Latest news with #Aptose
Yahoo
2 days ago
- Business
- Yahoo
Aptose Reports Early Data Demonstrating Tuspetinib Improves Standard of Care Treatment Across Diverse Populations of Newly Diagnosed AML in Phase 1/2 TUSCANY Trial
Addition of Tuspetinib (TUS) to Venetoclax (VEN) and Azacitidine (AZA) is being developed as safe and mutation agnostic frontline therapy for AML Addition of TUS to VEN+AZA improves response rates; 100% CR/CRh at 80 mg and 120 mg Addition of TUS to VEN+AZA improves MRD-negativity rates; 78% among responders 100% CR/CRh in FLT3 wildtype AML, representing 70% of AML population 100% CR/CRh and MRD-negativity rates in TP53, RAS and FLT3-ITD mutated AML Broad spectrum activity and excellent safety profile continue at 120 mg dose to date SAN DIEGO and TORONTO, Aug. 18, 2025 (GLOBE NEWSWIRE) -- Aptose Biosciences Inc. ('Aptose' or the 'Company') (OTC: APTOF, TSX: APS), a clinical-stage precision oncology company developing the tuspetinib (TUS)-based triple drug frontline therapy to treat patients with newly diagnosed AML, today provided a data update from the Phase 1/2 TUSCANY trial in newly diagnosed AML. The trial was initiated in December 2024, and the growing body of positive data includes the recently completed third cohort of 120 mg TUS in the TUS+VEN+AZA triplet therapy. Data to date from ten (10) patients across all three cohorts, 40 mg, 80 mg or 120 mg TUS dose in TUS+VEN+AZA, support the use of TUS with standard of care treatment across all AML populations, including those carrying mutations that are the most difficult to treat and those with mutated and unmutated (wildtype) FLT3 genes. The TUS+VEN+AZA triplet is being developed as a safe and well-tolerated mutation agnostic frontline therapy to treat large, mutationally diverse populations of newly diagnosed AML patients who are ineligible to receive induction chemotherapy. At the 120 mg TUS dose level in combination with VEN+AZA, as with the prior reported 40 mg and 80 mg TUS dose cohorts, no significant safety concerns or dose limiting toxicities (DLTs) have been observed in the TUSCANY trial, including no prolonged myelosuppression in Cycle 1 of subjects in remission, no reports of drug-related QTc prolongation or differentiation syndrome (DS), and no treatment-related deaths. Nine out of ten dosed patients remain on study across all dose cohorts and enrollment is being advanced to the 160 mg TUS dose level following the Cohort Safety Review Committee (CSRC) meeting. 'We already have data from three different TUS dose levels in the TUSCANY trial, and the data continue to strengthen at higher doses of TUS and over time. We are building a strong case for TUS+VEN+AZA as a triplet frontline therapy of choice to address a broad AML population, including subgroups with the most adverse of mutations,' said William G. Rice, Ph.D., Chairman, President and Chief Executive Officer of Aptose. Data highlights: Comparison of CR/CRh1 Response rates2-5: VEN+AZA2 TUS+VEN+AZA All subjects 65% 90% (9/10) NPM1-mutant 67% 100% (2/2) FLT3-ITD 61% 100% (2/2) TP53-mutant 52% 100% (2/2) Comparison of MRD-negativity6 rates among All Subjects and among CR/CRh Responders3: VEN+AZA2,3 TUS+VEN+AZA Among All Subjects 23.4% 70% (7/10) Among CR/CRh Responders 40.9% 78% (7/9) Comparison of MRD-negativity rates among more difficult-to-treat Patient Subpopulations defined as Lower Benefit (TP53-mutated) and Intermediate Benefit (FLT3-ITD or RAS-mutated) relative to VEN+AZA5: VEN+AZA3,5 TUS+VEN+AZA Intermediate Benefit 27.9% 100% (3/3) Lower Benefit 14.5% 100% (2/2) TUS+VEN+AZA - CR/CRh and MRD-negativity rates among Subjects with Adverse Mutations: TP53, FLT3-ITD, RAS mutations: Achieved CR/CRh and MRD-negativity 100% (5/5) 'As illustrated in the data highlights, the addition of TUS to VEN+AZA appears to boost response rates and MRD-negativity while maintaining favorable safety and tolerability,' said Rafael Bejar, M.D., Ph.D., Chief Medical Officer of Aptose, 'and the 100% CR/CRh and 100% MRD-negativity rates among the five biallelic TP53-mutant, FLT3-ITD, and RAS-mutant AML cases are exciting to see, as this can correlate with longer overall survival. We have observed a trend towards achieving CRs more quickly at the higher dose levels, so we are keen to see the activity as we advance into the 160 mg TUS dose cohort.' Key messages: Addition of TUS to VEN+AZA demonstrates excellent CR/CRh rates 100% CR/CRh among all subjects treated at 80 mg and 120 mg TUS dose levels Appear to be achieving CR earlier with 120 mg TUS than with 40 mg or 80 mg Addition of TUS to VEN+AZA demonstrates excellent MRD-negativity rates MRD-negativity in 7 of 9 (78%) already achieved in patients who responded to therapy Expect patient survival to be extended with continued long-term treatment Excellent safety and well tolerated with no dose-limiting toxicities (No DLT) at completed dose levels Broad-spectrum activity including patients with