APRE

Oversubscribed $30 million private placement closed, with proceeds expected to support ongoing development of APR-1051 Two partial responses observed with continued encouraging tolerability in the ongoing Phase 1 dose escalation ACESOT-1051 trial of WEE1 inhibitor APR-1051 Additional clinical data from ACESOT-1051 to be provided at the ASCO 2026 Annual Meeting on May 30, 2026 $46.5 million in cash and cash equivalents as of March 31, 2026, with anticipated cash runway into Q1 2028 DOYLESTOWN, Pa., May 13, 2026 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (Nasdaq: APRE) (“Aprea”, or the “Company”), a clinical-stage precision medicine oncology company focused on the discovery and development of targeted therapies for patients with biomarker-defined cancers, today reported financial results for the first quarter ended March 31, 2026, and provided a business update. “We are very encouraged by the progress made across both our clinical and corporate priorities during the first quarter of 2026, including two partial responses observed in the ACESOT-1051 trial evaluating APR-1051. One of these has been confirmed at a second imaging assessment and this patient remains on study,” said Oren Gilad, Ph.D., President and Chief Executive Officer of Aprea. “These efficacy results, coupled with the encouraging tolerability, support our precision medicine strategy and reinforce the potential of targeted therapies for patients who have limited treatment options. We look forward to presenting an update from ACESOT-1051 at ASCO 2026 and providing additional insight into APR-1051’s emerging clinical profile. The recent $30 million private placement significantly strengthens our balance sheet and enables us to meaningfully expand patient enrollment, generating the clinical data needed to inform the future clinical path for APR-1051. We are grateful for the trust and support of both new and existing investors, whose participation reflects confidence in our development strategy and the potential of our programs.” Key Business Updates and Upcoming Key Milestones ACESOT-1051: A Biomarker Focused, Phase 1 Trial of Oral WEE1 inhibitor, APR-1051 APR-1051 is a potent and selective, oral small molecule WEE1 inhibitor designed to potentially address therapeutic window limitations observed with earlier WEE1 programs. APR-1051 is being evaluated as monotherapy in uterine serous carcinoma pat...

Early clinical proof-of-concept for WEE1 inhibitor APR-1051 in the ongoing ACESOT-1051 trial with two partial responders at first scan in endometrial cancer patients with PPP2R1A mutation Clinical team strengthened with the appointment of Eugene (Gene) Kennedy, MD, as Chief Medical Advisor to support next phase of clinical development Capital is in place to support key milestones, including additional enrollment of patients at key dose levels in ongoing ACESOT-1051 trial DOYLESTOWN, Pa., March 16, 2026 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (Nasdaq: APRE) (“Aprea”, or the “Company”), a clinical-stage precision medicine oncology company focused on the discovery and development of targeted therapies for patients with biomarker-defined cancers, today reported financial results for the fourth quarter and full year ended December 31, 2025, and provided a business update. “We enter 2026 with strong momentum following a year of meaningful execution across our portfolio,” said Oren Gilad, Ph.D., President and Chief Executive Officer of Aprea. “We are particularly encouraged by the most recent data from the ongoing ACESOT trial evaluating APR-1051, including two patients achieving unconfirmed partial responses at first scan. These results provide early proof of clinical concept for APR-1051 and strengthen our conviction in the product’s ability to deliver a favorable therapeutic window, supporting its potential to be a differentiated WEE1 kinase inhibitor for patients with genomically defined solid tumors who have limited treatment options. We strengthened our balance sheet with successful private placements in late 2025 and early 2026, enhancing our financial flexibility and positioning the Company to execute on key development milestones. Taken together, we believe the recent progress underscores the opportunity within our DDR portfolio and reinforces our goal of developing targeted cancer therapies that have the potential to improve outcome and quality of life for patients, while also creating value for our shareholders.” Key Business Updates and Potential Upcoming Key Milestones ACESOT-1051: A Biomarker Focused, Phase 1 Trial of Oral WEE1 inhibitor, APR-1051 APR-1051 is a potent and selective, oral small molecule WEE1 inhibitor designed to potentially address therapeutic window limitations observed with earlier WEE1 programs. APR-1051 is being evaluated as...

