Core Viewpoint - Aptose Biosciences Inc. announced that KPMG LLP will not stand for re-appointment as the independent registered public accounting firm for the 2025 annual audit, while KPMG will continue to review the company's quarterly interim financial results through the first two fiscal quarters of 2025 [1]. Group 1: Company Announcement - KPMG did not seek the company's consent regarding its decision not to stand for re-appointment, and neither the Board of Directors nor the Audit Committee participated in this decision [2]. - KPMG issued unqualified reports on the company's consolidated financial statements for the fiscal years ended December 31, 2024, and 2023 [3]. - There were no disagreements or reportable events between the company and KPMG during the fiscal years ended December 31, 2024, and 2023, except for a communicated material weakness in internal control over financial reporting related to complex financial instruments [4]. Group 2: Company Overview - Aptose Biosciences is a clinical-stage biotechnology company focused on developing precision medicines for oncology, particularly in hematology [6]. - The company's lead compound, tuspetinib (TUS), is an oral kinase inhibitor being developed as a frontline triplet therapy for newly diagnosed acute myeloid leukemia (AML) [6].

SAN DIEGO and TORONTO, April 23, 2025 (GLOBE NEWSWIRE) -- Aptose Biosciences Inc. ("Aptose" or the "Company") (TSX:APS), a clinical-stage precision oncology company developing a tuspetinib (TUS) based triple drug frontline therapy to treat patients with newly diagnosed acute myeloid leukemia (AML), today announced that the Aptose management team will participate in the 2025 Bloom Burton & Co. Healthcare Investor Conference being held in Toronto, May 5-6, 2025. Dr. William G. Rice, Chairman, President and CE ...

SAN DIEGO and TORONTO, April 23, 2025 (GLOBE NEWSWIRE) -- Aptose Biosciences Inc. (“Aptose” or the “Company”) (TSX: APS), a clinical-stage precision oncology company developing a tuspetinib (TUS) based triple drug frontline therapy to treat patients with newly diagnosed acute myeloid leukemia (AML), today announced that the Aptose management team will participate in the 2025 Bloom Burton & Co. Healthcare Investor Conference being held in Toronto, May 5-6, 2025. Dr. William G. Rice, Chairman, President and C ...

SAN DIEGO and TORONTO, April 01, 2025 (GLOBE NEWSWIRE) -- Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ:APTO, TSX:APS), a clinical-stage precision oncology company developing a tuspetinib (TUS) based triple drug frontline therapy to treat patients with newly diagnosed acute myeloid leukemia (AML), today announced that the Nasdaq Hearings Panel (the "Panel") has determined to delist the common shares of the Company from The Nasdaq Stock Market ("Nasdaq" or the "Exchange"). Under the terms of th ...

