 BOSTON, Aug. 11, 2020 GLOBE NEWSWIRE -- Aprea Therapeutics, Inc. Nasdaq: APRE, a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate mutant tumor suppressor protein, p53, today reported financial results for the three and six months ended June 30, 2020 and provided a business update.The full enrollment in June of our Phase 3 clinical trial evaluating eprenetapopt APR-246 with azacitidine for the treatment of front-line TP53 mutant myelodysplastic syndromes MDS was a major milestone for Aprea and we look forward to top-line data by year-end 2020, said Christian S. Schade, President and Chief Executive Officer of Aprea. In addition, we continue to advance the clinical development of eprenetapopt in different clinical settings and have recently enrolled the first patient in our solid tumor clinical trial program.Business Operations Update: The Company is conducting, supporting and planning multiple clinical trials of eprenetapopt APR-246: Pivotal Phase 3 MDS TrialDuring the second quarter of 2020, the Company completed the full enrollment of 154 patients in its pivotal Phase 3 randomized, controlled trial evaluating eprenetapopt with azacitidine as frontline therapy in HMA-naïve TP53 mutant myelodysplastic syndromes MDS patients with a primary endpoint of complete remission CR rate. The Company remains confident it will have top-line data available by year-end 2020. Phase 2 MDSAML Post-Transplant TrialThe Company is currently enrolling its single-arm, open-label Phase 2 trial evaluating eprenetapopt with azacitidine as post-transplant maintenance therapy in TP53 mutant MDS and acute myeloid leukemia AML patients who have received an allogeneic stem cell transplant. Though the Company had initially observed a decrease in both patient screening and patient enrollment as a result of the COVID-19 pandemic, patient screening activity has returned to expected levels and the trial has currently enrolled 24 out of 31 patients with a number of additional patients in screening. The Company anticipates completing enrollment of this trial in the third quarter of 2020. Phase 1 AML TrialThe Company is currently enrolling its Phase 1 trial evaluating the safety, tolerability, and preliminary efficacy of eprenetapopt therapy in TP53 mutant AML patients. The lead-in portion of the trial evaluated the tolerability of eprenetapopt with venetoclax, with or without azacitidine, and no dose-limiting toxicities were observed in patients receiving either regimen. Based on these results, the Company has expanded the trial to treat approximately 30 additional frontline TP53 mutant AML patients with the combination of eprenetapopt, venetoclax and azacitidine. The Company also plans to activate a separate cohort in the trial to evaluate the combination of eprenetapopt with azacitidine in approximately 30 frontline TP53 mutant AML patients. Phase 1 NHL TrialTo further assess eprenetapopt in hematological malignancies, the Company has designed and plans to conduct a Phase 1 clinical trial in relapsedrefractory TP53 mutant chronic lymphoid leukemia CLL and mantle cell lymphoma MCL assessing eprenetapopt with venetoclax and rituximab, and eprenetapopt with ibrutinib. The Company is targeting the first patient to be enrolled in the second half of 2020. Phase 12 Solid Tumor TrialBased on in vivo data suggesting synergistic activity between eprenetapopt and immuno-therapy agents including anti-PD-1 antibody, the Company has designed and plans to conduct Phase 12 clinical trials in relapsedrefractory gastric, bladder and non-small cell lung cancers assessing eprenetapopt with anti-PD-1 therapy. The Company enrolled its first patient in August 2020. APR-548 -- The Companys second product candidate, APR-548, is a pre-clinical, next-generation p53 reactivator with the potential for oral administration. APR-548 exhibits high oral bioavailability in preclinical testing and is being developed in an oral dosage form. The Company completed Investigational New Drug, or IND, enabling preclinical studies of APR-548 and filed an IND with the FDA. However, based on feedback from the FDA, the Company will not be able to initiate human clinical trials of APR-548 until it is able to provide additional information necessary to address questions raised by the FDA.Second Quarter Financial Results Cash and cash equivalents: As of June 30, 2020, the Company had 112.9 million of cash and cash equivalents compared to 130.1 million of cash and cash equivalents as of December 31, 2019. The Company expects cash burn for the full year 2020 to be between 35.0 million 40.0 million. The Company believes its cash and cash