Aptose Reports Results for the Second Quarter 2023
- CRc Response Rate 50% with Tuspetinib/Venetoclax Doublet in Evaluable Patients -
- CRc 44% in Patients Who Failed Prior Venetoclax -
- Data Guide to Accelerated Approval Path for TUS/VEN Doublet in Patients Who Failed Prior Venetoclax, Including FLT3 Mutated and Wildtype -
- Hanmi Pharmaceutical Commits Investment in Aptose Up to 19.99% Ownership or $7 Million -
- Conference Call and Webcast at 5:00 pm ET Today -
SAN DIEGO and TORONTO, Aug. 10, 2023 (GLOBE NEWSWIRE) -- Aptose Biosciences Inc. (“Aptose” or the “Company”) (NASDAQ: APTO, TSX: APS), a clinical-stage precision oncology company developing highly differentiated oral targeted agents to treat hematologic malignancies, today announced financial results for the three months ended June 30, 2023, and provided a corporate update.
“While still early in our APTIVATE dose expansion trial with tuspetinib in combination with venetoclax (TUS/VEN), we are encouraged by what we’re seeing in very difficult to treat AML populations,” said William G. Rice, Ph.D., Chairman, President and Chief Executive Officer. “Of particular importance are the tolerability of the TUS/VEN doublet and the breadth of responses in deep relapsed or refractory (R/R) AML patients who failed prior therapy with venetoclax (4 of 9 evaluable with Prior-VEN), among which responses were achieved in patients with wildtype FLT3 (2 of 3 evaluable with FLT3-WT) and one of whom harbored a TP53 mutation. Given the paucity of treatment options in this subpopulation that failed prior venetoclax therapy, we're excited to build off of these positive results at future medical meetings later this year and leverage the TUS/VEN doublet data as a springboard to future triplet therapy in the front line setting.”
“We are delighted to strengthen our relationship with Hanmi Pharmaceutical, which we believe reflects their recognition of the growing value of tuspetinib as a unique treatment for AML and possibly MDS, of the significant progress that Aptose has made with tuspetinib’s clinical development, and of the experienced and thoughtful nature of our team,” said Dr. Rice. “We thank the Hanmi team, and in particular, Ms. Juhyun Lim, President of Hanmi Pharmaceutical, for her leadership and commitment to Aptose.”
Key Corporate Highlights
FINANCIAL RESULTS OF OPERATIONS
RESEARCH AND DEVELOPMENT EXPENSES
The research and development expenses for the three-month and six-month periods ended June 30, 2023, and 2022 were as follows:
Research and development expenses increased by $3.2 million to $10.6 million for the three-month period ended June 30, 2023, as compared to $7.3 million for the comparative period in 2022. Changes to the components of our research and development expenses presented in the table above are primarily as a result of the following events:
Research and development expenses increased by $4.7 million to $19.4 million for the six-month period ended June 30, 2023, as compared to $14.7 million for the comparative period in 2022. Changes to the components of our research and development expenses presented in the table above are primarily as a result of the following events:
*Analysts interested in participating in the question-and-answer session will pre-register for the event from the participant registration link above to receive the dial-in numbers and a unique PIN, which are required to access the conference call. They also will have the option to take advantage of a Call Me button and the system will automatically dial out to connect to the Q&A session.
The audio webcast also can be accessed through a link on the Investor Relations section of Aptose’s website here. A replay of the webcast will be available on the Company’s website for 30 days.
The press release, the financial statements and the management’s discussion and analysis for the quarter ended June 30, 2023 will be available on SEDAR+ at www.sedarplus.ca and EDGAR at www.sec.gov/edgar.shtml.
Aptose Biosciences is a clinical-stage biotechnology company committed to developing precision medicines addressing unmet medical needs in oncology, with an initial focus on hematology. The Company's small molecule cancer therapeutics pipeline includes products designed to provide single agent efficacy and to enhance the efficacy of other anti-cancer therapies and regimens without overlapping toxicities. The Company has two clinical-stage oral kinase inhibitors under development for hematologic malignancies: tuspetinib (HM43239), an oral, myeloid kinase inhibitor being studied as monotherapy and in combination therapy in the APTIVATE international Phase 1/2 expansion trial in patients with relapsed or refractory acute myeloid leukemia (AML); and luxeptinib (CG-806), an oral, dual lymphoid and myeloid kinase inhibitor in Phase 1 a/b stage development for the treatment of patients with relapsed or refractory hematologic malignancies. For more information, please visit www.aptose.com.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of Canadian and U.S. securities laws, including, but not limited to, statements regarding the expected cash runway of the Company, the investment of Hanmi into the Company, including the anticipated closing date, the structure of such investment, the ability to receive the full $7 million investment and the proposed use of proceeds, the Company’s clinical development plans, the clinical potential, anti-cancer activity, therapeutic potential and applications and safety profile of tuspetinib and luxeptinib, the APTIVATE clinical trial, patient enrollment, the luxeptinib Phase 1 a/b clinical trials and the upcoming milestones of such trials, the development and clinical potential of the G3 formulation of luxeptinib, upcoming updates regarding the clinical trials, and statements relating to the Company’s plans, objectives, expectations and intentions and other statements including words such as “continue”, “expect”, “intend”, “will”, “hope” “should”, “would”, “may”, “potential” and other similar expressions. Such statements reflect our current views with respect to future events and are subject to risks and uncertainties and are necessarily based upon a number of estimates and assumptions that, while considered reasonable by us, are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies. Many factors could cause our actual results, performance or achievements to be materially different from any future results, performance or achievements described in this press release. Such factors could include, among others: our ability to obtain requisite approvals, including approval of the TSX and Nasdaq for Hanmi’s investment; our ability to complete the Hanmi investment on the terms and structure described herein or at all; our ability to meet certain milestones related to tuspetinib in order to complete the second tranche of the investment; our ability to structure the second tranche of Hanmi’s Investment to receive the full $7 million; our ability to obtain the capital required for research and operations; the inherent risks in early stage drug development including demonstrating efficacy; development time/cost and the regulatory approval process; the progress of our clinical trials; our ability to find and enter into agreements with potential partners; our ability to attract and retain key personnel; changing market and economic conditions; inability of new manufacturers to produce acceptable batches of GMP in sufficient quantities; unexpected manufacturing defects; the potential impact of the COVID-19 pandemic and other risks detailed from time-to-time in our ongoing current reports, quarterly filings, annual information forms, annual reports and annual filings with Canadian securities regulators and the United States Securities and Exchange Commission.
Should one or more of these risks or uncertainties materialize, or should the assumptions set out in the section entitled "Risk Factors" in our filings with Canadian securities regulators and the United States Securities and Exchange Commission underlying those forward- looking statements prove incorrect, actual results may vary materially from those described herein. These forward-looking statements are made as of the date of this press release and we do not intend, and do not assume any obligation, to update these forward-looking statements, except as required by law. We cannot assure you that such statements will prove to be accurate as actual results and future events could differ materially from those anticipated in such statements. Investors are cautioned that forward-looking statements are not guarantees of future performance and accordingly investors are cautioned not to put undue reliance on forward-looking statements due to the inherent uncertainty therein.
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