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Aptose Biosciences Inc. (APTO): Business Model Canvas [Dec-2025 Updated] |
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Aptose Biosciences Inc. (APTO) Bundle
You're looking at a clinical-stage biotech right at a major inflection point, and honestly, the numbers tell a clear story. Aptose Biosciences Inc. is pushing its lead AML therapy, tuspetinib, through trials, but as of September 30, 2025, their cash on hand was just $\mathbf{\$613,000}$, making their financing channels and the announced acquisition by Hanmi Pharmaceutical the absolute core of their near-term value. Before you decide where this stock stands, you need to see how their entire operation-from R&D spend of $\mathbf{\$2.20}$ million in Q3 to their reliance on equity facilities-is structured in this Business Model Canvas. Dive in to see the blueprint for their potential payoff, it's quite the setup.
Aptose Biosciences Inc. (APTO) - Canvas Business Model: Key Partnerships
You're looking at the core relationships that kept Aptose Biosciences Inc. funded and moving its lead asset through late-stage trials before the acquisition news broke in November 2025. These aren't just names on a contract; they represent critical financial lifelines and operational muscle.
Hanmi Pharmaceutical: Loan Financing and Strategic Partner, now an Acquirer in late 2025
Hanmi Pharmaceutical Co. Ltd. transitioned from a key financial backer to the definitive acquirer of Aptose Biosciences Inc. The definitive arrangement agreement was announced on November 19, 2025. Hanmi, through its wholly owned subsidiary, HS North America Ltd., agreed to acquire all outstanding common shares not already owned by Hanmi or its affiliates.
The terms set a cash price of C$2.41 per common share for minority shareholders, which represented a 28% premium over the 30-day Volume Weighted Average Price of C$1.88 on the Toronto Stock Exchange (TSX). Prior to this, Hanmi had already supported Aptose Biosciences Inc. development of tuspetinib (TUS) through debt facilities totaling more than US$30 million over the preceding 18 months. Hanmi already held a stake of 19.93% of all outstanding Common Shares before the acquisition announcement. Should the agreement terminate under certain conditions, Aptose Biosciences Inc. faces an expense fee payable to Hanmi Purchaser of C$300,000. The transaction requires approval by at least two-thirds (66 2/3%) of votes cast by Aptose Biosciences Inc. shareholders at a Special Meeting scheduled for no later than January 16, 2026.
Clinical Research Organizations (CROs): Managing and Executing the Phase 1/2 TUSCANY Trial
The execution of the Phase 1/2 TUSCANY trial, testing the TUS+VEN+AZA triplet therapy, relied on elite clinical investigators across 10 leading U.S. clinical sites. The trial was initiated in December 2024. By late 2025, anticipated enrollment was between 18-24 patients. Data reported as of the third quarter ended September 30, 2025, included ten (10) patients across three dose cohorts (40 mg, 80 mg, or 120 mg TUS).
Here's a look at the efficacy data from the cohorts managed by the CROs:
| Metric | Dose Cohort (TUS + VEN+AZA) | Number of Patients | Result/Rate |
| Overall CR/CRh Response | All Doses (40, 80, 120 mg) | 10 | 90% (9/10) |
| CR/CRh Response | Higher Doses (80 mg and 120 mg) | 6 | 100% (6/6) |
| Expected VEN+AZA Alone CR/CRh | N/A | N/A | 66% |
The dose escalation continued, with patients now being treated at the 160 mg dose level of TUS.
Institutional Investor: Provider of a $25 million Committed Equity Facility for Capital Access
Aptose Biosciences Inc. established a Committed Equity Facility with an institutional investor on February 13, 2025. This facility provided the right to sell and issue up to $25 million of common shares over a period of 24 months. This was designed to bolster the financial position to support ongoing development of treatments for AML. For context, total cash, cash equivalents, and restricted cash equivalents as of March 31, 2025, stood at $4.7 million.
A.G.P./Alliance Global Partners: Agent for the At-The-Market (ATM) Equity Financing Facility
Aptose Biosciences Inc. engaged A.G.P./Alliance Global Partners as the Agent in connection with an 'at-the-market' sales facility established via a Sales Agreement dated February 3, 2025. This 2025 ATM Facility allowed Aptose Biosciences Inc. to sell common shares through distributions on Nasdaq. The aggregate offering value for this specific facility was up to $1 million. The costs associated with the proceeds from this ATM facility included a 3% cash commission.
