Core Insights - Aprea Therapeutics has made significant progress in its clinical programs and is optimistic about its growth potential in 2026 [2][10] Group 1: Clinical Programs - The lead program, APR-1051, a next-generation WEE1 inhibitor, is showing promising anti-tumor activity in the ongoing ACESOT-1051 dose-escalation study, with a notable 15% reduction in tumor burden observed [3][4] - The treatment has been well tolerated with no dose-limiting toxicities reported, and disease stabilization has been noted in several patients, with the longest duration of treatment reaching 222 days [3][4] - The company is expanding its clinical focus on HPV-positive patients due to early positive responses, aligning with preclinical data from MD Anderson Cancer Center [5] - Upcoming catalysts for APR-1051 include further safety and efficacy data expected in Q1 2026 and completion of dose escalation in 2026 [6] Group 2: ATR Inhibitor Program - The ATRN-119 program has reached its recommended Phase 2 dose for once-daily dosing, with a strategic shift towards evaluating combination therapies [7] - Enrollment in monotherapy dosing arms of the ABOYA-119 study is paused to conserve cash amid challenging fundraising conditions [7] - Future strategies may include combination therapies with DNA-damaging agents, supported by preclinical data indicating enhanced anti-tumor immune responses [8][9] Group 3: Financial Position - Aprea has completed a $3.1 million gross private placement financing, extending its cash runway into Q1 2027 [10][11] - The company emphasizes financial discipline and aims to enhance investor relations to better communicate its value proposition [11][12] Group 4: Company Overview - Aprea is focused on developing innovative cancer treatments that target cancer cell vulnerabilities while minimizing damage to healthy cells [14] - The company's lead programs, APR-1051 and ATRN-119, are both in clinical development for solid tumor indications [15]

Core Insights - Aprea Therapeutics, Inc. has entered into a securities purchase agreement to sell 2,623,023 shares of common stock and warrants to purchase an equal number of shares, raising approximately $3.1 million before expenses [2][3] Financing Details - The offering price for each share and accompanying warrant is set at $1.165, with warrants having an exercise price of $1.04 per share, exercisable immediately and expiring five years from the registration statement effectiveness date [2][3] - The gross proceeds from the offering are intended for general corporate purposes and research and development expenses, extending the company's cash runway into Q1 2027 [3] Company Overview - Aprea Therapeutics is focused on developing innovative cancer treatments that target specific vulnerabilities in cancer cells while minimizing harm to healthy cells, with applications across various cancer types including ovarian, endometrial, colorectal, prostate, and breast cancers [7] - The company's lead programs include 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 [8]

Clinical Development - The FDA cleared the IND application for APR-1051 in March 2024, with the first patient enrolled in the Phase 1 study in Q2 2024 [84]. - The recommended Phase 2 dose for ATRN-119 is 1,100 mg once daily, determined on October 15, 2025, during the ongoing Phase 1/2a study [86]. - The company has paused further enrollment in both monotherapy dosing arms of ATRN-119 to explore combination approaches with other therapies [86]. - The company is evaluating combination opportunities for its product candidates, including ATRN-119 and APR-1051, supported by a grant from the National Cancer Institute [88]. - The company has an early preclinical research program for an undisclosed DDR target, currently in the lead optimization stage [90]. Financial Performance - The company has not generated any revenue from product sales and does not expect to do so in the near future [94]. - Grant revenue for the three months ended September 30, 2025, was $1,848, a decrease of $352,773 from $354,621 in 2024 [116]. - Total operating expenses for the three months ended September 30, 2025, were $3,119,236, down from $4,451,637 in 2024, representing a decrease of $1,332,401 [116]. - Research and development expenses for the three months ended September 30, 2025, were approximately $1.6 million, a decrease of $1.2 million from approximately $2.8 million in 2024 [118]. - General and administrative expenses for the three months ended September 30, 2025, were approximately $1.5 million, down from approximately $1.6 million in 2024, a decrease of $124,919 [119]. - Net loss for the three months ended September 30, 2025, was $2,972,410, compared to a net loss of $3,783,769 in 2024, an improvement of $811,359 [116]. - Grant revenue for the nine months ended September 30, 2025, was approximately $0.3 million, a decrease of $1,014,342 from $1.3 million in 2024 [123]. - Total operating expenses for the nine months ended September 30, 2025, were $10,873,165, down from $12,390,374 in 2024, a decrease of $1,517,209 [122]. - Net cash used in operating activities for the nine months ended September 30, 2025, was $9,933,147, compared to $10,045,814 in 2024, a decrease of $112,667 [135]. - The accumulated deficit as of September 30, 2025, was $331.2 million, with significant losses primarily from research and development activities [129]. Cash and Financing - As of September 30, 2025, the company had cash and cash equivalents of $13.7 million, which is insufficient to fund operating expenses for the next twelve months [128]. - Net cash provided by financing activities was $0.8 million for the nine months ended September 30, 2025, after deducting approximately $36,000 in issuance costs from sales of common stock [138]. - For the nine months ended September 30, 2024, net cash provided by financing activities was $14.7 million, after deducting approximately $1.3 million in underwriting discounts and offering expenses [139]. - The company anticipates a substantial increase in expenses related to ongoing and planned development activities, including clinical trials and preclinical research [141]. - Additional financing will be required to support continuing operations, with potential sources including public or private equity, debt financings, and collaborations [144]. - The company may face significant delays or reductions in product development if it fails to raise necessary capital [149]. - The company has no committed external source of funds and may experience dilution of ownership interests if additional capital is raised through equity sales [147]. Risk Factors - The company is exposed to interest rate risk, with cash equivalents primarily in bank deposits and money market accounts [155]. - Inflation has not had a material effect on the company's business or financial condition during the nine months ended September 30, 2025 [158]. - The company does not currently have significant direct foreign exchange risk and has not used derivative financial instruments to hedge such exposure [157]. Company Status - The company qualifies as a "smaller reporting company," with a market value of common stock held by non-affiliates below $700 million [114]. - The company has not recorded any income tax expense or benefits due to uncertainty in realizing benefits from net losses [109].

