Aprea Therapeutics Inc.

08/12/2026 | Press release | Distributed by Public on 08/12/2026 06:35

Aprea Therapeutics Announces Second Quarter 2026 Financial Results (Form 8-K)

Aprea Therapeutics Announces Second Quarter 2026 Financial Results

Enrollment in the ongoing Phase 1 dose escalation ACESOT-1051 trial of oral WEE1 inhibitor APR-1051 is accelerating as dose escalation advances

Aprea plans to advance APR-1051 in uterine serous carcinoma (USC), and Cyclin E-overexpressing platinum-resistant ovarian cancer (PROC) while also evaluating combination regimens with standard of care in HPV-positive head and neck cancer and colorectal cancer

Updated Phase 1 data presented at ASCO 2026 showed early single-agent activity for APR-1051, including partial responses and disease stabilization, with a manageable tolerability profile

$41.2 million in cash and cash equivalents as of June 30, 2026

DOYLESTOWN, PA, August 12, 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 second quarter ended June 30, 2026, and provided a business update.

"Having observed early signs of clinical activity for APR-1051, we are now expanding the ongoing ACESOT-1051 trial," said Oren Gilad, Ph.D., President and Chief Executive Officer of Aprea. "We are accelerating enrollment, advancing dose escalation to inform dose selection, and preparing to evaluate APR-1051 both as a single agent in uterine serous carcinoma (USC) and Cyclin E-overexpressing platinum-resistant ovarian cancer (PROC) and also in combination with standard of care in HPV-positive head and neck cancer and colorectal cancer. We look forward to sharing our next clinical data update at a medical meeting in the fourth quarter of 2026. This ongoing progress reflects our commitment to developing targeted cancer therapies that have the potential to improve outcomes and quality of life for patients, while also creating value for our shareholders."

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. It is currently being evaluated in ACESOT-1051, a multi-center, open-label Phase 1 study. The primary objectives of this study are safety, dose-limiting toxicity, maximum tolerated or maximum administered dose, and
RP2D. Secondary objectives include pharmacokinetics and antitumor activity assessed by RECIST/PCWG3.
• Aprea expects to report the next clinical data update from ACESOT-1051 at a medical meeting in the fourth quarter of 2026. Enrollment is accelerating ahead of this anticipated clinical catalyst, with the number of active clinical sites expanding from three to ten. The Company expects enrollment to reach 6 to 10 patients per month by Q4 of 2026, potentially increasing the pace of clinical data generation.
• Supported by the $30 million private placement that closed in the first quarter of 2026, the Company is expanding enrollment in ACESOT to include at least 50 patients with uterine serous carcinoma or cyclin E-overexpressing, platinum-resistant ovarian cancer. Completion of dose escalation and backfill expansion is anticipated in the second quarter of 2027. This expansion is intended to further characterize the clinical activity of APR-1051 in biomarker-defined tumor populations with a mechanistic rationale for WEE1 inhibition.
• Aprea also plans to evaluate APR-1051 in combination settings, supported by preclinical synergy observed in relevant disease models. In HPV-positive head and neck squamous cell carcinoma, APR-1051 will be combined with immune checkpoint therapy. In colorectal cancer, APR-1051 will be combined with a standard-of-care chemotherapy. Advancing clinically evaluated, active doses are intended to support the tolerability and dosing of APR-1051 when added to standard-of-care treatment.
• For more information on ACESOT-1051, refer to ClinicalTrials.gov NCT06260514.

APR-1051 Presentation at ASCO 2026

• On May 30, 2026, Aprea presented updated data from ACESOT-1051 in a poster titled "Early results from the first-in-human phase 1 study of WEE1 inhibitor APR-1051 in patients with advanced solid tumors (ACESOT-1051)" (Abstract #3107) at the American Society of Clinical Oncology (ASCO) 2026 Annual Meeting in Chicago, Illinois. The presentation summarized data as of a May 6, 2026 cutoff. A copy of the poster can be found on the Aprea corporate website here.