The key financial arrangements are summarized below:
- The Committed Equity Facility provided access to up to $25,000,000.
- The ATM facility, with A.G.P./Alliance Global Partners as agent, had an aggregate offering price up to US $1,000,000.
- The commission rate for the ATM facility was 3% of proceeds.
- Hanmi Pharmaceutical debt financing totaled more than US$30,000,000.
- The acquisition offer price per share was C$2.41.
Finance: draft 13-week cash view by Friday.
Aptose Biosciences Inc. (APTO) - Canvas Business Model: Key Activities
You're looking at the core engine driving Aptose Biosciences Inc. right now-the necessary actions to move tuspetinib from trial data to potential market approval, all while managing a very tight financial situation. It's all about execution on the clinical front and securing the runway to get there.
Clinical Development: Advancing tuspetinib (TUS) in the TUSCANY trial for AML
The primary key activity centers on the TUSCANY Phase 1/2 trial, evaluating tuspetinib (TUS) as a frontline triple therapy (TUS+VEN+AZA) for newly diagnosed Acute Myeloid Leukemia (AML) patients ineligible for induction chemotherapy. This trial kicked off in December 2024. The goal is to establish a safe, mutation-agnostic therapy. The company anticipated enrolling between 18-24 patients by late 2025.
The activity involves dose escalation and data generation across multiple cohorts. The data presented in August 2025, covering the 40 mg, 80 mg, and 120 mg TUS dose cohorts, showed compelling early results. The Safety Cohort Review Committee (CSRC) recommended dose escalation to 160 mg. You need to track the response rates closely as they directly inform the next regulatory steps.
Here's a snapshot of the reported clinical activity and outcomes as of late 2025:
| Metric | Value/Status | Dose Cohort(s) |
| Trial Start Date | December 2024 | N/A |
| Anticipated Enrollment (Late 2025) | 18-24 patients | N/A |
| Complete Remission/CRh Rate | 100% | 80 mg and 120 mg |
| MRD-Negativity Rate (Among Responders) | 78% | 80 mg and 120 mg |
| CR/CRh Rate in FLT3 wildtype AML | 100% | All cohorts |
| TUS Program Cost (Q1 2025) | $1.479 million | N/A |
The activity of presenting data at major conferences is also critical for validation. Data was presented at the European Hematology Association (EHA) Congress in June 2025 and is scheduled for the American Society of Hematology (ASH) Annual Meeting on December 6, 2025.
Research and Development (R&D): Preclinical work on pipeline candidates like luxeptinib
While tuspetinib dominates the current cash burn, R&D activity includes maintaining the pipeline. This involves managing ongoing preclinical programs and, importantly, making decisions on assets that are no longer viable to conserve capital. The company reported program costs for its other candidates in Q1 2025.
The R&D expense breakdown for the first quarter ended March 31, 2025, shows the relative investment:
- Program costs - Luxeptinib: $0.098 million.
- Program costs - APTO-253: $0.
- Personnel related expenses (Total R&D): $0.646 million.
Total Research and Development Expense for Q1 2025 was $2.364 million, a significant reduction from $6.445 million in Q1 2024. This reduction is a direct result of shifting focus, including the cessation of activities for APTO-253.
Capital Raising: Executing financing plans to fund operations, given low cash balance
This is perhaps the most urgent key activity, given the company's financial state. Aptose Biosciences Inc. has been actively executing financing plans to extend its cash runway, which was projected to last only until the end of May 2025 based on the March 31, 2025, balance of $4.743 million in cash.
Financing activities in early 2025 included establishing a $25 million Committed Equity Facility and a separate At-The-Market (ATM) facility up to $1 million in February 2025. By the end of Q2 2025 (June 30, 2025), the cash balance had dropped to $1.3 million. To bridge this gap, the CEO provided a personal, non-interest bearing cash advance in June 2025.
Further support came from Hanmi Pharmaceutical. A loan agreement established in June 2025 provided up to US$8.5 million, with US$5.6M already received by August 2025, specifically to fund the TUSCANY trial. Separately, a $1.5 million debt conversion into shares occurred in March 2025 at a price of $3.70 per share. The company reported a net loss of $17.7 million for the nine months ended September 30, 2025, against total assets of $6.34 million. You see the pressure here; every dollar raised is immediately earmarked for clinical progression.
