Aptose Reports Second Quarter 2025 Results [Company Overview and Recent Developments](index=1&type=section&id=Company%20Overview%20and%20Recent%20Developments) Aptose reported Q2 2025 results, detailing TUSCANY triplet trial progress, tuspetinib dose escalation, a Hanmi loan, and OTCQB upgrade [Introduction and CEO Commentary](index=1&type=section&id=Introduction%20and%20CEO%20Commentary) Aptose reported Q2 2025 results, with CEO highlighting TUSCANY trial progress and tuspetinib's safety and activity in AML - Aptose Biosciences, a clinical-stage precision oncology company, announced Q2 2025 financial results and a corporate update. The company is developing **tuspetinib (TUS)-based triple drug frontline therapy** for newly diagnosed acute myeloid leukemia (AML)[2](index=2&type=chunk) - CEO Dr. William G. Rice noted the TUSCANY triplet trial's good progress, observing exciting safety and activity with **TUS added to VEN+AZA standard treatment** for difficult-to-treat AML mutations[3](index=3&type=chunk) [Key Corporate Highlights](index=1&type=section&id=Key%20Corporate%20Highlights) Tuspetinib showed excellent safety and CRs in TUSCANY, leading to 160 mg dose escalation; Hanmi loan secured, and OTCQB upgrade [Tuspetinib (TUS) Clinical Trial Updates](index=1&type=section&id=Tuspetinib%20(TUS)%20Clinical%20Trial%20Updates) Tuspetinib demonstrated excellent safety and complete responses in TUSCANY at 120 mg, leading to 160 mg dose escalation, with promising EHA 2025 data - Tuspetinib continues to demonstrate **excellent safety and complete responses (CRs)** in the TUSCANY clinical trial at the 120 mg dose[5](index=5&type=chunk)[6](index=6&type=chunk) - The Cohort Safety Review Committee (CSRC) recommended tuspetinib dose escalation to **160 mg**[5](index=5&type=chunk)[6](index=6&type=chunk) - Data from the first two cohorts (40 mg and 80 mg TUS+VEN+AZA) showed promising clinical safety and antileukemic activity, presented at EHA 2025, with **multiple CRs (3 of 4 at 40mg, 3 of 3 at 80mg)** and MRD-negative responses across diverse genetic populations[6](index=6&type=chunk) - Aptose's abstract on the TUSCANY study was accepted for a poster presentation at the ESH 7th International Conference in October 2025[6](index=6&type=chunk) [Corporate and Financial Milestones](index=2&type=section&id=Corporate%20and%20Financial%20Milestones) Aptose secured a loan agreement with Hanmi Pharmaceutical for up to US$8.5 million and upgraded its trading to the OTCQB Market - Aptose entered an uncommitted loan agreement with Hanmi Pharmaceutical Co. Ltd. for up to **US$8.5 million** to fund tuspetinib clinical development[8](index=8&type=chunk) - To date, Aptose has received an aggregate of **US$5.6 million** under the loan agreement[8](index=8&type=chunk) - On July 1, Aptose upgraded its listing to the **OTCQB Market** under the ticker symbol "APTOF," while maintaining its TSX listing[8](index=8&type=chunk) - Aptose's Board of Directors approved the selection of Ernst & Young LLP ("EY") as the Company's new independent auditor, with a shareholder meeting reconvened for August 22, 2025, to vote on the appointment[8](index=8&type=chunk) [Completed and Planned Value-Creating Milestones](index=2&type=section&id=Completed%20and%20Planned%20Value-Creating%20Milestones) Aptose outlined 2025 milestones, including reporting maturing TUS+VEN+AZA triplet study data and preparing for Phase 2/3 pivotal trials - **2025 1H Milestones:** * Reported maturing data from TUS+VEN+AZA triplet study at EHA[7](index=7&type=chunk)[8](index=8&type=chunk)[9](index=9&type=chunk) * Reported safety and efficacy with 40mg, 80mg, and 120mg TUS+VEN+AZA[7](index=7&type=chunk)[8](index=8&type=chunk)[9](index=9&type=chunk) * CSRC review of data and decision to dose escalate to 160 mg TUS+VEN+AZA[7](index=7&type=chunk)[8](index=8&type=chunk)[9](index=9&type=chunk) - **2025 2H Planned Milestones:** * Report evolving data from 120 mg TUS+VEN+AZA triplet[7](index=7&type=chunk)[9](index=9&type=chunk) * Report response rate and durability of TUS+VEN+AZA triplet[7](index=7&type=chunk)[9](index=9&type=chunk) * Select TUS dose for TUS+VEN+HMA triplet Ph 2/3 PIVOTAL trials[7](index=7&type=chunk)[9](index=9&type=chunk) * Prepare for initiation of Ph 2/3 PIVOTAL program[7](index=7&type=chunk)[9](index=9&type=chunk) * Report maturing data from TUS+VEN+AZA triplet study at ASH[7](index=7&type=chunk)[9](index=9&type=chunk) [Financial Results of Operations](index=2&type=section&id=FINANCIAL%20RESULTS%20OF%20OPERATIONS) Aptose reported a decreased net loss for Q2 and H1 2025, driven by reduced R&D expenses, but maintains a low cash position [Statements of Operations Data](index=3&type=section&id=Statements%20of%20Operations%20Data) For Q2 2025, Aptose's net loss decreased to $7.0 million from $7.3 million in Q2 2024, with H1 2025 net loss decreasing to $12.6 million from $16.9 million | Metric (in thousands) | Three months ended June 30, 2025 | Three months ended June 30, 2024 | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :-------------------- | :------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | | Research and development | $3,298 | $4,413 | $5,662 | $10,858 | | General and administrative | $3,623 | $2,932 | $6,720 | $6,247 | | Operating expenses | $6,921 | $7,345 | $12,382 | $17,105 | | Other (loss) income, net | $(122) | $93 | $(204) | $213 | | Net loss | $(7,043) | $(7,252) | $(12,586) | $(16,892) | | Net loss per share, basic and diluted | $(2.76) | $(12.99) | $(5.38) | $(33.91) | - Net loss for Q2 2025 decreased by **$0.2 million to $7.0 million** (from $7.3 million in Q2 2024)[11](index=11&type=chunk) - Net loss for the six months ended June 30, 2025, decreased by **$4.3 million to $12.6 million** (from $16.9 million in the comparable period of 2024)[11](index=11&type=chunk) [Balance Sheet Data](index=3&type=section&id=Balance%20Sheet%20Data) As of June 30, 2025, Aptose reported $1.3 million in cash, a significant decrease from December 31, 2024, alongside negative working capital and growing deficits | Metric (in thousands) | June 30, 2025 | December 31, 2024 | | :-------------------- | :------------ | :---------------- | | Cash, cash equivalents and restricted cash equivalents | $1,298 | $6,707 | | Working capital | $(5,729) | $5,053 | | Total assets | $5,591 | $10,127 | | Long-term liabilities | $10,962 | $10,193 | | Accumulated deficit | $(553,553) | $(540,967) | | Shareholders' deficit | $(14,371) | $(4,543) | [Research and Development Expenses Analysis](index=4&type=section&id=RESEARCH%20AND%20DEVELOPMENT%20EXPENSES) R&D expenses significantly decreased by $1.1 million (QoQ) and $5.2 million (YoY) for Q2 and H1 2025, primarily due to reduced tuspetinib program costs and lower personnel expenses | R&D Component (in thousands) | Three months ended June 30, 2025 | Three months ended June 30, 2024 | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :--------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | | Program costs – Tuspetinib | $2,233 | $2,666 | $3,712 | $6,589 | | Program costs – Luxeptinib | $100 | $304 | $198 | $512 | | Program costs – APTO-253 | $- | $(9) | $- | $13 | | Personnel related expenses | $952 | $1,379 | $1,598 | $3,333 | | Stock-based compensation | $13 | $70 | $154 | $398 | | Depreciation of equipment | $- | $3 | $- | $13 | | **Total R&D Expenses** | **$3,298** | **$4,413**

PART I—FINANCIAL INFORMATION [Item 1 – Financial Statements](index=4&type=section&id=Item%201%20%E2%80%93%20Financial%20Statements) Presents Aptose Biosciences Inc.'s unaudited interim financial statements, emphasizing significant accumulated deficit and going concern risk - The company's financial statements are prepared assuming it will continue as a **going concern**, despite **substantial doubt** due to **insufficient cash** to fund operations and **reliance on related party advances**[24](index=24&type=chunk) Key Financial Position Data (June 30, 2025 vs. December 31, 2024) | Metric | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :----------------------------- | :----------------------------- | :----------------------------- | | Cash and cash equivalents | $553 | $6,152 | | Total current assets | $3,271 | $9,530 | | Total assets | $5,591 | $10,127 | | Total current liabilities | $9,000 | $4,477 | | Total liabilities | $19,962 | $14,670 | | Total shareholders' deficit | $(14,371) | $(4,543) | Key Loss and Comprehensive Loss Data (Six Months Ended June 30, 2025 vs. 2024) | Metric | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | | :-------------------------------- | :-------------------------------------------- | :-------------------------------------------- | | Revenue | $— | $— | | Research and development expenses | $5,662 | $10,858 | | General and administrative expenses | $6,720 | $6,247 | | Net loss | $(12,586) | $(16,892) | | Basic and diluted loss per common share | $(5.38) | $(33.91) | [Condensed Consolidated Interim Statements of Financial Position](index=7&type=section&id=Condensed%20Consolidated%20Interim%20Statements%20of%20Financial%20Position) Details the company's financial position, including assets, liabilities, and shareholders' deficit, at June 30, 2025, and December 31, 2024 Condensed Consolidated Interim Statements of Financial Position (June 30, 2025 vs. December 31, 2024) | Metric | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :-------------------------- | :----------------------------- | :----------------------------- | | Cash and cash equivalents | $553 | $6,152 | | Restricted cash equivalents | $745 | $555 | | Total current assets | $3,271 | $9,530 | | Total assets | $5,591 | $10,127 | | Accounts payable | $2,879 | $1,258 | | Accrued liabilities | $5,414 | $2,773 | | Total current liabilities | $9,000 | $4,477 | | Loan payable to related party | $10,962 | $10,000 | | Total liabilities | $19,962 | $14,670 | | Total shareholders' deficit | $(14,371) | $(4,543) | [Condensed Consolidated Interim Statements of Loss and Comprehensive Loss](index=8&type=section&id=Condensed%20Consolidated%20Interim%20Statements%20of%20Loss%20and%20Comprehensive%20Loss) Presents the company's net loss and comprehensive loss for the three and six months ended June 30, 2025, and 2024 Condensed Consolidated Interim Statements of Loss and Comprehensive Loss (Three and Six Months Ended June 30, 2025 vs. 2024) | Metric | 3 Months Ended June 30, 2025 (in thousands) | 3 Months Ended June 30, 2024 (in thousands) | 6 Months Ended June 30, 2025 (in thousands) | 6 Months Ended June 30, 2024 (in thousands) | | :-------------------------------------------- | :------------------------------------------ | :------------------------------------------ | :------------------------------------------ | :------------------------------------------ | | Revenue | $— | $— | $— | $— | | Research and development | $3,298 | $4,413 | $5,662 | $10,858 | | General and administrative | $3,623 | $2,932 | $6,720 | $6,247 | | Net loss | $(7,043) | $(7,252) | $(12,586) | $(16,892) | | Basic and diluted loss per common share | $(2.76) | $(12.99) | $(5.38) | $(33.91) | [Condensed Consolidated Interim Statements of Changes in Shareholders' Deficit](index=9&type=section&id=Condensed%20Consolidated%20Interim%20Statements%20of%20Changes%20in%20Shareholders%27%20Deficit) Summarizes changes in shareholders' deficit for the six months ended June 30, 2025, including equity transactions and net loss Changes in Shareholders' Deficit (Six Months Ended June 30, 2025) | Item | Shares (June 30, 2025) | Amount (June 30, 2025, in thousands) | | :------------------------------------ | :--------------------- | :----------------------------------- | | Balance, December 31, 2024 | 2,006,028 | $457,404 | | Common shares issued under the ESPP | 338 | $1 | | Common shares issued under 2025 ATM | 137,000 | $828 | | Common shares issued pursuant to Hanmi debt conversion | 409,063 | $1,538 | | Stock-based compensation | — | $391 | | Net loss | — | $(12,586) | | Balance, June 30, 2025 | 2,552,429 | $459,771 | - The company's accumulated deficit increased from **$540.967 million** at December 31, 2024, to **$553.553 million** at June 30, 2025, reflecting **ongoing net losses**[19](index=19&type=chunk) [Condensed