Clinical Trials and Drug Development - Aptose is conducting a Phase 1/2 clinical trial for Tuspetinib (TUS) in combination with Venetoclax (VEN) and a hypomethylating agent (HMA) for newly diagnosed acute myeloid leukemia (AML) patients[258]. - In a completed trial, Tuspetinib as a single agent achieved a complete response (CR) rate of 36% among all patients and 50% among those with mutated FLT3[259]. - The TUS+VEN doublet combination maintained a favorable safety profile with no new safety signals and significant clinical responses in heavily pretreated relapsed/refractory AML patients[260]. - The TUS+VEN+HMA triplet therapy is expected to establish a new standard of care for newly diagnosed AML patients, particularly those who are VEN-naïve and FLT3i-naïve[261]. - The myeloMATCH precision medicine trials, launched in May 2024, aim to expedite tailored drug combination treatments for newly diagnosed AML and myelodysplastic syndromes (MDS) patients[266]. - The APTIVATE clinical trial demonstrated that TUS+VEN is active across diverse R/R AML populations, including those with adverse genetic mutations[272]. - At the 66th Annual ASH Meeting, Aptose presented findings supporting the advancement of TUS as a third agent in combination therapies for newly diagnosed AML[269]. - Aptose plans to initiate the TUS+VEN+AZA triplet study with a starting dose of 40 mg of Tuspetinib, escalating to 80 mg based on safety and activity[268]. - The ongoing APTIVATE Phase 1/2 trial has treated over 170 patients with TUS alone or in combination with VEN, showing a favorable safety profile and significant response rates[277]. - The APTIVATE trial aims to identify patient populations sensitive to TUS monotherapy and the TUS+VEN doublet, with brisk enrollment and early signs of antileukemic activity reported[287]. - Tuspetinib targets known VEN resistance mechanisms, potentially re-sensitizing prior-VEN failure patients to treatment[282][283]. Financial Performance and Compliance - Nasdaq notified the company of a deficiency regarding a private placement that violated shareholder approval rules[301]. - The company received a deficiency letter for not meeting the minimum bid price requirement, with a deadline to regain compliance by January 13, 2025[303]. - A reverse stock split of 1-for-30 was approved to regain compliance with Nasdaq listing requirements[305]. - As of December 31, 2024, the Company reported negative shareholders' equity of $4.5 million, compared to negative shareholders' equity of $2.9 million as of December 31, 2023[313]. - The Company has not regained compliance with Nasdaq's minimum equity requirement of $2.5 million as of March 28, 2025[308]. - The Company had cash, cash equivalents, and restricted cash of $6.7 million as of December 31, 2024, down from $9.3 million as of December 31, 2023[311]. - The Company has sufficient liquidity to support operations until April 2025, relying on equity financing and strategic partner payments[309]. - The Company raised approximately $9.7 million from a public offering on January 30, 2024, with cash transaction costs of $1.6 million[323]. - The Company completed a public offering on November 25, 2024, raising gross proceeds of $8.0 million before deducting placement agent fees and other expenses[332]. - The Company plans to raise additional funds through equity financing or other financing activities to meet capital requirements[313]. - The Company submitted a compliance plan to Nasdaq on May 17, 2024, and received an extension until September 30, 2024, to regain compliance[307]. - The company filed a short form base shelf prospectus allowing the distribution of up to $200 million of Common Shares, warrants, or units, effective until October 7, 2025[333]. Research and Development Expenses - Cash used in operating activities decreased from $44.6 million in 2023 to $36.0 million in 2024, a reduction of $8.6 million[336]. - The net loss for the year ended December 31, 2024, was $25.4 million, a decrease of approximately $25.8 million compared to a net loss of $51.2 million in 2023[346]. - Research and development expenses decreased by $21.7 million to $15.1 million in 2024 from $36.8 million in 2023, primarily due to reduced program costs for tuspetinib[350]. - General and administrative expenses decreased to $11.2 million in 2024 from $15.6 million in 2023, a reduction of $4.4 million[352]. - The company expects research and development expenses to be lower in 2025 than in 2024, contingent on successful financing activities[347]. Drug Formulation and Market Potential - The G3 formulation of Luxeptinib (LUX) achieved approximately 10-fold better absorption compared to the original formulation, but development has been paused in favor of prioritizing Tuspetinib[262]. - The G3 formulation of luxeptinib demonstrated an 18-fold improvement in plasma steady-state exposure compared to the original G1 formulation[295]. - Continuous dosing of the 50 mg G3 formulation showed plasma exposure levels equivalent to the 900 mg G1 formulation[296]. - The G3 formulation achieved 2-3 µM steady-state plasma levels at 200 mg BID, with approximately 10-fold better absorption than G1[300]. - The potential market for luxeptinib in R/R CLL patients with FLT3 mutations is estimated at $200 million by 2039[291].

Results to Date Highlight TUS Potential as an Ideal Third Drug to Include in AML Triplet Therapy Aptose Signs Debt Conversion Agreement with Hanmi SAN DIEGO and TORONTO, March 28, 2025 (GLOBE NEWSWIRE) -- Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ: APTO, TSX: APS), a clinical-stage precision oncology company developing a tuspetinib (TUS)-based triple drug frontline therapy to treat patients with newly diagnosed acute myeloid leukemia (AML), today announced financial results for the year end ...

Tuspetinib Triple Drug Frontline Therapy Advancing in TUSCANY Clinical Trial Results to Date Highlight TUS Potential as an Ideal Third Drug to Include in AML Triplet Therapy Aptose Signs Debt Conversion Agreement with Hanmi SAN DIEGO and TORONTO, March 28, 2025 (GLOBE NEWSWIRE) -- Aptose Biosciences Inc. (“Aptose” or the “Company”) (NASDAQ: APTO, TSX: APS), a clinical-stage precision oncology company developing a tuspetinib (TUS)-based triple drug frontline therapy to treat patients with newly diagnosed a ...

SAN DIEGO and TORONTO, March 17, 2025 (GLOBE NEWSWIRE) -- Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ:APTO, TSX:APS), a clinical-stage precision oncology company developing the tuspetinib (TUS)-based triple drug frontline therapy to treat patients with newly diagnosed acute myeloid leukemia (AML), today announced that it received a written notification from the Listing Qualifications Department of The Nasdaq Stock Market, LLC ("Nasdaq") notifying the Company that it is in compliance with Nas ...

On Thursday, Aptose Biosciences Inc. APTO announced that the Cohort Safety Review Committee monitoring Phase 1/2 TUSCANY trial of tuspetinib in combination with standard of care dosing of venetoclax and azacitidine (TUS+VEN+AZA triplet) has approved escalating from 40 mg TUS to 80 mg TUS based on its favorable review of data from the first four patients in the trial.The TUS+VEN+AZA triplet is being developed as a frontline therapy to treat large, mutationally diverse populations of newly diagnosed acute mye ...

TUS+VEN+AZA triplet achieves complete responses (CRs) in difficult-to-treat TP53-mutated/CK AML and FLT3-wildtype AML patients, including a measurable residual disease (MRD) negative remission Dosing of initial 40 mg cohort complete; no prolonged myelosuppression or dose-limiting toxicitiesNo dose reductions to the standard-of-care components of the regimen (AZA/VEN) in first cohortCSRC endorses escalation to 80 mg dosing, enrollment is open SAN DIEGO and TORONTO, Feb. 20, 2025 (GLOBE NEWSWIRE) -- Aptose Bi ...