Core Viewpoint - Aptose Biosciences Inc. is advancing its clinical-stage precision oncology efforts with a focus on a tuspetinib (TUS)-based triple drug therapy for newly diagnosed acute myeloid leukemia (AML), following shareholder approval for a significant acquisition by Hanmi Pharmaceutical [1][2][5]. Corporate Update - Shareholders approved the transition of Aptose from the Canada Business Corporations Act to the Business Corporations Act (Alberta) and the acquisition plan by Hanmi Pharmaceutical, which will acquire all outstanding common shares not owned by Hanmi [3]. - Hanmi has provided over US$41 million in financial support to Aptose over the past two years, facilitating the development of the TUS+VEN+AZA therapy [3][5]. - Under the acquisition terms, Aptose shareholders will receive C$2.41 per common share, representing a 28% premium over the 30-day volume-weighted average price (VWAP) of C$1.88 [3]. Voting Results - A total of 1,164,030 common shares were voted at the special meeting, with 92.42% voting in favor of the continuance resolution and 91.48% in favor of the arrangement resolution [4]. - Among shares voted by non-Hanmi affiliates, 84.87% supported the arrangement resolution [4]. Clinical Data Highlights - The TUS+VEN+AZA triplet therapy has shown promising safety and efficacy in newly diagnosed AML patients, achieving high rates of minimal residual disease (MRD)-negative remissions across diverse mutations [5][8]. - At the 160 mg dose level, early findings indicate patients achieving MRD-negativity and formal responses within the first few weeks of treatment [9]. Financial Results - For the year ended December 31, 2025, Aptose reported total operating expenses of $24.7 million, a decrease from $26.3 million in 2024 [12]. - The net loss for 2025 was $25.5 million, slightly higher than the $25.4 million loss in 2024 [12]. - Research and development expenses decreased to $11.3 million in 2025 from $15.1 million in 2024, primarily due to reduced activities in the APTIVATE clinical trial [17][19]. Balance Sheet Overview - As of December 31, 2025, Aptose had cash and cash equivalents of $4.1 million, down from $6.7 million in 2024 [14]. - The company reported a working capital deficit of $2.86 million and total assets of $10 million [14].

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 ...