Consolidated Interim Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Interim%20Statements%20of%20Cash%20Flows) Presents the company's cash flows from operating, investing, and financing activities for the six months ended June 30, 2025, and 2024 Cash Flow Summary (Six Months Ended June 30, 2025 vs. 2024) | Cash Flow Activity | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | | :-------------------------------- | :-------------------------------------------- | :-------------------------------------------- | | Operating activities | $(8,738) | $(17,541) | | Financing activities | $3,329 | $16,601 | | Investing activities | $— | $18 | | Net decrease in cash, cash equivalents and restricted cash equivalents | $(5,409) | $(922) | | Cash, cash equivalents, and restricted cash, end of period | $1,298 | $8,330 | - Cash used in operating activities decreased significantly from **$17.5 million** in H1 2024 to **$8.7 million** in H1 2025, primarily due to **reduced operating expenses** and an **increase in accrued liabilities**[21](index=21&type=chunk)[184](index=184&type=chunk) - Cash provided by financing activities decreased from **$16.6 million** in H1 2024 to **$3.3 million** in H1 2025, with 2025 financing primarily from **Hanmi Facility Agreement advances** and **2025 ATM share issuance**[21](index=21&type=chunk)[186](index=186&type=chunk)[187](index=187&type=chunk) [Notes to Condensed Consolidated Interim Financial Statements](index=11&type=section&id=Notes%20to%20Condensed%20Consolidated%20Interim%20Financial%20Statements) Provides detailed explanations and disclosures supporting the interim financial statements, including significant accounting policies and specific accounts [Note 1. Reporting entity](index=11&type=section&id=Note%201.%20Reporting%20entity) Describes Aptose Biosciences Inc. as a clinical-stage biotechnology company focused on developing precision oncology medicines - Aptose Biosciences Inc. is a science-driven, **clinical-stage biotechnology company** focused on developing **precision medicines for oncology**, particularly **hematology**[22](index=22&type=chunk) - The company's pipeline includes **two clinical-stage investigational products** for hematological malignancies: **tuspetinib** (lead agent, myeloid kinase inhibitor) and **luxeptinib** (dual lymphoid and myeloid kinase inhibitor)[23](index=23&type=chunk) [Note 2. Significant accounting policies](index=11&type=section&id=Note%202.%20Significant%20accounting%20policies) Outlines the key accounting policies and estimates used in preparing the financial statements, including the going concern assumption - On **February 26, 2025**, the Company effected a **1-for-30 reverse stock split** of its Common Shares, retroactively adjusted for all periods presented[24](index=24&type=chunk) - **Substantial doubt** exists about the Company's ability to continue as a **going concern** due to **insufficient cash** to fund operations and **reliance on advances from Hanmi**[24](index=24&type=chunk)[215](index=215&type=chunk) - The Company incurred a **net loss of $12.6 million** for the six months ended June 30, 2025, and had an **accumulated deficit of $553.6 million**, **negative working capital of $5.7 million**, and **negative shareholders' equity of $14.4 million** as of June 30, 2025[26](index=26&type=chunk) [Note 3. Cash and cash equivalents](index=13&type=section&id=Note%203.%20Cash%20and%20cash%20equivalents) Details the composition and changes in the company's cash and cash equivalents as of June 30, 2025, and December 31, 2024 Cash and Cash Equivalents (in thousands) | Metric | June 30, 2025 | December 31, 2024 | | :-------------------------- | :------------ | :---------------- | | Cash | $600 | $1,500 | | High interest savings accounts, money market funds | $0 | $4,700 | | Total | $600 | $6,200 | - Cash and cash equivalents significantly decreased from **$6.2 million** at December 31, 2024, to **$0.6 million** at June 30, 2025[33](index=33&type=chunk) [Note 4. Restricted cash equivalents](index=14&type=section&id=Note%204.%20Restricted%20cash%20equivalents) Provides details on restricted cash equivalents, primarily related to unspent proceeds from the Hanmi Facility Agreement Restricted Cash Equivalents (in thousands) | Metric | June 30, 2025 | December 31, 2024 | | :-------------------------- | :------------ | :---------------- | | Restricted cash balance | $700 | $600 | - Restricted cash equivalents were **$0.7 million** as of June 30, 2025, primarily reflecting **unspent proceeds from the Hanmi Facility Agreement**[34](index=34&type=chunk)[36](index=36&type=chunk) - Proceeds from the **$10.0 million Hanmi Loan Agreement** (August 2024) were **fully utilized** for Tuspetinib-related operations by June 30, 2025[35](index=35&type=chunk) - Hanmi provided an **uncommitted facility of up to $8.5 million** (Hanmi Facility Agreement, June 2025) for Tuspetinib development and operations, with **advances up to $2.5 million** each until December 31, 2025[36](index=36&type=chunk) [Note 5. Prepaid expenses](index=14&type=section&id=Note%205.%20Prepaid%20expenses) Details the composition and changes in the company's prepaid expenses as of June 30, 2025, and December 31, 2024 Prepaid Expenses (in thousands) | Category | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | Prepaid research and development | $651 | $1,648 | | Prepaid insurance | $218 | $558 | | Other prepaid operating expenses | $988 | $47 | | Total | $1,857 | $2,253 | - Total prepaid expenses decreased from **$2.253 million** at December 31, 2024, to **$1.857 million** at June 30, 2025, mainly due to a **reduction in prepaid R&D and insurance**[37](index=37&type=chunk) [Note 6. Right-of-use assets, operating leases](index=14&type=section&id=Note%206.