Aprea Therapeutics Announces Q3 2024 Financial Results and Business Update

Aprea Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on precision oncology through synthetic lethality, announced its financial results for the third quarter of 2024 and provided a business update. The company has two clinical-stage therapeutic candidates in its pipeline, which are making significant progress, according to Dr. Oren Gilad, President, and CEO of Aprea.

The company is ahead of schedule in the enrollment for the Phase 1 ACESOT-1051 trial of its new WEE1 inhibitor, APR-1051. Preliminary results at subtherapeutic doses indicate that APR-1051 is well-tolerated with no unexpected toxicities. APR-1051 is designed to limit off-target toxicity, which the company believes will make it best-in-class. The trial aims to address cancers that over-express Cyclin E, a condition that currently lacks effective treatments and is associated with poor prognosis.

Enrollment for the Phase 1 ACESOT-1051 trial, which focuses on patients with advanced solid tumors with cancer-associated gene alterations, is ongoing. The trial's primary objectives include assessing safety, dose-limiting toxicities, maximum tolerated dose, and recommended Phase 2 dose. Secondary objectives are to evaluate pharmacokinetics and preliminary efficacy. By October 7, 2024, data from three patients in the initial cohorts had shown that APR-1051 is well-tolerated without unexpected toxicities. The trial is progressing to Cohort 4 with a dose of 50 mg. Preliminary efficacy data from this trial are anticipated in the first half of 2025.

Aprea is also advancing the Phase 1/2a ABOYA-119 study of ATRN-119, a first-in-class macrocyclic ATR inhibitor. ATRN-119 targets patients with mutations in DDR-related genes, a group that currently has no effective therapies and poor prognosis. The ongoing open-label trial evaluates ATRN-119 as a monotherapy for advanced solid tumors with specific DDR-related gene mutations. The trial's primary endpoint is to assess the tolerability and pharmacokinetics of ATRN-119.

As of October 2, 2024, 14 out of 20 patients had reported adverse events considered related to ATRN-119, but no severe adverse effects or dose-limiting toxicities had been noted. Preliminary clinical benefits were observed in two patients at lower dose levels. To optimize dosing and scheduling, a protocol amendment has been submitted to include a higher once-daily dose and a twice-daily dosing regimen. The company expects to release the Phase 1 readout for ABOYA-119 in the second half of 2025.

On the corporate front, Aprea engaged Dr. Philippe Pultar as a senior medical advisor to support the development of APR-1051. Dr. Pultar, a seasoned executive with extensive oncology experience, has previously worked at Zentalis Pharmaceuticals where he contributed significantly to the development of a WEE1 inhibitor.

Financially, Aprea reported $26.2 million in cash and cash equivalents as of September 30, 2024, which is expected to fund operations for at least twelve months. For the quarter ended September 30, 2024, the company reported an operating loss of $4.1 million, an increase from $3.5 million in the same period of 2023. Research and development expenses rose to $2.8 million, primarily due to the costs of the ABOYA-119 trial and personnel expenses. General and administrative expenses slightly decreased to $1.6 million. The net loss for the quarter was $3.8 million, compared to $3.2 million in the comparable period of 2023.

In summary, Aprea Therapeutics is making significant strides in its clinical trials for APR-1051 and ATRN-119, with promising preliminary results and ongoing patient enrollment. Financially, the company is maintaining a steady cash position to support its operations and continued research efforts.