DOYLESTOWN, PA — Aprea Therapeutics, Inc. (Nasdaq: APRE) recently announced financial results for the fourth quarter and full year ended December 31, 2023. The company also provided an update on its business operations and key developments.
Aprea has made significant strides in 2023, making substantial progress across its diversified pipeline of synthetic lethality-based cancer therapeutics. President and CEO Oren Gilad, Ph.D., spoke about the company’s focus on successfully developing potentially safer and more effective therapies for cancer patients. One such treatment is their novel macrocyclic ATR inhibitor, ATRN-119, currently undergoing a Phase 1/2a study. The drug appears well tolerated, showing a manageable toxicity profile. Dose escalation will continue throughout 2024, with potential human efficacy data expected in the latter half of the year.
Aprea is also preparing to enter the clinic with its next-generation inhibitor of WEE1 kinase, APR-1051, after receiving FDA clearance on its IND. APR-1051 is believed to be best in class based on its unique characteristics.
The company’s recent private placement financing has bolstered its capital enough to fund these lead programs through meaningful clinical milestones. Dr. Gilad expressed gratitude to the dedicated team, academic collaborators, and both existing and new investors who have supported Aprea’s recent advancements. Aprea’s goal is to be a global leader in synthetic lethality, serving cancer patients in need while creating value for shareholders.
Two of Aprea’s key business updates and potential upcoming milestones are the ATR inhibitor, ATRN-119 and the Oral WEE1 inhibitor, APR-1051.
ATRN-119, a potent and highly selective first-in-class macrocyclic ATR inhibitor, is designed to be used in patients with mutations in DNA Damage Response (DDR) related-genes. The unique focus on DDR-related gene mutations sets Aprea apart – these patients currently have no effective therapies and represent a high unmet medical need. The ongoing Phase 1/2a clinical trial of ATRN-119 has shown promising early results, with two patients already showing stable disease.
APR-1051, a WEE1 inhibitor, is also set to begin Phase 1 of its clinical trial in the first half of 2024. This potent molecule has the potential to avoid off-target toxicity and achieve higher clinical activity than other WEE1 programs currently in development. APR-1051 is designed to help patients with Cyclin E overexpression, a group that currently has poor prognosis and no effective therapies.
Apart from these two significant programs, Aprea’s R&D team has identified a new target in synthetic lethality. A lead molecule for this third synthetic lethality program is expected to be declared in the second quarter of 2024. This program could provide meaningful differences for cancer patients who currently have limited therapies.
Despite the promising advancements in its portfolio, Aprea reported an operating loss of $3.7 million for the quarter ended December 31, 2023. This was, however, lower than the $2.7 million loss in the fourth quarter of 2022. The increase in R&D expenses – up to $2.0 million from $0.5 million in 2022 – was largely due to expenditures related to the ongoing clinical trials evaluating ATRN-119.
Looking ahead, Aprea believes its cash and cash equivalents, combined with the proceeds from the company’s recent private placement of common stock and warrants, will be sufficient to meet its projected operating expenses and capital expenditure requirements into the third quarter of 2025. As Aprea continues its groundbreaking work in cancer therapeutics, industry watchers would do well to follow its progress closely.
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