adverse TP53, RAS and FLT3-ITD mutations No loss of MRD-negativity observed to date, including in one patient with over 7 months of follow up MRD-negativity and remissions continue to mature over time on therapy No relapses reported to date and no treatment related deaths The only non-responder was a patient at the initial TUS dose level (40 mg) that did not achieve TUS exposures previously associated with response Additional data are included in the new Aptose corporate presentation here. TUSCANY: TUS+VEN+AZA Triplet Phase 1/2 Study The tuspetinib-based TUS+VEN+AZA triplet therapy is being advanced in the TUSCANY Phase 1/2 trial with the goal of creating an improved frontline therapy for newly diagnosed AML patients that is active across diverse AML populations, durable, and well tolerated. The TUSCANY triplet Phase 1/2 study, being conducted at 10 leading U.S. clinical sites by elite clinical investigators, is designed to test various doses and schedules of TUS in combination with standard dosing of AZA and VEN for patients with AML who are ineligible to receive induction chemotherapy. A convenient, once daily oral agent, TUS is being administered in 28-day cycles. Multiple U.S. sites are enrolling in the TUSCANY trial with anticipated enrollment of 18-24 patients by late 2025. Data will be released as it becomes available. More information on the TUSCANY Phase 1/2 study can be found on (here). About Aptose Aptose Biosciences is a clinical-stage biotechnology company committed to developing precision medicines addressing unmet medical needs in oncology, with an initial focus on hematology. The Company's lead clinical-stage, oral kinase inhibitor tuspetinib (TUS) has demonstrated activity as a monotherapy and in combination therapy in patients with relapsed or refractory acute myeloid leukemia (AML) and is being developed as a frontline triplet therapy in newly diagnosed AML. For more information, please visit Forward Looking Statements This press release may contain forward-looking statements within the meaning of Canadian and U.S. securities laws, including, but not limited to, statements relating to the therapeutic potential and safety profile of tuspetinib (including the triplet therapy) and its clinical development, the anticipated enrollment rate in the TUSCANY trial and the timing thereof, as well as statements relating to the Company's plans, objectives, expectations and intentions and other statements including words such as 'continue', 'expect', 'intend', 'will', 'should', 'would', 'may', and other similar expressions. Such statements reflect our current views with respect to future events and are subject to risks and uncertainties and are necessarily based upon a number of estimates and assumptions that, while considered reasonable by us are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies. Many factors could cause our actual results, performance or achievements to be materially different from any future results, performance or achievements described in this press release. Such factors could include, among others: our ability to obtain the capital required for research and operations and to continue as a going concern; the inherent risks in early stage drug development including demonstrating efficacy; development time/cost and the regulatory approval process; the progress of our clinical trials; our ability to find and enter into agreements with potential partners; our ability to attract and retain key personnel; changing market conditions; inability of new manufacturers to produce acceptable batches of GMP in sufficient quantities; unexpected manufacturing defects; and other risks detailed from time-to-time in our ongoing quarterly filings, annual information forms, annual reports and annual filings with Canadian securities regulators and the United States Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should the assumptions set out in the section entitled 'Risk Factors' in our filings with Canadian securities regulators and the United States Securities and Exchange Commission underlying those forward-looking statements prove incorrect, actual results may vary materially from those described herein. These forward-looking statements are made as of the date of this press release and we do not intend, and do not assume any obligation, to update these forward-looking statements, except as required by law. We cannot assure you that such statements will prove to be accurate as actual results and future events could differ materially from those anticipated in such statements. Investors are cautioned that forward-looking statements are not guarantees of future performance and accordingly investors are cautioned not to put undue reliance on forward-looking statements due to the inherent uncertainty therein. For further information, please contact: Aptose Biosciences PietropaoloCorporate Communications & Investor Relations201-923-2049spietropaolo@ 1 Complete Response / Complete Response with Partial Hematological Recovery2 DiNardo et al. New England Journal of Medicine, August 2020; Volume 383(7):617-629.3 Pratz et al. Journal of Clinical Oncology, December 2021; Volume 40 (8):855-865.4 Othman et. al. Blood Neoplasia; September 2024; Volume 1 (3):1-11.5 Döhner et. al. Blood. 2024 November 21;144(21):2211-2222.6 MRD-negative indicates that the amount of Measurable Residual Disease, as assessed by central flow cytometry, is such that the proportion of leukemic cells in a bone marrow sample falls below <0.1%Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Hamilton Spectator
