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Aptose Biosciences, Inc. (NASDAQ: APTO, TSX: APS) is a clinical-stage biotechnology company dedicated to developing precision medicines for the treatment of life-threatening cancers. This science-driven organization is focused on advancing first-in-class agents targeting acute myeloid leukemia (AML), high-risk myelodysplastic syndromes (MDS), and other hematologic malignancies. Based on a deep understanding of the genetic and epigenetic profiles of specific cancers and patient demographics, Aptose is building a robust pipeline of novel oncology therapies aimed at dysregulated processes and signaling pathways.
One of Aptose's pioneering agents, tuspetinib (TUS), is a highly potent, first-in-class pan-FLT3/BTK inhibitor. Developed as a small molecule therapeutic, tuspetinib targets various key kinases such as SYK, FLT3, JAK1/2, and mutant forms of KIT, RSK2, and TAK1-TAB1. This mechanism of action not only combats the proliferation of AML cells but also minimizes the typical cytotoxic side effects associated with conventional cancer treatments, thus enhancing the quality of life for patients.
Tuspetinib has shown significant promise in ongoing clinical trials. In the APTIVATE Phase 1/2 study, tuspetinib, both as a monotherapy and in combination with venetoclax (VEN), has demonstrated favorable safety profiles and robust efficacy in relapsed/refractory AML patients. This includes patients with various genetic mutations and those who have failed prior therapies. Notably, tuspetinib has demonstrated a 48% overall response rate when used in combination with venetoclax, making it a potential candidate for accelerated approval in difficult-to-treat VEN-resistant AML cases.
Aptose is also developing luxeptinib (CG-806), an oral, dual lymphoid and myeloid kinase inhibitor currently in Phase 1 a/b development. Luxeptinib targets relapsed or refractory hematologic malignancies and is being positioned for future clinical trials using its new generation 3 (G3) formulation, which has shown improved pharmacokinetics and tolerability.
Recently, Aptose has entered strategic financial transactions, including a public offering and private placement, to support the further development of tuspetinib and general corporate activities. With strong clinical data and robust financial backing, Aptose continues to make strides in the oncology field, aiming to bring life-saving treatments to patients in need.
Aptose Biosciences (NASDAQ: APTO, TSX: APS) announced positive results from its Phase 1/2 TUSCANY trial, testing tuspetinib (TUS) in combination with venetoclax and azacitidine for newly diagnosed AML patients. The Clinical Safety Review Committee approved dose escalation from 40mg to 80mg TUS following favorable results from the first cohort.
Key findings from the initial 40mg cohort of four patients include: complete responses in difficult-to-treat TP53-mutated/CK AML and FLT3-wildtype AML patients, no dose-limiting toxicities, no prolonged myelosuppression, and no required dose reductions to standard-of-care components. Three FLT3-WT patients completed Cycle 1 with two achieving complete remissions. The fourth patient with FLT3-ITD and NPM1 mutations is still in Cycle 1.
The trial aims to enroll 18-24 patients by mid-late 2025, with multiple U.S. sites participating. Pharmacokinetic analyses showed TUS plasma levels were unaffected by AZA addition, and venetoclax levels remained consistent with previous studies.
Aptose Biosciences (NASDAQ: APTO, TSX: APS) announced a 1-for-30 reverse share split approved by its board of directors. The consolidation will reduce outstanding common shares from 64,301,183 to approximately 2,143,372 shares. This strategic move aims to restore compliance with Nasdaq's minimum bid price requirement and maintain broad investor accessibility.
The reverse split is pending TSX approval, with trading of post-split shares expected to begin on February 26, 2025. No fractional shares will be issued, and registered shareholders will receive instructions via a Letter of Transmittal to exchange their certificates. The consolidation will proportionally adjust all outstanding warrants, convertible notes, stock options, and other convertible securities.
Aptose Biosciences (NASDAQ: APTO, TSX: APS) has announced two significant financial arrangements: a $25 million Committed Equity Facility with an institutional investor and a new At-The-Market (ATM) facility. The Committed Equity Facility gives Aptose the option, over 24 months, to sell up to $25 million of common shares to the investor, subject to regulatory conditions. Additionally, the company has established an ATM facility to sell shares on Nasdaq with an aggregate offering price of up to $1 million.
The company has filed Prospectus Supplements with the SEC for both offerings. No shares will be sold on the TSX or other Canadian trading markets under the common share purchase agreement. The TSX has conditionally approved the committed equity facility based on Section 602.1 of the TSX Company Manual.
Aptose Biosciences (NASDAQ: APTO, TSX: APS) reported promising early results from its Phase 1/2 TUSCANY trial testing tuspetinib in combination with venetoclax and azacitidine (TUS+VEN+AZA triplet) for newly diagnosed acute myeloid leukemia (AML) patients.