%20Right-of-use%20assets%2C%20operating%20leases) Details the company's right-of-use assets for operating leases as of June 30, 2025, and December 31, 2024 Right-of-Use Assets, Operating Leases (in thousands) | Metric | June 30, 2025 | December 31, 2024 | | :-------------------------- | :------------ | :---------------- | | Right-of-use assets, net | $377 | $571 | - Net right-of-use assets for operating leases decreased from **$0.571 million** at December 31, 2024, to **$0.377 million** at June 30, 2025, reflecting **accumulated amortization**[38](index=38&type=chunk) [Note 7. Fair value measurements and financial instruments](index=15&type=section&id=Note%207.%20Fair%20value%20measurements%20and%20financial%20instruments) Discusses the fair value measurements of the company's financial instruments as of June 30, 2025, and December 31, 2024 Fair Value of Assets (in thousands) | Asset | June 30, 2025 | December 31, 2024 | | :-------------------------- | :------------ | :---------------- | | High interest savings accounts | $0 | $5,201 | - The Company had **no assets measured at fair value** on a recurring basis as of June 30, 2025, compared to **$5.2 million** in high-interest savings accounts at December 31, 2024[40](index=40&type=chunk) [Note 8. Accrued liabilities](index=15&type=section&id=Note%208.%20Accrued%20liabilities) Details the composition and changes in the company's accrued liabilities as of June 30, 2025, and December 31, 2024 Accrued Liabilities (in thousands) | Category | June 30, 2025 | December 31, 2024 | | :-------------------------- | :------------ | :---------------- | | Accrued personnel related costs | $2,197 | $982 | | Accrued research and development expenses | $3,067 | $1,647 | | Other accrued expenses | $150 | $144 | | Total | $5,414 | $2,773 | - Total accrued liabilities increased significantly from **$2.773 million** at December 31, 2024, to **$5.414 million** at June 30, 2025, driven by **higher personnel and R&D related costs**[41](index=41&type=chunk) [Note 9. Lease liability](index=15&type=section&id=Note%209.%20Lease%20liability) Details the company's lease liabilities, including current and long-term portions, as of June 30, 2025, and December 31, 2024 Lease Liabilities (in thousands) | Metric | June 30, 2025 | December 31, 2024 | | :-------------------------- | :------------ | :---------------- | | Lease liability, current portion | $413 | $428 | | Lease liability, long-term portion | $0 | $193 | | Total | $413 | $621 | - The weighted-average remaining term of operating leases decreased from **1.4 years** at December 31, 2024, to **0.9 years** at June 30, 2025, with the weighted-average discount rate remaining at **7.90%**[44](index=44&type=chunk) [Note 10. Related party transactions](index=17&type=section&id=Note%2010.%20Related%20party%20transactions) Details significant transactions and agreements with related parties, primarily Hanmi, including licensing, loan, and facility agreements - Aptose has a licensing agreement with Hanmi for tuspetinib, involving an upfront payment (**$5.0M cash**, **$7.5M shares**) and potential future milestone payments up to **$407.5 million** plus tiered royalties[45](index=45&type=chunk) - Hanmi provided a **$10.0 million loan** (Hanmi Loan Agreement, August 2024) for Tuspetinib operations, repayable by January 31, 2027, at **6% interest**[48](index=48&type=chunk) - In March 2025, **$1.5 million** of Hanmi's loan indebtedness was converted into **409,063 Common Shares** at **$3.70 per share**[49](index=49&type=chunk) - Hanmi provided an **uncommitted facility of up to $8.5 million** (Hanmi Facility Agreement, June 2025) for Tuspetinib development and operations, with **$5.6 million received** as of the filing date[52](index=52&type=chunk) - The CEO provided a **$100,000 interest-free short-term advance** on June 17, 2025, which was repaid in full on June 26, 2025[55](index=55&type=chunk) [Note 11. Share capital](index=19&type=section&id=Note%2011.%20Share%20capital) Details the company's common share activity, including issuances, outstanding shares, and impact on loss per share - As of June 30, 2025, the Company had **2,552,429 common shares** issued and outstanding, up from **2,006,028** at December 31, 2024[15](index=15&type=chunk)[19](index=19&type=chunk) - The Company entered into a 2025 Committed Equity Facility with Keystone for up to **$25 million** in Common Shares and a 2025 At-The-Market (ATM) Facility with AGP for up to **$1.0 million** in Common Shares[57](index=57&type=chunk)[59](index=59&type=chunk) - In November 2024, the Company completed a public offering of **1,333,333 Common Shares** and warrants, generating **$8.0 million gross proceeds**[60](index=60&type=chunk) - Basic and diluted loss per common share for the six months ended June 30, 2025, was **$(5.38)**, significantly lower than **$(33.91)** for the same period in 2024, partly due to the **increased weighted average number of common shares outstanding**[75](index=75&type=chunk) [Note 12. Warrants](index=25&type=section&id=Note%2012.%20Warrants) Details the company's outstanding warrants, their exercise terms, and potential dilutive effects on common shares Warrant Activity (Six Months Ended June 30, 2025) | Metric | Common Shares Issuable upon Exercise | Weighted average exercise price | Weighted average remaining contractual life (years) | | :-------------------------- | :----------------------------------- | :------------------------------ | :------------------------------------------------ | | Outstanding, beginning of period | 1,267,585 | $22.40 | 4.4 | | Outstanding, end of period | 1,267,585 | $22.40 | 3.8 | - As of June 30, 2025, **1,267,585 Common Shares** were issuable upon the exercise of outstanding warrants, which could **dilute existing shareholders**[76](index=76&type=chunk) [Note 13. Stock‑based compensation](index=25&type=section&id=Note%2013.%20Stock%E2%80%91based%20compensation) Details the company's stock-based compensation expense and unrecognized compensation costs related to non-vested stock options - The Company recorded **$0.391 million** in share-based compensation expense for the six months ended June 30, 2025, down from **$1.016 million** in the prior year period[19](index=19&type=chunk)[87](index=87&type=chunk) - As of June 30, 2025, there was **$0.2 million** of total unrecognized compensation cost related to non-vested stock options, expected to be recognized over an estimated weighted-average period of **1.2 years**[84](index=84&type=chunk) [Note 14. Subsequent events](index=27&type=section&id=Note%2014.