APR-1051 (WEE1 kinase inhibitor): In ongoing Phase 1 ACESOT-1051dose-escalation trial, 3 out of 4 patients at Dose Level 6 (100 mg once daily) achieved stable disease, per RECIST v1.1, in heavily pretreated gastrointestinal and gynecologic malignancies ATRN-119 (ATR kinase Inhibitor): RP2D of 1,100 mg once daily identified in ABOYA-119 dose-escalation study Posters on APR-1051 and ATRN-119 featured at AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics DOYLESTOWN, Pa., Nov. 12, 2025 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (Nasdaq: APRE) (“Aprea”, or the “Company”), a clinical-stage biopharmaceutical company developing innovative treatments that exploit specific cancer cell vulnerabilities while minimizing damage to healthy cells, today reported financial results for the third quarter ended September 30, 2025, and provided a business update. The Company reported continued clinical progress across both its WEE1 and ATR inhibitor programs and has cash runway into the fourth quarter of 2026. “We are pleased with the continued progress in our development programs, as the emerging data on both of our clinical assets demonstrate evidence of activity,” said Oren Gilad, Ph.D., President and Chief Executive Officer of Aprea. “For APR-1051, our WEE1 kinase inhibitor, we’re encouraged by early signs of anti-tumor activity to date in the ongoing ACESOT-1051 trial, including 3 out of 4 patients with stable disease in the 100 mg once daily cohort. We have recently advanced into the 150 mg once daily cohort as dose escalation in this trial continues. For ATR-119, identifying the recommended Phase 2 dose for the once daily (QD) dosing provides a solid foundation for next-stage development, and we are now considering potential combination strategies, with radiation or checkpoint inhibitors, that could expand its clinical impact. These developments reinforce Aprea’s differentiated DDR approach and our commitment to helping patients with value creating clinical catalysts anticipated in 2026.” Key Business Updates and Potential Upcoming Key Milestones ACESOT-1051: A Biomarker Focused, Phase 1 Trial of Oral WEE1 inhibitor, APR-1051 APR-1051 is a potent and selective small molecule WEE1 inhibitor designed to potentially solve tolerability challenges of the WEE1 class and has the potential to achieve improved clinical activity than other progra...

Early evidence of disease control was observed in the ongoing Phase 1 ACESOT-1051 trial, with three patients achieving stable disease in the 70 mg and 100 mg cohorts treated with the WEE1 inhibitor, APR-1051 $16.5 million in cash and cash equivalents as of June 30, 2025 DOYLESTOWN, Pa., Aug. 12, 2025 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (Nasdaq: APRE) (“Aprea”, or the “Company”), a clinical-stage biopharmaceutical company developing innovative treatments that exploit specific cancer cell vulnerabilities while minimizing damage to healthy cells, today reported financial results for the second quarter ended June 30, 2025, and provided a business update. "We are pleased with our progress in 2025, as emerging data from both of our lead programs demonstrate evidence of clinical activity,” said Oren Gilad, Ph.D., President and Chief Executive Officer of Aprea. “In the ACESOT-1051 trial of our oral WEE1 inhibitor APR-1051, we have observed three patients with stable disease to date, one in the 70mg cohort and two in the 100mg cohort, including an early clinical signal in an HPV-positive head and neck squamous cell carcinoma, and in rectal and uterine cancer patients. For our macrocyclic ATR inhibitor, ATRN-119, the ongoing dose escalation study has shown early activity, with seven patients achieving stable disease to date, including three with meaningful tumor shrinkage at the 550 mg twice daily dose. Overall, these early signs of clinical validation continue to strengthen our confidence in the potential of our DDR assets and to deliver meaningful therapeutic advances for patients with cancer.” Key Business Updates and Potential Upcoming Key Milestones ACESOT-1051: A Biomarker Focused, Phase 1 Trial of Oral WEE1 inhibitor, APR-1051 APR-1051 is a potent and selective small molecule WEE1 inhibitor designed to potentially solve tolerability challenges of the WEE1 class and may achieve greater clinical activity than other programs currently in development. Aprea is advancing APR-1051 as monotherapy in cancers with well-defined biomarkers that may predict sensitivity to WEE1 inhibition. Among these, cancers over-expressing Cyclin E represent a high unmet medical need. Patients with Cyclin E over-expression have poor prognosis and, currently, lack effective therapies options. Patients are currently being enrolled at the 100 mg once-daily dose level in the ongoing...