Regulatory Strategy: Preparing for Phase 2/3 PIVOTAL trials and regulatory submissions
The regulatory strategy is tightly coupled with TUSCANY trial milestones. A key activity for 2025 was to finalize the optimal TUS dose based on the Phase 1/2 data to support the transition to the next stage.
The planned regulatory steps for 2025 included:
- Finalize the TUS dose for the Phase 2/3 pivotal trials at ASH 2025.
- Prepare for initiation of the Phase 2 portion of the planned Phase 2/3 pivotal program.
- Advance the Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) for myeloMATCH trials.
The TUSCANY trial protocol was reviewed by the FDA, supporting the current development path. Success in achieving high response and MRD-negativity rates is the core data driving the preparation for these pivotal trial submissions.
Aptose Biosciences Inc. (APTO) - Canvas Business Model: Key Resources
You're looking at the core assets Aptose Biosciences Inc. has right now to drive its business forward, especially given the tight liquidity situation. Here's the breakdown of what they are holding onto as of late 2025.
Intellectual Property: Proprietary small molecule kinase inhibitors (TUS, luxeptinib)
Aptose Biosciences Inc. is built around its pipeline of small molecule cancer therapeutics designed for single agent efficacy or to boost other anti-cancer regimens without overlapping toxicities. The key assets are:
- Tuspetinib (TUS): An oral, potent Myeloid Kinase Inhibitor (MKI) targeting kinases like SYK, FLT3, JAK, and c-KIT(mut).
- Luxeptinib: A novel, oral, dual Lymphoid and Myeloid Kinase Inhibitor (LKI/MKI) targeting wildtype and mutant forms of BTK, plus other pathways in B-cell malignancies.
- Luxeptinib is also being developed for Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML) and high-risk Myelodysplastic Syndromes (MDS).
- The third clinical asset, APTO-253 (a MYC oncogene inhibitor), had its clinical program discontinued effective December 20, 2021.
Scientific/Clinical Team: Specialized expertise in hematology and oncology drug development
The operational strength is centered on executing clinical trials in hematologic malignancies. The TUSCANY Phase 1/2 study is being conducted at 10 leading U.S. clinical sites by elite clinical investigators. The leadership, including William G. Rice, Ph.D., Chairman, President and Chief Executive Officer, is actively guiding the dose escalation and data presentation strategy.
Clinical Data: Promising safety and efficacy results from the TUSCANY trial
The data from the TUSCANY trial, combining Tuspetinib (TUS) with Venetoclax (VEN) and Azacitidine (AZA) in newly diagnosed AML patients ineligible for induction chemotherapy, shows strong early signals. Here's what the data reported as of the November 13, 2025, Q3 results update shows:
| Metric | Result/Value | Context |
| Overall CR/CRh Response Rate (TUS+VEN+AZA) | 9/10 (90%) | Across all three initial cohorts (40 mg, 80 mg, 120 mg TUS) |
| CR/CRh Response Rate (Higher Doses) | 6/6 (100%) | Patients treated at 80 mg and 120 mg TUS dose levels |
| Expected CR/CRh Rate (VEN+AZA Alone) | 66% | Benchmark for comparison |
| MRD Negativity Rate (Among Responders) | 78% | Observed in the triplet combination |
| Current TUS Dose Level | 160 mg | Dose escalation completed past the 120 mg cohort |
| Anticipated Enrollment (Late 2025) | 18-24 patients | Target for the TUSCANY Phase 1/2 study |
The trial has shown no significant safety concerns or dose-limiting toxicities (DLTs) up to the 120 mg dose level, specifically noting no prolonged myelosuppression in Cycle 1 or differentiation syndrome.
Financial Capital: Cash on hand of $613,000 as of September 30, 2025, plus available facilities
Liquidity is a near-term constraint, requiring external support to continue operations. The company has a formal going concern warning on its financial statements.
The financial position as of the end of the third quarter is stark:
- Cash, cash equivalents, and restricted cash as of September 30, 2025, totaled $1.6 million.
- As of early November 2025, the cash-on-hand was approximately $2.2 million.
- The company reported a working capital deficit of $3.3 million as of September 30, 2025.
