APRE

Business Context and Reporting Period

Aprea Therapeutics, Inc. (APRE) is a clinical-stage biopharmaceutical company focused on precision oncology through synthetic lethality. The company is developing two primary product candidates: APR-1051 (a WEE1 kinase inhibitor) and ATRN-119 (an ATR inhibitor). This Form 10-Q covers the quarterly period ended June 30, 2025. The company is classified as a non-accelerated filer and a smaller reporting company.

Key Financial Metrics

Material Changes vs. Prior Period

• Revenue: Grant revenue decreased significantly to $118,111 for the three months ended June 30, 2025, compared to $561,574 in the same period in 2024. This decline is attributed to receiving less grant revenue from the National Institutes of Health (NIH).
• Operating Expenses: Total operating expenses decreased by $902,614 to $3.5 million for the quarter compared to $4.4 million in the prior year quarter. Research and development (R&D) expenses decreased by $645,466, primarily due to reduced costs related to the initiation of the APR-1051 clinical trial and a reduction in staff. General and administrative (G&A) expenses decreased by $257,148, driven by lower professional fees and personnel costs.
• Net Loss: The net loss narrowed to $3.2 million for the quarter compared to $3.5 million in the prior year period, reflecting the reduction in operating expenses.
• Cash Position: Cash and cash equivalents decreased from $22.8 million at December 31, 2024, to $16.5 million at June 30, 2025, a reduction of approximately $6.3 million.

Guidance, Outlook, and Risks

• Going Concern: Management has concluded that substantial doubt exists regarding the company's ability to continue as a going concern. The current cash balance of approximately $16.5 million is not sufficient to fund operating expenses and capital expenditures for at least twelve months from the date of issuance. The company is actively seeking additional funding.
• Clinical Outlook:
  • APR-1051: The company is accelerating dose escalation in the ACESOT-1051 Phase 1 study. Open-label safety/efficacy data is anticipated in the second half of 2025, with dose-escalation completion expected in the first half of 2026.
  • ATRN-119: Enrollment is ongoing in the ABOYA-119 Phase 1/2a trial. Open-label safety/efficacy data is anticipated in the second half of 2025, with the Recommended Phase 2 Dose (RP2D) expected in the first half of 2026.
• Financing Activities: During the six months ended June 30, 2025, the company raised approximately $0.4 million in net proceeds through its At-the-Market (ATM) offering program. In April 2025, 25,033 shares of Series A convertible preferred stock were converted into common stock.
• Risks: Key risks include the failure of clinical trials, inability to secure additional financing, regulatory delays, and the high cost of drug development. The company also faces risks related to foreign currency fluctuations (Swedish Krona) and potential impacts from new U.S. tax legislation (OBBBA) enacted in July 2025.

Investor Verification Checklist

• Liquidity Runway: Verify the timeline for securing additional capital, as the company explicitly states it cannot fund operations for the next 12 months with current cash.
• Grant Dependency: Assess the sustainability of revenue given the significant drop in NIH grant funding and the lack of commercial product sales.
• Clinical Milestones: Monitor the upcoming data readouts for APR-1051 and ATRN-119 expected in the second half of 2025, which are critical for future valuation and financing.
• ATM Utilization: Track the remaining capacity under the $3.0 million ATM agreement and the pace of share issuance.
• Going Concern Disclosure: Review the specific plans management is executing to raise capital to avoid a potential cessation of operations.