01-08-2025
- Business
- Hamilton Spectator
Aptose Selects Ernst & Young Global Limited as its New Independent Auditor and Calls Reconvened Meeting of its Shareholders
SAN DIEGO and TORONTO, Aug. 01, 2025 (GLOBE NEWSWIRE) — Aptose Biosciences Inc. ('Aptose' or the 'Company') (TSX: APS; OTC: APTOF; OTCQB: APTOF), 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), announced today that the Company's Board of Directors (the 'Board') has unanimously approved the selection of Ernst & Young LLP ('EY') as the Company's independent registered public accounting firm to serve as the Company's independent auditor. The Company had previously adjourned their Annual and Special Meeting of shareholders held on May 27, 2025 (the 'Original Meeting'), for the purposes of completing its search for a successor independent auditor. EY is a top-ranked global accounting firm that offers a complete spectrum of tax, assurance, and advisory services; they have been selected due to their expertise, capabilities, fit, and understanding of the Company's industry and business. The Company will reconvene its Annual General and Special Meeting of shareholders (the 'Reconvened Meeting') on August 22, 2025 at 10:00 a.m. (Eastern Time) to vote on the appointment of EY and the authorization of the Board to fix EY's remuneration. All interested parties are invited to attend the Reconvened Meeting by using the live webcast link here: . Only registered shareholders and duly appointed proxyholders as of the record date on April 22, 2025, will be entitled to vote and ask questions at the Reconvened Meeting. Unless properly revoked, proxies previously completed, signed, dated and returned in respect of the Original Meeting will be effective at the Reconvened Meeting and shareholders do not need to vote again. New forms of proxies are not being distributed by the Company. Registered shareholders of record at the close of business on April 22, 2025, who have not previously deposited a form of proxy may deposit a properly executed form of proxy no later than 48 hours, excluding weekends and holidays, before the Reconvened Meeting, or any adjournments or postponements thereof, with Computershare Investor Services Inc. (i) via the internet at: ; (ii) by phone at: 1-866-732-VOTE (8683); or (iii) by mail to Computershare Investor Services Inc., 320 Bay Street, 14th Floor, Toronto, Ontario, M5H 4A6. Copies of the proxy statement and form of proxy have been filed on SEDAR+ and are available electronically at . Beneficial shareholders who wish to vote must follow the procedures and instructions received from their brokers or other intermediaries, and contact their brokers or other intermediaries if they need assistance. About Aptose Aptose Biosciences is a clinical-stage biotechnology company committed to developing precision medicines addressing unmet medical needs in oncology, with an initial focus on hematology. The Company's lead clinical-stage, oral kinase inhibitor tuspetinib (TUS) has demonstrated activity as a monotherapy and in combination therapy in patients with relapsed or refractory acute myeloid leukemia (AML) and is being developed as a frontline triplet therapy in newly diagnosed AML. For more information, please visit . Forward Looking Statements This press release may contain forward-looking statements within the meaning of Canadian and U.S. securities laws, including statements relating but not limited to, the appointment of a new independent auditor of the Company, the date and time of the Reconvened Meeting, the development of tuspetinib, and statements relating to the Company's plans, objectives, expectations and intentions and other statements including words such as 'continue', 'expect', 'intend', 'will', 'should', 'would', 'may', and other similar expressions. Such statements reflect our current views with respect to future events and are subject to risks and uncertainties and are necessarily based upon a number of estimates and assumptions that, while considered reasonable by us are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies. Many factors could cause our actual results, performance or achievements to be materially different from any future results, performance or achievements described in this press release. Such factors could