8-K: Aprea Therapeutics Announces Second Quarter 2024 Financial Results and Provides Clinical Pipeline Update

Aprea Therapeutics reported its second quarter 2024 financial results, highlighted by the initiation of a Phase 1 trial for APR-1051 and a cash runway extended into Q4 2025.

Summary

• Aprea Therapeutics announced its financial results for the second quarter ended June 30, 2024, and provided an update on its clinical programs.
• The company initiated enrollment in the ACESOT-1051 Phase 1 trial for APR-1051, a WEE1 inhibitor, with no myelosuppression observed in the first cohort.
• Aprea has $28.7 million in cash and cash equivalents as of June 30, 2024, which is expected to fund operations into the fourth quarter of 2025.
• The company reported an operating loss of $3.8 million for the quarter ended June 30, 2024, compared to a $3.7 million loss in the same period of 2023.
• Research and development expenses increased to $2.6 million for the quarter, up from $2.2 million in the prior year, primarily due to the initiation of the ACESOT-1051 trial.
• The net loss for the quarter was $3.5 million, or $0.58 per basic share, compared to a net loss of $3.3 million, or $0.87 per basic share, in the second quarter of 2023.
• Aprea is also continuing enrollment in the ABOYA-119 trial for ATRN-119, an ATR inhibitor, with a planned protocol amendment to investigate twice-daily dosing and the effect of food on absorption.
• The company appointed Nadeem Q. Mirza, M.D., M.P.H., as Chief Medical Officer, effective May 1, 2024.

Sentiment

Score: 7

Explanation: The document presents a generally positive outlook with the initiation of a new clinical trial and a cash runway extended into Q4 2025. However, the company is still in the early stages of clinical development and is incurring losses, which tempers the overall sentiment.

Positives

• Aprea has a strong cash position of $28.7 million, providing a runway into Q4 2025.
• The initiation of the ACESOT-1051 trial for APR-1051 is a significant milestone, with early data showing no myelosuppression.
• APR-1051 is designed to potentially solve liabilities and achieve greater clinical activity than other WEE1 programs.
• The company is actively progressing two clinical assets, ATRN-119 and APR-1051, targeting significant unmet medical needs.
• The appointment of a new Chief Medical Officer strengthens the leadership team.
• The company is exploring different dosing strategies for ATRN-119 to optimize its effectiveness.

Negatives

• The company reported an operating loss of $3.8 million for the quarter ended June 30, 2024.
• The net loss for the quarter was $3.5 million, or $0.58 per basic share.
• Research and development expenses increased to $2.6 million for the quarter, primarily due to the initiation of the ACESOT-1051 trial.
• General and administrative expenses increased to $1.9 million for the quarter, primarily related to an increase in personnel costs including severance expense.

Risks

• The company's clinical trials are subject to risks related to success, timing, and cost.
• The company's ability to fully fund its clinical trials depends on no material changes to currently projected expenses.
• The company's forward-looking statements are subject to risks and uncertainties, including the success and timing of clinical trials.
• The company is dependent on additional financing to fund operations and complete the development and commercialization of product candidates.
• The company has a limited history and preclinical status of the assets acquired from Atrin Pharmaceuticals Inc.

Future Outlook

The company believes its cash and cash equivalents will be sufficient to meet its currently projected operating expenses and capital expenditure requirements into the fourth quarter of 2025. Open-label safety/efficacy data for the ACESOT-1051 trial and the ABOYA-119 Phase 1 readout are expected in the first half of 2025. The company plans to provide an update on the progress of the ACESOT-1051 clinical study by year end.

Management Comments

• Aprea continues to make excellent progress advancing its clinical pipeline of therapeutic candidates, said Oren Gilad, Ph.D., President and Chief Executive Officer of Aprea.
• We initiated enrollment in the ACESOT-1051 trial, advancing a second clinical asset in our pipeline, APR-1051.
• We believe that our ongoing progress positions Aprea at the forefront of synthetic lethality drug development.
• We remain committed to developing new treatments that have a positive impact on the lives of cancer patients while creating value for our shareholders.

Industry Context

Aprea is operating in the precision oncology space, focusing on synthetic lethality, a growing area of interest in cancer therapeutics. The company's focus on DDR inhibitors like ATR and WEE1 aligns with current trends in targeted cancer therapies. The company is competing with other companies developing similar inhibitors, but is attempting to differentiate itself with its macrocyclic ATR inhibitor and its highly selective WEE1 inhibitor.

Comparison to Industry Standards

• Aprea's ATR inhibitor, ATRN-119, is a macrocyclic compound, which is structurally different from first-generation acyclic ATR inhibitors like AZD6738 (AstraZeneca), BAY 1895344 (Bayer), and RP-3500 (Repare).
• First-generation ATR inhibitors have reported hematological toxicities and intermittent dosing schedules, while Aprea's ATRN-119 is designed for continuous daily dosing with potentially improved tolerability.
• Aprea's WEE1 inhibitor, APR-1051, is designed to be more selective than other WEE1 inhibitors like Adavosertib (AstraZeneca) and Azenosetrib (Zentalis), with lower off-target inhibition of PLK kinases.
• Preclinical data suggests APR-1051 has favorable pharmacokinetic properties compared to other WEE1 inhibitors, with potentially better drug exposure.
• Multiple Phase 2 studies have shown substantial single-agent activity of the WEE1 inhibitor Adavosertib, but it has been associated with significant Grade 3 hematological, GI and CV toxicities, which Aprea is attempting to address with APR-1051.

Management Changes

Stakeholder Impact

• Shareholders may view the clinical progress and extended cash runway positively.
• Employees may be impacted by the increase in personnel costs, including severance expenses.
• Patients with advanced solid tumors may benefit from the development of new treatments.
• The company's suppliers and creditors may be impacted by the company's financial performance.

Next Steps

• Aprea will continue to enroll patients in the ACESOT-1051 and ABOYA-119 clinical trials.
• The company plans to amend the ABOYA-119 study protocol to investigate twice-daily dosing and the effect of food on absorption.
• Aprea will provide an update on the progress of the ACESOT-1051 clinical study by year end.
• Open-label safety/efficacy data for the ACESOT-1051 trial and the ABOYA-119 Phase 1 readout are expected in the first half of 2025.

Key Dates

Keywords

Aprea Therapeutics, Oncology, Synthetic Lethality, ATRN-119, APR-1051, ATR Inhibitor, WEE1 Inhibitor, Clinical Trial, DDR, Cancer, Biopharmaceutical