Preclinical data demonstrate potent single-agent and combination effects in head and neck squamous cell carcinoma (HNSCC) models, including synergy with anti–PD-1 therapy Initial Phase 1 clinical update shows early disease control in first HPV+ patient treated with APR-1051 DOYLESTOWN, Pa., June 25, 2025 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (Nasdaq: APRE) (“Aprea”, or the “Company”), a clinical-stage biopharmaceutical company developing innovative treatments that exploit specific cancer cell vulnerabilities while minimizing damage to healthy cells, today announced new preclinical data and a clinical update on APR-1051, the Company’s next-generation oral WEE1 inhibitor, in human papillomavirus–positive (HPV+) head and neck squamous cell carcinoma (HNSCC). These findings result from an ongoing translational research collaboration with renowned oncology leader MD Anderson Cancer Center and support the potential of APR-1051 both as a single agent and in rational immunotherapy combinations for biomarker-driven treatment of HPV+ HNSCC. “We are excited by the preclinical data generated by independent researchers, and the early clinical signal of APR-1051 in an HPV-positive cancer patient,” said Oren Gilad, Ph.D., President and Chief Executive Officer of Aprea Therapeutics. “We believe that APR-1051 could offer significant differentiation in the competitive oncology landscape, as a single agent, as well as in combination with checkpoint inhibitors.” Preclinical Highlights from MD Anderson Collaboration: Potent single-agent activity: APR-1051 demonstrated robust antiproliferative effects across a broad panel of human and murine head and neck cancer cell lines, including HPV+ subtypes, with IC₅₀ values ranging from 8.9 to 230 nM. Enhanced combination synergy: Significant anti-tumor synergy was observed with APR-1051 and anti–PD-1 therapies in HPV+ HNSCC models, positioning APR-1051 as a candidate for combination-based clinical trials. Mechanistic rationale: APR-1051 was shown to activate cGAS/STING-mediated immunogenic cell death and to exploit the HPV E6-driven G2 checkpoint dependency in HPV+ tumors. Given WEE1’s central role in regulating the G2/M checkpoint, HPV+ tumor cells appear highly reliant on WEE1 signaling for survival. This provides a biomarker driven strategy for targeted patient selection and optimized clinical outcomes. The chart below shows ho...

ATRN-119, our ATR inhibitor, exhibits early evidence of single agent, anti-tumor activity and is progressing toward the recommended Phase 2 dose (RP2D) in the ongoing ABOYA-119 clinical trial Three patients in the 550 mg twice daily cohort in the ongoing ABOYA-119 clinical trial demonstrated tumor shrinkage of 7%, 14% and 21% ACESOT-1051, the Phase 1 trial of WEE1 inhibitor APR-1051, continues to advance, with patients now being dosed at 100 mg once daily $19.3 million in cash and cash equivalents as of March 31, 2025, providing runway into early Q2 2026 DOYLESTOWN, Pa., May 14, 2025 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (Nasdaq: APRE) (“Aprea”, or the “Company”), a clinical-stage biopharmaceutical company developing innovative treatments that exploit specific cancer cell vulnerabilities while minimizing damage to healthy cells, today reported financial results for the first quarter ended March 31, 2025, and provided a business update. “2025 is off to a strong start with significant clinical progress across both of our lead therapeutic candidates,” said Oren Gilad, Ph.D., President and Chief Executive Officer of Aprea. “In our ongoing ATRN-119 clinical program, three patients in the latest twice daily cohort demonstrated stable disease, with tumor shrinkage of 7%, 14% and 21%, marking early evidence of single agent, anti-tumor activity. Notably, these encouraging results were achieved at a dose level below the recommended Phase 2 dose, reinforcing our belief in ATRN-119’s potential to address the urgent needs of patients with DDR-deficient cancers. As we progress to a dose level where clinical activity is emerging, our focus is shifting toward RP2D selection. Enrollment also continues in the ACESOT-1051 trial of our WEE1 inhibitor, APR-1051, and we expect to report preliminary efficacy data in the second half of 2025. At Aprea, we aim to redefine what is possible for patients with limited treatment options and we see ATRN-119 and APR-1051 as important clinical assets that may help us achieve this goal.” Key Business Updates and Potential Upcoming Key Milestones ACESOT-1051: A Biomarker Focused, Phase 1 Trial of Oral WEE1 inhibitor, APR-1051 APR-1051 is a potent and selective small molecule WEE1 inhibitor designed to potentially solve tolerability challenges of the WEE1 class and may achieve greater clinical activity than other programs currently in de...

