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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 announced the initiation of the APTIVATE Expansion Trial for tuspetinib, targeting relapsed/refractory acute myeloid leukemia (AML) patients, including a combination treatment arm with venetoclax. The company reported a net loss of $10 million for Q4 2022, a significant reduction from $24.3 million in Q4 2021, and a total 2022 net loss of $41.8 million, down from $65.4 million in 2021. As of December 31, 2022, Aptose held $47 million in cash and investments, providing sufficient resources for ongoing operations into Q1 2024. The company reports promising early activity data from tuspetinib and plans to present more data throughout the year.
Aptose Biosciences Inc. (Nasdaq: APTO; TSX: APS) released an update concerning its financial situation in light of issues surrounding Silicon Valley Bank (SVB). The company clarifies that it has not entered into any credit lines with SVB and thus has no exposure to related credit facilities. Aptose holds about $0.3 million in deposits with SVB, which exceeds the $250,000 FDIC-insured limit but is not considered material. The company does not anticipate any adverse effects on operations, payroll, or clinical trials, stating that non-SVB institutions manage its investments, ensuring limited risk from SVB's liquidity concerns.
Aptose Biosciences Inc. (Nasdaq: APTO) will announce its financial results for the fourth quarter and full year ending December 31, 2022, on March 23, 2023, after market close. The company, focused on developing oral kinase inhibitors for hematologic malignancies, will also provide a corporate update during the announcement. Interested analysts can participate in a Q&A session following the results by pre-registering for the conference call. The financial statements will be accessible on SEDAR and EDGAR. For more details about Aptose's clinical-stage pipeline and ongoing studies, visit the company's website.
Aptose Biosciences (Nasdaq: APTO; TSX: APS), a clinical-stage precision oncology firm, announced its participation in the Oppenheimer 33rd Annual Healthcare Conference, scheduled for March 13-15, 2023. The company’s Chairman and CEO, William G. Rice, Ph.D., will engage in a fireside chat on March 13 from 12:40 – 1:10 PM ET alongside Oppenheimer's Senior Analyst, Matthew Biegler. An audio webcast of the event will be available shortly after the live session and can be accessed via Aptose’s website. Additionally, the Aptose management team will conduct virtual one-on-one meetings during the conference.
Aptose Biosciences has initiated the APTIVATE Phase 1/2 trial for tuspetinib, a mutation-agnostic TKI for relapsed or refractory acute myeloid leukemia (R/R AML). The trial starts with a 120 mg monotherapy dosing, following another clinical response from a patient on 40 mg. Tuspetinib has demonstrated complete remissions across various dose levels and mutational profiles with a favorable safety profile, avoiding severe toxicities seen with competitors. The trial aims to enrich specific patient populations, including those with TP53 and FLT3 mutations, as backed by FDA fast-track designation.
Aptose Biosciences announced that its Chairman and CEO, William G. Rice, Ph.D., will present at the Biotech Showcase™ 2023 Conference on January 10, 2023, at 10:00 a.m. PST in San Francisco. The company specializes in developing oral kinase inhibitors for hematologic malignancies, with two clinical-stage products: tuspetinib for acute myeloid leukemia and luxeptinib for other hematologic conditions. Additionally, Aptose will hold meetings at the LifeSci Advisors Corporate Access Event from January 9-11, 2023. The presentation will be available via webcast on the company’s website.
Aptose Biosciences announced an equity distribution agreement with JonesTrading to sell common shares through at-the-market offerings on NASDAQ. The company can issue shares worth up to US$50 million as outlined in a prospectus filed with the SEC. Aptose focuses on developing oral kinase inhibitors for hematologic malignancies, with two candidates, tuspetinib and luxeptinib, currently in clinical trials. This strategic move may enhance capital for ongoing research and operations.
Aptose Biosciences has released a clinical update on tuspetinib, a myeloid kinase inhibitor, showing promising results in a Phase 1/2 trial for patients with relapsed/refractory acute myeloid leukemia (AML). As of October 6, 2022, 60 patients have been treated with doses ranging from 20 mg to 200 mg, achieving multiple complete remissions (CR). Tuspetinib's favorable safety profile and high response rates suggest potential for combination therapies. Additionally, luxeptinib continues to show efficacy in hematologic malignancies, with ongoing trials for modified formulations.
Aptose Biosciences Inc. (NASDAQ: APTO, TSX: APS) will present key updates at the ASH Annual Meeting on December 11, 2022. The webcast at 10:00 AM EST will cover clinical data for tuspetinib and luxeptinib. Tuspetinib, a myeloid kinase inhibitor, is in a Phase 1/2 trial for acute myeloid leukemia (AML). Key poster presentations include data on the Phase 1/2 dose escalation study of tuspetinib and luxeptinib. Additional data will be shared at the event, providing insights into the company’s advancements in oncology.
Aptose Biosciences has initiated dosing for the first patient in a continuous dosing regimen of the G3 formulation of luxeptinib for relapsed or refractory acute myeloid leukemia (AML). This Phase 1a/b clinical trial seeks to enhance drug bioavailability significantly, as the new formulation is expected to provide similar plasma exposure to the higher dose of the original formulation while reducing potential toxicity. The company is optimistic about the G3's efficacy and hopes it will yield better clinical responses in difficult-to-treat AML patients.
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