Aptose Receives Second Advance under the Loan Agreement with Hanmi Pharmaceutical to Continue Development of Tuspetinib in Triplet Therapy for AML
Aptose Biosciences (OTC: APTOF) has received a second advance of $2.0 million from Hanmi Pharmaceutical as part of an $8.5 million loan facility agreement. The company has now received a total of $4.5 million under this agreement announced on June 20, 2025.
The funding supports the development of tuspetinib (TUS), a daily oral treatment being tested in combination with venetoclax and azacitidine for newly diagnosed acute myeloid leukemia (AML) patients. The TUSCANY triplet Phase 1/2 study has shown promising early results, demonstrating safety and complete responses across diverse AML mutations, including TP53-mutated and wildtype AML populations.
Aptose Biosciences (OTC: APTOF) ha ricevuto un secondo anticipo di 2,0 milioni di dollari da Hanmi Pharmaceutical nell'ambito di un accordo per una linea di credito da 8,5 milioni di dollari. Ad oggi, la società ha incassato un totale di 4,5 milioni di dollari secondo quanto annunciato il 20 giugno 2025.
Il finanziamento sostiene lo sviluppo di tuspetinib (TUS), un trattamento orale giornaliero in fase di sperimentazione in combinazione con venetoclax e azacitidina per pazienti con leucemia mieloide acuta (LMA) di nuova diagnosi. Lo studio di fase 1/2 TUSCANY triplet ha mostrato risultati preliminari promettenti, dimostrando sicurezza e risposte complete in diverse mutazioni della LMA, inclusi i pazienti con mutazione TP53 e quelli con LMA wildtype.
Aptose Biosciences (OTC: APTOF) ha recibido un segundo adelanto de 2,0 millones de dólares de Hanmi Pharmaceutical como parte de un acuerdo de línea de crédito por 8,5 millones de dólares. La compañía ha recibido hasta ahora un total de 4,5 millones de dólares bajo este acuerdo anunciado el 20 de junio de 2025.
La financiación apoya el desarrollo de tuspetinib (TUS), un tratamiento oral diario que se está probando en combinación con venetoclax y azacitidina para pacientes con leucemia mieloide aguda (LMA) recién diagnosticados. El estudio de fase 1/2 TUSCANY triplet ha mostrado resultados iniciales prometedores, demostrando seguridad y respuestas completas en diversas mutaciones de LMA, incluyendo poblaciones con mutación TP53 y LMA tipo salvaje.
Aptose Biosciences (OTC: APTOF)는 한미약품으로부터 2백만 달러의 두 번째 선지급금을 8.5백만 달러 대출 계약의 일부로 받았습니다. 회사는 이제 2025년 6월 20일에 발표된 이 계약에 따라 총 4.5백만 달러를 수령했습니다.
이 자금은 새로 진단된 급성 골수성 백혈병(AML) 환자를 대상으로 베네토클락스와 아자시티딘과 병용하여 시험 중인 매일 경구 투여 치료제인 투스페티닙(TUS) 개발을 지원합니다. TUSCANY triplet 1/2상 연구는 초기 유망한 결과를 보여 다양한 AML 돌연변이, 특히 TP53 변이와 야생형 AML 환자군에서 안전성과 완전 반응을 입증했습니다.
Aptose Biosciences (OTC : APTOF) a reçu une deuxième avance de 2,0 millions de dollars de la part de Hanmi Pharmaceutical dans le cadre d'une ligne de crédit de 8,5 millions de dollars. La société a désormais reçu un total de 4,5 millions de dollars au titre de cet accord annoncé le 20 juin 2025.
Ce financement soutient le développement de tuspetinib (TUS), un traitement oral quotidien testé en combinaison avec le venetoclax et l'azacitidine chez des patients nouvellement diagnostiqués avec une leucémie myéloïde aiguë (LMA). L'étude de phase 1/2 TUSCANY triplet a montré des résultats préliminaires prometteurs, démontrant la sécurité et des réponses complètes sur diverses mutations de la LMA, y compris les populations mutées TP53 et de type sauvage.
Aptose Biosciences (OTC: APTOF) hat von Hanmi Pharmaceutical eine zweite Vorauszahlung in Höhe von 2,0 Millionen US-Dollar im Rahmen einer 8,5 Millionen US-Dollar Kreditfazilität erhalten. Das Unternehmen hat damit insgesamt 4,5 Millionen US-Dollar gemäß der am 20. Juni 2025 bekanntgegebenen Vereinbarung erhalten.
Die Finanzierung unterstützt die Entwicklung von Tuspetinib (TUS), einer täglich oral einzunehmenden Behandlung, die in Kombination mit Venetoclax und Azacitidin bei neu diagnostizierten Patienten mit akuter myeloischer Leukämie (AML) getestet wird. Die Phase 1/2-Studie TUSCANY triplet zeigte vielversprechende erste Ergebnisse und belegte Sicherheit sowie komplette Ansprechraten bei verschiedenen AML-Mutationen, einschließlich TP53-mutierter und Wildtyp-AML-Populationen.
- None.
- Company requires external funding through loans to continue clinical development
- Treatment still in early Phase 1/2 trials with limited data
SAN DIEGO and TORONTO, July 15, 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 received an additional advance of US
“Tuspetinib in combination with venetoclax and azacitidine (the TUS+VEN+AZA triplet) continues to demonstrate exciting antileukemic activity and safety across genetically diverse populations of newly diagnosed AML patients – including TP53-mutated AML and wildtype AML, representing large AML populations for which there are few treatment options,” said William G. Rice, Ph.D., Chairman, President and Chief Executive Officer of Aptose. “We are very grateful to Hanmi for its continued support to help advance tuspetinib clinical development and further extend Aptose's ability to fund this important study.”
Tuspetinib is a convenient once daily oral agent that potently inhibits targets that drive excessive proliferation and anti-apoptotic mechanisms, including SYK, mutated and wild type forms of FLT3, mutated KIT, JAK1/2, and RSK2 kinases. Yet, TUS maintains a favorable safety profile by avoiding 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. At the European Hematology Association Congress in June, Aptose reported early data from the first two dose cohorts that have demonstrated safety, CRs and minimal residual disease (MRD) negativity across patients with diverse mutations (press release here).
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 Loan Facility Agreement, the development of tuspetinib, 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 Nasdaq listing requirements 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
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