- Shareholders' deficit widened to $19.5 million at September 30, 2025.
- The company reported no revenue for the three or nine months ended September 30, 2025.
- Net loss for the nine months ended September 30, 2025, was $17.7 million.
To address this, Aptose Biosciences Inc. relies on financing, specifically from Hanmi Pharmaceutical Co. Ltd. The prior Facility Agreement with Hanmi provided up to US$8.5 million, which has been fully received. A new, uncommitted Facility Agreement was established in September 2025, allowing advances up to US$2,000,000 per advance, with interest accruing at six percent (6%) per annum, available until December 31, 2025.
Aptose Biosciences Inc. (APTO) - Canvas Business Model: Value Propositions
You're looking at the core reasons why a physician or patient would choose Aptose Biosciences Inc.'s lead asset over alternatives. The value propositions center squarely on superior clinical outcomes in a difficult-to-treat patient population.
Mutation-Agnostic AML Therapy: Tuspetinib Triplet is Active Across Diverse AML Populations
The clinical data from the TUSCANY trial strongly suggests Tuspetinib (TUS) plus standard of care venetoclax and azacitidine (TUS+VEN+AZA) works across a broad genetic spectrum of Acute Myeloid Leukemia (AML) patients ineligible for intensive induction chemotherapy. This is a key differentiator for Aptose Biosciences Inc.
- Overall Complete Response (CR) or CR with incomplete blood count recovery (CRh) rate across all AML patients was 90% (9/10 patients).
- The combination achieved CR/CRh responses in 100% (6/6) of patients treated at the higher dose levels of 80 mg and 120 mg TUS.
- This 100% response rate significantly exceeds the 66% rate expected from VEN+AZA alone.
- Minimal Residual Disease (MRD) negativity was achieved in 78% (7/9) responding patients by central flow cytometry.
- Responses were documented across adverse mutational subtypes, including biallelic TP53, FLT3-ITD, and NPM1c.
- For FLT3 wildtype AML, which represents about 70% of the AML population, CR/CRh responses were seen in 88% (7/8) of patients.
The TUSCANY trial is currently dosing patients at the 160 mg TUS level, having escalated from 40 mg, 80 mg, and 120 mg cohorts. Aptose Biosciences Inc. anticipates trial enrollment of 18-24 patients by the end of 2025.
Precision Oncology: Small Molecule Therapeutics Targeting Key Kinases
Aptose Biosciences Inc. is developing Tuspetinib as a small molecule kinase inhibitor, positioning it as a precision medicine approach. This mechanism allows it to target specific pathways driving the cancer.
| Product Attribute | Detail |
| Therapeutic Class | Small molecule kinase inhibitor |
| Targeted Kinases | Key kinases, including those implicated in AML signaling pathways |
| Combination Efficacy | Demonstrated activity in combination with standard of care agents |
Improved Frontline Treatment: Potential for a Safe, Active Triplet Regimen (TUS+VEN+AZA) for Newly Diagnosed AML
The TUSCANY study is specifically designed to test the TUS+VEN+AZA triplet as an improved frontline therapy for newly diagnosed AML patients who cannot receive intensive induction chemotherapy. The safety profile appears supportive of this goal, as no significant safety concerns or dose-limiting toxicities (DLTs) have been observed to date across the tested dose levels.
- CR/CRh rate for TUS triple therapy: 90% overall.
- MRD negativity rate for TUS triple therapy: 78%.
- Comparison to Standard of Care (SoC) alone: 78% MRD negativity vs. 40.9% in SoC.
Oral Administration: Tuspetinib is an Oral Drug, Offering Patient Convenience
A significant convenience factor for patients and prescribers is the formulation of Tuspetinib. It is an oral agent, which generally translates to less burden compared to intravenous therapies.
- Tuspetinib (TUS) is a once daily oral agent.
- Administration is in 28-day cycles.
The company reported total operating expenses of $4.9 million for the third quarter ended September 30, 2025, with R&D at $2.2 million. Cash on hand as of September 30, 2025, was $1.6 million, with management noting reliance on advances from Hanmi to fund operations.
Aptose Biosciences Inc. (APTO) - Canvas Business Model: Customer Relationships
You're looking at the relationships Aptose Biosciences Inc. maintains with the key groups that fund and advance its science as of late 2025. These aren't typical customer relationships; they are deep collaborations and financial dependencies that keep the lights on and the trials moving forward.
