Aprea Therapeutics — Third Quarter 2026 Earnings Summary
Financial Performance:
- Reported cash and cash equivalents of $37.8 million as of September 30, 2026, an increase from $14.6 million as of December 31, 2025.
- Reported an operating loss of $5.2 million for the quarter ended September 30, 2026, compared to an operating loss of $3.1 million in the same period of 2025.
- Research and development expenses were $3.3 million for the quarter ended September 30, 2026, compared to $1.6 million in the third quarter of 2025.
- General and administrative expenses were $1.8 million for the quarter ended September 30, 2026, compared to $1.5 million in the third quarter of 2025.
- Reported a net loss of $4.8 million, or $(0.09) per basic and diluted share, for the quarter ended September 30, 2026, compared to a net loss of $3.0 million, or $(0.47) per basic and diluted share, in the comparable 2025 period.
- Weighted-average common shares outstanding for the quarter ended September 30, 2026, were approximately 53.7 million, compared to approximately 6.4 million in the prior year period.
- Total assets were $38.8 million as of September 30, 2026, compared to $15.9 million as of December 31, 2025.
- Total stockholders' equity was $34.1 million as of September 30, 2026, compared to $12.4 million as of December 31, 2025.
- Accumulated deficit increased to $(345.3) million as of September 30, 2026, from $(333.6) million as of December 31, 2025.
Guidance and Future Outlook:
- Cash runway is expected to extend into the first quarter of 2028 based on current operating plans.
- Enrollment in the ACESOT-1051 trial is expected to reach six to ten patients per month during the fourth quarter of 2026.
- The Company expects to select the dose for Part 2 of the ACESOT-1051 study (focused on dose optimization) in the first half of 2027.
- Expansion enrollment for ACESOT-1051, targeting at least 50 patients with uterine serous carcinoma or Cyclin E-overexpressing, platinum-resistant ovarian cancer, is expected to complete in the second quarter of 2027.
- The Company anticipates increased research and development expenses for APR-1051 relative to prior plans due to the trial expansion and activation of additional clinical sites.
- Lead identification for the early-stage macrocyclic DYRK1A/B inhibitor program is targeted for the second quarter of 2027, subject to resource availability.
Business Segments and Product Lines:
- APR-1051 (WEE1 Inhibitor): The Phase 1 clinical trial (ACESOT-1051) expanded from three to nine active sites. Immunohistochemistry (IHC) testing for Cyclin E expression is now in place to support biomarker assessment. The Company is focusing on biomarker-defined endometrial cancers, including uterine serous carcinoma, and tumors with PPP2R1A, CCNE1, CCNE2, or FBXW7 mutations.
- APRN-119 (ATR Inhibitor): The ABOYA-119 Phase 1/2a dose-escalation study was closed in October 2025 after determining the Recommended Phase 2 Dose (RP2D) of 1,100 mg once daily. The Company is exploring combination approaches for ATRN-119 with immuno-oncology agents, chemotherapy, antibody-drug conjugates, and radiation, potentially through third-party collaborations.
- Pipeline: An early-stage program for macrocyclic DYRK1A/B inhibitors is in development.
- Intellectual Property: The portfolio includes 30 issued patents and 29 pending applications. Pending applications could provide protection through 2047 for the WEE1 program and extend protection for the ATR program into 2045.
Market and Competitive Landscape:
- The Company is positioning APR-1051 as a potentially best-in-class WEE1 inhibitor designed to address therapeutic window limitations observed with earlier WEE1 programs.
- Aprea believes ATRN-119 was the first oral macrocyclic ATR inhibitor to enter clinical trials.
- The Company hosted a virtual expert panel on October 20, 2026, titled "The State of WEE1 Inhibition in Precision Oncology," to discuss selectivity challenges and market perspectives.
Risks and Challenges:
- Clinical trial success, timing, and cost remain uncertain, including risks related to enrollment pace, trial completion, and regulatory interactions.
- The Company may require substantial additional funding, which may not be available on acceptable terms or at all.
- Interim or preliminary results are not necessarily indicative of final results.
- The Company must maintain compliance with The Nasdaq Stock Market continued listing requirements.
Management Commentary and Tone:
- Oren Gilad, Ph.D., President and CEO, stated the Company is making meaningful progress toward developing a differentiated WEE1 inhibitor and is well-positioned to execute its clinical development strategy.
- Management highlighted encouraging early clinical activity in biomarker-defined endometrial cancers and manageable tolerability observed to date.
- The Company plans to present updated Phase 1 interim results at the 38th EORTC-NCI-AACR Symposium in Barcelona on November 20, 2026.
Other Key Points:
- The Company reported 14,191,136 shares of common stock outstanding as of September 30, 2026.
- Weighted-average common shares outstanding for the 2026 period included approximately 39.8 million shares issuable upon exercise of pre-funded warrants exercisable for nominal consideration.
- Accounts payable increased to $1.3 million as of September 30, 2026, from $0.7 million as of December 31, 2025.
- Interest income for the quarter ended September 30, 2026, was $360,702, compared to $150,669 in the same period of 2025.
- Company
- APREA THERAPEUTICS INC
- Sector
- Healthcare
- Industry
- Biotechnology