Aprea Therapeutics, Inc. Stock Price, News & Analysis

Aprea Therapeutics (Nasdaq: APRE) announced the FDA's Orphan Drug designation for eprenetapopt, aimed at treating acute myeloid leukemia (AML). This follows the prior Fast Track designation granted in November 2020. Orphan Drug designation offers several benefits, including a seven-year market exclusivity post-approval and FDA support in clinical trial design. Eprenetapopt is being developed to reactivate the mutant p53 protein in cancer cells, with additional designations for other conditions, including myelodysplastic syndromes and ovarian cancer.

Aprea Therapeutics (Nasdaq: APRE) reported financial results for 2020, highlighting a net loss of $15.4 million, or $0.73 per share. Their pivotal Phase 3 trial for eprenetapopt missed its primary endpoint for complete remission but showed a 53% improvement versus control. The Company has multiple ongoing trials for eprenetapopt and APR-548, their next-generation p53 reactivator, and expects to present additional findings in Q2 2021. As of December 31, 2020, cash and cash equivalents were $89 million, with anticipated cash burn of $30-35 million for 2021.

Aprea Therapeutics (Nasdaq: APRE), a biopharmaceutical company, is set to present a corporate update at the 39th Annual J.P. Morgan Healthcare Conference on January 12, 2021, at 2:50 p.m. ET. The presentation will provide insights into the company's innovative cancer therapeutics aimed at reactivating the p53 tumor suppressor protein. A live webcast will be available on the company's website. Aprea's lead product candidate, eprenetapopt (APR-246), is in clinical development and has received various FDA designations for myelodysplastic syndromes and acute myeloid leukemia.

Aprea Therapeutics (Nasdaq: APRE) announced the results of its Phase 3 clinical trial evaluating eprenetapopt with azacitidine (AZA) for TP53 mutant myelodysplastic syndromes (MDS). The trial did not achieve its primary endpoint of complete remission (CR) rate, with 33.3% CR in the eprenetapopt plus AZA arm compared to 22.4% in the AZA alone arm (P = 0.13). Despite this, secondary endpoints showed some favor toward the experimental arm. The combination was well-tolerated, and further analyses will be conducted as patient data matures.

Aprea Therapeutics (Nasdaq: APRE) announced that the FDA granted Fast Track designation for eprenetapopt, aimed at treating patients with TP53 mutant acute myeloid leukemia (AML). This designation helps expedite the development and review process for drugs addressing serious conditions. Aprea previously obtained Breakthrough Therapy and Orphan Drug designations for eprenetapopt for myelodysplastic syndromes (MDS). The company is actively enrolling patients in clinical trials for eprenetapopt combined with azacitidine and venetoclax, with promising initial data expected in 2021.

Aprea Therapeutics (Nasdaq: APRE), a biopharmaceutical company focused on cancer therapeutics, will have its CEO Christian S. Schade and CMO Eyal Attar participate in a fireside chat at the virtual Piper Sandler Healthcare Conference from December 1-3, 2020. The pre-recorded chat will be available for limited viewing starting November 23, 2020, on the company's investors website. Aprea is known for developing drugs that reactivate the mutant tumor suppressor protein, p53, with its lead product candidate, eprenetapopt (APR-246), targeting hematologic malignancies.

Aprea Therapeutics (Nasdaq: APRE) reported its Q3 2020 financial results and business updates, focusing on its lead product candidate, eprenetapopt. The company has completed enrollment in pivotal Phase 3 trials for TP53 mutant MDS with azacitidine and is enhancing its clinical pipeline in AML and solid tumors. As of September 30, 2020, Aprea had $101.1 million in cash, down from $130.1 million at 2019 year-end, and anticipates a cash burn of $35-40 million for 2020. The net loss for Q3 2020 was $12.3 million, or $0.58 per share, compared to $6.2 million in Q3 2019.

Aprea Therapeutics (Nasdaq: APRE) hosted a virtual R&D Day Webinar on October 30, 2020, featuring discussions by experts in hematology regarding clinical therapies for TP53 mutant MDS/AML patients. The agenda included a review of Aprea's Phase 3 clinical program and commercial strategies. Aprea's lead candidate, eprenetapopt, targets mutant tumor suppressor protein p53 and has received multiple FDA designations for MDS. The company is developing APR-548 as a next-generation agent with a planned Phase 1 trial. For more information, visit Aprea's website.

Aprea Therapeutics, Inc. (Nasdaq: APRE) has launched p53reactivation.com to enhance disease awareness regarding p53 mutations in cancer. This initiative aims to educate healthcare professionals on how these mutations are linked to poor treatment outcomes. With approximately half of all cancers featuring p53 mutations, the site seeks to promote understanding of diagnostic tests and potential targeted therapies, marking a significant step in addressing this unmet medical need.