Financial Performance - As of September 30, 2025, Aprea reported cash and cash equivalents of $13.7 million, down from $22.8 million as of December 31, 2024, indicating a decrease of approximately 40%[8] - The company reported an operating loss of $3.1 million for Q3 2025, an improvement from an operating loss of $4.1 million in Q3 2024, reflecting a reduction of about 24%[13] - The net loss for Q3 2025 was $3.0 million, or $0.47 per basic share, compared to a net loss of $3.8 million, or $0.64 per basic share, in the same period of 2024, representing a reduction of about 21% in net loss per share[13] - Total operating expenses for Q3 2025 were $3,119,236, down from $4,451,637 in Q3 2024, representing a decrease of approximately 30%[19] - Net loss for Q3 2025 was $(2,972,410), an improvement from $(3,783,769) in Q3 2024, indicating a reduction in losses[19] - Total comprehensive loss for the nine months ended September 30, 2025, was $(10,146,094), compared to $(10,057,386) for the same period in 2024[19] Research and Development - Research and Development (R&D) expenses decreased to $1.6 million in Q3 2025 from $2.8 million in Q3 2024, a decline of approximately 43%[13] - Research and development expenses for the nine months ended September 30, 2025, were $6,034,196, compared to $7,004,451 for the same period in 2024, reflecting a decrease of about 14%[19] - The recommended Phase 2 dose (RP2D) for ATRN-119 was identified as 1,100 mg once daily, following the completion of the dose-escalation study[9] - Aprea is considering combination strategies for ATRN-119 with radiation or checkpoint inhibitors to enhance clinical impact[3] - In the ongoing Phase 1 ACESOT-1051 trial for APR-1051, 3 out of 4 patients (75%) in the 100 mg once daily cohort achieved stable disease[5] Assets and Equity - Aprea's total assets as of September 30, 2025, were reported at $14.3 million, down from $24.0 million as of December 31, 2024, reflecting a decrease of approximately 40%[17] - Total stockholders' equity decreased to $10.9 million as of September 30, 2025, from $19.3 million at the end of 2024, a decline of about 44%[17] Revenue and Income - Grant revenue for Q3 2025 was $1,848, compared to $354,621 in Q3 2024, showing a significant increase[19] - Interest income for Q3 2025 was $150,669, compared to $348,741 in Q3 2024, showing a decline of approximately 57%[19] - Total other income for Q3 2025 was $144,978, down from $313,247 in Q3 2024, indicating a decrease of approximately 54%[19] Shareholder Information - The weighted average common shares outstanding for Q3 2025 were 6,372,938, an increase from 5,939,755 in Q3 2024[19] - The net loss per share attributable to common stockholders for Q3 2025 was $(0.47), an improvement from $(0.64) in Q3 2024[19] Currency Impact - Foreign currency translation resulted in a loss of $(1,117) in Q3 2025, contrasting with a gain of $23,557 in Q3 2024[19] Cash Runway - The company has cash runway projected into the fourth quarter of 2026, indicating sufficient funds to meet operational needs[2]

