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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