ACESOT-1051 Study Design ACESOT-1051 (A Multi-Center Evaluation of WEE1 Inhibitor in Patients with Advanced Solid Tumors, APR- 1051) is designed to assess the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of single-agent APR-1051 in advanced solid tumors harboring cancer-associated gene alterations. Oral APR-1051 will be administered once daily for 28-day cycles. The study consists of two parts. Part 1 is dose escalation and is expected to enroll up to 39 patients with advanced solid ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the year ended December 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-39069 Aprea Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 84-2246769 (State or other jurisdictio ...

Drug Development and Clinical Trials - Aprea Therapeutics is advancing its WEE1 inhibitor, APR-1051, which has shown a 29.4% overall response rate (ORR) in a Phase 2 study for recurrent uterine serous carcinoma[16]. - The company is currently enrolling the fourth cohort in a Phase 1 study for APR-1051, with safety and efficacy data expected in H1 2025[6]. - Aprea's ATR inhibitor, ATRN-119, is in a Phase 1/2a study, with data readout anticipated in H2 2025[6]. - The clinical study for ACESOT-1051 is enrolling up to 79 patients, focusing on advanced solid tumors with specific gene alterations[40]. - The ongoing study for ATRN-119 aims to establish a maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) with a total enrollment of up to 132 patients[62]. - The study design for ATRN-119 includes a dose escalation phase with up to 72 patients, followed by a dose expansion phase[62]. - Aprea Therapeutics is conducting ongoing Phase 1/2a clinical studies for ATRN-119, with preliminary signs of clinical benefit observed at low doses[74]. Drug Safety and Efficacy - Aprea's WEE1 inhibitor has demonstrated minimal off-target effects, preserving hematologic safety profiles in clinical trials[6]. - APR-1051 has shown negligible inhibition of hERG channels, suggesting a low risk of QT prolongation at effective doses[29]. - APR-1051 has been reported to be safe and well-tolerated, with no hematologic toxicity observed in preclinical studies[48]. - No serious adverse events (SAE) or Grade 4 adverse events related to ATRN-119 were reported, with the most common adverse events being Grade 1 and Grade 2[71]. - ATRN-119 is potentially differentiated from other ATR inhibitors in selectivity and toxicity profile, providing continuous tumor suppression[74]. Financial Position and Funding - Aprea Therapeutics reported cash and equivalents of approximately $22.8 million as of December 31, 2024[77]. - The company closed a private placement of common stock in March 2024, raising approximately $16.0 million, with potential additional funds of up to $18.0 million from warrant exercises[77]. - Aprea Therapeutics is financed into Q4 2025, with near-term catalysts expected from ongoing clinical trials[81]. Strategic Goals and Market Positioning - The company aims to identify lead candidates for its discovery platform by 2024, focusing on optimizing drug development[6]. - Aprea's clinical pipeline includes multiple anticipated milestones from 2024 to 2026, indicating a robust development strategy[7]. - The company emphasizes the need for highly efficient WEE1 inhibitors with improved safety profiles, addressing significant unmet medical needs in oncology[16]. - The company is focused on expanding its market presence through innovative therapies that address critical gaps in cancer treatment[5]. - Aprea Therapeutics has a strong intellectual property portfolio, including four issued US patents protecting lead molecules and analogs[76]. - The company aims to achieve short-term inflection points and evaluate optimal strategic partnerships in the oncology space[81]. - The company has opportunities in various cancers, including ovarian, colorectal, prostate, and breast cancers, with both single-agent and combination therapies being explored[81]. Drug Characteristics and Performance - APR-1051 demonstrated a Cmax of 1,460 ng/ml at a dose of 10 mg/kg/day, indicating potentially favorable drug exposure compared to competitors[28]. - In preclinical studies, APR-1051 showed a tumor volume reduction in OVCAR-3 xenograft models, with significant suppression of tumor growth[32]. - ATRN-119 exhibits near-dose proportional exposure following oral administration, with a Tmax of approximately 2 hours and a half-life estimated between 4-6 hours[68][74]. - APR-1051 is being developed as a best-in-class WEE1 inhibitor, targeting specific cancer-associated gene alterations[47]. - ATRN-119 is positioned as a potentially best-in-class oral ATR inhibitor, with continuous daily dosing being evaluated[55].

