Aptose and Hanmi Pharmaceutical Extend Loan Agreement to Continue Development of Tuspetinib in Triplet Therapy for AML
Aptose Biosciences (OTC: APTOF) has secured an amended US$11.9 million loan facility agreement with Hanmi Pharmaceutical to advance the development of tuspetinib (TUS) in AML treatment. The facility, available through multiple advances until December 31, 2025, carries a 6% annual interest rate with individual advances capped at US$2 million.
The company recently reported promising clinical results from its TUSCANY triplet Phase 1/2 study, where TUS combined with standard AML therapy showed 90% response rate across patients. Notably, the 80mg and 120mg cohorts achieved 100% complete remission, including in patients with difficult-to-treat mutations.
Additionally, Aptose received a final advance of US$1.4 million, completing the total US$8.5 million from the prior June 2025 facility agreement with Hanmi.
Aptose Biosciences (OTC: APTOF) ha assicurato un accordo di facilitazione creditizia modificato per US$11,9 milioni con Hanmi Pharmaceutical per accelerare lo sviluppo di tuspetinib (TUS) nel trattamento dell’AML. La facilities, disponibile tramite varie erogazioni fino al 31 dicembre 2025, prevede un tasso di interesse annuo del 6% con massimale di US$2 milioni per ciascuna erogazione.
L’azienda ha recentemente riportato risultati clinici promettenti dal suo studio di fase 1/2 triplo TUSCANY, in cui TUS in combinazione con la terapla standard per AML ha mostrato un tasso di risposta del 90% tra i pazienti. In particolare, i gruppi da 80 mg e 120 mg hanno ottenuto il 100% di remissione completa, anche in pazienti con mutazioni difficili da trattare.
Inoltre, Aptose ha ricevuto un’ulteriore erogazione di US$1,4 milioni, completando l’importo totale di US$8,5 milioni previsto dall’accordo della precedente facility di giugno 2025 con Hanmi.
Aptose Biosciences (OTC: APTOF) ha asegurado un acuerdo de facilidad crediticia revisado por US$11,9 millones con Hanmi Pharmaceutical para avanzar el desarrollo de tuspetinib (TUS) en el tratamiento de AML. La facilidad, disponible a través de múltiples avances hasta el 31 de diciembre de 2025, tiene una tasa de interés anual del 6% y avances individuales limitados a US$2 millones.
La empresa informó recientemente resultados clínicos prometedores de su estudio de fase 1/2 triplete TUSCANY, donde TUS, en combinación con la terapia estándar para AML, mostró una tasa de respuesta del 90% entre los pacientes. En particular, las cohortes de 80 mg y 120 mg lograron un 100% de remisión completa, incluso en pacientes con mutaciones difíciles de tratar.
Además, Aptose recibió un último avance de US$1,4 millones, completando el total de US$8,5 millones acordado en la facility previa de junio de 2025 con Hanmi.
Aptose Biosciences (OTC: APTOF)가 Hanmi Pharmaceutical와 US$11.9백만의 수정된 대출 시설 계약을 체결하여 AML 치료제인 tuspetinib(TUS)의 개발을 추진합니다. 본 시설은 2025년 12월 31일까지 여러 차례의 인출이 가능하며, 연이자 6%의 조건으로 개별 인출액은 US$2백만으로 제한됩니다.
회사는 최근 TUSCANY 3제(트리플) 1/2상 연구에서 TUS가 표준 AML 치료와 함께 사용될 때 환자들 사이에서 응답률 90%을 보였다는 유망한 임상 결과를 보고했습니다. 특히 80mg 및 120mg 코호트는 완전 관해 100%를 달성했고, 치료가 어려운 변이 환자들도 포함되었습니다.
또한 Aptose는 미화 140만 달러의 추가 인출을 받아 2025년 6월 Hanmi와의 이전 시설 계약에서 총 US$8.5백만을 완성했습니다.
Aptose Biosciences (OTC: APTOF) a obtenu un amendement à une facilité de prêt de 11,9 millions de dollars US avec Hanmi Pharmaceutical pour faire progresser le développement du tuspetinib (TUS) dans le traitement de l’AML. La facilité, disponible par le biais de multiples avances jusqu’au 31 décembre 2025, porte un taux d’intérêt annuel de 6% avec des avances individuelles plafonnées à 2 millions de dollars US.
La société a récemment annoncé des résultats cliniques prometteurs de son étude TUSCANY triplet de phase 1/2, où le TUS, en association avec la thérapie standard de l’AML, a montré un taux de réponse de 90% chez les patients. Notamment, les cohorts 80 mg et 120 mg ont atteint 100 % de rémissions complètes, y compris chez des patients présentant des mutations difficiles à traiter.
