Aprea Therapeutics (NasdaqCM:APRE) FY Conference February 26, 2026 08:40 AM ET Company ParticipantsOren Gilad - President and CEONone - AssociateNoneMorning, everyone, thanks for joining us. My name is Anthony, and I'm an associate here at Oppenheimer. It's my pleasure to introduce Aprea Therapeutics, a precision oncology company focused on targeting the DNA damage response pathway. Their lead program is APRN-1051, a next-gen WEE1 inhibitor. The company is also advancing ATRN-119, a macrocyclic ATR inhibito ...

Core Viewpoint - Aprea Therapeutics shares are experiencing an increase following the announcement of additional preliminary data from the Phase 1 trial of APR-1051, a WEE1 kinase inhibitor [1] Group 1: Cancer Trial Data - A second unconfirmed partial response was reported in a patient with advanced endometrial cancer, showing a 50% reduction in target lesion measurements [2] - CA-125 tumor biomarker levels decreased significantly from 362 U/mL at baseline to 47 U/mL, indicating promising anti-tumor activity [2] Group 2: Trial Progress and Future Plans - Enrollment in the 220 mg dose cohort is ongoing, with plans to expand the study to include more patients with specific genetic alterations [3] - The trial aims to evaluate the safety and efficacy of APR-1051, with further updates expected in the second quarter of 2026 [3] Group 3: Analyst Consensus & Recent Actions - The stock currently carries a Buy Rating, with Aprea Therapeutics shares up 16.62% at $0.70 at the time of publication [4] - Recent analyst actions include Wedbush rating it as Outperform with a target lowered to $7.00 and HC Wainwright & Co. maintaining a Buy rating with a target lowered to $4.00 [4]

Core Viewpoint - Aprea Therapeutics announced preliminary data from the Phase 1 ACESOT-1051 trial for its WEE1 kinase inhibitor APR-1051, showing promising anti-tumor activity in patients with advanced endometrial cancer, particularly those with PPP2R1A mutations [1][5]. Trial Findings - The trial has reported a second unconfirmed partial response in a patient with advanced endometrial cancer at the 220 mg dose level, with a 50% reduction in target lesion measurements and a significant drop in the tumor biomarker CA-125 from 362 U/mL to 47 U/mL, representing an 87% decrease [2][3]. - The trial has treated a total of 22 patients at doses ranging from 10 mg to 220 mg, with the ongoing evaluation of safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity [6][10]. - Two patients with endometrial cancer harboring PPP2R1A mutations achieved unconfirmed partial responses at their first scan, observed at the 150 mg and 220 mg dose levels [8]. Safety and Tolerability - The treatment has been well tolerated, with only Grade 1 treatment-emergent adverse effects reported in the responding patient [3][7][14]. - The good safety profile supports the development strategy of differentiated WEE1 inhibition, aiming for an improved therapeutic index [5][7]. Future Directions - The company plans to expand enrollment in the 220 mg dose cohort, particularly focusing on patients with PPP2R1A endometrial and HPV-positive head and neck squamous cell carcinoma [9]. - Further updates from the trial are expected in the second quarter of 2026, reinforcing the ongoing commitment to advancing APR-1051 [4][10].

Core Viewpoint - Aprea Therapeutics, Inc. is set to provide a corporate update at the Oppenheimer 36th Annual Healthcare Life Sciences Conference, highlighting its innovative cancer therapies that target cancer-specific vulnerabilities while minimizing harm to healthy cells [1]. Group 1: Company Overview - Aprea is a clinical-stage biopharmaceutical company focused on developing therapies that exploit cancer cell mutations to treat various cancer types, including ovarian, endometrial, colorectal, and head and neck squamous cell carcinoma [3]. - 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 currently in clinical development for solid tumor indications [4]. Group 2: Presentation Details - The corporate update will be presented virtually on February 26, 2026, at 8:40 am EST, with a webcast available for 90 days [2]. - Investors interested in one-on-one meetings with Aprea management during the conference can contact their Oppenheimer representative [2].

Core Insights - Aprea Therapeutics has expanded its global intellectual property estate with new patents granted in 2025 in Australia and Japan, enhancing protection for its WEE1 and ATR programs, expected to provide exclusivity until 2045 [1][3] - The lead WEE1 inhibitor candidate, APR-1051, is currently in Phase 1 trials, showing early clinical proof of concept, with multiple data readouts anticipated in 2026 [1][3] - Aprea's robust patent strategy aims to secure long-term commercial value and de-risk clinical development by protecting proprietary molecules and therapeutic applications [2][3] WEE1 Program - The WEE1 inhibitor APR-1051 is being evaluated in the ACESOT-1051 Phase 1 clinical trial for advanced/metastatic solid tumors with specific gene alterations [3] - The WEE1 patent portfolio includes one provisional U.S. patent application, two pending U.S. applications, one issued patent in Australia, and 13 pending applications internationally, with core patents expected to provide protection through 2042 [3] ATR Program - The ATR inhibitor ATRN-119 is under evaluation in the ABOYA-119 clinical trial as a monotherapy for patients with advanced solid tumors [4] - The ATR patent estate consists of four issued U.S. patents, one pending U.S. application, one international application, and 21 granted patents, including one issued in Japan in 2025, with existing patents expected to remain in force through 2035-2037 [4] Company Overview - Aprea is focused on developing innovative cancer therapies that exploit cancer-specific vulnerabilities while minimizing damage to healthy cells, aiming to reduce toxicity associated with traditional treatments [6] - The company's lead programs, APR-1051 and ATRN-119, are small-molecule inhibitors targeting solid tumor indications [7]

Core Insights - Aprea Therapeutics has appointed Dr. Eugene Kennedy as Chief Medical Advisor, enhancing its clinical leadership during a pivotal phase of its WEE1 inhibitor APR-1051 development [1][2][3] Company Overview - Aprea Therapeutics is a clinical-stage biopharmaceutical company focused on developing therapies that target cancer-specific vulnerabilities while minimizing harm to healthy cells [6] - The company's lead programs include APR-1051, an oral small-molecule WEE1 kinase inhibitor, and ATRN-119, a small molecule ATR inhibitor, both aimed at treating solid tumors [7] Recent Developments - The appointment of Dr. Kennedy follows early clinical proof-of-concept results from a Phase 1 dose-escalation study of APR-1051 in patients with advanced solid tumors [2][3] - Dr. Kennedy brings over 20 years of experience in oncology clinical development and regulatory strategy, which is expected to strengthen Aprea's clinical efforts [2][4] Strategic Goals - The company aims to optimize dose and patient selection for its WEE1 program and advance its DNA damage response (DDR) pipeline towards key clinical and regulatory milestones [3][4] - Dr. Kennedy expressed alignment with Aprea's strategy to lead in DDR inhibition, emphasizing the potential to transform treatment approaches for difficult-to-treat cancers [3][5]

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]