Aprea Therapeutics(APRE) - 2024 Q2 - Quarterly Results

Executive Summary Aprea Therapeutics presents its Q2 2024 performance, emphasizing clinical trial advancements and a strong cash position Second Quarter 2024 Highlights Aprea Therapeutics reported Q2 2024 results, initiating ACESOT-1051 Phase 1 trial with no myelosuppression and extending cash runway into Q4 2025 - Enrollment commenced in the ACESOT-1051 Phase 1 trial evaluating APR-1051, with no myelosuppression observed in the first of eight planned cohorts at a sub-therapeutic dose[1] - The Company reported $28.7 million in cash and cash equivalents as of June 30, 2024[1] - Cash runway is extended into Q4 2025[1] Business Update Aprea provides updates on its clinical pipeline progress and key corporate developments, including leadership changes Clinical Pipeline Progress Aprea advances its clinical pipeline with APR-1051 and ATRN-119, targeting oncology with promising early clinical development ACESOT-1051 (APR-1051, WEE1 Inhibitor) Details on the ACESOT-1051 Phase 1 trial for APR-1051, a WEE1 inhibitor, covering enrollment and anticipated readouts - APR-1051 is a potent and selective small molecule WEE1 inhibitor designed for greater clinical activity, especially in cancers with Cyclin E overexpression[2] - Enrollment commenced in June 2024 for the ACESOT-1051 Phase 1 clinical trial, with the first patient dosed without dose-limiting toxicities or myelosuppression[2] - Primary objectives of the Phase 1 study include measuring safety, dose-limiting toxicities (DLTs), maximum tolerated dose (MTD/MAD), and recommended Phase 2 dose (RP2D)[2] - An update on clinical study progress is expected by year-end 2024, with open-label safety/efficacy data anticipated in H1 2025[3] - APR-1051 was featured in a virtual KOL event in June 2024 and two posters at the AACR annual meeting in April 2024[3] ABOYA-119 (ATRN-119, ATR Inhibitor) Outlines the ABOYA-119 Phase 1/2a clinical trial for ATRN-119, an ATR inhibitor, detailing dose cohorts and protocol amendments - ATRN-119 is a potent and highly selective first-in-class macrocyclic ATR inhibitor, designed for patients with DDR-related gene mutations[4] - The ABOYA-119 Phase 1/2a clinical trial is ongoing as monotherapy in advanced solid tumors with DDR-related gene mutations, with five dose cohorts completed[4] - Aprea plans to amend the study protocol to add a group for twice-daily ATRN-119 administration and investigate food effect on drug absorption[4] - The ABOYA-119 Phase 1 readout is anticipated in H1 2025[4] - An update on the ongoing trial was featured in a poster at the AACR Annual Meeting in April[4] Corporate Developments Aprea strengthened its leadership with the appointment of Nadeem Q. Mirza as Chief Medical Officer, effective May 1, 2024 - Nadeem Q. Mirza, M.D., M.P.H. was appointed as Chief Medical Officer (CMO), effective May 1, 2024, to lead the Company's clinical pipeline development[5] Financial Results Aprea presents its financial performance, including balance sheet and statements of operations, detailing key changes Balance Sheet Overview Aprea's cash and cash equivalents increased to $28.7 million by June 30, 2024, extending cash runway into Q4 2025, with decreased liabilities Consolidated Balance Sheet Highlights | Metric | June 30, 2024 ($) | December 31, 2023 ($) | Change ($) | Change (%) | | :-------------------------- | :------------ | :---------------- | :--------- | :--------- | | Cash and cash equivalents | $28,694,694 | $21,606,820 | $7,087,874 | 32.8% | | Total current assets | $29,559,786 | $22,521,095 | $7,038,691 | 31.3% | | Total assets | $29,964,587 | $22,650,174 | $7,314,413 | 32.3% | | Total current liabilities | $3,094,229 | $4,385,605 | $(1,291,376) | -29.4% | | Total liabilities | $3,094,229 | $4,385,605 | $(1,291,376) | -29.4% | | Total stockholders' equity | $25,559,295 | $16,953,506 | $8,605,789 | 50.7% | - The Company believes its cash and cash equivalents as of June 30, 2024, will be sufficient to meet operating expenses and capital expenditure requirements into Q4 2025[5] Statements of Operations Overview Aprea reported a Q2 2024 operating loss of $3.8 million, driven by increased R&D and G&A expenses, with decreased net loss per share Consolidated Statements of Operations Highlights (Three Months Ended June 30) | Metric | Q2 2024 ($) | Q2 2023 ($) | Change ($) | Change (%) | | :-------------------------- | :------------ | :------------ | :--------- | :--------- | | Grant revenue | $561,574 | $249,688 | $311,886 | 124.9% | | Research and development | $2,557,679 | $2,202,657 | $355,022 | 16.1% | | General and administrative | $1,850,819 | $1,698,712 | $152,107 | 9.0% | | Total operating expenses | $4,408,498 | $3,901,369 | $507,129 | 13.0% | | Loss from operations | $(3,846,924) | $(3,651,681) | $(195,243) | 5.3% | | Net loss | $(3,470,052) | $(3,259,097) | $(210,955) | 6.5% | | Net loss per share (basic) | $(0.58) | $(0.87) | $0.29 | -33.3% | | Weighted-average common shares outstanding | 5,937,291 | 3,731,571 | 2,205,720 | 59.1% | - Research and development expenses increased by approximately $0.35 million, primarily due to the initiation of the ACESOT-1051 Phase 1 dose-escalation study in Q2 2024[6] - General and administrative expenses increased by approximately $0.15 million, primarily due to increased personnel costs, including severance expense[7] Company Information Overview of Aprea Therapeutics, its forward-looking statements, and contact information for investors and media About Aprea Therapeutics Aprea Therapeutics is a clinical-stage biopharmaceutical company focused on precision oncology, with lead programs ATRN-119 and APR-1051 - Aprea Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on precision oncology through synthetic lethality[8] - The Company's lead programs are ATRN-119, a clinical-stage small molecule ATR inhibitor, and APR-1051, an oral, small-molecule WEE1 inhibitor that recently entered the clinic[8] Forward-Looking Statements Standard disclaimer on forward-looking statements, cautioning about inherent risks and uncertainties, with no obligation to update unless legally required - The press release contains "forward-looking statements" regarding study analyses, clinical trials, regulatory submissions, and projected cash position, based on current beliefs and expectations but involving risks and uncertainties[9] - These statements are subject to risks including the success, timing, and cost of ongoing and anticipated clinical trials, and readers are cautioned not to place undue reliance on them[10] - The Company undertakes no obligation to update such forward-looking statements for any reason, except as required by law[10] Investor and Media Contacts Contact information for investor relations and media inquiries is provided for external communication - Investor contact: Mike Moyer at LifeSci Advisors (mmoyer@lifesciadvisors.com)[11] - Media contact: Ignacio Guerrero-Ros, Ph.D., or David Schull at Russo Partners, LLC (Ignacio.guerrero-ros@russopartnersllc.com, David.schull@russopartnersllc.com)[11]