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Aptose Presents Highlights from Clinical Update

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Finalized Dose Escalation/Dose Exploration Trial in 77 R/R AML Sufferers
Favorable security with monotherapy responses throughout 4 dose ranges with no DLT in mutationally various and tough to deal with R/R AML Populations
TP53MUT CR/CRh = 20% │ RASMUT CR/CRh = 22%

Accomplished Profitable Sort B EOP1 Assembly with US FDA
Monotherapy RP2D chosen as 80mg day by day and single arm accelerated path stays open

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Initiated APTIVATE Growth Trial with R/R AML
Tuspetinib monotherapy and Tuspetinib + Venetoclax (TUS/VEN) doublet present brisk enrollment
TUS/VEN doublet effectively tolerated, all sufferers stay on research, preliminary CR exercise reported amongst
first sufferers handled

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SAN DIEGO and TORONTO, June 10, 2023 (GLOBE NEWSWIRE) — Aptose Biosciences Inc. (“Aptose” or the “Firm”) (NASDAQ: APTO, TSX: APS), a clinical-stage precision oncology firm creating extremely differentiated oral kinase inhibitors to deal with hematologic malignancies, right this moment launched highlights from a scientific replace occasion held right this moment, June 10, 2023, along side EHA 2023 Worldwide Congress of the European Hematology Affiliation in Frankfurt, Germany. The occasion included an up-to-date evaluation of scientific information for Aptose’s two investigational merchandise below improvement for hematologic malignancies: tuspetinib, an oral, myeloid kinase inhibitor within the Part 1/2 APTIVATE trial in sufferers with relapsed or refractory acute myeloid leukemia (AML); and luxeptinib, an oral, twin lymphoid and myeloid kinase inhibitor in Part 1 a/b stage improvement for the remedy of sufferers with relapsed or refractory hematologic malignancies. The webcast of the presentation is obtainable on Aptose’s web site here.

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Aptose supplied up to date scientific findings with tuspetinib, a potent suppressor of FLT3, SYK, JAK 1/2, mutant types of cKIT, and the RSK1/2 kinases operative in AML:

  • Accomplished tuspetinib dose escalation and dose exploration Part 1/2 trial in 77 R/R AML sufferers.
    • Tuspetinib demonstrated a positive security profile.
    • Tuspetinib delivered monotherapy responses throughout 4 dose ranges with no DLT in mutationally various and tough to deal with R/R AML populations, together with TP53-mutated sufferers with a CR/CRh = 20% and RAS-mutated sufferers with a CR/CRh = 22%.
  • Accomplished profitable Finish of Part 1 (EOP1) Assembly with US FDA for tuspetinib, and a monotherapy RP2D was chosen as 80mg day by day, and all improvement paths stay open, together with the one arm accelerated path.
  • Initiated tuspetinib APTIVATE growth trial with R/R AML sufferers.
    • Tuspetinib is being administered as a monotherapy and as a mix doublet with tuspetinib + venetoclax (TUS/VEN), and enrollment has been brisk.
    • TUS/VEN doublet has been effectively tolerated, all sufferers stay on research, and preliminary CR exercise has already been reported in sufferers beforehand handled with VEN.

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Aptose additionally reviewed scientific findings with the brand new G3 formulation of luxeptinib (Lux):

  • 50mg G3 formulation with steady dosing achieves roughly equal PK profile as 900mg unique G1 formulation.
  • Count on to dose escalate G3 formulation with steady dosing in sufferers quickly.

“We’re delighted to have finalized our dose escalation and dose exploration Part 1/2 trial with tuspetinib (TUS), to have demonstrated single agent responses throughout 4 dose ranges that had no DLTs and throughout a variety of R/R AML populations with a range of hostile mutations,” mentioned William G. Rice, Ph.D., Chairman, President and Chief Government Officer. “As a part of our EOP1 assembly with the FDA, we designated 80mg day by day as our monotherapy really useful part 2 dose (RP2D), and now we focus all consideration on our APTIVATE growth trial to put monotherapy TUS in additional sufferers with extremely hostile mutations and to guage TUS together with venetoclax (VEN) as a doublet in R/R AML sufferers. Notably, thus far, the doublet seems to be effectively tolerated, with all sufferers remaining on research, together with a preliminary CR in a R/R AML affected person who beforehand failed venetoclax. We look ahead to accelerating testing of the doublet, including MDS sufferers to our APTIVATE trial, and with the purpose of shifting into triplet remedy (TUS/VEN/HMA) in 1L AML sufferers.”

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About
Aptose

Aptose Biosciences is a clinical-stage biotechnology firm creating precision medicines addressing unmet medical wants in oncology, with an preliminary deal with hematology. The Firm’s small molecule most cancers therapeutics pipeline consists of merchandise designed to supply single agent efficacy and to boost the efficacy of different anti-cancer therapies and regimens with out overlapping toxicities. The Firm has two clinical-stage oral kinase inhibitors below improvement for hematologic malignancies: tuspetinib (HM43239), an oral, myeloid kinase inhibitor being studied as monotherapy and together remedy within the APTIVATE worldwide Part 1/2 growth trial in sufferers with relapsed or refractory acute myeloid leukemia (AML); and luxeptinib (CG-806), an oral, twin lymphoid and myeloid kinase inhibitor in Part 1 a/b stage improvement for the remedy of sufferers with relapsed or refractory hematologic malignancies. For extra info, please go to www.aptose.com.

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Ahead Trying Statements

This press launch could comprise forward-looking statements inside the that means of Canadian and U.S. securities legal guidelines, together with, however not restricted to, statements referring to the therapeutic potential of tuspetinib, its scientific improvement and security profile, in addition to statements referring to the Firm’s plans, goals, expectations and intentions and different statements together with phrases akin to “proceed”, “count on”, “intend”, “will”, “ought to”, “would”, “could”, and different related expressions. Such statements mirror our present views with respect to future occasions and are topic to dangers and uncertainties and are essentially primarily based upon a variety of estimates and assumptions that, whereas thought of affordable by us are inherently topic to important enterprise, financial, aggressive, political and social uncertainties and contingencies. Many elements may trigger our precise outcomes, efficiency or achievements to be materially totally different from any future outcomes, efficiency or achievements described on this press launch. Such elements may embrace, amongst others: our potential to acquire the capital required for analysis and operations and to proceed as a going concern; the inherent dangers in early stage drug improvement together with demonstrating efficacy; improvement time/price and the regulatory approval course of; the progress of our scientific trials; our potential to seek out and enter into agreements with potential companions; our potential to draw and retain key personnel; altering market situations; incapacity of recent producers to supply acceptable batches of GMP in enough portions; surprising manufacturing defects; and different dangers detailed from time-to-time in our ongoing quarterly filings, annual info kinds, annual experiences and annual filings with Canadian securities regulators and the USA Securities and Alternate Fee.

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Ought to a number of of those dangers or uncertainties materialize, or ought to the assumptions set out within the part entitled “Danger Components” in our filings with Canadian securities regulators and the USA Securities and Alternate Fee underlying these forward-looking statements show incorrect, precise outcomes could fluctuate materially from these described herein. These forward-looking statements are made as of the date of this press launch and we don’t intend, and don’t assume any obligation, to replace these forward-looking statements, besides as required by legislation. We can’t guarantee you that such statements will show to be correct as precise outcomes and future occasions may differ materially from these anticipated in such statements. Traders are cautioned that forward-looking statements are usually not ensures of future efficiency and accordingly traders are cautioned to not put undue reliance on forward-looking statements as a result of inherent uncertainty therein.

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