High-Touch Clinical Collaboration
The relationship with clinical investigators and sites is intensely managed because the success of tuspetinib (TUS) hinges on clean, compelling data from the TUSCANY Phase 1/2 trial. You need investigators to enroll patients and execute the protocol precisely. The enthusiasm from the field is reflected in the response rates reported.
For instance, data presented in November 2025 showed that across the TUS triplet therapy (TUS+VEN+AZA), 9 out of 10 patients responded. This level of engagement is critical when you're dealing with small cohorts. The company escalated the TUS dose based on investigator confidence; patients evaluated at the 80 mg and 120 mg TUS dose levels (6/6; 100%) achieved Complete Remission/Complete Remission with hematologic recovery (CR/CRh) responses, beating the expected 66% rate from VEN+AZA alone.
Here's a snapshot of the clinical collaboration activity around the TUSCANY trial as of mid-2025:
| Dose Cohort (TUS in TUS+VEN+AZA) | Number of Patients Evaluated (n) | CR/CRh Response Rate | Status/Update |
| 40 mg | 4 | 100% (as of May 2025) | Initial dose cohort |
| 80 mg | 3 (total) | 100% (as of Nov 2025) | Dose escalated from 40 mg |
| 120 mg | 3 (total) | 100% (as of Nov 2025) | Dose escalated from 80 mg |
| 160 mg | N/A | N/A | Dosing commenced as of November 2025 |
Also, Aptose Biosciences Inc. has a formal collaboration with the NCI's Cancer Therapy Evaluation Program (CTEP) for myeloMATCH trials, showing a high-level institutional relationship.
Investor Relations
For a clinical-stage company, investor relations is about securing the runway to hit milestones. You're constantly communicating the science to bridge the gap between cash burn and value inflection points. The latest reported cash position shows the urgency of this relationship management.
The total cash, cash equivalents and restricted cash equivalents as of September 30, 2025, stood at $1.6 million. This is tight, especially considering the net loss for the nine months ended September 30, 2025, was $17.7 million. The company is definitely deploying financing and cost reduction efforts to extend that runway.
Key recent capital events include:
- Closing a public offering in November 2024 for aggregate gross proceeds of $8 million at $0.20 per share.
- As of November 7, 2025, there were 2,552,429 common shares issued and outstanding.
- Regular updates are provided, such as the Q3 2025 Earnings Release for the quarter ended September 30, 2025.
The relationship with shareholders is currently defined by the proposed acquisition, offering minority shareholders C$2.41 in cash per Common Share.
Strategic Partner Management
Hanmi Pharmaceutical Co. Ltd. is more than a partner; they are the primary financial backstop and the entity moving to acquire the company. This relationship is the most critical element of Aptose Biosciences Inc.'s current structure.
Hanmi's support over the past 18 months leading up to November 2025 totaled more than US$30 million through debt facilities, specifically to support tuspetinib development. This financial lifeline is substantial compared to the $1.6 million cash on hand at the end of Q3 2025.
The financing history shows deep commitment:
- Hanmi now owns 19.93% of all outstanding Common Shares as of November 19, 2025.
- A US$11.9 million Amended Facility Agreement was announced in September 2025, administered through advances until December 31, 2025.
- Prior to that, an advance of US$1.5 million was received under an US$8.5M loan facility announced in June 2025, bringing the total received under that specific facility to US$7.1M.
The original licensing agreement for HM43239 (tuspetinib) included an upfront payment of $12.5 million ($5 million cash and $7.5 million in Aptose shares) to Aptose, with potential future milestones up to $407.5 million plus royalties. Now, this relationship culminates in the Arrangement Agreement where Hanmi Purchaser seeks to acquire the shares not already owned by Hanmi affiliates.
Aptose Biosciences Inc. (APTO) - Canvas Business Model: Channels
You're looking at how Aptose Biosciences Inc. gets its science and corporate status out to the world-the channels it uses to connect with investigators, investors, and regulators. For a clinical-stage company, these channels are critical for everything from trial recruitment to maintaining a listing.
Clinical Trial Sites: Primary channel for drug delivery and patient access
The primary channel for delivering the drug candidate, tuspetinib (TUS), and accessing the target patient population is through active clinical trial sites. This is where the drug moves from paper to patient care, which is the ultimate validation point for any biotech.
