Aptose Biosciences(APTO) - 2025 Q2 - Quarterly Results

Aptose Reports Second Quarter 2025 Results Company Overview and Recent Developments Aptose reported Q2 2025 results, detailing TUSCANY triplet trial progress, tuspetinib dose escalation, a Hanmi loan, and OTCQB upgrade Introduction and CEO Commentary Aptose reported Q2 2025 results, with CEO highlighting TUSCANY trial progress and tuspetinib's safety and activity in AML - Aptose Biosciences, a clinical-stage precision oncology company, announced Q2 2025 financial results and a corporate update. The company is developing tuspetinib (TUS)-based triple drug frontline therapy for newly diagnosed acute myeloid leukemia (AML)[2] - CEO Dr. William G. Rice noted the TUSCANY triplet trial's good progress, observing exciting safety and activity with TUS added to VEN+AZA standard treatment for difficult-to-treat AML mutations[3] Key Corporate Highlights Tuspetinib showed excellent safety and CRs in TUSCANY, leading to 160 mg dose escalation; Hanmi loan secured, and OTCQB upgrade Tuspetinib (TUS) Clinical Trial Updates Tuspetinib demonstrated excellent safety and complete responses in TUSCANY at 120 mg, leading to 160 mg dose escalation, with promising EHA 2025 data - Tuspetinib continues to demonstrate excellent safety and complete responses (CRs) in the TUSCANY clinical trial at the 120 mg dose[5][6] - The Cohort Safety Review Committee (CSRC) recommended tuspetinib dose escalation to 160 mg[5][6] - Data from the first two cohorts (40 mg and 80 mg TUS+VEN+AZA) showed promising clinical safety and antileukemic activity, presented at EHA 2025, with multiple CRs (3 of 4 at 40mg, 3 of 3 at 80mg) and MRD-negative responses across diverse genetic populations[6] - Aptose's abstract on the TUSCANY study was accepted for a poster presentation at the ESH 7th International Conference in October 2025[6] Corporate and Financial Milestones Aptose secured a loan agreement with Hanmi Pharmaceutical for up to US$8.5 million and upgraded its trading to the OTCQB Market - Aptose entered an uncommitted loan agreement with Hanmi Pharmaceutical Co. Ltd. for up to US$8.5 million to fund tuspetinib clinical development[8] - To date, Aptose has received an aggregate of US$5.6 million under the loan agreement[8] - On July 1, Aptose upgraded its listing to the OTCQB Market under the ticker symbol "APTOF," while maintaining its TSX listing[8] - Aptose's Board of Directors approved the selection of Ernst & Young LLP ("EY") as the Company's new independent auditor, with a shareholder meeting reconvened for August 22, 2025, to vote on the appointment[8] Completed and Planned Value-Creating Milestones Aptose outlined 2025 milestones, including reporting maturing TUS+VEN+AZA triplet study data and preparing for Phase 2/3 pivotal trials - 2025 1H Milestones: * Reported maturing data from TUS+VEN+AZA triplet study at EHA[7][8][9] * Reported safety and efficacy with 40mg, 80mg, and 120mg TUS+VEN+AZA[7][8][9] * CSRC review of data and decision to dose escalate to 160 mg TUS+VEN+AZA[7][8][9] - 2025 2H Planned Milestones: * Report evolving data from 120 mg TUS+VEN+AZA triplet[7][9] * Report response rate and durability of TUS+VEN+AZA triplet[7][9] * Select TUS dose for TUS+VEN+HMA triplet Ph 2/3 PIVOTAL trials[7][9] * Prepare for initiation of Ph 2/3 PIVOTAL program[7][9] * Report maturing data from TUS+VEN+AZA triplet study at ASH[7][9] Financial Results of Operations Aptose reported a decreased net loss for Q2 and H1 2025, driven by reduced R&D expenses, but maintains a low cash position Statements of Operations Data For Q2 2025, Aptose's net loss decreased to $7.0 million from $7.3 million in Q2 2024, with H1 2025 net loss decreasing to $12.6 million from $16.9 million | Metric (in thousands) | Three months ended June 30, 2025 | Three months ended June 30, 2024 | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :-------------------- | :------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | | Research and development | $3,298 | $4,413 | $5,662 | $10,858 | | General and administrative | $3,623 | $2,932 | $6,720 | $6,247 | | Operating expenses | $6,921 | $7,345 | $12,382 | $17,105 | | Other (loss) income, net | $(122) | $93 | $(204) | $213 | | Net loss | $(7,043) | $(7,252) | $(12,586) | $(16,892) | | Net loss per share, basic and diluted | $(2.76) | $(12.99) | $(5.38) | $(33.91) | - Net loss for Q2 2025 decreased by $0.2 million to $7.0 million (from $7.3 million in Q2 2024)[11] - Net loss for the six months ended June 30, 2025, decreased by $4.3 million to $12.6 million (from $16.9 million in the comparable period of 2024)[11] Balance Sheet Data As of June 30, 2025, Aptose reported $1.3 million in cash, a significant decrease from December 31, 2024, alongside negative working capital and growing deficits | Metric (in thousands) | June 30, 2025 | December 31, 2024 | | :-------------------- | :------------ | :---------------- | | Cash, cash equivalents and restricted cash equivalents | $1,298 | $6,707 | | Working capital | $(5,729) | $5,053 | | Total assets | $5,591 | $10,127 | | Long-term liabilities | $10,962 | $10,193 | | Accumulated deficit | $(553,553) | $(540,967) | | Shareholders' deficit | $(14,371) | $(4,543) | Research and Development Expenses Analysis R&D expenses significantly decreased by $1.1 million (QoQ) and $5.2 million (YoY) for Q2 and H1 2025, primarily due to reduced tuspetinib program costs and lower personnel expenses | R&D Component (in thousands) | Three months ended June 30, 2025 | Three months ended June 30, 2024 | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :--------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | | Program costs – Tuspetinib | $2,233 | $2,666 | $3,712 | $6,589 | | Program costs – Luxeptinib | $100 | $304 | $198 | $512 | | Program costs – APTO-253 | $- | $(9) | $- | $13 | | Personnel related expenses | $952 | $1,379 | $1,598 | $3,333 | | Stock-based compensation | $13 | $70 | $154 | $398 | | Depreciation of equipment | $- | $3 | $- | $13 | | Total R&D Expenses | $3,298 | $4,413