Core Insights - Aptose Biosciences is advancing its lead investigational drug tuspetinib in combination with venetoclax and azacitidine for the frontline treatment of newly diagnosed acute myeloid leukemia (AML) [2][3] - The TUSCANY Phase 1/2 trial is showing promising results, with complete remissions achieved in difficult-to-treat AML patients [3] - Financial results for the year ended December 31, 2024, indicate a significant reduction in net loss compared to the previous year [10] Clinical Development - The TUSCANY trial aims to create an improved frontline therapy for newly diagnosed AML patients, demonstrating activity across diverse AML populations [3] - The triplet therapy has achieved complete remissions in TP53-mutated and FLT3-wildtype AML patients, with no significant safety concerns reported [3] - The Cohort Safety Review Committee approved an increase in the dose of tuspetinib from 40 mg to 80 mg based on early results [3] Financial Overview - Total operating expenses for the year ended December 31, 2024, were $26.3 million, a decrease from $52.4 million in 2023 [8] - Research and development expenses decreased to $15.1 million in 2024 from $36.8 million in 2023, primarily due to reduced activity in clinical trials [13][19] - The net loss for 2024 was $25.4 million, down from $51.2 million in 2023, reflecting improved financial management [10] Corporate Activities - Aptose completed several financings totaling approximately $37 million in 2024, including a $10 million loan from Hanmi Pharmaceutical [3] - A Debt Conversion Agreement was executed with Hanmi, converting $1.5 million of debt into equity [3] - A Cooperative Research and Development Agreement (CRADA) was signed with the National Cancer Institute to collaborate on the clinical development of tuspetinib [3] Compliance and Market Position - Aptose has regained compliance with Nasdaq's minimum bid price requirement, with the closing bid price of its common shares exceeding $1.00 for ten consecutive business days [4] - The company is currently operating under an exception regarding the shareholders' equity requirement, providing additional time to regain compliance [4]

Core Insights - Aptose Biosciences Inc. has regained compliance with Nasdaq's minimum bid price requirement, with the closing bid price of its common shares being $1.00 or greater for ten consecutive business days [2] - The company is still not in compliance with the $2.5 million shareholders equity requirement but is operating under an exception granted by the Hearing Panel, allowing additional time to regain compliance [2] - Aptose is focused on developing precision oncology therapies, particularly for hematology, with its lead compound tuspetinib (TUS) being developed as a frontline triplet therapy for newly diagnosed acute myeloid leukemia (AML) [3] Company Overview - Aptose Biosciences is a clinical-stage biotechnology company dedicated to developing precision medicines for unmet medical needs in oncology [3] - The company's pipeline includes small molecule cancer therapeutics aimed at providing single-agent efficacy and enhancing the effectiveness of other anti-cancer therapies without overlapping toxicities [3] - Tuspetinib (TUS) is an oral kinase inhibitor that has shown activity as both a monotherapy and in combination therapy for patients with relapsed or refractory AML [3]

Core Insights - Aptose Biosciences Inc. announced the approval to escalate the dosage of tuspetinib from 40 mg to 80 mg in the TUSCANY trial based on favorable data from the initial four patients [1][2] - The TUS+VEN+AZA triplet is being developed as a frontline therapy for newly diagnosed acute myeloid leukemia (AML) patients who cannot receive induction chemotherapy [2][3] - No significant safety concerns or dose-limiting toxicities have been reported in the trial, with all four subjects in the 40 mg cohort remaining in the study [2][4] Trial Details - The TUSCANY trial is enrolling multiple U.S. sites, with an expected total of 18-24 patients by mid-late 2025 [3] - Three patients with wildtype FLT3 completed Cycle 1 without dose-limiting toxicities, with two achieving complete remissions [3][4] - Pharmacokinetic analyses indicate that plasma levels of tuspetinib are unaffected by the addition of azacitidine [4] Market Reaction - Following the announcement, Aptose Biosciences Inc. stock increased by 31.50%, reaching $0.20 [4]

