Aprea continues to advance its ATR inhibitor, ATRN-119, through the ABOYA-119 trial. ATRN-119 is a potent macrocyclic ATR inhibitor targeting cancers with mutations in DDR-related genes. The Phase 1/2a clinical trial has completed five dose cohorts, and patient enrollment is ongoing. The trial aims to assess the tolerability and pharmacokinetics of ATRN-119, with a planned amendment to include twice-daily dosing and food effect evaluation. Results from this trial are anticipated in the first half of 2025.

The company also hosted a virtual Key Opinion Leader (KOL) event in June 2024 to discuss APR-1051, featuring insights from experts in medicinal chemistry and preclinical findings. The event underscored the scientific rationale behind APR-1051 and its potential advantages over other WEE1 inhibitors currently in development. APR-1051 was also highlighted in two posters at the American Association of Cancer Research (AACR) annual meeting in April 2024, showcasing pre-clinical data and the trial design for ACESOT-1051.

On the corporate front, Aprea appointed Dr. Nadeem Q. Mirza as Chief Medical Officer (CMO) in May 2024. Dr. Mirza had previously served as a consultant to the company and brings extensive expertise to lead the development of Aprea's expanding clinical pipeline.

Financially, Aprea reported cash and cash equivalents of $28.7 million as of June 30, 2024, an increase from $21.6 million at the end of 2023. This financial position is expected to support the company's operating expenses and capital requirements into the fourth quarter of 2025. For the second quarter of 2024, Aprea reported an operating loss of $3.8 million, slightly higher than the $3.7 million loss in the same period of 2023. Grant revenue increased to $0.6 million, up from $0.2 million in the previous year, primarily from the National Institutes of Health (NIH).

Research and development expenses rose to $2.6 million, driven by costs associated with the ACESOT-1051 trial. General and administrative expenses also saw an increase to $1.9 million, mainly due to higher personnel-related costs. The company ended the quarter with a net loss of $3.5 million, or $0.58 per share, compared to a net loss of $3.3 million, or $0.87 per share, in the same quarter of 2023.

Aprea's strategic focus on synthetic lethality and precision oncology positions it at the forefront of developing innovative cancer treatments. The company's ongoing clinical trials and financial stability underscore its commitment to advancing therapeutic candidates that address high unmet medical needs in oncology.

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