%20Subsequent%20events) Reports significant events occurring after the reporting period, including additional advances received from Hanmi - After June 30, 2025, Aptose received additional advances of **$2.0 million** (July 15, 2025) and **$1.1 million** (August 4, 2025) from Hanmi under the Hanmi Facility Agreement, bringing the total advances to **$5.6 million**[88](index=88&type=chunk) [Item 2 – Management's Discussion and Analysis of Financial Condition and Results of Operations](index=28&type=section&id=Item%202%20%E2%80%93%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Discusses Aptose Biosciences Inc.'s business, clinical programs, corporate developments, financial condition, liquidity, and results of operations - Aptose is a **clinical-stage biotechnology company** focused on developing **precision medicines for hematologic oncology**, with executive offices in San Diego, California, and head office in Toronto, Canada[92](index=92&type=chunk) - The company **does not currently generate revenues** from drug candidates and **relies on equity financing and strategic partners** to fund R&D and commercialization[152](index=152&type=chunk)[157](index=157&type=chunk) - As of the filing date, the company **lacks sufficient cash** to fund operations and **depends on advances from Hanmi**, raising **substantial doubt** about its ability to continue as a **going concern**[152](index=152&type=chunk)[159](index=159&type=chunk)[161](index=161&type=chunk) [Overview](index=28&type=section&id=Overview) Provides a general overview of Aptose's business, strategic focus, and clinical development programs, particularly for Tuspetinib and Luxeptinib - Aptose's lead program, **Tuspetinib**, is an **oral myeloid kinase inhibitor** being developed for **frontline combination therapy** in newly diagnosed **Acute Myeloid Leukemia (AML)** patients[93](index=93&type=chunk) - **Tuspetinib** is positioned as an **ideal third agent** for addition to the **VEN+HMA backbone therapy** (TUS+VEN+HMA triplet) due to its **broad activity** across AML populations, **favorable safety profile**, and ability to avoid typical toxicities[94](index=94&type=chunk) - **Luxeptinib development has been paused** due to **current funding constraints** and **prioritization of tuspetinib**, despite a new G3 formulation showing improved absorption[101](index=101&type=chunk)[143](index=143&type=chunk) [Program Updates](index=30&type=section&id=Program%20Updates) Provides updates on the clinical development status and progress of the company's investigational product candidates, Tuspetinib and Luxeptinib [Tuspetinib](index=30&type=section&id=Tuspetinib) Details the clinical development progress of Tuspetinib, including trial status, key findings, and regulatory designations - **Tuspetinib** is in a U.S.-based **Phase 1/2 clinical trial (TUSCANY Study)** as a **TUS+VEN+HMA triplet** in newly diagnosed AML patients, with **dose escalation approved up to 160 mg**[95](index=95&type=chunk)[103](index=103&type=chunk)[108](index=108&type=chunk) - The TUSCANY study has shown **complete remissions (CRs)** and **MRD-negativity** in difficult-to-treat AML patients across 40 mg, 80 mg, and 120 mg TUS doses, with **no significant safety concerns or dose-limiting toxicities**[95](index=95&type=chunk)[111](index=111&type=chunk)[116](index=116&type=chunk) - **Tuspetinib** received **Orphan Drug Designation** from the FDA in October 2018 for AML, providing benefits like tax credits, grant opportunities, and **seven years of marketing exclusivity**[104](index=104&type=chunk) - Aptose is **collaborating with the National Cancer Institute (NCI)** on the clinical development of tuspetinib in **NCI-sponsored myeloMATCH trials** for molecularly defined AML and MDS populations[105](index=105&type=chunk)[106](index=106&type=chunk) - Preclinical studies indicate **tuspetinib targets venetoclax (VEN) resistance mechanisms** and, in combination with VEN, could **prevent the emergence of resistance to both agents**[128](index=128&type=chunk)[136](index=136&type=chunk)[137](index=137&type=chunk) [Luxeptinib](index=46&type=section&id=Luxeptinib) Provides an update on the development status of Luxeptinib, noting the pause in funding due to strategic prioritization - **Funding for luxeptinib development has been paused** due to **current financial constraints** and the **prioritization of tuspetinib**[101](index=101&type=chunk)[143](index=143&type=chunk) [Other corporate matters](index=46&type=section&id=Other%20corporate%20matters) Discusses various corporate developments, including compliance issues with Nasdaq listing requirements and subsequent delisting [Nasdaq private placement deficiency requirement](index=46&type=section&id=Nasdaq%20private%20placement%20deficiency%20requirement) Addresses the Nasdaq deficiency related to a private placement to Hanmi and the company's subsequent actions to regain compliance - The Company received a **Nasdaq deficiency letter** in February 2024 for **violating Rule 5635(d)** due to a **private placement to Hanmi without shareholder approval**[144](index=144&type=chunk) - Aptose **regained compliance** by April 2024 after **amending the warrant agreement** with Hanmi to prohibit exercise beyond the **19.99% Nasdaq cap** without shareholder approval[145](index=145&type=chunk) [Nasdaq Minimum Bid Price requirement](index=46&type=section&id=Nasdaq%20Minimum%20Bid%20Price%20requirement) Discusses the Nasdaq deficiency related to the minimum bid price and the company's actions, including a reverse stock split, to regain compliance - Aptose received a **Nasdaq deficiency letter** in July 2024 for failing to meet the **minimum $1.00 bid price requirement**[146](index=146&type=chunk) - A **1-for-30 reverse stock split** was effected on February 26, 2025, and the Company **regained compliance** with the Minimum Bid Price Requirement by March 14, 2025[148](index=148&type=chunk)[149](index=149&type=chunk) [Nasdaq