The TUSCANY Phase 1/2 study, testing the TUS+VEN+AZA triplet therapy for newly diagnosed AML patients ineligible for induction chemotherapy, relies on a network of investigators across the U.S. to enroll patients and administer the therapy. This network is the physical delivery channel for their value proposition.
| Trial Metric | Data Point (Late 2025) |
|---|---|
| Number of Leading U.S. Clinical Sites (TUSCANY) | 10 |
| Anticipated Patient Enrollment by Mid-Late 2025 | 18-24 patients |
| Dose Cohorts Reported with Safety/CR Data | 3 (40 mg, 80 mg, and 120 mg TUS) |
| Complete Remission (CR/CRh) Rate at 80 mg and 120 mg TUS Cohorts | 100% |
Scientific Conferences: Presenting clinical data at events like ASH and EHA
Presenting data at major medical meetings is the key channel for communicating clinical progress to the scientific community, potential partners, and key opinion leaders. This builds credibility for the tuspetinib program.
Aptose Biosciences Inc. successfully used two major hematology conferences in 2025 to disseminate updated data from the TUSCANY trial, showing the safety and antileukemic activity of the TUS triplet therapy.
- EHA 2025 Congress (Milan, Italy, June 12-15, 2025): Data presented via an Oral Presentation (Abstract #: S139).
- ASH 2025 Annual Meeting (Orlando): TUSCANY trial data selected for Poster Presentation (Abstract available October 16, 2025).
Capital Markets: Nasdaq and TSX for equity financing (though delisted from Nasdaq in April 2025)
The capital markets channel is essential for funding operations, especially given the company's lack of revenue. You need to know where the stock trades and its recent corporate actions affecting that access.
Aptose Biosciences Inc. failed to regain compliance with Nasdaq Listing Rule 5550(b)(1) (the Equity Rule) by the March 31, 2025, deadline, leading to a suspension of trading and delisting from Nasdaq effective April 2, 2025. The company continues to trade on the Toronto Stock Exchange (TSX) and also gained access to the OTCQB Market.
| Exchange/Market | Symbol | Status as of Late 2025 | Latest Reported Price/Value |
|---|---|---|---|
| Toronto Stock Exchange (TSX) | APS | Continued Listing | Last Price: $2.29 (as of Nov 24, 2025) |
| OTCQB Market (U.S.) | APTOF | Began trading on July 1, 2025 | N/A |
| Nasdaq Capital Market | APTO | Delisted effective April 2, 2025 | N/A |
Financing activity in 2025 included a significant corporate event near the end of the year: an Arrangement Agreement announced on November 19, 2025, for acquisition by Hanmi Pharmaceutical at C$2.41 per share cash. This offer represented a 28% premium to the 30-day VWAP of C$1.88 on the TSX. Earlier in the year, the company implemented a 1-for-30 reverse stock split effective February 26, 2025.
SEC/TSX Filings: Official communication channel for financial and corporate news
Regulatory filings are the formal, mandated channel for disclosing financial health and material corporate events to the public and regulators (SEC in the U.S. and SEDAR/TSX in Canada). These documents provide the hard numbers on the company's operational burn and cash runway.
As of the third quarter end, the financial picture showed no revenue, which is common for pre-commercial biotechs, but also a shrinking cash position and a working capital deficit.
- Latest Quarterly Report (10-Q) filed: November 13, 2025.
- Latest Current Report (8-K) filed: November 25, 2025 (reporting the acquisition agreement).
- Shareholders' Deficit as of September 30, 2025: $19.5 million.
- Cash, Cash Equivalents, and Restricted Cash as of September 30, 2025: $1.6 million.
- Net Loss for Q3 2025: $5.1 million.
- Cash Used in Operating Activities for the first nine months of 2025: $16.1 million.
- Common Shares Outstanding as of November 7, 2025: 2,552,429.
Finance: draft 13-week cash view by Friday.
Aptose Biosciences Inc. (APTO) - Canvas Business Model: Customer Segments
Newly Diagnosed AML Patients: Primary focus for the TUSCANY triplet therapy.
The TUSCANY Phase 1/2 clinical study targets patients with newly diagnosed Acute Myeloid Leukemia (AML) ineligible to receive induction chemotherapy.