include, among others: our ability to appoint a new independent auditor, our ability to hold the Reconvened Meeting and other risks detailed from time-to-time in our ongoing quarterly filings, annual information forms, annual reports and annual filings with Canadian securities regulators. Should one or more of these risks or uncertainties materialize, or should the assumptions set out in the section entitled 'Risk Factors' in our filings with Canadian securities regulators underlying those forward-looking statements prove incorrect, actual results may vary materially from those described herein. These forward-looking statements are made as of the date of this press release and we do not intend, and do not assume any obligation, to update these forward-looking statements, except as required by law. We cannot assure you that such statements will prove to be accurate as actual results and future events could differ materially from those anticipated in such statements. Investors are cautioned that forward-looking statements are not guarantees of future performance and accordingly investors are cautioned not to put undue reliance on forward-looking statements due to the inherent uncertainty therein. For further information, please contact: Aptose Biosciences Inc. Susan Pietropaolo Corporate Communications & Investor Relations 201-923-2049 spietropaolo@
Yahoo
01-08-2025
- Business
- Yahoo
Aptose Selects Ernst & Young Global Limited as its New Independent Auditor and Calls Reconvened Meeting of its Shareholders
Aptose to hold a reconvened shareholder meeting on August 22, 2025 at 10:00 a.m. (Eastern Time) to vote on appointment of new auditor SAN DIEGO and TORONTO, Aug. 01, 2025 (GLOBE NEWSWIRE) -- Aptose Biosciences Inc. ('Aptose' or the 'Company') (TSX: APS; OTC: APTOF; OTCQB: APTOF), 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), announced today that the Company's Board of Directors (the 'Board') has unanimously approved the selection of Ernst & Young LLP ('EY') as the Company's independent registered public accounting firm to serve as the Company's independent auditor. The Company had previously adjourned their Annual and Special Meeting of shareholders held on May 27, 2025 (the 'Original Meeting'), for the purposes of completing its search for a successor independent auditor. EY is a top-ranked global accounting firm that offers a complete spectrum of tax, assurance, and advisory services; they have been selected due to their expertise, capabilities, fit, and understanding of the Company's industry and business. The Company will reconvene its Annual General and Special Meeting of shareholders (the 'Reconvened Meeting') on August 22, 2025 at 10:00 a.m. (Eastern Time) to vote on the appointment of EY and the authorization of the Board to fix EY's remuneration. All interested parties are invited to attend the Reconvened Meeting by using the live webcast link here: Only registered shareholders and duly appointed proxyholders as of the record date on April 22, 2025, will be entitled to vote and ask questions at the Reconvened Meeting. Unless properly revoked, proxies previously completed, signed, dated and returned in respect of the Original Meeting will be effective at the Reconvened Meeting and shareholders do not need to vote again. New forms of proxies are not being distributed by the Company. Registered shareholders of record at the close of business on April 22, 2025, who have not previously deposited a form of proxy may deposit a properly executed form of proxy no later than 48 hours, excluding weekends and holidays, before the Reconvened Meeting, or any adjournments or postponements thereof, with Computershare Investor Services Inc. (i) via the internet at: (ii) by phone at: 1-866-732-VOTE (8683); or (iii) by mail to Computershare Investor Services Inc., 320 Bay Street, 14th Floor, Toronto, Ontario, M5H 4A6. Copies of the proxy statement and form of proxy have been filed on SEDAR+ and are available electronically at Beneficial shareholders who wish to vote must follow the procedures and instructions received from their brokers or other intermediaries, and contact their brokers or other intermediaries if they need assistance. About Aptose Aptose Biosciences is a clinical-stage biotechnology company committed to developing precision medicines addressing unmet medical needs in oncology, with an initial focus on hematology. The Company's lead clinical-stage, oral kinase inhibitor tuspetinib (TUS) has demonstrated activity as a monotherapy and in combination therapy in patients with relapsed or refractory acute myeloid leukemia (AML) and is being developed as a frontline triplet therapy in newly diagnosed AML. For more information, please visit Forward Looking Statements This press release may contain forward-looking statements within the meaning of Canadian and U.S. securities laws, including statements relating but not limited to, the appointment of a