Core Viewpoint - Aptose Biosciences is advancing its clinical-stage drug tuspetinib (TUS) in a Phase 1/2 trial called TUSCANY, focusing on a triplet therapy for newly diagnosed acute myeloid leukemia (AML) patients who cannot receive induction chemotherapy, with recent data showing promising safety and efficacy results [1][3][6]. Group 1: Trial Progress and Results - The Cohort Safety Review Committee (CSRC) has approved escalating the dose of TUS from 40 mg to 80 mg based on favorable data from the initial four patients in the trial [1][2]. - No significant safety concerns or dose-limiting toxicities (DLTs) have been reported, with all four subjects in the 40 mg cohort remaining on study [2][6]. - The triplet therapy has shown complete responses (CRs) in difficult-to-treat AML patients, including those with TP53 mutations and FLT3-wildtype [6][7]. Group 2: Study Design and Objectives - The TUSCANY trial aims to test various doses of TUS in combination with standard doses of azacitidine (AZA) and venetoclax (VEN) for AML patients ineligible for induction chemotherapy [5][6]. - The trial is designed to create an improved frontline therapy that is active across diverse AML populations, durable, and well tolerated [4][5]. - Enrollment is ongoing, with 18-24 patients expected to be enrolled by mid-late 2025 [5][6]. Group 3: Drug Characteristics and Mechanism - Tuspetinib (TUS) is a convenient, once-daily oral agent administered in 28-day cycles, starting at 40 mg [5][6]. - Pharmacokinetic analyses indicate that TUS plasma levels are unaffected by the addition of AZA, ensuring predictability and avoiding dose alterations due to interactions [12]. - The triplet therapy is being developed to address unmet medical needs in oncology, particularly in hematology [9].

Core Viewpoint - Aptose Biosciences Inc. has announced a plan to consolidate its outstanding common shares on a 1-for-30 basis to comply with Nasdaq's minimum bid price requirement and to attract a broader range of investors [1][2]. Group 1: Share Consolidation Details - The company currently has 64,301,183 common shares outstanding, which will be reduced to approximately 2,143,372 common shares post-consolidation [2]. - The reverse share split is subject to approval by the Toronto Stock Exchange and is expected to take effect on February 26, 2025 [2]. - No fractional common shares will be issued; any resulting fractions will be canceled without consideration [2]. Group 2: Shareholder Instructions - Registered shareholders will receive a Letter of Transmittal to facilitate the exchange of pre-reverse split common shares for post-reverse split shares [3]. - Shareholders holding shares through brokers will not need to complete a Letter of Transmittal [3]. Group 3: Impact on Securities - The exercise or conversion price and the number of common shares under outstanding warrants, convertible notes, and stock options will be proportionately adjusted to reflect the reverse share split [4]. Group 4: Company Overview - Aptose Biosciences is focused on developing precision medicines for oncology, particularly in hematology, with its lead product being the oral kinase inhibitor tuspetinib (TUS) [5]. - Tuspetinib is being developed as a frontline triplet therapy for newly diagnosed acute myeloid leukemia (AML) [5].

Core Viewpoint - Aptose Biosciences Inc. has entered into a common share purchase agreement with an institutional investor to raise capital for its clinical-stage oncology developments, particularly focusing on its lead drug tuspetinib for treating acute myeloid leukemia (AML) [1][5]. Group 1: Financing Agreements - The Committed Equity Facility agreement allows Aptose to sell and issue up to $25 million of its common shares over 24 months, subject to certain conditions and regulatory limitations [2]. - Aptose has also established a sales agreement for "at-the-market" (ATM) distributions on Nasdaq, with an aggregate offering price of up to $1 million [3]. Group 2: Company Overview - Aptose is a clinical-stage biotechnology company focused on developing precision medicines for unmet medical needs in oncology, with an emphasis on hematology [5]. - The company's lead product, tuspetinib (TUS), is being developed as a frontline triplet therapy for newly diagnosed AML and has shown efficacy as both a monotherapy and in combination therapy for relapsed or refractory AML [5].

