Aptose Announces Positive Decision by Nasdaq Hearings Panel

Rhea-AI Summary

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.

Positive

• Secured extension for Nasdaq listing compliance until March 31, 2025
• Completed $8 million public offering
• Established clinical development agreement with National Cancer Institute
• Presented positive clinical data for tuspetinib triplet therapy

Negative

• Risk of Nasdaq delisting if $2.5M shareholders' equity requirement not met by March 2025
• Stock trading below $1.00, requiring price recovery to maintain listing
• Recent need for public offering indicates cash constraints

Insights

Financial Analyst

The Nasdaq Panel's extension decision is important for Aptose Biosciences, providing vital breathing room until March 31, 2025 to meet listing requirements. The company must achieve $2.5 million in shareholders' equity and maintain a $1.00 minimum share price for 10 consecutive business days. The recent $8 million public offering strengthens their financial position, though with a market cap of only $10.7 million, significant challenges remain. The stock must appreciate substantially from current levels to avoid delisting and the company needs to carefully manage its cash burn while advancing its clinical programs. The NCI collaboration could reduce development costs, but additional financing may be needed to maintain compliance and operations through 2025.

Medical Research Analyst

The National Cancer Institute (NCI) collaboration represents a strategic validation for tuspetinib's development in AML and MDS. The recent ASH presentation demonstrating positive clinical data for tuspetinib triplet therapy in newly diagnosed AML patients adds scientific credibility. This partnership could accelerate development timelines and reduce costs through NCI's extensive clinical trial infrastructure. However, while these developments are scientifically promising, the company's precarious financial position and listing status create execution risks for the clinical program. The path forward requires both clinical success and financial stability to fully capitalize on tuspetinib's potential in the competitive hematologic malignancies space.

SAN DIEGO and TORONTO, Dec. 19, 2024 (GLOBE NEWSWIRE) -- Aptose Biosciences Inc. (“Aptose” or the “Company”) (NASDAQ: APTO, TSX: APS), a clinical-stage precision oncology company developing highly differentiated targeted agents to treat hematologic malignancies, today announced that the Nasdaq Hearings Panel (“Panel”) has granted the Company’s request for an extension to evidence compliance with all applicable criteria for continued listing on The Nasdaq Stock Market.

On or before March 31, 2025, the Company will be required to demonstrate compliance with NASDAQ Listing Rule 5550(b)(1) requiring the Company to have a minimum of $2.5 million in shareholders’ equity (the “Equity Rule”) and NASDAQ Listing Rule 5550(a)(2) requiring the Company to have a minimum bid price of $1.00 (the “Minimum Bid Price Rule”). To evidence compliance with the Minimum Bid Price requirement, the Company’s common stock must close at or above $1.00 per share for a minimum of 10 consecutive business days by March 31, 2025.

The Nasdaq hearing on the matter was held on November 21, 2024. Since the hearing, Aptose announced the closing of an $8 million public offering, announced the signing of a prestigious clinical development agreement with the National Cancer Institute to develop the Company’s lead drug tuspetinib for acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS), and presented clinical data at the American Society of Hematology (ASH) Annual Meeting supporting tuspetinib triplet drug therapy for newly diagnosed AML patients.

About Aptose

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’s lead clinical-stage, oral kinase inhibitor tuspetinib (TUS) has demonstrated activity as a monotherapy and in combination therapy in patients with relapsed or refractory acute myeloid leukemia (AML) and is being developed as a frontline triplet therapy in newly diagnosed AML. For more information, please visit www.aptose.com.

Forward Looking Statements

This press release may contain forward-looking statements within the meaning of Canadian and U.S. securities laws, including, but not limited to, statements relating to the therapeutic potential of tuspetinib, its clinical development and safety profile, as well as statements relating to the Company’s and other statements including words such as “continue”, “expect”, “intend”, “will”, “should”, “would”, “may”, 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 regain compliance with the NASDAQ Listing Rules prior to March 31, 2025; our ability to obtain the capital required for research and operations and to continue as a going concern; 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 conditions; inability of new manufacturers to produce acceptable batches of GMP in sufficient quantities; unexpected manufacturing defects; and other risks detailed from time-to-time in our ongoing 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.

For further information, please contact:

Aptose Biosciences Inc.                        
Susan Pietropaolo                        
Corporate Communications & Investor Relations                
201-923-2049                        
spietropaolo@aptose.com

FAQ

What are the Nasdaq compliance requirements Aptose (APTO) needs to meet by March 31, 2025?

Aptose must achieve minimum shareholders' equity of $2.5 million and maintain a minimum bid price of $1.00 for at least 10 consecutive business days by March 31, 2025.

How much was Aptose's (APTO) recent public offering worth?

Aptose completed an $8 million public offering following their Nasdaq hearing.

What is the significance of Aptose's (APTO) agreement with the National Cancer Institute?

The agreement allows for clinical development of tuspetinib for acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS), representing a prestigious collaboration.

What clinical data did Aptose (APTO) present at the ASH Annual Meeting?

Aptose presented clinical data supporting tuspetinib triplet drug therapy for newly diagnosed acute myeloid leukemia (AML) patients.