Core Insights - Aptose Biosciences Inc. reported promising clinical results for its tuspetinib-based triple drug therapy for newly diagnosed acute myeloid leukemia (AML), demonstrating a complete response (CR) rate of 100% at higher dose levels [2][3] - The company announced a net loss of $5.1 million for Q3 2025, a decrease from $7.0 million in Q3 2024, indicating improved financial performance [8][12] - The ongoing TUSCANY trial data presented at the European School of Haematology highlighted the safety and efficacy of tuspetinib in combination with venetoclax and azacitidine [3][5] Clinical Development - Tuspetinib in combination with VEN+AZA has shown high activity and tolerability, with 100% CR/CRh responses in patients at 80 mg and 120 mg dose levels, exceeding the expected 66% response rate from VEN+AZA alone [2][3] - The TUSCANY trial data supports the use of tuspetinib across various AML populations, including those with adverse mutations [3][5] - The company is now dosing patients at the 160 mg level of tuspetinib and anticipates further updates at the upcoming ASH meeting [2][3] Financial Performance - For the three months ended September 30, 2025, total operating expenses were $4.9 million, down from $7.0 million in the same period in 2024 [8][12] - Research and development expenses decreased to $2.2 million for Q3 2025 from $4.7 million in Q3 2024, primarily due to reduced activity in the APTIVATE clinical trial [12][15] - The net loss for the nine months ended September 30, 2025, was $17.7 million, a decrease from $23.8 million in the same period in 2024 [8][12] Corporate Updates - The company’s abstract on the TUSCANY study has been accepted for poster presentation at the 67th American Society of Hematology (ASH) Annual Meeting scheduled for December 6-9, 2025 [3][4] - As of September 30, 2025, the company had cash and cash equivalents of $1.6 million, indicating a need for financing to support ongoing operations [10][14] - The company has discontinued further development of APTO-253, focusing resources on tuspetinib and luxeptinib [15][18]

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]

APTOSE BIOSCIENCES INC. Table of Contents As filed with the Securities and Exchange Commission on December 29, 2023 Registration No. 333-275870 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO.2 To FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Aptose Biosciences U.S. Inc. Unit 120, 12770 High Bluff Drive San Diego, California 92130 (858) 926-2730 (Name, address, including zip code, and telephone number, including area code, of agent for service) COPIES ...