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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) 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.
Aptose Biosciences has announced the pricing of an $8 million public offering, consisting of up to 40,000,000 shares of common stock and warrants to purchase up to 20,000,000 shares. The combined offering price is set at $0.20 per share and accompanying warrant. The warrants will have an exercise price of $0.25 per share, will be immediately exercisable, and will expire in five years. The offering, which includes participation from the CEO and healthcare-focused investors, is expected to close around November 25, 2024. A.G.P./Alliance Global Partners is acting as the sole placement agent, and proceeds will be used for working capital and general corporate purposes.
Aptose Biosciences (NASDAQ: APTO, TSX: APS) has initiated the TUSCANY Phase 1/2 study to evaluate tuspetinib (TUS) in combination with azacitidine (AZA) and venetoclax (VEN) as a frontline triplet therapy for newly diagnosed acute myeloid leukemia (AML) patients. The study will be conducted at multiple U.S. sites, with planned enrollment of 18-24 patients by mid-late 2025. Tuspetinib, a once-daily oral agent targeting multiple kinases, has shown broad activity and favorable safety in the APTIVATE trial for relapsed/refractory AML patients, including those with prior treatments and adverse genetics.
Aptose Biosciences (NASDAQ: APTO, TSX: APS) announced Q3 2024 financial results and updates on tuspetinib development. The company received a $10 million loan from Hanmi Pharmaceutical for tuspetinib development. Net loss decreased to $7.0 million compared to $11.4 million in Q3 2023. Total cash and investments were $8 million as of September 30, 2024, expected to fund operations through January 2025. The company is advancing tuspetinib as part of a triplet therapy with azacitidine and venetoclax for newly diagnosed AML patients. Aptose is currently addressing Nasdaq listing compliance issues regarding stockholders' equity and minimum bid price requirements.
Aptose Biosciences Inc. (NASDAQ: APTO, TSX: APS) held a special meeting of shareholders on September 5, 2024, with 33.42% of issued and outstanding shares represented. Two key proposals were approved:
1. Issuance of common shares underlying certain warrants pursuant to Nasdaq Listing Rules.
2. Authorization for potential meeting adjournments to allow further proxy solicitation if needed.
The Nasdaq 20% Issuance Proposal was approved with 93.34% of votes in favor, while the Multiple Adjournments proposal received 97.05% approval. Detailed voting results will be filed on SEDAR+ and EDGAR.
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