ATR inhibitor, ATRN-119

• ATRN-119 is a potent and highly selective potentially first-in-class macrocyclic ATR inhibitor designed for patients with tumors harboring mutations in DDR-related genes. Cancers with mutations in DDR-related genes represent a high unmet medical need, and these patients often have a poor prognosis and currently lack effective therapeutic options.
• During 2025, Aprea determined the recommended Phase 2 monotherapy dose (RP2D) of 1,100 mg once daily for ATRN-119 in the ABOYA-119 Phase 1/2a dose-escalation study and subsequently closed this study to focus resources on the clinical development of APR-1051. Building on the completion of dose escalation, the Company is considering further ATRN-119 development in combination approaches that could expand its therapeutic potential. Aprea believes ATRN-119's mechanism of action, potentially favorable safety profile, and pharmacologic characteristics could make it an ideal candidate for combination with other anti-cancer therapies, including radiation therapy, chemotherapy, antibody-drug conjugates (ADCs) and immune checkpoint inhibitors.
• Aprea is currently in discussions with leading academic centers to explore various combinations for ATRN-119. These include investigator-initiated studies evaluating ATRN-119 in combination with I/O
agents, chemotherapy, ADCs and/or radiation. Potential indications for these combinations include advanced solid tumors (e.g. HPV+ head and neck cancers, sarcomas, ovarian, colorectal, lung) and hematologic malignancies (e.g. Acute Myeloid Leukemia, Myelodysplastic syndromes).

Pipeline

• Aprea also has an early-stage program, a macrocyclic DYRK1A/B inhibitor, that potentially could enter IND enabling studies in the fourth quarter of 2026, subject to available resources.

Financial Results for the Second Quarter Ended June 30, 2026

• As of June 30, 2026, the Company reported cash and cash equivalents of $41.2 million, compared to $14.6 million as of December 31, 2025. The Company believes that its cash and cash equivalents as of June 30, 2026 will be sufficient to meet its currently projected operating expenses and capital expenditure requirements into the first quarter of 2028.
• For the second quarter ended June 30, 2026, the Company reported an operating loss of $4.0 million, compared to an operating loss of $3.4 million in the second quarter of 2025.
• Research and Development (R&D) expenses were $2.5 million for the quarter ended June 30, 2026, compared to $1.9 million for the second quarter of 2025. The increase in R&D expense was primarily related to higher expenses in ACESOT-1051, our Phase 1 dose-escalation study for APR-1051, partially offset by lower expense in the ABOYA-119 clinical trial to evaluate ATRN-119, which has been closed.
• General and Administrative (G&A) expenses were $1.6 million for each of the quarters ended June 30, 2026 and 2025.
• The Company reported a net loss of $3.6 million, or $(0.07) per basic share, on approximately 53.5 million weighted-average common shares outstanding for the quarter ended June 30, 2026, compared to a net loss of $3.2 million, or $(0.53) per basic share, on approximately 6.1 million weighted-average common shares outstanding for the comparable period in 2025.

About Aprea

Aprea is a clinical-stage precision medicine oncology company focused on the discovery and development of targeted therapies for patients with biomarker-defined cancers. The Company is pioneering a new approach to treat cancer by exploiting vulnerabilities associated with cancer cell mutations. This approach was developed to kill tumors while minimizing the effect on normal, healthy cells. Aprea's technology has potential applications across multiple cancer types, enabling it to target a range of tumors, including ovarian, endometrial, colorectal and head and neck squamous cell carcinoma. The company's lead programs are APR-1051, an oral, small-molecule inhibitor of WEE1 kinase, and ATRN-119, a small molecule ATR inhibitor, both in clinical development for solid tumor indications. For more information, please visit the company website at www.aprea.com.

The Company may use, and intends to use, its investor relations website at https://ir.aprea.com/ as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD.

Aprea Therapeutics Inc. published this content on August 12, 2026, and is solely responsible for the information contained herein. Distributed via EDGAR on August 12, 2026 at 12:37 UTC. If you believe the information included in the content is inaccurate or outdated and requires editing or removal, please contact us at [email protected]