Aprea Therapeutics, Inc. Stock Price, News & Analysis

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.

Aprea Therapeutics (Nasdaq: APRE) announced a clinical hold by the FDA on its trial evaluating eprenetapopt in combination with acalabrutinib or venetoclax and rituximab for lymphoid malignancies. This follows a previous clinical hold on its myeloid malignancies program, stemming from concerns regarding safety and efficacy data from a Phase 3 trial. Patients who are currently benefiting from the study can continue treatment, yet no new patients can be enrolled until the hold is lifted. Aprea is committed to working with the FDA to resolve these issues promptly.

Aprea Therapeutics (Nasdaq: APRE) announced a partial clinical hold on its eprenetapopt trials in myeloid malignancies after a review by the FDA. About 20 patients are currently in the program, which includes MDS and AML, and can continue treatment. No new enrollments are permitted until the hold is resolved. Aprea aims to address FDA concerns and resume trials quickly. Ongoing trials in lymphoid malignancies and solid tumors remain unaffected. A webcast to discuss the situation will be held on August 6, 2021.

Aprea Therapeutics, Inc. (Nasdaq: APRE) announced positive results from a Phase 2 trial of eprenetapopt combined with azacitidine for post-transplant maintenance therapy in patients with TP53 mutant MDS and AML. The trial showed a 58% relapse-free survival and 79% overall survival at one year post-transplant. Previous trials reported much lower outcomes, indicating the potential impact of this therapy. The regimen was well tolerated, and discussions with the FDA are planned. Aprea has received multiple designations for its products aimed at treating hematologic malignancies.