De plus, Aptose a reçu une dernière avance de 1,4 million de dollars US, portant le total à 8,5 millions de dollars US dans le cadre de l’accord précédent de juin 2025 avec Hanmi.
Aptose Biosciences (OTC: APTOF) hat eine geänderte Kreditfazilität in Höhe von 11,9 Mio. USD mit Hanmi Pharmaceutical gesichert, um die Entwicklung von Tuspetinib (TUS) in der AML-Behandlung voranzutreiben. Die Fazilität ist bis zum 31. Dezember 2025 durch mehrere Abrufe verfügbar und trägt einen Jahreszinssatz von 6%, wobei einzelne Abrufe auf bis zu 2 Mio. USD begrenzt sind.
Das Unternehmen berichtete zuletzt über vielversprechende klinische Ergebnisse aus der Triplet-Phase-1/2- Studie TUSCANY, in der TUS in Kombination mit der Standardtherapie bei AML eine Antwortquote von 90% zeigte. Insbesondere die Kohorten 80 mg und 120 mg erreichten 100% vollständige Remission, auch bei Patienten mit schwer behandelbaren Mutationen.
Zusätzlich erhielt Aptose eine weitere Auszahlung von 1,4 Mio. USD, wodurch der Gesamtbetrag von 8,5 Mio. USD aus der vorherigen Juni-2025-Fazilität mit Hanmi erreicht wurde.
Aptose Biosciences (OTC: APTOF) قد أبرمت اتفاقية تسهيل ائتماني معدلة بقيمة 11.9 مليون دولار أميركي مع Hanmi Pharmaceutical لدفع تطوير دواء tuspetinib (TUS) في علاج AML. وتتوفر التسهيلات من خلال عدة دفعات حتى 31 ديسمبر 2025، وتحتوي على معدل فائدة سنوي مقداره 6% مع حد أقصى للدفعة الواحدة عند 2 مليون دولار أميركي.
أعلنت الشركة مؤخرًا عن نتائج سريرية واعدة من دراسة المرحلة 1/2 الثلاثية TUSCANY، حيث أظهر TUS، عند دمجه مع العلاج القياسي لـ AML، معدل استجابة 90% بين المرضى. وبشكل خاص، حققت cohorts 80 mg و120 mg إجمالاً 100% لشفاء كامل، حتى مع وجود طفرات صعبة العلاج.
بالإضافة إلى ذلك، تلقت Aptose دفعة أخيرة قدرها 1.4 مليون دولار أمريكي، مما أكمل الإجمالي 8.5 ملايين دولار من اتفاقية يونيو 2025 السابقة مع Hanmi.
Aptose Biosciences (OTC: APTOF) 已与 Hanmi Pharmaceutical 取得修改后的11.9百万美元贷款额度，以推进 tuspetinib (TUS) 在 AML 疗法中的开发。该额度可通过多次拨款使用，直至 2025 年 12 月 31 日，年利率为 6%，单次拨款上限为 200 万美元。
公司最近公布了 TUSCANY 三药联用的1/2期研究显示的有前景的临床结果，TUS 与 AML 标准治疗联合使用，患者的 反应率为 90%。值得注意的是，80 mg 和 120 mg 组达到了 100% 的完全缓解，包括在难以治疗的突变患者中。
此外，Aptose 还获得了最后一笔 140万美元的拨款，使得前次2025年6月与 Hanmi 的总额达到 850 万美元。
- 90% response rate (9 out of 10 patients) to TUS triplet therapy
- 100% complete remission achieved in 80mg and 120mg cohorts
- 100% CR/CRh rate in difficult-to-treat mutations (TP53, RAS, FLT3)
- Secured US$11.9M loan facility for continued development
- Successfully completed previous US$8.5M facility agreement
- Company requires additional funding through loan agreements
- Loan agreement includes 6% interest rate burden
- Company facing financial hardship as indicated by MI 61-101 exemption
SAN DIEGO and TORONTO, Sept. 22, 2025 (GLOBE NEWSWIRE) -- 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), today announced that it has entered into a US
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
In addition, Aptose has received the final advance of US
“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
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.
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 compound tuspetinib (TUS), is an oral kinase inhibitor that 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 statements relating but not limited to, the use of proceeds of the September 2025 Loan Facility Agreement, the development of tuspetinib, the therapeutic potential and safety profile of tuspetinib, the timing of the [first] advance under the September 2025 Loan Facility Agreement, and statements relating to the Company’s plans, objectives, expectations and intentions 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 negotiate a collaboration agreement to jointly develop tuspetinib with Hanmi, our ability to remain compliant with TSX listing requirements and other risks detailed from time-to-time in our ongoing quarterly filings, , 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
1 CR/CRh refer to the types of complete responses required by the U.S. FDA approval of any AML Drug.
FAQ
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