Tuspetinib Continues to Demonstrate Excellent Safety and Complete Responses in the TUSCANY Clinical Trial of Tuspetinib in AML Triple Drug Frontline Therapy at Increased Dose LevelsPatients are Now Being Treated at 160 mg Dose of Tuspetinib SAN DIEGO and TORONTO, Nov. 13, 2025 (GLOBE NEWSWIRE) -- Aptose Biosciences Inc. (“Aptose” or the “Company”) (TSX: APS and OTC: APTOF), a clinical-stage precision oncology company developing a tuspetinib (TUS)-based triple drug frontline therapy to treat patients with ne ...

Core Insights - Aptose Biosciences Inc. reported financial results for Q2 2025, highlighting progress in the TUSCANY triplet trial for treating newly diagnosed acute myeloid leukemia (AML) with tuspetinib-based therapy [1][2] Financial Performance - The net loss for Q2 2025 was $7.0 million, a decrease from $7.3 million in Q2 2024. For the first half of 2025, the net loss was $12.6 million, down from $16.9 million in the same period of 2024 [11][12] - Research and development expenses for Q2 2025 were $3.3 million, down from $4.4 million in Q2 2024. For the first half of 2025, these expenses totaled $5.7 million, compared to $10.9 million in the first half of 2024 [14][17] Clinical Development - The TUSCANY trial is advancing with promising safety and efficacy results for the tuspetinib (TUS) combination therapy, showing complete responses (CRs) across various genetic backgrounds in AML patients [4][5] - The Cohort Safety Review Committee (CSRC) recommended escalating the tuspetinib dose from 120 mg to 160 mg based on positive safety data [4][5] - Data from the TUSCANY trial was presented at the European Hematology Association (EHA) 2025 Congress, indicating that TUS can be safely combined with standard treatments [5][6] Corporate Developments - Aptose entered a loan agreement with Hanmi Pharmaceutical for up to $8.5 million to support the development of tuspetinib [6][9] - The company has been upgraded to trade on the OTCQB Market, enhancing its visibility among investors [9] - Aptose selected Ernst & Young as its new independent auditor and will hold a reconvened shareholder meeting on August 22, 2025 [9][10] Research and Development Focus - The company is focusing on the development of precision oncology therapies, particularly for hematological malignancies, with tuspetinib as a lead candidate [17][19] - Program costs for tuspetinib were $2.2 million for Q2 2025, down from $2.7 million in Q2 2024, attributed to reduced clinical trial activities [18]

Core Insights - Aptose Biosciences is advancing its TUSCANY clinical trial of tuspetinib in combination with venetoclax and azacitidine for newly diagnosed acute myeloid leukemia (AML), showing promising safety and efficacy data [2][3][4] - The company reported a net loss of $5.5 million for Q1 2025, a decrease from $9.6 million in Q1 2024, indicating improved financial performance [8][14] - Aptose's common shares are now listed on the OTC Markets under the ticker "APTOF," enhancing accessibility for U.S. investors [4] Clinical Trial Progress - The TUSCANY trial has shown that patients receiving both 40 mg and 80 mg doses of tuspetinib achieved complete remissions, with no safety concerns reported [2][3][4] - In the first cohort, three patients on the 40 mg dose achieved complete remissions, while in the second cohort, all three patients on the 80 mg dose also achieved complete remissions [3][4] - The trial aims to create a mutation-agnostic triplet frontline therapy for AML patients, including those without FLT3 mutations [3] Financial Performance - Research and development expenses decreased to $2.3 million in Q1 2025 from $6.4 million in Q1 2024, primarily due to reduced clinical trial activities and lower personnel costs [8][12][15] - The company reported total cash, cash equivalents, and restricted cash of $4.7 million as of March 31, 2025, with expectations to fund operations until the end of May 2025 [14] - The net loss per share for Q1 2025 was $2.61, compared to $22.02 in Q1 2024, reflecting a significant reduction in losses [8] Corporate Developments - Aptose is preparing for upcoming milestones, including reporting maturing data from the TUSCANY trial at the European Hematology Association (EHA) meeting and the American Society of Hematology (ASH) conference [5][6][11] - The company has implemented financing and cost reduction efforts to extend its cash runway, indicating proactive management of financial resources [14]