Equity Rule requirement](index=48&type=section&id=Nasdaq%20Equity%20Rule%20requirement) Addresses the company's failure to meet the Nasdaq stockholders' equity requirement, resulting in delisting from Nasdaq - The Company was **delisted from Nasdaq** effective April 2, 2025, for failing to regain compliance with the **$2.5 million stockholders' equity requirement** by March 31, 2025[150](index=150&type=chunk)[151](index=151&type=chunk) - Aptose's Common Shares **remain listed on the TSX** under "APS" and were **upgraded to trade on the OTCQB Market** under "APTOF" starting July 1, 2025[151](index=151&type=chunk) [Liquidity and Capital Resources](index=48&type=section&id=Liquidity%20and%20Capital%20Resources) Discusses the company's liquidity, capital resources, and reliance on external financing, highlighting significant challenges and going concern risks - The Company's cash and cash equivalents, including restricted cash, decreased from **$6.7 million** at December 31, 2024, to **$1.3 million** at June 30, 2025[154](index=154&type=chunk) - Working capital shifted from a **positive $5.1 million** at December 31, 2024, to a **negative $5.7 million** at June 30, 2025[154](index=154&type=chunk) - Shareholders' deficit increased from **$4.5 million** at December 31, 2024, to **$14.4 million** at June 30, 2025[154](index=154&type=chunk) - The Company incurred a **net loss of $12.6 million** for the six months ended June 30, 2025, and had an **accumulated deficit of $553.6 million**[158](index=158&type=chunk) - Management plans to **raise additional funds** through debt or equity financing, collaborations, or reorganization to reduce operational expenses, but there's **no assurance of obtaining liquidity on acceptable terms**[159](index=159&type=chunk) [Sources of liquidity](index=48&type=section&id=Sources%20of%20liquidity) Identifies the historical and current sources of funding for the company's operations, including equity financing and related party advances - Aptose has historically financed operations through **equity financing**, warrant/option exercises, and interest income, but **does not expect positive cash flow from operations** in the foreseeable future[157](index=157&type=chunk) - The Hanmi Facility Agreement provides an **uncommitted facility of up to $8.5 million** for Tuspetinib development and operations, with **$5.6 million received** as of the filing date, but **Hanmi can cancel availability at any time**[152](index=152&type=chunk) [Equity Financing Activities](index=50&type=section&id=Equity%20Financing%20Activities) Summarizes recent equity financing activities, including committed equity facilities, ATM offerings, and public offerings of common shares and warrants - In February 2025, Aptose entered a 2025 Committed Equity Facility with Keystone for up to **$25 million** in Common Shares and a 2025 At-The-Market (ATM) Facility with AGP for up to **$1.0 million**, issuing **137,000 shares** for **$0.8 million net proceeds** under the ATM[162](index=162&type=chunk)[163](index=163&type=chunk)[165](index=165&type=chunk) - In November 2024, a public offering generated **$8.0 million gross proceeds** from the sale of **1,333,333 Common Shares** and warrants[166](index=166&type=chunk) - In June 2024, a Registered Direct Offering and concurrent private placement generated approximately **$4.4 million gross proceeds** from **60,000 Common Shares** and pre-funded warrants[168](index=168&type=chunk)[170](index=170&type=chunk) - In January 2024, a public offering generated **$9.7 million gross proceeds** from **188,304 Common Shares** and warrants, and a concurrent private placement with Hanmi generated **$4.0 million gross proceeds** from **70,175 Common Shares** and warrants[171](index=171&type=chunk)[173](index=173&type=chunk)[174](index=174&type=chunk) [Cash flows](index=55&type=section&id=Cash%20flows) Analyzes the company's cash flows from operating, financing, and investing activities for the six months ended June 30, 2025, and 2024 Cash Flow Summary (Six Months Ended June 30, 2025 vs. 2024) | Cash Flow Activity | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | | :-------------------------------- | :-------------------------------------------- | :-------------------------------------------- | | Operating activities | $(8,738) | $(17,541) | | Financing activities | $3,329 | $16,601 | | Investing activities | $— | $18 | | Net decrease in cash and cash equivalents | $(5,409) | $(922) | - Cash used in operating activities **decreased by $8.8 million** (from **$17.5M** to **$8.7M**) for the six months ended June 30, 2025, compared to 2024, primarily due to **reduced operating expenses** and **increased accrued liabilities**[183](index=183&type=chunk)[184](index=184&type=chunk) - Cash provided by financing activities **decreased by $13.3 million** (from **$16.6M** to **$3.3M**) for the six months ended June 30, 2025, compared to 2024, mainly from **lower proceeds from equity offerings**[186](index=186&type=chunk)[187](index=187&type=chunk) [Contractual Obligations and Commitments](index=56&type=section&id=CONTRACTUAL%20OBLIGATIONS%20AND%20COMMITMENTS%20DESCRIBED%20UNDER%20ITEM%207) States that there were no material changes to the company's contractual obligations and commitments since the last annual report - There were **no material changes** to the Company's contractual obligations and commitments as described in its Annual Report on Form 10-K for the fiscal year ended December 31, 2024[189](index=189&type=chunk) [Results of Operations](index=56&type=section&id=RESULTS%20OF%20OPERATIONS) Analyzes the company's financial performance, highlighting changes in net loss, R&D, and general and administrative expenses Results of Operations (Three and Six Months Ended June 30, 2025 vs. 2024) | Metric | 3 Months Ended June 30, 2025 (in thousands) | 3 Months Ended June 30, 2024 (in thousands) | 6 Months Ended June 30, 2025 (in thousands) | 6 Months Ended June 30, 2024 (in thousands) | | :-------------------------------------------- | :------------------------------------------ | :------------------------------------------ | :------------------------------------------ | :------------------------------------------ | | Revenue | $— | $— | $— | $— | | Research and development expenses | $3,298 | $4,413 | $5,662 | $10,858 | | General and administrative expenses | $3,623 | $2,932 | $6,720 | $6,247 | | Net loss | $(7,043) | $(7,252) | $(12,586) | $(16,892) | - Net loss **decreased by $0.2 million** to **$7.0 million** for the three months ended June 30, 2025, and by **$4.3 million** to **$12.6 million** for the six months ended June 30, 2025, compared to the respective prior year periods[190](index=190&type=chunk) [Research and Development](index=56&type=section&id=Research%20and%20Development) Analyzes changes in research and development expenses, detailing program costs for Tuspetinib and Luxeptinib, and personnel-related expenses Research and Development Expenses (Three and Six Months Ended June 30, 2025 vs. 2024) | Category | 3 Months Ended June 30, 2025 (in thousands) | 3 Months Ended June 30, 2024 (in thousands) | 6 Months Ended June 30, 2025 (in thousands) | 6 Months Ended June 30, 2024 (in thousands) | | :-------------------------- | :------------------------------------------ | :------------------------------------------ | :------------------------------------------ | :------------------------------------------ | | Program costs – Tuspetinib | $2,233 | $2,666 | $3,712 | $6,589 | | Program costs – Luxeptinib | $100 | $304 | $198 | $512 | | Personnel-related expenses | $952 | $1,379 | $1,598 | $3,333 | | Total | $3,298 | $4,413 | $5,662 | $10,858 | - R&D expenses **decreased by $1.1 million (25%)** for the three months and **$5.2 million (48%)** for the six months ended June 30, 2025, compared to 2024[194](index=194&type=chunk) - The decrease in R&D expenses was primarily due to **reduced activity in the APTIVATE clinical trial**, **lower manufacturing activity for tuspetinib**, and **decreased clinical trial and manufacturing activities for luxeptinib**, along with **lower headcount**[198](index=198&type=chunk) [General and Administrative](index=57&type=section&id=General%20and%20Administrative) Analyzes changes in general and administrative expenses, including personnel-related costs, stock-based compensation, and other operating expenses General and Administrative Expenses (Three and Six Months Ended June 30, 2025 vs. 2024) | Category | 3 Months Ended June 30, 2025 (in thousands) | 3 Months Ended June 30, 2024 (in thousands) | 6 Months Ended June 30, 2025 (in thousands) | 6 Months Ended June 30, 2024 (in thousands) | | :-------------------------------------------- | :------------------------------------------ | :------------------------------------------ | :------------------------------------------ | :------------------------------------------ | | General and administrative, excluding items below | $3,568 | $2,790 | $6,476 | $5,618 | | Stock-based compensation | $51 | $137 | $237 | $618 | | Total | $3,623 | $2,932 | $6,720 | $6,247 | - G&A expenses **increased by $0.7 million (24%)** for the three months and **$0.5 million (8%)** for the six months ended June 30, 2025, compared to 2024[197](index=197&type=chunk)[199](index=199&type=chunk) - The increase in G&A expenses was primarily due to **higher legal expenses and bonuses** recognized in the current period, partially offset by a **decrease in stock-based compensation**[202](index=202&type=chunk) [Critical Accounting Policies](index=59&type=section&id=CRITICAL%20ACCOUNTING%20POLICIES) Discusses the company's critical accounting policies and estimates, emphasizing management judgment and assumptions for uncertain future outcomes - The Company's **critical accounting policies and estimates**, particularly regarding research and development expenses, involve **significant management judgment and assumptions** about **inherently uncertain future outcomes**[200](index=200&type=chunk) - Management **estimates R&D expenses** based on services received and progress of clinical studies, with **potential for $0.4 million over/understatement** if estimates differ by 10%[200](index=200&type=chunk)[201](index=201&type=chunk) [Updated share information](index=60&type=section&id=Updated%20share%20information) Provides updated information on the company's outstanding common shares, stock options, and warrants as of August 8, 2025 Outstanding Shares and Options (As of August 8, 2025) | Item | Number of Shares | | :-------------------------- | :--------------- | | Common Shares outstanding | 2,552,429 | | Stock options issuable | 38,211 | | Warrants issuable | 1,267,585 | [Item 3 – Qualitative and Quantitative Disclosures about Market Risk](index=61&type=section&id=Item%203%20%E2%80%93%20Qualitative%20and%20Quantitative%20Disclosures%20about%20Market%20Risk) As a smaller reporting company, Aptose Biosciences Inc. is exempt from providing qualitative and quantitative disclosures about market risk - The Company is **not required to provide** qualitative and quantitative disclosures about market risk due to its status as a **smaller reporting company**[207](index=207&type=chunk) [Item 4 – Controls and Procedures](index=61&type=section&id=Item%204%20%E2%80%93%20Controls%20and%20Procedures) Management concluded disclosure controls were ineffective due to a material weakness in accounting for complex financial instruments, with a remediation plan initiated - Disclosure controls and procedures were deemed **not effective** as of June 30, 2025, due to a **material weakness** in internal control over financial reporting related to **accounting for complex financial instruments (warrants)**[208](index=208&type=chunk)[210](index=210&type=chunk) - The **remediation plan** includes **identifying specific clauses** for warrant liability classification, **engaging a specialized firm** for technical accounting analysis of warrants, and **providing additional training** to employees[211](index=211&type=chunk) - **No other material changes** in internal control over financial reporting occurred during the quarter, apart from the remediation efforts for the identified material