Financial Performance - The net loss for the nine months ended September 30, 2025, was $17,709,000, compared to a net loss of $23,845,000 for the same period in 2024, indicating a 25.8% improvement[17]. - The Company incurred a net loss of $17.7 million for the nine months ended September 30, 2025, compared to a net loss of $23.8 million for the same period in 2024[26]. - The Company reported a net loss of $5.1 million for the three months ended September 30, 2025, with a loss per share of $2.01[87]. - Net loss for the three months ended September 30, 2025, decreased by $1.8 million to $5.1 million, compared to $7.0 million in the same period in 2024[205]. - Basic and diluted loss per common share for the nine months ended September 30, 2025, was $(7.34), compared to $(44.41) for the same period in 2024[205]. Assets and Liabilities - Total current assets decreased from $9,530,000 as of December 31, 2024, to $3,777,000 as of September 30, 2025, representing a decline of approximately 60.4%[15]. - Total liabilities increased significantly from $14,670,000 as of December 31, 2024, to $25,791,000 as of September 30, 2025, an increase of about 75.7%[15]. - Cash and cash equivalents decreased from $6,152,000 as of December 31, 2024, to $613,000 as of September 30, 2025, a decline of approximately 90%[15]. - The total shareholders' deficit increased from $4,543,000 as of December 31, 2024, to $19,450,000 as of September 30, 2025, indicating a deterioration in the company's equity position[15]. - The Company has negative shareholder's equity of $19.5 million as of September 30, 2025, compared to negative $4.5 million as of December 31, 2024[26]. - Current assets less current liabilities are negative $3.3 million, and negative shareholder's equity is $19.5 million as of December 31, 2024[173]. Cash Flow and Financing Activities - Cash used in operating activities for the nine months ended September 30, 2025, was approximately $16.1 million, a decrease from $27.9 million in the same period in 2024[197]. - Financing activities provided cash flow of $11.1 million for the nine months ended September 30, 2025, primarily from advances under the Hanmi Facility Agreement[201]. - The Company completed a public offering on November 25, 2024, raising gross proceeds of $8.0 million from the sale of 1,333,333 Common Shares at $6.00 per share[179]. - The Company completed a public offering on January 30, 2024, raising approximately $9.7 million from the sale of 188,304 Common Shares at a price of $51.30 per share, with transaction costs of $1.6 million[75]. - The Company plans to raise additional funds through debt or other financing activities to meet capital requirements[27]. Research and Development - Research and development expenses for the nine months ended September 30, 2025, were $7,867,000, down from $15,560,000 in the same period of 2024, a decrease of 49.6%[17]. - Research and development expenses for the three months ended September 30, 2025, decreased by $2.5 million to $2.2 million compared to $4.7 million in 2024[208]. - The company expects research and development expenses to be lower in 2025 than in 2024, subject to successful financing activities[207]. - The company discontinued further clinical development of APTO-253, impacting research and development expenses[208]. Clinical Trials and Product Development - The Company has two clinical-stage investigational products for hematological malignancies, tuspetinib and luxeptinib, focusing on treating life-threatening cancers[23]. - The Company is conducting a Phase 1/2 clinical trial for tuspetinib, which has shown excellent safety and robust clinical activity in R/R AML patients[114]. - The TUSCANY Study is currently evaluating the TUS+VEN+HMA triplet therapy in newly diagnosed AML patients, with 10 patients enrolled across three dose levels as of June 30, 2025[107]. - Tuspetinib (TUS) in combination with standard dosing of venetoclax (VEN) and azacitidine (AZA) achieved complete responses (CR/CRh) in 6 out of 6 (100%) patients at higher doses of 80 mg and 120 mg, exceeding the expected 66% response rate from VEN+AZA alone[120]. - The ongoing TUS+VEN+HMA triplet trial aims to establish a new standard of care for newly diagnosed AML patients[140]. Agreements and Collaborations - Aptose entered a licensing agreement with Hanmi for tuspetinib, receiving an upfront payment of $12.5 million, including $5.0 million in cash and $7.5 million in Common Shares[50]. - The Company has entered into a Cooperative Research and Development Agreement with the NCI to collaborate on the clinical development of tuspetinib[116]. - The Company has entered into a loan agreement with Hanmi Pharmaceutical Co. Ltd. for $10.0 million, which is fully utilized as of September 30, 2025[38]. - An amended facility agreement with Hanmi provides an additional uncommitted facility for up to $11.9 million, also fully utilized as of September 30, 2025[40]. Market and Compliance Issues - The company is facing substantial doubt about its ability to continue as a going concern due to insufficient cash to fund operations[24]. - Nasdaq notified Aptose of non-compliance with listing rules due to a deficiency in stockholders' equity, requiring a compliance plan[165].
Aptose Biosciences(APTO) - 2025 Q3 - Quarterly Report