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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 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.
Aptose Biosciences Inc. (NASDAQ: APTO, TSX: APS) has secured a $10 million loan from Hanmi Pharmaceutical Co. through a Facility Agreement. The funds will be used for the development of tuspetinib, Aptose's lead compound for treating acute myeloid leukemia (AML). The loan is convertible as prepayment of milestone obligations under a future collaboration agreement or repayable after completing a triple drug combination trial in newly diagnosed AML patients.
Additionally, Aptose and Hanmi are negotiating a new co-development collaboration agreement for tuspetinib, aimed at providing further funding to accelerate its clinical development. Aptose initially licensed tuspetinib from Hanmi in November 2021.
Aptose Biosciences Inc. (NASDAQ: APTO, TSX: APS) announced the adjournment of its special meeting of shareholders due to lack of quorum. The meeting, originally scheduled for August 15, 2024, has been postponed to September 5, 2024, at 1 p.m. ET. At the time of adjournment, proxies submitted represented only 32.76% of the company's outstanding common shares, falling short of the required 33.33% quorum.
Despite the lack of quorum, the company reports that based on proxy votes cast to date, all resolutions currently have the requisite levels of shareholder support. The board of directors believes that approving all matters outlined in the July 11, 2024 proxy statement is in the best interests of the company and its shareholders. The deadline for proxy submissions has been extended to September 4, 2024, at 1 p.m. ET.
Aptose Biosciences Inc. (NASDAQ: APTO, TSX: APS) reported financial results for Q2 2024 and provided a corporate update. Key highlights include:
1. FDA approval for tuspetinib triplet therapy protocol with venetoclax and azacitidine for newly diagnosed AML patients
2. Abstract submission to ASH 2024 for TUS+VEN+AZA triplet therapy
3. Nasdaq deficiency notice received for minimum bid price requirement
4. Q2 2024 net loss of $7.3 million, down from $14.1 million in Q2 2023
5. Cash position of $8.3 million as of June 30, 2024, expected to fund operations through August 2024
6. Research and development expenses decreased to $4.4 million in Q2 2024 from $10.6 million in Q2 2023
Aptose Biosciences Inc. (NASDAQ: APTO, TSX: APS), a clinical-stage precision oncology company, has received a deficiency notice from Nasdaq due to its stock price falling below the $1.00 minimum bid requirement for 30 consecutive business days. The company has until January 10, 2025, to regain compliance by maintaining a closing bid price of $1.00 or higher for at least 10 consecutive business days. This notice does not immediately affect Aptose's Nasdaq listing, and its shares continue to trade on both Nasdaq and the Toronto Stock Exchange. If compliance is not achieved by the deadline, Aptose may be granted an additional 180-day period to meet the requirement. The company is monitoring the situation and considering options to address the deficiency.
Aptose Biosciences, a clinical-stage oncology company, announced the results of its annual and special meeting of shareholders held on June 18, 2024. Shareholders representing 49.67% of common shares participated in the voting. All nominees listed in the May 14, 2024 proxy statement were re-elected as Directors, including Carol G. Ashe, Denis Burger, Erich Platzer, William G. Rice, Bernd Seizinger, Mark D. Vincent, and Warren Whitehead. Shareholders also approved the re-appointment of KPMG LLP as the independent auditor for the fiscal year ending December 31, 2024.
Additional resolutions passed include an advisory vote on executive compensation, the potential issuance of common shares to warrant holders exceeding 19.99% of outstanding shares under Nasdaq rules, and an adjournment resolution to permit further solicitation of proxies if needed. Complete voting details will be available on SEDAR+ and EDGAR.
Aptose Biosciences presented clinical and preclinical findings on Tuspetinib (TUS) at the European Hematology Association (EHA) 2024 Hybrid Congress.
TUS, both as monotherapy and combined with Venetoclax (VEN), demonstrated broad clinical activity and strong safety data in relapsed or refractory (R/R) Acute Myeloid Leukemia (AML) patients. The APTIVATE Phase 1/2 trial showed that TUS targets multiple kinases and maintains efficacy even in patients with adverse genetic mutations.
The company announced the initiation of a new triplet therapy trial combining TUS, VEN, and Azacitidine (AZA) for newly diagnosed AML patients.
Preclinical studies indicated that TUS targets VEN resistance mechanisms and retains activity against VEN-resistant AML cells.
Aptose aims to enhance treatment for newly diagnosed AML patients, showing promise in safety and efficacy. These findings highlight TUS's potential in overcoming VEN resistance and treating diverse genetic AML subgroups.
Aptose Biosciences announced the closing of a $4.43 million registered direct offering priced at-the-market under Nasdaq rules. The offering included 3,855,000 common shares at $1.15 per share. Concurrently, unregistered series A and B warrants were issued to purchase up to 3,855,000 common shares each at $1.15 per share. Series A warrants expire five years from shareholder approval, while series B warrants expire in eighteen months. Gross proceeds were approximately $4.43 million before fees and expenses. Funds will be used for working capital and general corporate purposes. H.C. Wainwright & Co. acted as the exclusive placement agent.
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