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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 Inc. (Nasdaq: APTO) announced its participation in the Oppenheimer Fall Healthcare Life Sciences and MedTech Summit on September 22, 2020, at 1:40 PM EDT. The event will feature a fireside chat with Matthew Biegler, Senior Analyst at Oppenheimer. The audio webcast can be accessed via the Aptose website and will be archived post-event. Aptose focuses on developing targeted cancer therapeutics, including CG-806 and APTO-253, currently in clinical trials for hematologic malignancies.
Aptose Biosciences (Nasdaq: APTO; TSX: APS) has announced participation in two upcoming virtual conferences in September 2020. The H. C. Wainwright 22nd Annual Global Investment Conference is scheduled for September 14, 2020, at 2:30 PM EDT, while the Cantor Virtual Global Healthcare Conference will take place on September 17, 2020, at 10:00 AM EDT. The management team, led by Dr. William G. Rice, will present and discuss their innovative oncology therapies targeting hematologic malignancies. Webcasts are available through the Aptose website.
Aptose Biosciences Inc. (NASDAQ: APTO, TSX: APS) announced participation in the Canaccord Genuity 40th Annual Growth Conference from August 11-13, 2020. Key executives, including Dr. William G. Rice, will present a corporate overview and strategic direction on August 13 at 2:00 p.m. ET. The live presentation can be accessed via Webcast Link, with an archived version available for 90 days on the company's website.
Aptose Biosciences announced advancements in its clinical trials for CG-806 and APTO-253, with progress into higher dose cohorts and FDA approval for CG-806's IND in AML at a 450 mg dose. Financially, the company reported a net loss of $15.8 million for Q2 2020, up from $6.2 million YOY, primarily due to increased stock-based compensation and program costs. Cash and investments totaled $82.7 million, sufficient for operations through 2023. The company recently raised approximately $55.125 million through a public offering of common shares.
Aptose Biosciences (APTO) plans to release its financial results for Q2 2020 on August 4, 2020, after market close. The results will provide insights into the company's performance and development in oncology therapeutics. The upcoming conference call is scheduled for 5 PM EDT on the same day, allowing investors to discuss the results. Aptose focuses on personalized cancer therapies addressing unmet medical needs, with investigational products like CG-806 and APTO-253 in clinical trials targeting hematological malignancies.
Aptose Biosciences has announced the pricing of a public offering of 10,500,000 common shares at US$5.25 per share, aiming to raise gross proceeds of approximately US$55 million. The offering is set to close around July 20, 2020, pending customary conditions. The funds will be utilized to enhance clinical trials for CG-806 and APTO-253, acquire new clinical assets, and support working capital. The offering is managed by Piper Sandler & Co., with additional involvement from RBC Capital Markets and others. No shares will be sold in Canada as part of this offering.
Aptose Biosciences has initiated an underwritten public offering of its common shares, with an option for underwriters to purchase an additional 15%. The proceeds will be directed toward expanding clinical trials for CG-806 and APTO-253, acquiring additional clinical assets, and general corporate purposes. The offering is contingent on market conditions and requires approval from both the Toronto Stock Exchange and Nasdaq. Piper Sandler & Co. is the sole active book-running manager for this offering.
Aptose Biosciences Inc. (Nasdaq: APTO) announced the FDA's approval of the IND application for CG-806, an oral FLT3/BTK inhibitor, allowing a Phase 1a/b study in acute myeloid leukemia (AML) patients. This follows its ongoing Phase 1 study in B-cell malignancies. The trial aims to address challenges faced by patients with relapsed or refractory AML, with the initiation planned for the second half of 2020. CG-806 showcases a promising profile with preclinical evidence of efficacy against AML and safety in animal models, offering new hope for difficult-to-treat patient populations.
Aptose Biosciences (NASDAQ: APTO) announced promising early results from a Phase 1 trial of CG-806, a novel oral FLT3/BTK inhibitor for treating chronic lymphocytic leukemia (CLL) and other B-cell cancers. The trial evaluated CG-806 safety and tolerability across three dose levels (150mg, 300mg, 450mg), reporting no serious adverse events. Significant pharmacologic activity was observed, with complete inhibition of phospho-BTK and phospho-FLT3 in treated patients. An Investigational New Drug (IND) application for further studies in acute myeloid leukemia (AML) has also been submitted.
Aptose Biosciences Inc. (NASDAQ: APTO, TSX: APS) held its annual meeting on June 2, 2020, where 73.21% of shareholders participated. All nominees listed in the proxy statement dated April 24, 2020, were elected as Directors. Voting outcomes showed high approval rates, with over 99% of votes cast in favor for most nominees. Additionally, shareholders re-appointed KPMG LLP as the independent registered public accounting firm. The company focuses on developing innovative cancer therapies, particularly for hematological malignancies, with two investigational drugs currently in clinical trials.
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