Aptose Bioscienc Stock Price, News & Analysis

Aptose (OTC: APTOF) reported Phase 1/2 TUSCANY data showing the tuspetinib (TUS) triplet with venetoclax and azacitidine (TUS+VEN+AZA) produced high remission and MRD results in newly diagnosed AML patients ineligible for induction chemotherapy.

Key data: CR/CRh 9/10 (90%) overall, 100% CR/CRh (6/6) at 80/120 mg TUS, 88% CR/CRh (7/8) in FLT3 wildtype, and MRD-negativity 7/9 (78%) of responders. No DLTs, no treatment-related deaths, no QTc prolongation, no differentiation syndrome, and no prolonged myelosuppression reported to date. Dosing at 160 mg TUS has begun; enrollment of 18–24 patients is anticipated by end-2025.

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), a clinical-stage precision oncology company, announced two significant developments. First, shareholders approved the appointment of Ernst & Young LLP as the company's new independent registered public accounting firm at their reconvened annual meeting.

Additionally, the company received an additional US$1.5 million advance from Hanmi Pharmaceutical, bringing the total received to US$7.1 million under their US$8.5 million loan facility agreement. These funds will support the continued clinical development of tuspetinib, their drug candidate for treating newly diagnosed acute myeloid leukemia (AML) in a triple drug frontline therapy.

Aptose Biosciences (OTC:APTOF) reported promising early data from its Phase 1/2 TUSCANY trial evaluating tuspetinib (TUS) in combination with venetoclax (VEN) and azacitidine (AZA) for newly diagnosed AML patients. The trial demonstrated 100% CR/CRh response rates at 80mg and 120mg doses and 78% MRD-negativity among responders.

Key findings include 100% CR/CRh in FLT3 wildtype AML (representing 70% of AML population) and 100% CR/CRh and MRD-negativity rates in TP53, RAS and FLT3-ITD mutated AML. The treatment showed excellent safety with no dose-limiting toxicities across all completed dose cohorts. Nine out of ten dosed patients remain on study, and enrollment is advancing to the 160mg TUS dose level.

Aptose Biosciences (OTC:APTOF) reported Q2 2025 results and provided updates on its TUSCANY clinical trial for tuspetinib (TUS) in acute myeloid leukemia (AML). The trial demonstrated promising results with multiple complete responses (CRs) across different dose cohorts, including MRD-negative responses in diverse genetic populations.

The Clinical Safety Review Committee approved dose escalation to 160 mg following successful results at 120 mg. Key financial metrics show a net loss of $7.0 million for Q2 2025, with cash position at $1.3 million. The company secured a loan facility of up to $8.5 million from Hanmi to support tuspetinib's development.

Aptose Biosciences (OTC: APTOF) has received approval to escalate dosing to 160 mg in its Phase 1/2 TUSCANY trial, evaluating tuspetinib (TUS) in combination with venetoclax and azacitidine for newly diagnosed AML patients. The trial has successfully completed three dosing cohorts (40 mg, 80 mg, and 120 mg) with no dose-limiting toxicities.

The TUS+VEN+AZA triplet therapy has demonstrated complete remissions (CRs) and minimal residual disease (MRD) negativity in difficult-to-treat AML populations, including patients with adverse biallelic TP53 or FLT3-ITD mutations. The company also received a US$1.1M advance from Hanmi Pharmaceutical, bringing total advances under their loan agreement to US$5.6M.

The TUSCANY trial, conducted at 10 leading U.S. clinical sites, aims to enroll 18-24 patients by late 2025, targeting AML patients ineligible for induction chemotherapy.

Aptose Biosciences (OTC: APTOF), a clinical-stage precision oncology company, has announced the selection of Ernst & Young LLP (EY) as its new independent registered public accounting firm. The company will hold a reconvened shareholder meeting on August 22, 2025 at 10:00 a.m. ET to vote on EY's appointment and remuneration.

The meeting follows an adjournment from the Original Meeting held on May 27, 2025, which was paused to complete the search for a successor auditor. Shareholders of record as of April 22, 2025 who haven't previously voted can submit their proxies up to 48 hours before the reconvened meeting. Previously submitted proxies will remain valid for the reconvened meeting.

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), a clinical-stage precision oncology company, announced its upgrade to the OTCQB Market effective July 1, 2025. The company, which develops tuspetinib (TUS) based triple drug frontline therapy for newly diagnosed acute myeloid leukemia (AML), will maintain its listing on the Toronto Stock Exchange (TSX) under the symbol "APS".

The OTCQB Venture Market caters to early-stage and developing U.S. and international companies that meet current reporting requirements and undergo annual verification and management certification processes.