- Anticipated enrollment of 18-24 patients by mid-late 2025.
- Data reported from 10 patients across three dose cohorts (40 mg, 80 mg, or 120 mg tuspetinib in TUS+VEN+AZA).
- Overall CR/CRh responses achieved in 9/10 patients.
- Dosing escalated to the 160 mg TUS dose level.
Relapsed/Refractory AML Patients: Target for initial tuspetinib monotherapy and combination trials.
Earlier APTIVATE trials of tuspetinib as a single agent and in combination as TUS+VEN demonstrated activity in diverse relapsed or refractory (R/R) AML populations.
- More than 170 patients were treated across the TUS single agent dose escalation and the TUS+VEN doublet APTIVATE studies, which were completed during 2024.
The following table summarizes key clinical data points relevant to the patient segments as of late 2025:
| Metric | TUSCANY Trial (Newly Diagnosed AML) | VEN+AZA Alone Expected Rate |
| CR/CRh Response (80mg & 120mg cohorts) | 6/6 (100%) | 66% |
| Overall CR/CRh Response (All cohorts) | 9/10 (90%) | N/A |
| MRD-Negativity (Among Responders) | 7/9 (78%) | N/A |
Hematology/Oncology Specialists: Physicians and clinical centers running the trials.
These specialists are the investigators administering the investigational product and enrolling patients in the clinical studies.
- The TUSCANY Phase 1/2 study is being conducted at 10 leading U.S. clinical sites.
Strategic Biopharma Acquirers: Hanmi Pharmaceutical, the announced acquirer.
Hanmi Pharmaceutical entered a definitive arrangement agreement to acquire the remaining stake in Aptose Biosciences Inc. on November 19, 2025.
| Transaction Detail | Value/Percentage |
| Cash per Common Share for Minority Shareholders | C$2.41 |
| Premium over 30-day VWAP (C$1.88) | 28% |
| Hanmi Ownership Pre-Acquisition | 19.93% |
| Debt Facilities Provided to Aptose (Past 18 months) | More than US$30 million |
Aptose Biosciences Inc. reported a net loss of $5.12 million for the third quarter ended September 30, 2025. Total Assets were reported at $6.34 million as of September 30, 2025, with cash and cash equivalents at $1.6 million at quarter-end. The shareholders' deficit widened to $(19.45 million) at September 30, 2025.
Aptose Biosciences Inc. (APTO) - Canvas Business Model: Cost Structure
You're looking at the core expenditures for Aptose Biosciences Inc. as of late 2025, which is almost entirely driven by the pursuit of clinical success for its pipeline assets. For a clinical-stage biotech, the cost structure is a direct reflection of its R&D strategy and cash runway management.
The primary burn comes from Research and Development, but General and Administrative costs are also significant overhead you need to track. Here's the quick math on the major components based on the third quarter results ending September 30, 2025.
Research and Development (R&D): Primary expenditure
R&D expenses for the third quarter of 2025 were reported at $2.20 million. This figure actually represents a notable decrease compared to the $4.7 million reported in Q3 2024, which the company attributed to lower Tuspetinib program costs and a headcount reduction. For the first nine months of 2025, total R&D spend reached $7.9 million, down significantly from $15.6 million in the same period last year. That's a clear sign of cost-cutting measures impacting the burn rate.
General and Administrative (G&A): Overhead and corporate costs
General and Administrative costs for Q3 2025 were $2.70 million. This was slightly higher than the $2.3 million seen in Q3 2024, primarily due to ongoing operating and personnel costs. Year-to-date through nine months of 2025, G&A totaled $9.4 million, up from $8.5 million in the prior year period.
You can see the direct comparison of these two main cost drivers below:
| Cost Category | Q3 2025 Amount (USD) | Nine Months Ended Sep 30, 2025 Amount (USD) |
| Research and Development (R&D) | $2.20 million | $7.9 million |
| General and Administrative (G&A) | $2.70 million | $9.4 million |
Clinical Trial Expenses
Clinical trial expenses are embedded within the R&D line item, as they cover patient enrollment, drug manufacturing for trials, and site monitoring for ongoing studies like the TUSCANY trial involving tuspetinib for newly diagnosed Acute Myeloid Leukemia (AML). The reduction in Q3 R&D spend directly reflects lower costs associated with the Tuspetinib program. The focus here is on maximizing the efficiency of patient recruitment and trial execution to meet data readouts.