new independent auditor of the Company, the date and time of the Reconvened Meeting, the development of tuspetinib, and statements relating to the Company's plans, objectives, expectations and intentions and other statements including words such as 'continue', 'expect', 'intend', 'will', 'should', 'would', 'may', and other similar expressions. Such statements reflect our current views with respect to future events and are subject to risks and uncertainties and are necessarily based upon a number of estimates and assumptions that, while considered reasonable by us are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies. Many factors could cause our actual results, performance or achievements to be materially different from any future results, performance or achievements described in this press release. Such factors could include, among others: our ability to appoint a new independent auditor, our ability to hold the Reconvened Meeting and other risks detailed from time-to-time in our ongoing quarterly filings, annual information forms, annual reports and annual filings with Canadian securities regulators. Should one or more of these risks or uncertainties materialize, or should the assumptions set out in the section entitled 'Risk Factors' in our filings with Canadian securities regulators underlying those forward-looking statements prove incorrect, actual results may vary materially from those described herein. These forward-looking statements are made as of the date of this press release and we do not intend, and do not assume any obligation, to update these forward-looking statements, except as required by law. We cannot assure you that such statements will prove to be accurate as actual results and future events could differ materially from those anticipated in such statements. Investors are cautioned that forward-looking statements are not guarantees of future performance and accordingly investors are cautioned not to put undue reliance on forward-looking statements due to the inherent uncertainty therein. For further information, please contact: Aptose Biosciences Inc. Susan Pietropaolo Corporate Communications & Investor Relations 201-923-2049 spietropaolo@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
17-06-2025
- Business
- Yahoo
Aptose Provides Corporate Updates
Announces short-term cash advance SAN DIEGO and TORONTO, June 17, 2025 (GLOBE NEWSWIRE) -- Aptose Biosciences Inc. ('Aptose' or the 'Company') (TSX: APS; OTC: APTOF), a clinical-stage precision oncology company, announced today that the Company has secured a short-term cash advance from Dr. William G. Rice, the Company's Chairman of the Board, President and Chief Executive Officer (the 'Advance'), to support near-term obligations, including payroll, and to enable continued advancement of its clinical-stage oral kinase inhibitor, tuspetinib, while it engages in ongoing negotiations with prospective funding partners. The Advance is non-interest bearing and the Company may repay the Advance in whole or in part with no penalty at any time and from time to time. The Advance is unsecured, and no securities will be issued in connection with the Advance. The Advance constitutes a 'related-party transaction' within the meaning of Multilateral Instrument 61-101 – Protection of Minority Security Holders in Special Transactions ('MI 61-101') as Dr. Rice is a related party of the Company under Canadian securities laws. However, the Company is relying on the exemptions from the formal valuation and minority shareholder approval requirements contained in MI 61-101. Despite this advance, if Aptose does not receive additional funding in the coming days, the Corporation does not expect to have sufficient financial resources to fund planned Company operation and will have certain alternatives that could include insolvency Aptose announced that effective June 16, 2025, Ms. Carol Ashe has resigned as a director of the Company. The Company wishes to thank Ms. Ashe for her valuable contributions during her tenure as an Aptose board member and wishes her every success in her future endeavors. About Aptose Aptose Biosciences is a clinical-stage biotechnology company committed to developing precision medicines addressing unmet medical needs in oncology, with an initial focus on hematology. The Company's lead clinical-stage, oral kinase inhibitor tuspetinib (TUS) has demonstrated activity as a monotherapy and in combination therapy in patients with relapsed or refractory acute myeloid leukemia (AML) and is being developed as a frontline triplet therapy in newly diagnosed AML. For more information, please visit Forward Looking Statements This press release may contain forward-looking statements within the meaning of Canadian and U.S. securities laws, including, but not limited to, statements relating to the terms of the Advance, including the purpose of the Advance, expectations with respect to the repayment