Aprea Therapeutics Reports $12.96 Million Net Loss for 2024, Grant Revenue Increases

Aprea Therapeutics, Inc. reported a net loss of $12.96 million for the year ended December 31, 2024, compared to a net loss of $14.29 million in 2023. Grant revenue increased to $1.5 million in 2024 from $0.58 million in 2023. Research and development expenses rose to $9.36 million in 2024 from $7.63 million in 2023, primarily due to the initiation of a Phase 1 study for APR-1051 and continued enrollment in the ABOYA-119 trial for ATRN-119, as well as increased personnel costs. General and administrative expenses decreased to $6.46 million in 2024 from $8.43 million in 2023, mainly due to lower personnel costs and reduced insurance premiums.

The company's lead product candidates are APR-1051, a WEE1 inhibitor currently in a Phase 1 dose escalation study (ACESOT-1051), and ATRN-119, an ATR inhibitor in a Phase 1/2a trial (ABOYA-119). As of March 4, 2025, ACESOT-1051 was enrolling cohort 5, while ABOYA-119 had completed six dose cohorts with a seventh currently enrolling. Preliminary data for APR-1051 indicated it was safe and well-tolerated with no hematologic toxicity. The ABOYA-119 trial protocol was amended to include twice-daily dosing schedules in addition to the original once-daily schedule. Aprea anticipates open-label safety/efficacy data for APR-1051 in the second half of 2025 and completion of dose escalation in the first half of 2026. For ATRN-119, Phase 1 readout is expected in the second half of 2025, with the Recommended Phase 2 Dose (RP2D) to be determined in the first quarter of 2026.

Aprea Therapeutics also has an early-stage preclinical program for an undisclosed DNA-damage response (DDR) target. The company's strategy includes efficient development of APR-1051 and ATRN-119, identification of combination therapy opportunities, and maximizing commercial opportunities globally. The company retains worldwide development and commercialization rights to all its product candidates. Aprea's discovery platform integrates RepliBiom, ATRIZE™, and SCET™ technologies to identify novel synthetic lethality targets and biomarkers. The company relies on third-party contract manufacturers for the production of its product candidates.

The company's operations are subject to significant competition from major pharmaceutical and biotechnology companies. As of December 31, 2024, Aprea's patent portfolio included 4 issued U.S. patents and 3 U.S. patent applications for DDR inhibitors, and 3 issued U.S. patents and 1 pending U.S. application for p53 reactivators. The company's operations are extensively regulated by government authorities in the U.S. and other jurisdictions, including requirements for preclinical and clinical testing, manufacturing, and marketing approval. Aprea's financial statements include a statement that substantial doubt exists about the company's ability to continue as a going concern within one year. As of December 31, 2024, the company had 8 full-time employees.

Aprea's 10-K filing includes numerous risk factors, including the risks associated with clinical trial success, regulatory approval, competition, intellectual property protection, financing, and compliance with healthcare laws and regulations. The company's financial position and the need for additional funding are highlighted as significant risks. The filing also discusses the company's efforts to comply with cybersecurity requirements, although a formal program is not yet in place. The company's financial statements are presented in accordance with U.S. GAAP and include notes detailing significant accounting policies and estimates.