Aprea Therapeutics, Inc. Stock Price, News & Analysis

Aprea Therapeutics, Inc. (Nasdaq: APRE) will present a corporate update at the 40th Annual J.P. Morgan Healthcare Conference on January 13, 2022, at 11:15 a.m. ET. The presentation will be led by CEO Christian S. Schade and will be available via live webcast on the company's investor relations website. Aprea focuses on developing innovative cancer therapeutics, particularly eprenetapopt, aimed at reactivating the mutant p53 protein, currently under clinical evaluation. Eprenetapopt has received multiple FDA designations.

Aprea Therapeutics (APRE) showcased promising data for its lead candidate, eprenetapopt, at the 2021 ASH Annual Meeting. Key findings include:

• 1-year relapse-free survival (RFS) of 60% and overall survival (OS) of 79% in a trial involving post-transplant patients.
• A 69% overall response rate (ORR) and 43% complete response (CR) in patients with TP53 mutant MDS/AML.
• 64% ORR with 39% CR in patients treated with a combination of eprenetapopt, venetoclax, and azacitidine.

The data indicate the treatment is well-tolerated across trials.

Aprea Therapeutics (Nasdaq: APRE) announced promising updates from its Phase 2 trial of eprenetapopt combined with azacitidine for post-transplant maintenance in patients with TP53 mutant myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML). Key results include a 60% relapse-free survival rate at one year and an overall survival rate of 79% in the same period, significantly higher than historical data. The combination therapy was well tolerated, leading the company to consider future randomized clinical trials to further evaluate its efficacy.

Aprea Therapeutics, Inc. (Nasdaq: APRE) announced the U.S. FDA has lifted the full clinical hold on its clinical trial for eprenetapopt, its lead compound, in combination with acalabrutinib and venetoclax for lymphoid malignancies. This decision allows Aprea to proceed with further evaluations of eprenetapopt, enhancing its potential as a treatment option for patients with non-Hodgkin's lymphoma. The company emphasized the importance of addressing the FDA's concerns and looks forward to advancing the clinical study.

Aprea Therapeutics, Inc. (Nasdaq: APRE) reported its financial results for Q3 2021. Cash and cash equivalents stood at $61.4 million, down from $89.0 million at the end of 2020. The expected cash burn for 2021 is between $30 million and $35 million. R&D expenses decreased to $6.0 million from $8.8 million year-over-year, while G&A expenses slightly fell to $3.4 million. The net loss was $9.5 million, or $0.45 per share, compared to a loss of $12.3 million, or $0.58 per share in Q3 2020. However, the FDA has placed partial clinical holds on two ongoing clinical trials due to safety concerns regarding eprenetapopt.

Aprea Therapeutics (NASDAQ: APRE) announced presentations of clinical trial data for eprenetapopt at the 63rd American Society of Hematology Annual Meeting. Key oral presentations include long-term follow-up results combining eprenetapopt with azacitidine in TP53 mutant myelodysplastic syndromes and acute myeloid leukemia, scheduled for December 11 and 12, 2021. A poster presentation is also planned for December 13, 2021, featuring a Phase I study of eprenetapopt with venetoclax and azacitidine for TP53-mutant AML. The company continues to develop innovative therapies targeting mutant p53.

Aprea Therapeutics, Inc. (Nasdaq: APRE) presented data from its Phase I/II trial at ESMO Congress 2021, evaluating the efficacy of eprenetapopt in combination with pembrolizumab for advanced solid tumors. As of July 31, 2021, 33 patients were enrolled, with no dose-limiting toxicities reported. The trial showed promising results, including complete remission in a bladder cancer patient and tumor reductions in lung cancer patients. Adverse events were primarily grade 1/2. Despite a previous trial failure for MDS, the company continues to progress with eprenetapopt in various cancers.

Aprea Therapeutics (Nasdaq: APRE) announced a presentation of data regarding eprenetapopt in combination with pembrolizumab for treating advanced solid tumors at the ESMO Congress 2021, scheduled from September 16-21, 2021. This presentation will cover the Phase I/II study and is set for September 20, 2021. The company is focused on developing therapies targeting the mutant tumor suppressor protein p53. Notably, a pivotal Phase 3 clinical trial of eprenetapopt in TP53 mutant myelodysplastic syndromes recently failed to meet its primary endpoint.

Aprea Therapeutics (Nasdaq: APRE) reported its financial results for Q2 2021, showing a net loss of $10.3 million or $0.48 per share, improved from a net loss of $16.4 million or $0.78 per share in Q2 2020. As of June 30, 2021, the company had $69.8 million in cash, projected to sustain operations into 2023. However, the FDA placed partial clinical holds on trials for eprenetapopt, affecting enrollment, despite positive results in some ongoing studies. The company emphasizes ongoing efforts to resolve these holds with the FDA and to present trial data at future conferences.