Core Insights - Aprea Therapeutics, Inc. reported financial results for Q3 2025, highlighting clinical progress in its WEE1 and ATR inhibitor programs, with cash runway extending into Q4 2026 [1][2]. Clinical Development - The ongoing ACESOT-1051 trial for APR-1051 (WEE1 kinase inhibitor) shows promising early signs of anti-tumor activity, with 3 out of 4 patients achieving stable disease at the 100 mg once daily dose [2][4]. - APR-1051 has advanced to the 150 mg once daily cohort as part of the dose escalation strategy [2][4]. - ATRN-119 (ATR kinase inhibitor) has identified a recommended Phase 2 dose of 1,100 mg once daily, with plans to explore combination strategies with radiation or checkpoint inhibitors [2][9]. Financial Performance - As of September 30, 2025, Aprea reported cash and cash equivalents of $13.7 million, down from $22.8 million at the end of 2024 [9][13]. - The company recorded an operating loss of $3.1 million for Q3 2025, an improvement from a $4.1 million loss in Q3 2024 [9][16]. - Research and Development (R&D) expenses decreased to $1.6 million in Q3 2025 from $2.8 million in the same quarter of 2024, primarily due to reduced study startup costs [9][16]. Business Strategy - Aprea is focusing on a differentiated DNA damage response (DDR) approach to treat cancers with specific vulnerabilities, particularly those over-expressing Cyclin E [5][8]. - The company is considering future studies of APR-1051 in combination with checkpoint inhibitors to address unmet medical needs across distinct patient populations [5][9].

Core Insights - Aprea Therapeutics, Inc. has provided an update on the Phase 1 ACESOT-1051 study, showing promising results for its WEE1 inhibitor, APR-1051, in patients with advanced solid tumors [1][2][5] Study Results - At the 100 mg dose level of APR-1051, 3 out of 4 patients achieved stable disease according to RECIST v1.1 criteria [1][5][6] - Disease stabilization was observed in patients with tumors harboring mutations relevant to WEE1 kinase inhibition, specifically FBXW7, CCNE1, KRAS, and TP53 [5][6][11] - The trial is currently progressing to a higher dose level of 150 mg following successful results from the 100 mg cohort [5][6] Presentation and Data - Preliminary results from the ACESOT-1051 trial will be presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics [2][5] - The poster presentation will summarize updated data with a cutoff date of September 17, 2025 [2] Company Overview - Aprea Therapeutics focuses on developing innovative cancer therapies that target specific vulnerabilities in cancer cells while minimizing damage to healthy cells [7] - The company's clinical programs include APR-1051, an oral small-molecule inhibitor of WEE1 kinase, and ATRN-119, a macrocyclic small molecule ATR inhibitor [7]

Core Insights - Aprea Therapeutics has identified the recommended Phase 2 dose of 1,100 mg once daily for ATRN-119, an oral ATR inhibitor, in the ongoing ABOYA-119 Phase 1/2a study for patients with advanced solid tumors [1][6] ATR Program - Aprea is considering further development of ATRN-119 in combination with DNA-damaging agents, radiation therapy, antibody-drug conjugates, and immune checkpoint inhibitors, based on preclinical data suggesting synergistic anti-tumor effects [2][4] - The company is pausing further enrollment in monotherapy dosing arms of ABOYA-119 while ensuring current patients continue to receive therapy without interruption [3] Clinical Data - Preliminary Phase 1 monotherapy data indicate that ATRN-119 has a favorable tolerability profile with manageable adverse events at the RP2D of 1,100 mg once daily, and shows durable disease stabilization in heavily pretreated patients across multiple tumor types [8] - The company plans to present updated data from the ABOYA-119 trial at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics on October 24, 2025 [6] WEE1 Program - Aprea is advancing its lead program, the WEE1 kinase inhibitor APR-1051, with ongoing Phase 1 studies actively enrolling patients [7][9] - Early signals of clinical benefit have been observed in patients treated with APR-1051, supporting continued dose escalation and further clinical evaluation [9] Company Overview - Aprea Therapeutics focuses on developing novel cancer therapies that target cancer cells while minimizing damage to healthy cells, aiming to reduce toxicity associated with conventional treatments [10]

