Seasoned oncology drug development leader joins following early clinical proof-of-concept for WEE1 inhibitor, APR-1051DOYLESTOWN, Pa., Feb. 04, 2026 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (Nasdaq: APRE) (“Aprea” or the “Company”), a clinical-stage biopharmaceutical company developing innovative therapies that exploit cancer-specific vulnerabilities while minimizing damage to healthy cells, today announced the appointment of Eugene (Gene) Kennedy, MD, as Chief Medical Advisor. Dr. Kennedy joins Aprea a ...

FDA Approvals & Rejections - Intellia Therapeutics has received FDA approval to resume its MAGNITUDE-2 Phase 3 trial for nexiguran ziclumeran (nex-z) targeting hereditary transthyretin amyloidosis with polyneuropathy, increasing target enrollment from 50 to 60 patients [2][4] - Outset Medical's next-generation Tablo Hemodialysis System has been granted FDA 510(k) clearance, making it the first dialysis device to meet enhanced cybersecurity standards, with shipping expected to begin in Q2 2026 [6][7] - OKYO Pharma has received positive feedback from the FDA for its Phase 2b/3 trial design for Urcosimod, a candidate for neuropathic corneal pain, with plans to start the trial in the first half of 2026 [8][9] - REGENXBIO has faced clinical holds on its RGX-111 and RGX-121 gene therapy programs due to a case of CNS tumor in a child treated with RGX-111, although no similar findings were reported in other patients [10][11] - Almirall has received NMPA approval for Seysara in China for treating moderate-to-severe acne vulgaris, expanding its dermatology portfolio in the region [12][13] Clinical Trials - Breakthroughs - Aprea Therapeutics reported early clinical activity for APR-1051 in endometrial cancer, achieving a 50% reduction in target lesion size in a patient with PPP2R1A-mutated uterine serous carcinoma [19][21] - Fractyl Health's Revita demonstrated positive results in weight maintenance after GLP-1 drug discontinuation, showing a 4.5% weight regain compared to 7.5% in the sham group [22][24] - Ascletis Pharma announced positive Phase 3 results for Denifanstat in moderate-to-severe acne vulgaris, focusing on long-term safety in a trial with 240 patients [25][26] - GRI Bio reported new gene expression data from its Phase 2a study of GRI-0621 in idiopathic pulmonary fibrosis, showing significant improvements in lung injury and fibrosis progression [27][28] - Cardiff Oncology announced encouraging results from its Phase 2 trial of Onvansertib in RAS-mutated metastatic colorectal cancer, with a well-tolerated regimen and plans to advance to a registrational program [31][32] - Genentech's CT-388 Phase 2 trial for obesity showed a significant placebo-adjusted weight loss of 22.5% at 48 weeks, with a high percentage of participants achieving significant weight loss [34][36] - Sarepta Therapeutics reported positive three-year results from its EMBARK study for ELEVIDYS in Duchenne muscular dystrophy, showing significant slowing of disease progression in treated patients [38][41] Deals - YD Bio Limited has signed a letter of intent to acquire Safe Save Medical for approximately $26.87 million, aiming to enhance its capabilities in advanced cellular therapeutics [14][15][17]

Core Insights - Aprea Therapeutics announced the first unconfirmed partial response (uPR) in a patient from its Phase 1 ACESOT-1051 study, indicating early clinical activity of APR-1051 in treating advanced solid tumors [1][2] Group 1: Clinical Trial Results - The uPR was observed in a patient with PPP2R1A-mutated uterine serous carcinoma, showing a 50% reduction in target lesion size and a decrease in CA-125 levels from 732 to 70 U/mL after treatment with APR-1051 at the 150 mg dose level [2][7] - Earlier cohorts in the ACESOT-1051 study reported stable disease in multiple patients, including a 5% reduction in tumor burden in a patient with HPV-positive head and neck squamous cell carcinoma and a 15% reduction in a patient with FBXW7-mutated colon cancer [3] - The ongoing dose-escalation study is currently enrolling patients in the 220 mg cohort, with plans to increase enrollment of HPV-positive patients [4][6] Group 2: Drug Mechanism and Strategy - APR-1051 is a small-molecule inhibitor of WEE1 kinase, designed to exploit cancer-specific vulnerabilities while minimizing damage to healthy cells [8][9] - The company aims to target cancers with specific genomic alterations, including mutations in PPP2R1A, FBXW7, CCNE1, TP53, and KRAS, reinforcing the potential of APR-1051 as a differentiated treatment option [5] Group 3: Future Outlook - Aprea Therapeutics plans to provide additional updates in the first half of 2026 and complete dose escalation later in the year, indicating ongoing commitment to the development of APR-1051 [5]

Core Viewpoint - Aprea Therapeutics has announced a private placement of common stock and warrants, aiming to raise approximately $5.6 million to support its ongoing clinical studies and general corporate purposes [1][2][3] Group 1: Offering Details - Aprea will sell a total of 6,288,857 shares of common stock (or pre-funded warrants) along with warrants to purchase an equal number of shares, at an effective offering price of $0.89 per share [1][2] - The warrants will have an exercise price of $0.765 per share, exercisable immediately upon issuance, and will expire two years from the effectiveness date of the registration statement [1][2] Group 2: Use of Proceeds - The gross proceeds from the offering are estimated to be around $5.6 million before deducting fees and expenses, which will be used for general corporate purposes and research and development expenses [2] Group 3: Clinical Development Focus - The financing is intended to support the ongoing ACESOT-1 dose-escalation study of APR-1051, a WEE1 kinase inhibitor, with the goal of optimizing dosage and patient population [3] - The addition of more patients to the study is expected to enhance the dataset for safety and early efficacy, potentially leading to significant clinical milestones [3] Group 4: Company Overview - Aprea Therapeutics is focused on developing innovative cancer treatments that target specific vulnerabilities in cancer cells while minimizing harm to healthy cells [6] - The company's lead programs include APR-1051 and ATRN-119, both of which are in clinical development for solid tumor indications [7]

Group 1 - Aprea Therapeutics, Inc. (APRE) has been added to the Zacks Rank 5 (Strong Sell) List due to a 61.5% downward revision in the consensus estimate for its current year earnings over the last 60 days [1] - Culp, Inc. (CULP) is also on the Zacks Rank 5 (Strong Sell) List, with a 38.5% downward revision in the consensus estimate for its current year earnings over the last 60 days [1] - Paramount Skydance Corporation (PSKY) has seen a 36% downward revision in the consensus estimate for its current year earnings over the last 60 days, leading to its inclusion in the Zacks Rank 5 (Strong Sell) List [2]

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].