of the Advance, as well as statements relating to the Company's plans, objectives, expectations and intentions and other statements including words such as 'continue', 'expect', 'intend', 'will', 'should', 'would', 'may', and other similar expressions. Such statements reflect our current views with respect to future events and are subject to risks and uncertainties and are necessarily based upon a number of estimates and assumptions that, while considered reasonable by us are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies. These risks and uncertainties include, among others: our ability to obtain the capital required for research and operations and to continue as a going concern; the inherent risks in early stage drug development including demonstrating efficacy; development time/cost and the regulatory approval process; the progress of our clinical trials; our ability to find and enter into agreements with potential partners; our ability to attract and retain key personnel; changing market conditions; inability of new manufacturers to produce acceptable batches of GMP in sufficient quantities; unexpected manufacturing defects; and other risks detailed from time-to-time in our ongoing quarterly filings, annual information forms, annual reports and annual filings with Canadian securities regulators and the United States Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should the assumptions set out in the section entitled 'Risk Factors' in our filings with Canadian securities regulators and the United States Securities and Exchange Commission underlying those forward-looking statements prove incorrect, actual results may vary materially from those described herein. These forward-looking statements are made as of the date of this press release and we do not intend, and do not assume any obligation, to update these forward-looking statements, except as required by law. We cannot assure you that such statements will prove to be accurate as actual results and future events could differ materially from those anticipated in such statements. Investors are cautioned that forward-looking statements are not guarantees of future performance and accordingly investors are cautioned not to put undue reliance on forward-looking statements due to the inherent uncertainty therein. For further information, please contact Aptose Biosciences PietropaoloCorporate Communications & Investor Relations201-923-2049spietropaolo@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Hamilton Spectator
12-06-2025
- Business
- Hamilton Spectator
Aptose Presents Safety, Response, and MRD Clinical Data from TUSCANY Phase 1/2 Clinical Trial of Tuspetinib Triplet Therapy in Newly Diagnosed AML at the 2025 EHA Congress
SAN DIEGO and TORONTO, June 12, 2025 (GLOBE NEWSWIRE) — Aptose Biosciences Inc. ('Aptose' or the 'Company') (TSX: APS; OTC: APTOF), a clinical-stage precision oncology company, today announced data from its Phase 1/2 TUSCANY trial in newly diagnosed AML patients treated with tuspetinib (TUS) in combination with standard of care dosing venetoclax and azacitidine (TUS+VEN+AZA triplet) in an oral presentation at the European Hematology Association Congress (EHA 2025), being held June 12-15, 2025, in Milan, Italy. The TUS+VEN+AZA triplet is being developed as a mutation agnostic frontline therapy to treat large, mutationally diverse populations of newly diagnosed AML patients who are ineligible to receive induction chemotherapy. Dr. Gabriel Mannis, Associate Professor of Medicine, Stanford University School of Medicine, and an investigator in the TUSCANY study, reported safety and efficacy data from the first two dose cohorts at 40 mg of TUS or 80 mg of TUS in the TUS+VEN+AZA triplet. Dr. Mannis also noted three patients were rapidly enrolled on the third dose cohort of 120 mg TUS in the TUS+VEN+AZA triplet, and that no DLTs have been observed to date. The oral presentation at EHA included updated safety, complete remission, minimal residual disease (MRD) assessments, and longer duration of follow-up: Title: TUSCANY Study of Safety and Efficacy of Tuspetinib Plus Standard of Care Venetoclax and Azacitidine in Study Participants with Newly Diagnosed AML Ineligible for Induction Chemotherapy Presenter: Dr. Gabriel Mannis, Associate Professor of Medicine, Stanford University School of Medicine Abstract #: S139 Key findings: 'The TUSCANY triplet trial is well under way, and we are observing exciting activity with the addition of TUS to the VEN+AZA standard treatment,' said William G. Rice, Ph.D., Chairman, President and Chief Executive Officer of Aptose. 