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MILAN - Aptose Biosciences Inc. (TSX: APS; OTC: APTOF), a clinical-stage biotechnology company with a market capitalization of $4.4 million, presented data Thursday from its Phase 1/2 TUSCANY trial showing that tuspetinib (TUS) combined with venetoclax and azacitidine demonstrated activity in newly diagnosed acute myeloid leukemia (AML) patients across various mutation profiles. According to InvestingPro data, the company faces significant financial challenges, with its stock down 93.5% over the past year.
The trial, presented at the European Hematology Association Congress in Milan, tested the triple-drug therapy in patients ineligible for induction chemotherapy. Ten patients received the combination across three dosage cohorts (40mg, 80mg, and 120mg of TUS). With the company’s next earnings report due on August 7, 2025, InvestingPro subscribers can access 12 additional key investment tips and comprehensive financial metrics to evaluate the company’s progress.
In the 40mg TUS cohort, three of four patients achieved complete remissions with minimal residual disease (MRD) negativity, including patients with FLT3-ITD, FLT3-wildtype, and TP53/complex karyotype mutations. All three patients in the 80mg cohort achieved composite complete remissions, including a TP53-mutated patient who achieved an early CRi (complete remission with incomplete hematologic recovery).
The three patients in the 120mg cohort remain on therapy, though it’s too early for formal response assessments. According to the company, no dose-limiting toxicities have been observed across any dosage level.
"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," said Dr. Gabriel Mannis, Associate Professor of Medicine at Stanford University School of Medicine and study investigator.
The company reported that the combination therapy has been well-tolerated with no treatment-related deaths, QTc prolongation, CPK elevations, differentiation syndrome, or non-hematologic serious adverse events.
The TUSCANY trial is ongoing at 10 U.S. clinical sites with anticipated enrollment of 18-24 patients by mid-late 2025, according to the press release statement. While the clinical progress continues, InvestingPro analysis indicates the company faces financial headwinds with a weak Financial Health Score of 1.23 and rapidly depleting cash reserves, factors that investors should carefully consider alongside the promising clinical developments.
In other recent news, Aptose Biosciences Inc. has announced a significant development regarding its compliance with Nasdaq’s listing requirements. The company has regained compliance with the minimum bid price rule, as confirmed by Nasdaq’s Listing Qualifications Department, after maintaining a closing bid price of at least $1.00 for ten consecutive business days. However, Aptose still faces challenges with Nasdaq’s shareholders’ equity requirement and is currently operating under an exception granted by the Hearing Panel to address this issue. In another development, Aptose Biosciences is set to be delisted from Nasdaq following a decision by the Nasdaq Hearings Panel due to non-compliance with the equity rule by the March 31, 2025 deadline. Despite the delisting, Aptose’s shares will continue to be traded on the Toronto Stock Exchange. The company is exploring options, including a possible appeal of the delisting decision and considering listing on another U.S. national Securities Exchange. Additionally, Aptose Biosciences reported a change in its independent accounting firm, with KPMG LLP opting not to seek re-appointment for the 2025 annual audit. KPMG will continue to review the company’s quarterly financial results for the first half of 2025, and Aptose is in the process of selecting a new accounting firm for future audits.
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