DOYLESTOWN, PA — Aprea Therapeutics Inc. (Nasdaq: APRE) is expanding clinical testing of its experimental cancer drug APR-1051 as research spending pushes quarterly losses higher, with the Doylestown-based biotechnology company holding enough cash to fund its development plans into early 2028.
The company reported a net loss of $4.8 million, or 9 cents per share, for the third quarter ended Sept. 30, 2026, compared with a loss of $3 million, or 47 cents per share, a year earlier.
Operating losses widened to $5.2 million from $3.1 million, primarily reflecting increased spending on APR-1051, an oral treatment designed to inhibit WEE1, a protein involved in regulating cell division and DNA damage responses.
Aprea ended September with $37.8 million in cash and equivalents, up from $14.6 million at the end of 2025. Management expects those resources to support projected operating and capital expenditures into the first quarter of 2028.
The company’s financial position provides funding for an expanded Phase 1 clinical program and several planned development milestones in 2027, although the broader trial will require additional research spending.
Aprea has increased the number of active clinical sites evaluating APR-1051 from three to nine and expects enrollment to reach six to 10 patients per month during the fourth quarter.
The expansion is part of ACESOT-1051, a multicenter, open-label Phase 1 trial assessing the drug’s safety, tolerability, dosing characteristics and preliminary antitumor activity in patients with advanced solid tumors.
Aprea is concentrating development on cancers with specific genetic abnormalities, particularly endometrial cancers, including uterine serous carcinoma.
The company is targeting tumors with PPP2R1A, CCNE1, CCNE2 or FBXW7 mutations, as well as tumors exhibiting elevated Cyclin E expression.
Immunohistochemistry testing for Cyclin E expression has been implemented at clinical sites to support biomarker analysis and future patient selection.
The trial is being expanded to enroll at least 50 patients with uterine serous carcinoma or platinum-resistant ovarian cancer characterized by Cyclin E overexpression.
Aprea expects to complete dose escalation and enrollment in the additional patient groups during the second quarter of 2027.
The company remains on schedule to select a dose for the second, dose-optimization portion of the study during the first half of 2027.
Preliminary findings have shown antitumor activity and a tolerability profile that management considers supportive of continued development, although the treatment remains in early-stage testing.
“We have expanded our clinical site network from three to nine active sites and expect enrollment in ACESOT-1051 to reach six to ten patients per month during the fourth quarter of 2026, positioning us to accelerate clinical development,” President and Chief Executive Officer Oren Gilad stated.
Aprea plans to present updated interim results from ACESOT-1051 on Nov. 20 at the 38th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics in Barcelona, Spain.
Timothy A. Yap of the University of Texas MD Anderson Cancer Center will deliver the presentation, which will include updated clinical findings from patients enrolled after the study’s May 6 data cutoff.
The associated abstract covers the trial design and interim findings available as of that earlier date.
Aprea is also considering combination treatments involving APR-1051, including a planned evaluation with pembrolizumab in patients with HPV-positive head and neck squamous cell carcinoma.
The strategy reflects an effort to identify patient populations most likely to benefit from WEE1 inhibition while examining whether the treatment could be effective alongside established cancer therapies.
Aprea’s research spending increased substantially during the quarter as the company concentrated resources on APR-1051.
Research and development expenses rose to $3.3 million from $1.6 million a year earlier, driven by approximately $2.1 million in additional spending on ACESOT-1051.
The increase was partially offset by a $500,000 reduction in spending on ATRN-119, another experimental cancer treatment whose earlier clinical study has been closed.
General and administrative expenses increased to $1.8 million from $1.5 million, primarily because of higher professional fees and consulting costs.
Although the company’s net loss widened, its reported loss per share declined because the weighted-average share count increased substantially.
Aprea calculated third-quarter earnings using approximately 53.7 million weighted-average shares, compared with 6.4 million a year earlier.
The 2026 calculation included approximately 39.8 million shares issuable through pre-funded warrants exercisable for nominal consideration. The company had 14,191,136 common shares outstanding as of Sept. 30.
Beyond APR-1051, Aprea is evaluating possible development partnerships for ATRN-119, an oral macrocyclic inhibitor of ATR, another protein involved in the cellular response to DNA damage.
The company established a recommended Phase 2 dose of 1,100 milligrams once daily in October 2025 through its ABOYA-119 Phase 1/2a study before closing the trial to prioritize APR-1051.
Further development of ATRN-119 may depend on collaborations with academic institutions and other partners.
Potential research programs include combinations with immunotherapies, chemotherapy, antibody-drug conjugates and radiation treatment.
Aprea is exploring applications across several solid tumors, including HPV-positive head and neck cancers, sarcomas, and ovarian, colorectal and lung cancers, as well as blood cancers such as acute myeloid leukemia and myelodysplastic syndromes.
The company also maintains an early-stage program targeting DYRK1A/B proteins, with a goal of identifying a lead compound in the second quarter of 2027, subject to available resources.
Its intellectual property portfolio includes 30 issued patents and 29 pending applications covering its WEE1 and ATR inhibitor programs.
If granted, pending applications could extend patent protection for the WEE1 program, including APR-1051, through 2047 and for the ATR program, including ATRN-119, into 2045.
Aprea’s immediate development priorities center on the upcoming APR-1051 clinical presentation, expansion of patient enrollment and selection of a dose for further testing.
Those milestones will help determine whether the company’s biomarker-focused cancer treatment strategy can advance beyond initial safety and dose-finding studies while operating within its projected cash runway.
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