Core Insights - Aprea Therapeutics, Inc. announced the acceptance of two abstracts for poster presentations at the EORTC-NCI-AACR International Conference on Molecular Targets and Cancer Therapeutics, scheduled for October 22 - 26, 2025 [1] Group 1: Clinical Programs - The first abstract focuses on APR-1051, a novel WEE1 inhibitor, detailing early safety and efficacy data from the ACESOT-1051 phase 1 trial [2] - The second abstract presents updated data from the ABOYA-119 trial, which involves ATRN-119, a macrocyclic ATR inhibitor, in patients with advanced solid tumors [2] Group 2: Company Mission and Approach - Aprea's mission is to develop innovative cancer therapies that specifically target cancer cells while minimizing damage to healthy cells, aiming to reduce toxicity associated with conventional treatments [3] - The company is currently developing APR-1051 and ATRN-119 for solid tumor indications, utilizing unique vulnerabilities in cancer cell mutations [3]

Aprea Therapeutics FY Conference Summary Company Overview - **Company**: Aprea Therapeutics (NasdaqCM: APRE) - **Industry**: Biopharmaceuticals, focusing on cancer treatment through small molecule inhibitors targeting genetic mutations [1][2] Core Points and Arguments - **Focus on Precision Medicine**: Aprea Therapeutics operates at the intersection of precision medicine and synthetic lethality, emphasizing a targeted approach to cancer treatment [2] - **Pipeline Overview**: The company is developing multiple programs, including: - ATR inhibitor - WE-one inhibitor (APR 1051) - Legacy p53 reactivator - An undisclosed target to be revealed later for intellectual property (IP) reasons [3][4] - **Clinical Trials**: - The WE-one inhibitor has progressed with the first patient enrolled and an open-label study ongoing. Data will be shared at an upcoming conference [4][5] - The ATR program has seen a shift from a once-daily (QD) to a twice-daily (BID) regimen due to pharmacokinetic properties, which has shown positive results [5][6] - **Dosing and Safety**: Initial maximum tolerated dose (MTD) was projected at 150 mg, but increased to 220 mg and 300 mg based on positive safety data, enhancing the therapeutic index [7][8] - **Early Clinical Data**: - Early signs of activity observed in the 70 mg cohort and stable disease in the 100 mg cohort, indicating potential efficacy as doses increase [9][10] - A case study of an 86-year-old patient showed improved response and stability after multiple lines of treatment, supporting the drug's potential [12][13] - **Biomarker-Driven Approach**: All programs are biomarker-driven, focusing on matching mutations with appropriate therapies, which is a key aspect of their personalized medicine strategy [15][16] Additional Important Information - **Collaboration with MD Anderson**: Aprea has a strong collaboration with MD Anderson for HPV positive head and neck cancer, generating promising preclinical data [14][15] - **Combination Therapy Potential**: Preclinical models indicate strong potential for both single-agent activity and combination therapies, with minimal side effects observed [17][19] - **Financial Position**: The company reported $16.5 million in cash, indicating a solid financial foundation to support ongoing and future programs [24] - **Investment Opportunity**: Aprea believes there is a good entry opportunity for investors, with upcoming catalysts expected to drive progress in their clinical programs [25] Conclusion Aprea Therapeutics is positioned as a promising player in the biopharmaceutical industry, focusing on innovative cancer treatments through a precision medicine approach. The ongoing clinical trials and strong financial backing present potential investment opportunities as the company continues to advance its pipeline.

Core Insights - Aprea Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing innovative cancer treatments that target specific vulnerabilities in cancer cells while minimizing damage to healthy cells [1][2] Presentation Details - Aprea will present at the H.C. Wainwright 27th Annual Global Investment Conference on September 9, 2025, at 3:30 PM ET, located at the Lotte New York Palace Hotel [2] - A webcast of the presentation will be available for 90 days on the Aprea Investors page [2] Company Overview - Aprea's mission is to create novel cancer therapies that directly target cancer cells, reducing toxicity risks associated with conventional treatments [2] - The company's lead programs include APR-1051, an oral small-molecule inhibitor of WEE1 kinase, and ATRN-119, a macrocyclic small molecule ATR inhibitor, both in clinical development for solid tumor indications [2]