- Costs tied to Tuspetinib program activities.
- Drug manufacturing for ongoing clinical sites.
- Site monitoring and patient management fees.
- Stock-based compensation related to R&D personnel was $0.4 million for the nine months ended September 30, 2025.
Financing Costs: Expenses related to capital raises and loan interest
For a company with no reported revenue in Q3 2025, financing activities are critical to sustaining operations. Cash used in operating activities for the first nine months of 2025 was $16.1 million. To offset this, cash provided by financing activities totaled $11.1 million over the same nine-month period. This financing cash inflow was mainly sourced from two areas:
- A related party loan from Hanmi Pharmaceutical amounting to $10.4 million.
- Equity issuances, including $828,000 raised under the 2025 ATM facility.
The total related party loan balance from Hanmi increased to $18.7 million as of September 30, 2025. What this estimate hides is the actual interest expense paid, but the cash flow statement shows the reliance on debt and equity to fund the deficit. Finance: draft 13-week cash view by Friday.
Aptose Biosciences Inc. (APTO) - Canvas Business Model: Revenue Streams
You're looking at the revenue side of Aptose Biosciences Inc. (APTO) as of late 2025, and honestly, it's a story of non-product funding sources keeping the lights on while tuspetinib moves through trials. Since Aptose Biosciences Inc. remains clinical-stage, product sales revenue is exactly what you'd expect.
Current Revenue
Aptose Biosciences Inc. reported $0 in revenue for the three and nine months ended September 30, 2025. This is standard for a company focused entirely on clinical development, meaning all operational cash flow must come from external sources. The company posted a net loss of $17.71 million for the nine months ended September 30, 2025. By September 30, 2025, cash, cash equivalents, and restricted cash stood at $1.6 million, though this figure was reported to be approximately $2.2 million as of early November 2025.
Financing Proceeds and Debt/Loan Advances
The primary lifeblood for Aptose Biosciences Inc. has been capital raised through various financing and debt arrangements, predominantly with its major shareholder, Hanmi Pharmaceutical Co. Ltd. For the first nine months of 2025, financing activities provided $11.1 million in cash. This inflow was mainly driven by related-party loans, with equity issuances contributing the remainder.
Here's a quick breakdown of the key cash inflows that constitute the current revenue streams:
| Source of Funds | Amount Reported | Date/Period Reference |
| Total Cash from Financing Activities | $11.1 million | Nine Months Ended September 30, 2025 |
| Cash from Related Party Loan (Component of Financing) | $10.4 million | Nine Months Ended September 30, 2025 |
| Cash from Equity Issuances (Component of Financing) | Approx. $0.7 million | Nine Months Ended September 30, 2025 |
| Total Drawn from June 2025 Hanmi Loan Facility | US$8.5 million | By September 2025 |
| Total Available under September 2025 Hanmi Loan Facility | US$11.9 million | As of September 22, 2025 |
The June 2025 Loan Agreement with Hanmi Pharmaceutical Co. Ltd. was an uncommitted facility for up to US$8.5 million, and by the time the September 2025 agreement was announced, the final advance of US$1.4 million had been received, bringing the total drawn under the prior agreement to US$5.6 million by Q2 2025, and ultimately US$8.5 million total drawn from that facility. The subsequent September 2025 Facility Agreement increased the total available loan amount to US$11.9 million, with advances capped at US$2,000,000 each, accruing interest at six percent (6%) per annum.
The financing activities in 2024 included a public offering that closed in November 2024, which brought in aggregate gross proceeds of $8 million.
Acquisition Proceeds
The most significant near-term financial event is the announced acquisition by Hanmi Pharmaceutical Co. Ltd. on November 19, 2025. This transaction structure dictates the final cash realization for most shareholders, effectively converting equity into a final cash payout.
The key terms related to this future cash event are:
- Minority shareholders are set to receive C$2.41 in cash per Common Share.
- This offer represents a 28% premium over the 30-day Volume Weighted Average Price (VWAP) of C$1.88.
- Hanmi already owned 19.93% of the outstanding Common Shares prior to the agreement.
- A termination expense fee of C$300,000 is payable to Hanmi Purchaser under certain conditions.
Finance: draft 13-week cash view by Friday.
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