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Aprea Therapeutics, Inc. (NASDAQ: APRE) is a clinical-stage biopharmaceutical company headquartered in Doylestown, Pennsylvania, focused on precision oncology through synthetic lethality. The company’s pioneering research aims to develop and commercialize cancer therapeutics that target the DNA damage response (DDR) pathways. Aprea's lead product candidate, ATRN-119, is a macrocyclic ATR inhibitor designed for treating solid tumors with DDR-related gene mutations. This inhibitor is currently in a Phase 1/2a clinical trial and has shown promising preliminary data, being well tolerated with no dose-limiting toxicities.
Another key candidate, APR-1051, is a highly selective WEE1 kinase inhibitor. The company recently received FDA clearance for an Investigational New Drug (IND) application for APR-1051, enabling the initiation of a Phase 1 clinical trial aimed at treating cancers that overexpress Cyclin E, including ovarian and breast cancers. Preclinical studies have demonstrated APR-1051's potential low toxicity and high selectivity, making it a candidate for best-in-class treatment.
Aprea’s commitment to advancing precision oncology is underscored by recent financial results and corporate developments. For instance, as of March 31, 2024, the company reported $32.4 million in cash and cash equivalents. Notably, Aprea has secured a private placement financing of up to $34 million to support its ongoing and upcoming clinical trials. Furthermore, Aprea’s strong leadership team, including newly appointed Chief Medical Officer Dr. Nadeem Q. Mirza, continues to drive the company’s strategic initiatives.
Recent achievements include the presentation of promising preclinical and clinical data at major conferences such as the AACR Annual Meeting. These presentations highlighted the potential of ATRN-119 and APR-1051 in treating cancers with specific genetic mutations, reinforcing Aprea’s potential to fill significant unmet medical needs in oncology.
For more detailed information about Aprea Therapeutics and its innovative approaches to cancer treatment, please visit their website at www.aprea.com.
Aprea Therapeutics (Nasdaq: APRE) reported its Q2 2022 financial results, revealing a net loss of $98.3 million or $4.34 per share, significantly higher than the $10.3 million loss in Q2 2021. Cash and cash equivalents declined to $39.1 million by June 30, 2022, from $53.1 million at the end of 2021. R&D expenses remained stable at $6.8 million. The company completed the acquisition of Atrin Pharmaceuticals, heightening its focus on DNA damage response therapeutics. Upcoming clinical trials for ATRN-119 and APR-548 are expected to progress through late 2022.
Aprea Therapeutics, Inc. (Nasdaq: APRE), a Boston-based biopharmaceutical company focused on cancer therapeutics, announced that CEO Oren Gilad, Ph.D., will speak at the 2022 Wedbush PacGrow Healthcare Conference on August 9, 2022, at 12:35 p.m. ET. He will participate in a panel on synthetic lethality, hosted by Robert Driscoll, Ph.D. Aprea's lead program, ATRN-119, targets DNA damage response pathways and is Phase 1-ready for solid tumors. The company is dedicated to developing novel cancer treatments and regularly updates investors via its website.
Aprea Therapeutics, Inc. (Nasdaq: APRE) announced the acquisition of Atrin Pharmaceuticals on May 16, 2022, enhancing its oncology pipeline. The acquisition, structured as a stock-for-stock transaction, is expected to create substantial shareholder value. Aprea will focus on clinical trials for ATRN-119 and potential new therapies like ATRN-354 and ATRN-W1051. As of March 31, 2022, Aprea reported $47.6 million in cash, projected to last through mid-2023. The company saw a decrease in R&D expenses and a net loss of $7.9 million for Q1 2022.
Aprea Therapeutics (Nasdaq: APRE) reported its financial results for the year ending December 31, 2021, showing a cash balance of $53.1 million, down from $89 million in 2020. The company anticipates a cash burn of $25-$30 million in 2022, expected to fund operations into 2023. Fourth-quarter R&D expenses decreased to $4.5 million from $9.3 million a year prior, while net loss improved to $7.8 million ($0.36 per share) from $13.1 million ($0.73 per share) in Q4 2020. Aprea has received FDA clearance for new trials in myeloid malignancies and continues to advance its drug pipeline.
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.
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