DOYLESTOWN, Pa., Dec. 18, 2025 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (Nasdaq: APRE) (“Aprea”, or the “Company”), a clinical-stage biopharmaceutical company developing innovative treatments that target weaknesses in cancer cells while minimizing damage to healthy cells, today issued the following letter to shareholders from Chief Executive Officer, Oren Gilad. The letter highlights the Company’s ongoing clinical progress, operational execution, and plans for 2026.
Dear Shareholders --
As 2025 comes to a close, I am proud of what Aprea has accomplished over the past 12 months and excited for the year ahead. This year, we achieved meaningful milestones that we believe validate our approach and position us for long-term growth. These accomplishments reflect our team’s hard work and dedication, and we are pleased to share them with you.
WEE1 Inhibitor Program, APR-1051
Our lead program, APR-1051, a next-generation WEE1 inhibitor, continues to demonstrate promising anti-tumor activity in our ongoing ACESOT-1051 dose-escalation study. We are enrolling patients in the 220 mg cohort (Cohort 8), and so far, through the 150mg dose, the treatment has been well tolerated with no dose-limiting toxicities (DLTs) or unexpected safety findings or issues.
We have observed disease stabilization in several patients, with the longest duration of treatment reaching 222 days. The most notable response to date is a 15% reduction in tumor burden. Encouragingly, the number of patients achieving disease stabilization appears to increase with higher doses.1
After observing encouraging early single-agent activity in a patient with HPV-positive head and neck cancer at the 70 mg dose, we amended our clinical protocol to augment the number of HPV-positive patients. We believe this approach will broaden our clinical experience in HPV-positive tumor types, an area with substantial unmet medical need, and aligns with data from our translational research collaboration with MD Anderson Cancer Center. Their preclinical studies showed strong single-agent activity across a broad panel of human and animal head and neck squamous cell carcinoma models, as well as synergy between our APR-1051 and anti-PD-1 therapy.
Near term catalysts for the ongoing APR-1051 clinical program include the availability of further safety and efficacy data in Q1 2026 and completion of dose escalation in 2026.
ATR Inhibitor Program, ATRN-119
Earlier this year, we announced that the ATRN-119 program had reached its recommended Phase 2 dose (RP2D) for once-daily dosing, and we are now shifting our focus toward evaluating combination therapies with this agent. As part of this strategic direction and to preserve cash in a still difficult fundraising environment, Aprea is pausing further enrollment in both once-daily and twice-daily monotherapy dosing arms of the ABOYA-119 study.
Building on the completion of dose escalation and supported by new preclinical data suggesting synergistic anti-tumor activity, we may consider combination strategies to expand ATRN-119’s therapeutic potential as our balance sheet strengthens. With its favorable safety profile, ATRN-119 is well positioned for use alongside DNA-damaging agents, including radiation therapy, antibody-drug conjugates, and immune checkpoint inhibitors.
As previously disclosed, we are in discussions with leading academic centers to investigate ATRN-119 in combination with radiation and immunotherapy, based on preclinical findings that ATR inhibition may enhance anti-tumor immune responses.
We will continue to share updates on this program throughout the coming year.
Cash Runway Into Q1 2027
We remain committed to maintaining financial discipline and delivering value for our shareholders. We believe our recently completed $3.1 million (gross) private placement financing extends our cash runway into 2027 based on current projections. Our focus is on executing our programs with discipline and continuing to expand our investor relations and visibility efforts so the market better understands the value Aprea is creating.
Our strategy is to advance the science, deliver on clinical and regulatory milestones, broaden awareness of the story, and let the fundamentals drive a valuation that better reflects the opportunity.
In this last round of financing, myself, as well as our CFO, and a Board member participated alongside external investors, which included healthcare focused funds and a long-term existing shareholder, reflecting confidence in our strategy and potential.
Aprea remains committed to advancing the fight against cancer. I want to sincerely thank our dedicated employees, our engaged Board of Directors, our patients and their families, clinical investigators and our valued shareholders. Your commitment and belief in our mission are essential to everything we do.
All my best,
Oren Gilad
President & Chief Executive Officer
Aprea Therapeutics
- For more detailed clinical results from the ongoing ACESOT-1051 trial, refer to Aprea’s corporate presentation which can be found at https://aprea.com/.
About Aprea
Aprea is pioneering a new approach to treat cancer by exploiting vulnerabilities associated with cancer cell mutations. This approach was developed to kill tumors but to minimize the effect on normal, healthy cells, decreasing the risk of toxicity that is frequently associated with chemotherapy and other treatments. Aprea’s technology has potential applications across multiple cancer types, enabling it to target a range of tumors, including ovarian, endometrial, colorectal, prostate, and breast cancers.
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.
Forward-Looking Statement
Certain information contained in this press release includes “forward-looking statements”, within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended related to our study analyses, clinical trials, regulatory submissions, and projected cash position. We may, in some cases use terms such as “future,” “predicts,” “believes,” “potential,” “continue,” “anticipates,” “estimates,” “expects,” “plans,” “intends,” “targeting,” “confidence,” “may,” “could,” “might,” “likely,” “will,” “should” or other words that convey uncertainty of the future events or outcomes to identify these forward-looking statements. Our forward-looking statements are based on current beliefs and expectations of our management team and on information currently available to management that involve risks, potential changes in circumstances, assumptions, and uncertainties. All statements contained in this press release other than statements of historical fact are forward-looking statements, including statements regarding our ability to develop, commercialize, and achieve market acceptance of our current and planned products and services, our research and development efforts, including timing considerations and other matters regarding our business strategies, use of capital, results of operations and financial position, and plans and objectives for future operations. Any or all of the forward-looking statements may turn out to be wrong or be affected by inaccurate assumptions we might make or by known or unknown risks and uncertainties. These forward-looking statements are subject to risks and uncertainties including, without limitation, the risk that the proposed private placement and the transactions described herein may not be completed in a timely manner or at all, the failure to realize the anticipated benefits of the private placement and related transactions, market and other conditions, as well as other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. For all these reasons, actual results and developments could be materially different from those expressed in or implied by our forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements, which are made only as of the date of this press release. We undertake no obligation to update such forward-looking statements for any reason, except as required by law.
Investor Contact:
Mike Moyer
LifeSci Advisors
mmoyer@lifesciadvisors.com
