Aprea Therapeutics(APRE) - 2025 Q3 - Quarterly Report

Clinical Development - The FDA cleared the IND application for APR-1051 in March 2024, with the first patient enrolled in the Phase 1 study in Q2 2024 [84]. - The recommended Phase 2 dose for ATRN-119 is 1,100 mg once daily, determined on October 15, 2025, during the ongoing Phase 1/2a study [86]. - The company has paused further enrollment in both monotherapy dosing arms of ATRN-119 to explore combination approaches with other therapies [86]. - The company is evaluating combination opportunities for its product candidates, including ATRN-119 and APR-1051, supported by a grant from the National Cancer Institute [88]. - The company has an early preclinical research program for an undisclosed DDR target, currently in the lead optimization stage [90]. Financial Performance - The company has not generated any revenue from product sales and does not expect to do so in the near future [94]. - Grant revenue for the three months ended September 30, 2025, was $1,848, a decrease of $352,773 from $354,621 in 2024 [116]. - Total operating expenses for the three months ended September 30, 2025, were $3,119,236, down from $4,451,637 in 2024, representing a decrease of $1,332,401 [116]. - Research and development expenses for the three months ended September 30, 2025, were approximately $1.6 million, a decrease of $1.2 million from approximately $2.8 million in 2024 [118]. - General and administrative expenses for the three months ended September 30, 2025, were approximately $1.5 million, down from approximately $1.6 million in 2024, a decrease of $124,919 [119]. - Net loss for the three months ended September 30, 2025, was $2,972,410, compared to a net loss of $3,783,769 in 2024, an improvement of $811,359 [116]. - Grant revenue for the nine months ended September 30, 2025, was approximately $0.3 million, a decrease of $1,014,342 from $1.3 million in 2024 [123]. - Total operating expenses for the nine months ended September 30, 2025, were $10,873,165, down from $12,390,374 in 2024, a decrease of $1,517,209 [122]. - Net cash used in operating activities for the nine months ended September 30, 2025, was $9,933,147, compared to $10,045,814 in 2024, a decrease of $112,667 [135]. - The accumulated deficit as of September 30, 2025, was $331.2 million, with significant losses primarily from research and development activities [129]. Cash and Financing - As of September 30, 2025, the company had cash and cash equivalents of $13.7 million, which is insufficient to fund operating expenses for the next twelve months [128]. - Net cash provided by financing activities was $0.8 million for the nine months ended September 30, 2025, after deducting approximately $36,000 in issuance costs from sales of common stock [138]. - For the nine months ended September 30, 2024, net cash provided by financing activities was $14.7 million, after deducting approximately $1.3 million in underwriting discounts and offering expenses [139]. - The company anticipates a substantial increase in expenses related to ongoing and planned development activities, including clinical trials and preclinical research [141]. - Additional financing will be required to support continuing operations, with potential sources including public or private equity, debt financings, and collaborations [144]. - The company may face significant delays or reductions in product development if it fails to raise necessary capital [149]. - The company has no committed external source of funds and may experience dilution of ownership interests if additional capital is raised through equity sales [147]. Risk Factors - The company is exposed to interest rate risk, with cash equivalents primarily in bank deposits and money market accounts [155]. - Inflation has not had a material effect on the company's business or financial condition during the nine months ended September 30, 2025 [158]. - The company does not currently have significant direct foreign exchange risk and has not used derivative financial instruments to hedge such exposure [157]. Company Status - The company qualifies as a "smaller reporting company," with a market value of common stock held by non-affiliates below $700 million [114]. - The company has not recorded any income tax expense or benefits due to uncertainty in realizing benefits from net losses [109].