Key findings from the first cohort of four patients receiving the lowest dose (40mg) include:
- Two FLT3-wildtype patients achieved complete remissions by end of Cycle 1
- One patient with biallelic TP53 mutations achieved complete remission
- One patient showed significant reduction in bone marrow leukemic blasts
- The fourth patient with FLT3-ITD and NPM1 mutations is still in Cycle 1
The treatment showed favorable safety with no dose-limiting toxicities or dose adjustments needed. The TUSCANY trial aims to enroll 18-24 patients by mid-late 2025, testing various doses of tuspetinib with standard dosing of venetoclax and azacitidine.
Aptose Biosciences (NASDAQ: APTO, TSX: APS) has initiated dosing of the first patients in its TUSCANY Phase 1/2 study, testing tuspetinib (TUS) in combination with venetoclax (VEN) and azacitidine (AZA) as a frontline triple therapy for newly diagnosed acute myeloid leukemia (AML) patients.
The TUS+VEN+AZA triplet therapy aims to provide an improved frontline treatment option that is effective across diverse AML populations. Earlier APTIVATE trials showed that TUS, both as a single agent and combined with VEN, demonstrated favorable safety and broad activity in relapsed or refractory AML patients, including those with prior-VEN and prior-FLT3 inhibitor therapies.
The TUSCANY study will evaluate various doses and schedules of TUS with standard dosing of azacitidine and venetoclax in AML patients ineligible for induction chemotherapy. Starting at 40mg once daily, the trial plans to enroll 18-24 patients by mid-late 2025 across multiple U.S. sites.
Aptose Biosciences (NASDAQ: APTO, TSX: APS) received a positive decision from the Nasdaq Hearings Panel, granting an extension until March 31, 2025 to meet continued listing requirements. The company must demonstrate compliance with two key criteria: maintaining minimum shareholders' equity of $2.5 million and achieving a minimum bid price of $1.00 for at least 10 consecutive business days.
Following the November 21 hearing, Aptose has made significant progress, including closing an $8 million public offering, securing a clinical development agreement with the National Cancer Institute for tuspetinib development in AML and MDS, and presenting clinical data at ASH supporting tuspetinib triplet therapy for newly diagnosed AML patients.
Aptose Biosciences (NASDAQ: APTO, TSX: APS) announced the publication of preclinical data for tuspetinib (TUS) in Cancer Research Communications. The study demonstrates TUS's effectiveness as an oral kinase inhibitor for treating acute myeloid leukemia (AML). Key findings show that TUS inhibits specific oncogenic signaling kinases in AML, effectively kills AML cell lines, and shows enhanced activity when combined with venetoclax (VEN) or azacitidine (AZA).
The research revealed TUS's favorable pharmacokinetic profile supporting once-daily dosing and its ability to prolong survival in multiple AML models. Aptose is currently enrolling newly diagnosed AML patients in a Phase 1/2 clinical study for the TUS+VEN+AZA triplet combination therapy.
Aptose Biosciences presented clinical data for tuspetinib (TUS) at the 66th ASH Annual Meeting, highlighting its potential in treating acute myeloid leukemia (AML). The data supports the advancement of TUS+VEN+AZA triplet therapy for newly diagnosed AML patients.
Key findings show that TUS as a single agent achieved 60% and 42% CR/CRh rates with 80mg in FLT3 mutated and all-comer VEN-naïve AML respectively. In combination therapy, TUS+VEN showed 40% ORR with 80mg TUS + 400mg VEN in FLT3 mutated patients, with 83% of these patients having failed prior-VEN treatment.
The drug demonstrated favorable safety profiles both as monotherapy and in combination, with no dose-limiting toxicities through 160mg daily dosing, no drug-related discontinuations, and no deaths.
Aptose Biosciences (NASDAQ: APTO, TSX: APS) has entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) to develop tuspetinib for AML and MDS treatment. The collaboration will focus on testing tuspetinib in targeted drug combinations through the NCI's myeloMATCH precision medicine trials, which launched on May 16, 2024. The trials aim to develop tailored drug combinations for newly diagnosed AML and MDS patients.
Separately, Aptose is developing tuspetinib as part of a triple drug combination (tuspetinib, venetoclax, and azacitidine) in newly diagnosed AML patients unfit for chemotherapy, with the Phase 1/2 TUSCANY study set to begin in Q4.
Aptose Biosciences has closed its previously announced public offering, raising $8 million through the sale of 40 million common shares at $0.20 per share. The offering included warrants to purchase up to 20 million common shares at $0.25 per share, exercisable immediately and expiring in five years. The CEO and both existing and new healthcare-focused investors participated in the offering. The company plans to use the net proceeds for working capital and general corporate purposes. A.G.P./Alliance Global Partners served as the sole placement agent for the offering.
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