Core Viewpoint - Aptose Biosciences Inc. presented promising clinical data for its lead compound tuspetinib (TUS) in combination with venetoclax (VEN) and azacitidine (AZA) at the 67th American Society of Hematology (ASH) Annual Meeting, indicating its potential as a treatment for acute myeloid leukemia (AML) [1][2][3] Group 1: Clinical Data and Efficacy - The TUSCANY trial showed a 100% clinical response rate (CR/CRh) at the higher doses of 80 mg and 120 mg of TUS [5][6] - The triplet therapy demonstrated high rates of efficacy and minimal residual disease (MRD)-negative remissions across diverse AML mutations, including FLT3 wildtype and adverse genetic subgroups [5][6] - Preliminary findings at the 160 mg dose level indicate early responses and blast clearance in patients [6][7] Group 2: Safety Profile - TUS-based therapies exhibited notable safety, with no dose-limiting toxicities (DLTs) reported across all evaluable TUS dose levels [6][7] - No drug-related deaths, differentiation syndrome, QTc prolongation, or CPK elevation were observed, and febrile neutropenia was reported in only 16.7% of subjects [6][7] - 8 out of 10 evaluable subjects achieved red cell and platelet transfusion independence for over 8 weeks after their best response [6][7] Group 3: Mechanism and Development - Tuspetinib is an oral agent that targets multiple kinases associated with AML, including SYK, FLT3, and JAK1/2, while minimizing typical toxicity concerns [7][8] - The ongoing TUSCANY Phase 1/2 study aims to evaluate various doses and schedules of TUS in combination with standard therapies for newly diagnosed AML patients ineligible for induction chemotherapy [7][8]

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. is advancing its clinical-stage precision oncology drug, tuspetinib, for treating newly diagnosed acute myeloid leukemia (AML) [1][4] - The company has received an additional US$1.5 million from Hanmi Pharmaceutical as part of an US$8.5 million loan facility to support the development of tuspetinib [3] - Shareholders have appointed Ernst & Young LLP as the new independent auditor, which is expected to enhance the company's transparency and growth in the life sciences sector [2] Financial Updates - The total amount received by Aptose under the loan agreement with Hanmi to date is US$7.1 million, indicating significant financial backing for ongoing clinical development [3] - The additional advance of US$1.5 million is part of a structured financial strategy to ensure continued progress in drug development [3] Corporate Governance - The appointment of Ernst & Young LLP as the independent auditor reflects the company's commitment to maintaining high standards of financial oversight and transparency [2] - The decision was made during a reconvened annual and special meeting of shareholders, highlighting active shareholder engagement in corporate governance [1][2]

Core Insights - Aptose Biosciences Inc. has entered into a loan agreement with Hanmi Pharmaceutical for up to US$8.5 million to support the clinical development of tuspetinib, a drug aimed at treating newly diagnosed acute myeloid leukemia (AML) [1][2] Group 1: Loan Agreement Details - The loan agreement is classified as a "related-party transaction" under Canadian securities laws, with Aptose relying on the "financial hardship" exemption from formal valuation and minority shareholder approval requirements [2] - The loan will be administered through multiple advances to facilitate ongoing clinical trials for tuspetinib [1] Group 2: Drug Development and Clinical Trials - Tuspetinib is a once-daily oral agent that targets various kinases associated with AML, showing promising antileukemic activity and safety in early trials [3] - The ongoing TUSCANY triplet Phase 1/2 study is evaluating the combination of tuspetinib with azacitidine and venetoclax in patients with newly diagnosed AML who cannot receive induction chemotherapy [3] - Early data from the first two dose cohorts indicate safety, complete responses (CRs), and minimal residual disease (MRD) negativity across diverse patient mutations [3] Group 3: Company Overview - Aptose Biosciences is focused on developing precision medicines for oncology, particularly in hematology, with a pipeline that includes small molecule cancer therapeutics designed to enhance efficacy without overlapping toxicities [4] - The lead compound, tuspetinib, is being developed as a frontline triplet therapy for newly diagnosed AML patients [4]

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 ...