DOYLESTOWN, Pa., March 11, 2025 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (Nasdaq: APRE) (“Aprea”, or the “Company”), a clinical-stage biopharmaceutical company developing innovative treatments that exploit specific cancer cell vulnerabilities while minimizing damage to healthy cells, announced today that it has entered into a Material Transfer Agreement (MTA) with MD Anderson Cancer Center. Under the agreement, Aprea will supply its proprietary WEE1 kinase inhibitor, APR-1051, to support preclinical res ...

Core Insights - Aprea Therapeutics is focused on developing innovative cancer treatments that target specific vulnerabilities in cancer cells while minimizing harm to healthy cells [1][4] - The company emphasizes the importance of its strong patent portfolio in advancing its oncology treatments and protecting its intellectual property [2] Patent Portfolio - Aprea's ATR inhibitor program includes four granted U.S. patents, one pending U.S. application, and one pending provisional application, with 19 granted non-U.S. patents and 16 pending non-U.S. applications [2] - The granted patents for the ATR inhibitor program will expire between 2035 and 2037, with potential extensions of exclusivity into 2044 if pending applications are granted [2] - The WEE1 kinase inhibitor program has one pending U.S. patent application and 12 pending non-U.S. patent applications, with potential expiration in 2043 [3] Clinical Development - The lead ATR inhibitor, ATRN-119, is currently in the ABOYA-119 clinical trial for patients with advanced solid tumors having specific mutations in DNA damage response-related genes [2] - The lead WEE1 inhibitor, APR-1051, is being evaluated in the ACESOT-1051 Phase 1 clinical trial for advanced/metastatic solid tumors with certain gene alterations [3] Company Overview - Aprea is pioneering a treatment approach that targets cancer cell mutations while reducing toxicity to normal cells, applicable across various cancer types including ovarian, colorectal, prostate, and breast cancers [4]

Twice daily (BID) dosing regimen expected to maximize clinical benefit for patients by optimizing the activity of Aprea’s experimental drug, ATRN-119, over a 24-hour daily cycle New regimen potentially optimizes clinical outcomes and strengthens the clinical path forward ATRN-119 is the first macrocyclic ATR inhibitor to enter clinical trials DOYLESTOWN, Pa., Dec. 11, 2024 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (Nasdaq: APRE) (“Aprea”, or the “Company”), a clinical-stage precision oncology company dev ...

Shares of Aprea Therapeutics, Inc. (APRE) have been struggling lately and have lost 11.1% over the past week. However, a hammer chart pattern was formed in its last trading session, which could mean that the stock found support with bulls being able to counteract the bears. So, it could witness a trend reversal down the road.The formation of a hammer pattern is considered a technical indication of nearing a bottom with likely subsiding of selling pressure. But this is not the only factor that makes a bullis ...

Financial Position - As of September 30, 2024, the company expects cash and cash equivalents to be approximately $26.2 million, down from approximately $28.7 million as of June 30, 2024, representing a decrease of about 8.7%[4] - The preliminary cash and cash equivalents figure is subject to completion and may vary from the actual financial position as of September 30, 2024[5] Management Changes - The company announced the engagement of Dr. Phillipe Pultar as Senior Medical Advisor, while Dr. Nadeem Mirza will step down as Chief Medical Officer effective October 9, 2024[6]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-39069 Aprea Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 84-2246769 (State or o ...

DOYLESTOWN, Pa., Oct. 14, 2024 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (Nasdaq: APRE) (“Aprea”, or the “Company”), a clinical-stage biopharmaceutical company focused on precision oncology through synthetic lethality, today announced that Dr. Oren Gilad, President and CEO, will participate in two presentations at the Maxim Healthcare Virtual Summit, to take place October 15 to 17, 2024. Presentation Details Session:Precision and Immune Oncology PanelDate/ time:Wednesday, October 16, 2:00 - 3:00 PM ET  S ...