'The data presented today reveal complete responses across patients with diverse mutations, including TP53-mutated/CK AML and FLT3-wildtype AML patients. TUS appears to have tremendous opportunity in the largest markets and the most challenging of AML cases.' Abstracts are available on the EHA2025 website here . The presentation is available on the Aptose website here . TUSCANY: TUS+VEN+AZA Triplet Phase 1/2 Study The tuspetinib-based TUS+VEN+AZA triplet therapy is being advanced in the TUSCANY Phase 1/2 clinical study with the goal of creating an improved frontline therapy for newly diagnosed AML patients that is active across diverse AML populations, durable, and well tolerated. Earlier APTIVATE trials of TUS as a single agent and in combination as TUS+VEN demonstrated favorable safety and broad activity in diverse relapsed or refractory (R/R) AML populations that went beyond the more prognostically favorable NPM1 and IDH mutant subgroups. Indeed, responses were also in R/R AML patients with highly adverse TP53 and RAS mutations, and those with mutated or unmutated (wildtype) FLT3 genes. The TUSCANY Phase 1/2 study, being conducted at 10 leading U.S. clinical sites by elite clinical investigators, is designed to test various doses and schedules of TUS in combination with standard dosing of AZA and VEN for patients with AML who are ineligible to receive induction chemotherapy. A convenient, once daily oral agent, TUS, is being administered in 28-day cycles. Multiple U.S. sites are enrolling in the TUSCANY trial with anticipated enrollment of 18-24 patients by mid-late 2025. Data will be released as it becomes available. More information on the TUSCANY Phase 1/2 study can be found on ( here ). About Aptose Aptose Biosciences is a clinical-stage biotechnology company committed to developing precision medicines addressing unmet medical needs in oncology, with an initial focus on hematology. The Company's lead clinical-stage, oral kinase inhibitor tuspetinib (TUS) has demonstrated activity as a monotherapy and in combination therapy in patients with relapsed or refractory acute myeloid leukemia (AML) and is being developed as a frontline triplet therapy in newly diagnosed AML. For more information, please visit . Forward Looking Statements This press release may contain forward-looking statements within the meaning of Canadian and U.S. securities laws, including, but not limited to, statements relating to the therapeutic potential and safety profile of tuspetinib (including the triplet therapy) and its clinical development, the anticipated enrollment rate in the TUSCANY trial and the timing thereof, as well as statements relating to the Company's plans, objectives, expectations and intentions and other statements including words such as 'continue', 'expect', 'intend', 'will', 'should', 'would', 'may', and other similar expressions. Such statements reflect our current views with respect to future events and are subject to risks and uncertainties and are necessarily based upon a number of estimates and assumptions that, while considered reasonable by us are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies. Many factors could cause our actual results, performance or achievements to be materially different from any future results, performance or achievements described in this press release. Such factors could include, among others: our ability to obtain the capital required for research and operations and to continue as a going concern; the inherent risks in early stage drug development including demonstrating efficacy; development time/cost and the regulatory approval process; the progress of our clinical trials; our ability to find and enter into agreements with potential partners; our ability to attract and retain key personnel; changing market conditions; inability of new manufacturers to produce acceptable batches of GMP in sufficient quantities; unexpected manufacturing defects; and other risks detailed from time-to-time in our ongoing quarterly filings, annual information forms, annual reports and annual filings with Canadian securities regulators and the United States Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should the assumptions set out in the section entitled "Risk Factors" in our filings with Canadian securities regulators and the United States Securities and Exchange Commission underlying those forward-looking statements prove incorrect, actual results may vary materially from those described herein. These forward-looking statements are made as of the date of this press release and we do not intend, and do not assume any obligation, to update these forward-looking statements, except as required by law. We cannot assure you that such statements will prove to be accurate as actual results and future events could differ materially from those anticipated in such statements. Investors are cautioned that forward-looking statements are not guarantees of future performance and accordingly investors are cautioned not to put undue reliance on forward-looking statements due to the inherent uncertainty therein. For further information, please contact: Aptose Biosciences Inc. Susan Pietropaolo Corporate Communications & Investor Relations 201-923-2049 spietropaolo@
