Aprea Therapeutics Q1 2024 Financial Results and Business Update

Aprea Therapeutics, Inc., a clinical-stage biopharmaceutical company specializing in precision oncology, has reported significant developments for the first quarter of 2024, ending March 31. The company's efforts focus on advancing synthetic lethality-based therapies, targeting cancer treatment through innovative molecular inhibitors.

A major achievement for Aprea this quarter was the U.S. FDA clearance of their Investigational New Drug (IND) application for APR-1051, a next-generation oral WEE1 inhibitor. This approval allows Aprea to move forward with the Phase 1 clinical trial, named ACESOT-1051, scheduled to begin in June 2024. APR-1051 is designed to address Cyclin E overexpressing cancers, such as ovarian and breast cancers, which currently have poor prognoses and lack effective treatments.

Meanwhile, Aprea's ATRN-119, a first-in-class macrocyclic ATR inhibitor, is progressing in the ABOYA-119 clinical trial. This trial is focused on patients with advanced solid tumors characterized by specific DDR-related gene mutations. The dose escalation phase of this trial is expected to conclude by the end of 2024, with initial efficacy data anticipated in the second half of the year. ATRN-119 has shown promising preliminary clinical benefits and has been found to be safe and well-tolerated at various dosage levels.

Financially, Aprea reported cash and cash equivalents totaling $32.4 million as of March 31, 2024, an increase from $21.6 million at the end of December 2023. This financial stability is bolstered by a recent securities purchase agreement announced in March 2024, which aims to raise up to $34.0 million, including initial funding of $16.0 million and potential additional funds from warrant exercises. The capital will be used for general working purposes and to support the ongoing clinical trials for APR-1051 and ATRN-119.

The company also presented four posters at the AACR Annual Meeting, providing updates on APR-1051 and ATRN-119. These presentations highlighted the pre-clinical data for APR-1051 and detailed the design of the upcoming ACESOT-1051 trial. Additionally, Aprea is exploring a combination approach using their macrocyclic ATR inhibitor, ATRN-333, to enhance the efficacy of existing treatments for glioblastoma, an aggressive type of brain cancer.

In terms of corporate developments, Aprea has appointed Dr. Nadeem Q. Mirza as Chief Medical Officer, effective May 1, 2024. Dr. Mirza, who has been a consultant for Aprea since early 2023, will now play a central role in advancing the company’s clinical pipeline.

For the first quarter of 2024, Aprea reported an operating loss of $3.1 million, an improvement from the $4.6 million loss in the same period the previous year. Research and Development (R&D) expenses increased slightly to $1.6 million, primarily due to IND enabling studies for APR-1051. General and Administrative (G&A) expenses decreased to $1.9 million from $3.4 million, mainly due to reduced personnel costs. Net loss for the quarter was $2.8 million ($0.67 per share), compared to $4.4 million ($1.34 per share) in the first quarter of 2023.

Overall, Aprea remains committed to leveraging its expertise in synthetic lethality to develop new treatment options for cancer patients, aiming to create substantial value for shareholders through its strategic initiatives and expanding pipeline.