Aptose Reports Second Quarter 2025 Results

Executive Summary

• Aptose Biosciences reported financial results for Q2 2025, showing a net loss of $7.0 million (down from $7.3 million in Q2 2024) and cash on hand of $1.3 million as of June 30, 2025.
• The TUSCANY Phase 1/2 clinical trial for tuspetinib in AML demonstrated excellent safety and complete responses at the 120 mg dose, prompting the Cohort Safety Review Committee (CSRC) to recommend dose escalation to 160 mg, which is now open for enrollment.
• The Company entered into an uncommitted loan facility with Hanmi Pharmaceutical for up to US$8.5 million to advance tuspetinib development; $5.6 million has been drawn to date.

Key Details

• Financial Results (Q2 2025):
  • Net loss: $7.0 million (vs. $7.3 million in Q2 2024).
  • Net loss per share (basic/diluted): $(2.76) (vs. $(12.99) in Q2 2024).
  • Research and Development (R&D) expenses: $3.3 million (vs. $4.4 million in Q2 2024).
  • General and Administrative (G&A) expenses: $3.6 million (vs. $2.9 million in Q2 2024).
  • Total Operating expenses: $6.9 million (vs. $7.3 million in Q2 2024).
• Financial Results (Six Months Ended June 30, 2025):
  • Net loss: $12.6 million (vs. $16.9 million in 2024).
  • R&D expenses: $5.7 million (vs. $10.9 million in 2024).
  • G&A expenses: $6.7 million (vs. $6.2 million in 2024).
• Balance Sheet Data (June 30, 2025):
  • Cash, cash equivalents, and restricted cash: $1.3 million.
  • Total assets: $5.6 million.
  • Total liabilities: $11.0 million (Long-term liabilities: $11.0 million).
  • Shareholders’ deficit: $(14.4) million.
  • Shares outstanding: 2,552,429 common shares.
  • Options issuable: 38,211.
  • Warrants issuable: 1,267,585.
• Clinical Trial Updates (TUSCANY Phase 1/2):
  • 120 mg Cohort: Tuspetinib demonstrated excellent safety and complete responses (CRs). No Dose-Limiting Toxicities (DLTs) were observed. Multiple CRs were achieved, including MRD-negative responses across diverse genetic populations (including biallelic TP53 mutations and complex karyotypes). No prolonged myelosuppression in Cycle 1; no treatment-related deaths. 9 of 10 enrolled subjects remained on study.
  • Dose Escalation: CSRC recommended escalating to 160 mg. The 160 mg cohort is now open for enrollment.
  • Previous Cohorts: 40 mg dose showed 3 of 4 CRs (MRD-negative); 80 mg dose showed 3 of 3 CR/CRi.
  • Drug Interactions: Tuspetinib PK properties not significantly altered by Venetoclax (VEN), Azacitidine (AZA), antifungals, or food.
• Financing:
  • Loan Agreement with Hanmi Pharmaceutical Co. Ltd. for up to US$8.5 million.
  • Uncommitted facility administered through multiple advances.
  • Aggregate amount received to date: US$5.6 million.
• Corporate Actions:
  • Selected Ernst & Young LLP as new independent auditor.
  • Reconvened Shareholder Meeting scheduled for August 22, 2025, to vote on the appointment of EY.
  • Trading upgraded to OTCQB Market under ticker "APTOF" (in addition to TSX: APS).
• Upcoming Milestones:
  • ESH 7th International Conference (Oct 16-18, 2025): Poster presentation accepted.
  • ASH 2025: Report response rate/durability; select dose for Phase 2/3 pivotal trials.

Notable Quotes

• “During the second quarter, the TUSCANY triplet trial continued to progress well. Our investigators are eager to improve outcomes for patients with mutations that are especially difficult to treat in AML, and we continue to observe exciting safety and activity with the addition of TUS to the VEN+AZA standard treatment,” said William G. Rice, Ph.D., Chairman, President and Chief Executive Officer of Aptose.