Aptose Reports Third Quarter 2025 Results

Executive Summary
- Aptose reported Q3 2025 financial results showing a reduced net loss of $5.1 M versus $7.0 M YoY and cash of $1.6 M, highlighting ongoing financing needs.
- The TUSCANY trial demonstrated 90% CR/CRh response rate (9/10 patients) across three dose levels of tuspetinib combined with venetoclax + azacitidine, with 100% responses at the higher 80 mg and 120 mg doses.
- The company secured poster presentations at the European School of Haematology (ESH) conference and will present updated data at the ASH Annual Meeting in December 2025.
Key Details
- Clinical Efficacy:
- Overall CR/CRh rate: 9/10 patients (90%).
- CR/CRh at 80 mg & 120 mg doses: 6/6 patients (100%), exceeding the 66% benchmark for VEN+AZA alone.
- MRD‑negativity achieved in 7/9 responding patients (78%).
- Responses observed across diverse mutational subtypes (FLT3‑ITD, NPM1c, TP53 biallelic, RAS, etc.).
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Two patients have proceeded to hematopoietic stem cell transplant.
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Trial Progress & Milestones:
- Data from 10 patients presented at ESH conference (October 2025).
- Abstract accepted for poster presentation at ASH 67th Annual Meeting (Dec 6‑9, 2025).
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Planned upcoming updates: safety/efficacy data for 120 mg dose (2H 2025) and dose escalation to 160 mg TUS+VEN+AZA.
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Financial Results – Q3 2025 (unaudited):
- Net loss: $5.1 M (down $1.8 M YoY).
- Net loss per share: $(2.01).
- Cash & cash equivalents: $1.637 M (down from $6.707 M year‑end 2024).
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Working capital: –$3.302 M (vs. +$5.053 M prior year).
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Operating Expenses:
- R&D expense Q3 2025: $2.205 M (down from $4.702 M YoY).
- Program costs for tuspetinib: $1.423 M (vs. $4.067 M YoY).
- Program costs for luxeptinib: $0.091 M (vs. –$0.225 M YoY).
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G&A expense Q3 2025: $2.708 M (down from $2.263 M YoY).
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Balance Sheet Highlights:
- Total assets: $6.341 M (down from $10.127 M YoY).
- Long‑term liabilities increased to $18.712 M (from $10.193 M).
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Shares outstanding: 2,552,429 common shares; options exercisable: 37,370; warrants exercisable: 1,267,585.
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Liquidity & Funding:
- Company relies on advances from Hanmi to fund operations and is actively pursuing additional financing and cost‑reduction measures to extend cash runway.
Notable Quotes
“Tuspetinib in combination with VEN+AZA standard treatment has been highly active and so well tolerated… Patients evaluated at the higher dose levels of 80 mg and 120 mg TUS have all (6/6; 100%) achieved CR/CRh responses…” – William G. Rice, Ph.D., Chairman, President & CEO
All forward‑looking statements are subject to risks and uncertainties as described in the company's filings.