Net loss: US$13.0m (loss narrowed by 9.3% from FY 2023). US$2.35 loss per share (improved from US$3.95 loss in FY 2023). This technology could replace computers: discover the 20 stocks are working to make quantum computing a reality. All figures shown in the chart above are for the trailing 12 month (TTM) period Revenue exceeded analyst estimates by 12%. Earnings per share (EPS) also surpassed analyst estimates by 7.7%. Looking ahead, revenue is forecast to grow 53% p.a. on average during the next 3 years, compared to a 20% growth forecast for the Biotechs industry in the US. Performance of the American Biotechs industry. The company's shares are down 7.6% from a week ago. We should say that we've discovered 5 warning signs for Aprea Therapeutics (1 is potentially serious!) that you should be aware of before investing here. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com.This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

ACESOT-1051 trial evaluating WEE1 kinase inhibitor APR-1051 now enrolling patients in Cohort 5; open label safety and efficacy data expected H2 2025 Twice daily (BID) dosing regimen in ongoing ABOYA-119 trial expected to maximize clinical benefit of ATR inhibitor ATRN-119; plan to complete dose escalation H2 2025 $22.8 million in cash and cash equivalents as of December 31, 2024 DOYLESTOWN, Pa., March 25, 2025 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (Nasdaq: APRE) (“Aprea”, or the “Company”), a clinical-stage biopharmaceutical company developing innovative treatments that exploit specific cancer cell vulnerabilities while minimizing damage to healthy cells, today reported financial results for the fourth quarter and full year ended December 31, 2024, and provided a business update. “We made excellent progress across our pipeline in 2024, laying a strong foundation for the year ahead,” said Oren Gilad, Ph.D., President and Chief Executive Officer of Aprea. “We continue to enroll patients in the ACESOT-1051 trial evaluating our WEE1 kinase inhibitor, APR-1051, which we believe has best in class potential. The compound appears safe and well tolerated to date with no hematologic toxicity. We look forward to reporting open label data from ACESOT-1051 in the second half of the year. We are also advancing ATRN-119, our highly selective first-in-class macrocyclic ATR inhibitor. The ongoing ABOYA-119 trial is now evaluating ATRN-119 as continuous once daily and twice daily monotherapy in order to maximize therapeutic benefit. Our ultimate goal is to transform the treatment paradigm for difficult to treat cancers by unlocking the full potential of DDR-based therapies.” Key Business Updates and Potential Upcoming Key Milestones ACESOT-1051: A Biomarkers Focused, Phase 1 Trial of Oral WEE1 inhibitor, APR-1051 APR-1051 is a potent and selective small molecule that has been designed to potentially solve tolerability challenges of the WEE1 class and may achieve greater clinical activity than other programs currently in development. Aprea is advancing APR-1051 as monotherapy in cancers with Cyclin E over-expression, as well as other biomarkers that may predict sensitivity to WEE1 inhibition. Cancers over-expressing Cyclin E represent a high unmet medical need. Patients with Cyclin E over-expression have poor prognosis and, currently, have no effective therapies availab...