equivalents as of June 30, 2020 will be sufficient to meet its current projected operating requirements into 2023. Research and Development RD expenses: RD expenses were 10.7 million for the quarter ended June 30, 2020, compared to 4.3 million for the comparable period in 2019. The increase in RD expenses was primarily related to the advancement of the Companys lead product candidate, eprenetapopt. In Q1 2019 the Company commenced a pivotal Phase 3 clinical trial of eprenetapopt with azacitidine for frontline treatment of TP53 mutant MDS which completed enrollment in Q2 2020 and is supported by two ongoing Phase 1b2 investigator initiated trials, one in the U.S. and one in France, testing eprenetapopt with azacitidine as frontline treatment in TP53 mutant MDS and AML patients. In addition, in Q1 2020, the Company continued enrolling patients in a Phase 2 post-transplant MDSAML clinical trial began enrolling patients in a Phase 1 clinical trial in frontline and relapsedrefractory TP53 mutant AML assessing eprenetapopt with venetoclax with or without azacitidine. General and Administrative GA expenses: GA expenses were 3.8 million for the quarter ended June 30, 2020, compared to 1.7 million for the comparable period in 2019. The increase in GA expenses was primarily due to increased insurance expense, non-cash stock-based compensation, personnel related costs and commercial development expense. Net loss: Net loss was 16.4 million, or 0.78 per share for the quarter ended June 30, 2020, compared to a net loss of 5.3 million, or 4.45 per share for the quarter ended June 30, 2019. The Company had 21,186,827 shares of common stock outstanding as of June 30, 2020.About Aprea Therapeutics, Inc.Aprea Therapeutics, Inc. is a biopharmaceutical company headquartered in Boston, Massachusetts with research facilities in Stockholm, Sweden, focused on developing and commercializing novel cancer therapeutics that reactivate mutant tumor suppressor protein, p53. The Companys lead product candidate is APR-246 eprenetapopt, a small molecule in clinical development for hematologic malignancies, including myelodysplastic syndromes MDS and acute myeloid leukemia AML. APR-246 has received Breakthrough Therapy, Orphan Drug and Fast Track designations from the FDA for MDS, and Orphan Drug designation from the European Commission for MDS, AML and ovarian cancer. For more information, please visit the company website at Company may use, and intends to use, its investor relations website at as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD.About p53 and APR-246 eprenetapoptThe p53 tumor suppressor gene is the most frequently mutated gene in human cancer, occurring in approximately 50 of all human tumors. These mutations are often associated with resistance to anti-cancer drugs and poor overall survival, representing a major unmet medical need in the treatment of cancer.Eprenetapopt APR-246 is a small molecule that has demonstrated reactivation of mutant and inactivated p53 protein by restoring wild-type p53 conformation and function thereby inducing programmed cell death in human cancer cells. Pre-clinical anti-tumor activity has been observed with eprenetapopt in a wide variety of solid and hematological cancers, including MDS, AML, and ovarian cancer, among others. Additionally, strong synergy has been seen with both traditional anti-cancer agents, such as chemotherapy, as well as newer mechanism-based anti-cancer drugs and immuno-oncology checkpoint inhibitors. In addition to pre-clinical testing, a Phase 12 clinical program with eprenetapopt has been completed, demonstrating a favorable safety profile and both biological and confirmed clinical responses in hematological malignancies and solid tumors with mutations in the TP53 gene.A pivotal Phase 3 clinical trial of eprenetapopt and azacitidine for frontline treatment of TP53 mutant MDS is ongoing. Eprenetapopt has received Breakthrough Therapy, Orphan Drug and Fast Track designations from the FDA for MDS, and Orphan Drug designation from the EMA for MDS, AML and ovarian cancer.Forward-Looking Statement Certain information contained in this press release includes forward-looking statements, within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, related to our clinical trials, regulatory submissions and projected cash position. We may, in some cases use terms such as predicts, believes, potential, continue, anticipates, estimates, expects, plans, intends, targeting, confidence, may, could, might, likely, will, should or other words that convey uncertainty of the future events or outcomes to identify these forward-looking statements. 