Core Insights - The TUS+VEN+AZA triplet therapy has shown promising early results in achieving complete remission in newly diagnosed acute myeloid leukemia (AML) patients, particularly those with TP53 mutations [1][3] - The therapy demonstrates a favorable safety profile, with no need for dose adjustments of venetoclax (VEN) and azacitidine (AZA) [1][3] - The TUSCANY trial aims to establish this triplet as a frontline treatment for diverse AML populations, including those traditionally difficult to treat [4][5] Company Overview - Aptose Biosciences Inc. is a clinical-stage biotechnology company focused on developing precision medicines for oncology, with an emphasis on hematology [7] - The company's lead product, tuspetinib (TUS), is being evaluated as a frontline triplet therapy for newly diagnosed AML patients [7] Clinical Trial Details - The TUSCANY Phase 1/2 trial is designed to test various doses of TUS in combination with standard doses of AZA and VEN for AML patients ineligible for induction chemotherapy [5][6] - Initial data from the trial indicates that four newly diagnosed AML patients have received the lowest dose of TUS (40 mg), with two achieving complete remissions by the end of Cycle 1 [5][6] - Pharmacokinetic analyses show that TUS levels remain stable and unaffected by the addition of AZA, indicating predictable dosing without the need for adjustments [5]

Core Insights - The TUS+VEN+AZA triplet therapy has shown promising early results in achieving complete remission in newly diagnosed acute myeloid leukemia (AML) patients, particularly those with TP53 mutations [1][3][4] - The therapy demonstrates a favorable safety profile, with no need for dose adjustments of venetoclax (VEN) and azacitidine (AZA) during treatment [1][3][6] - The TUSCANY trial aims to establish this triplet as a frontline therapy for diverse AML populations, including those traditionally difficult to treat [4][5][8] Company Overview - Aptose Biosciences is a clinical-stage biotechnology company focused on developing precision medicines for oncology, particularly in hematology [8] - The company's lead product, tuspetinib (TUS), is being evaluated as a frontline triplet therapy for newly diagnosed AML patients [8] Trial Details - The TUSCANY Phase 1/2 trial is designed to test various doses of TUS in combination with standard doses of AZA and VEN for AML patients ineligible for induction chemotherapy [5] - The initial cohort received a starting dose of 40 mg of TUS, with plans for dose escalations based on safety reviews [5] - Enrollment is ongoing, with an expected 18-24 patients by mid to late 2025 [5] Early Results - Four newly diagnosed AML patients have been treated with the 40 mg dose of TUS, with three patients achieving complete remissions by the end of Cycle 1 [6] - Notably, a patient with biallelic TP53 mutations achieved complete remission, highlighting the potential of the therapy in challenging cases [6] - Pharmacokinetic analyses indicate that TUS levels remain stable and unaffected by the addition of AZA, suggesting predictability in dosing [6]

Core Viewpoint - Aptose Biosciences has initiated dosing for the first patients in the TUSCANY Phase 1/2 study, evaluating the triplet therapy of tuspetinib (TUS), venetoclax (VEN), and azacitidine (AZA) for newly diagnosed acute myeloid leukemia (AML) patients [1][2][3] Group 1: Study Details - The TUSCANY Phase 1/2 trial aims to establish an improved frontline therapy for newly diagnosed AML patients, focusing on safety, durability, and broad activity across diverse AML populations [2][4] - The trial will test various doses and schedules of TUS in combination with standard doses of azacitidine and venetoclax, with TUS starting at 40mg once daily in 28-day cycles [4] - Enrollment is expected to include 18-24 patients by mid to late 2025 across multiple U.S. sites [4] Group 2: Drug Efficacy and Safety - Previous APTIVATE trials indicated that TUS as a single agent and in combination with VEN showed favorable safety and broad activity in relapsed or refractory AML populations, including those with adverse mutations [2][3] - The triplet therapy is anticipated to deliver high response rates and longer survival for newly diagnosed AML patients while minimizing toxicities associated with other treatments [3] Group 3: Company Overview - Aptose Biosciences is a clinical-stage biotechnology company focused on developing precision medicines for oncology, particularly in hematology [6] - The lead clinical-stage oral kinase inhibitor, tuspetinib, has shown promise as both a monotherapy and in combination therapy for AML [6]

SAN DIEGO and TORONTO, Dec. 19, 2024 (GLOBE NEWSWIRE) -- Aptose Biosciences Inc. (“Aptose” or the “Company”) (NASDAQ: APTO, TSX: APS), a clinical-stage precision oncology company developing highly differentiated targeted agents to treat hematologic malignancies, today announced that the Nasdaq Hearings Panel (“Panel”) has granted the Company’s request for an extension to evidence compliance with all applicable criteria for continued listing on The Nasdaq Stock Market. On or before March 31, 2025, the Compan ...