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Aprea Therapeutics(APRE) - 2025 Q1 - Quarterly Report

Oncology Development - The company is focused on precision oncology through synthetic lethality, aiming to establish a pipeline of clinical and preclinical programs for cancer treatment [88]. - The lead product candidate, APR-1051, received FDA clearance for its IND application in March 2024, with the first patient enrolled in a Phase 1 study in Q2 2024 [90]. - The second product candidate, ATRN-119, is an oral small molecule inhibitor currently in a Phase 1/2a clinical trial, with safety and efficacy data expected in the second half of 2025 [91]. - The company is exploring combination therapies with other agents, such as PARP inhibitors, to enhance the therapeutic impact of its product candidates [92]. - The company has a preclinical research program in lead optimization for an undisclosed DDR target, focusing on synthetic lethality in oncology [93]. Financial Performance - Grant revenue for the three months ended March 31, 2025 was approximately $0.2 million, a decrease of 47.4% compared to $0.4 million for the same period in 2024 [125]. - Total operating expenses increased to $4.25 million for the three months ended March 31, 2025, up 20.4% from $3.53 million in the same period in 2024 [124]. - Research and development expenses rose to approximately $2.48 million for the three months ended March 31, 2025, an increase of 55.1% from $1.6 million in 2024 [126]. - Net loss for the three months ended March 31, 2025 was $3.93 million, compared to a net loss of $2.81 million for the same period in 2024, reflecting an increase of 40% [130]. - Cash and cash equivalents as of March 31, 2025 were $19.3 million, with substantial doubt about the ability to fund operations for the next twelve months [143]. - Net cash used in operating activities was $3.63 million for the three months ended March 31, 2025, a decrease of 7.7% from $3.94 million in 2024 [137]. - Foreign currency loss for the three months ended March 31, 2025 was $51,803, compared to a gain of $56,176 in 2024, indicating a change of $107,979 [128]. Future Outlook - The company anticipates completing dose escalation for APR-1051 in the first half of 2026 and determining the Recommended Phase 2 Dose for ATRN-119 in the same timeframe [90][91]. - The company expects to incur significant expenses and increasing operating losses for at least the next several years due to ongoing development activities [130]. - The company plans to seek marketing approvals for product candidates that successfully complete clinical trials and establish a commercialization infrastructure [145]. - The company requires additional financing to support ongoing operations and may rely on public or private equity, debt financings, or collaborations [147]. - There is uncertainty regarding the timing and amount of increased expenses, and the company may not achieve or maintain profitability [148]. - Developing drug products is a lengthy and costly process, and the company may not generate necessary data for marketing approval [149]. - The company currently has no committed external source of funds and may face dilution of ownership interests if additional capital is raised through equity sales [150]. - Collaborations or licensing arrangements may require the company to relinquish valuable rights to technology or future revenue streams [151]. - The company anticipates costs related to patent applications, headcount growth, and operating as a public company [152]. Risk Factors - The company is exposed to interest rate risk, but historical fluctuations in interest income have not been significant [158]. - Foreign currency exchange rate changes may affect the revenues and expenses of the company's foreign subsidiaries [159]. - The company does not currently have significant direct foreign exchange risk and has not used derivative financial instruments for hedging [160]. - Inflation has not materially affected the company's business or financial condition in the recent quarter [161].