On September 22, 2025 Aptose Biosciences Inc. ("Aptose" or the "Company") (TSX: APS; OTC: APTOF), a clinical-stage precision oncology company developing a tuspetinib (TUS) based triple drug frontline therapy to treat patients with newly diagnosed acute myeloid leukemia (AML), reported that it has entered into a US$11.9 million loan Amended Facility Agreement ( "Facility Agreement") with Hanmi Pharmaceutical Co. Ltd. ("Hanmi") (Press release, Aptose Biosciences, SEP 22, 2025, View Source [SID1234656139]).
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The Facility Agreement is uncommitted and administered through multiple advances until December 31, 2025, and will be used to fund Aptose’s business and clinical operations expenses reasonably related to the advancement of TUS. Aptose has not yet received funds from this Facility Agreement but expects the first advance soon. This Facility Agreement has been amended and restated from the prior June 2025 Facility Agreement between Hanmi and Aptose. No single advance shall be for an amount in excess of US$2,000,000, and any unpaid principal amount with respect to each advance shall accrue interest at six percent (6%) per annum. The Facility Agreement contains customary affirmative and negative covenants and securities that are subject to a number of limitations and exceptions.
In addition, Aptose has received the final advance of US$1.4 million for a total of US$8.5 million from the prior June 2025 Facility Agreement with Hanmi (press release here).
"The growing body of positive data on tuspetinib demonstrates that, by adding TUS to the VEN+AZA standard of care in AML, we can safely and more effectively treat some of AML’s largest patient populations, in addition to subgroups having adverse genetics defined by FLT3, NKRAS, and TP53 genes," said William G. Rice, Ph.D., Chairman, President and Chief Executive Officer of Aptose. "We are very grateful for Hanmi’s support for the continued development of an important new treatment in the AML armamentarium."
Tuspetinib is a convenient once daily oral agent that potently targets SYK, mutated and wild type forms of FLT3, mutated KIT, JAK1/2, and RSK2 kinases, while avoiding many typical toxicity concerns observed with other agents. The ongoing TUSCANY triplet Phase 1/2 study is designed to test various doses and schedules of TUS in combination with standard dosing of azacitidine and venetoclax in newly diagnosed patients with AML who are ineligible to receive induction chemotherapy. Aptose recently reported data from the first three dose cohorts that have demonstrated safety, CRs and minimal residual disease (MRD) negativity across patients with diverse mutations. The early data showed that 9 out of 10 patients responded to the TUS triplet therapy, with 100% complete remission (CR/CRh)1 achieved in the 80mg and 120mg cohorts. Notably, patients with difficult-to-treat mutations in TP53, RAS and FLT3 genes also achieved a 100% CR/CRh rate (press release here).
The September 2025 Loan Facility Agreement constitutes a "related-party transaction" within the meaning of Multilateral Instrument 61-101 – Protection of Minority Security Holders in Special Transactions ("MI 61-101") as Hanmi is a related party of the Company under Canadian securities laws. However, the Company is relying on the exemption from the formal valuation and minority shareholder approval requirements contained in MI 61-101 on the basis of the "financial hardship" exemption therein. In its consideration and approval of the September 2025 Loan Facility Agreement, the Board of Directors of the Company, acting in good faith and having taken into account the liquidity, financial position and cash needs of the Company, the alternatives available to the Company, relevant benefits, risks and other factors, including the relative impacts on applicable stakeholders, and such matters they considered relevant or appropriate, unanimously determined that entering into the September 2025 Loan Facility Agreement will result in an improvement of the Company’s financial position, and that the terms of the September 2025 Loan Facility Agreement are reasonable in the circumstances of Aptose. The Company did not file a material change report 21 days prior to the execution of the September 2025 Loan Facility Agreement as details of the September 2025 Loan Agreement were unknown at such time.