weakness[212](index=212&type=chunk) [Ongoing Remediation Plan](index=61&type=section&id=Ongoing%20Remediation%20Plan) Outlines the specific steps and initiatives undertaken by management to address the identified material weakness in internal controls [Changes in Internal Control Over Financial Reporting](index=61&type=section&id=CHANGES%20IN%20INTERNAL%20CONTROL%20OVER%20FINANCIAL%20REPORTING) Reports on any material changes in the company's internal control over financial reporting during the most recent fiscal quarter PART II—OTHER INFORMATION [Item 1 – Legal Proceedings](index=62&type=section&id=Item%201%20%E2%80%93%20Legal%20Proceedings) Aptose Biosciences Inc. is not currently involved in material active legal actions, but may face various pending or threatened legal actions - The Company is **not involved in any material active legal actions** but **may face various pending or threatened legal actions** in the ordinary course of business[214](index=214&type=chunk) [Item 1A – Risk Factors](index=62&type=section&id=Item%201A%20%E2%80%93%20Risk%20Factors) Outlines key risk factors, particularly substantial doubt about the company's going concern ability due to insufficient cash and reliance on Hanmi advances - The Company's financial statements are prepared on a **going concern basis**, but management believes its **cash balance is insufficient for the next 12 months**, relying on **Hanmi advances**[215](index=215&type=chunk) - **Substantial doubt** exists about the Company's ability to continue as a **going concern** without significant restructuring and/or financing, with risks including **imminent bankruptcy** and the **need for immediate substantial funding**[215](index=215&type=chunk)[217](index=217&type=chunk) - Key risks include the **inability to obtain additional equity or debt financing** on satisfactory terms, **potential work stoppages** by suppliers or clinical sites, and **challenges in maintaining an adequate supply** of clinical drug product[215](index=215&type=chunk)[216](index=216&type=chunk) - As of the filing date, the Company has approximately **$1.6 million cash-on-hand** and a **working capital deficiency**, with **no material product sales or cash sources other than financings**[217](index=217&type=chunk) [Item 6 – Exhibits](index=65&type=section&id=Item%206%20%E2%80%93%20Exhibits) Lists the exhibits filed with the Form 10-Q, including officer certifications and consolidated financial statements in Inline XBRL format - The report includes **certifications from the Principal Executive Officer and Principal Financial Officer** (Exhibits 31.1, 31.2, 32.1, 32.2)[219](index=219&type=chunk) - Consolidated financial statements are provided in **Inline XBRL format** as Exhibit 101[219](index=219&type=chunk) [Signatures](index=66&type=section&id=Signatures) Contains the required signatures for the Form 10-Q, confirming its submission on August 13, 2025, by Aptose Biosciences Inc. - The report was signed on **August 13, 2025**, by **William G. Rice, Ph.D., President and Chief Executive Officer** of Aptose Biosciences Inc.[222](index=222&type=chunk)[223](index=223&type=chunk)

PART I—FINANCIAL INFORMATION [Financial Statements](index=4&type=section&id=Item%201%20%E2%80%93%20Financial%20Statements) This section presents unaudited condensed consolidated interim financial statements, highlighting a 'going concern' warning due to cash projected to fund operations only through May 2025 - The company's ability to continue as a going concern is in substantial doubt, as its cash and cash equivalents as of March 31, 2025, are projected to support operations only through **May 2025**[24](index=24&type=chunk)[26](index=26&type=chunk)[30](index=30&type=chunk) Condensed Consolidated Statements of Financial Position (Unaudited) | (In thousands of US dollars) | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $4,743 | $6,152 | | Total current assets | $6,969 | $9,530 | | Total assets | $7,467 | $10,127 | | **Liabilities and Shareholders' Deficit** | | | | Total current liabilities | $6,318 | $4,477 | | Total liabilities | $14,860 | $14,670 | | Total shareholders' deficit | $(7,393) | $(4,543) | Condensed Consolidated Statements of Loss and Comprehensive Loss (Unaudited) | (In thousands of US dollars, except per share data) | Three months ended March 31, 2025 | Three months ended March 31, 2024 | | :--- | :--- | :--- | | Revenue | $— | $— | | Research and development | $2,364 | $6,445 | | General and administrative | $3,097 | $3,315 | | Net loss | $(5,543) | $(9,640) | | Basic and diluted loss per common share | $(2.61) | $(22.02) | Condensed Consolidated Statements of Cash Flows (Unaudited) | (In thousands of US dollars) | Three months ended March 31, 2025 | Three months ended March 31, 2024 | | :--- | :--- | :--- | | Cash used in operating activities | $(2,795) | $(11,763) | | Cash used in investing activities | $— | $(1,991) | | Cash provided by financing activities | $829 | $11,847 | | Decrease in cash, cash equivalents and restricted cash | $(1,964) | $(1,906) | - On February 26, 2025, the company executed a **1-for-30 reverse stock split** of its Common Shares. All share and per-share amounts have been retroactively adjusted[24](index=24&type=chunk) - On March 18, 2025, the company entered into a Debt Conversion Agreement with Hanmi Pharmaceutical, converting **$1.5 million of debt** into **409,063 Common Shares** at **$3.70 per share**[50](index=50&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=20&type=section&id=Item%202%20%E2%80%93%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management analyzes the company's financial condition and operational results, focusing on clinical programs, liquidity, and capital resources, amidst significant 'going concern' risk [Overview and Program Updates](index=20&type=section&id=Overview%20and%20Program%20Updates) Aptose, a clinical-stage biotech, focuses on hematology with its lead program, tuspetinib, showing promising early data in AML, while luxeptinib development is paused - The lead program, tuspetinib, is being developed as a frontline triplet combination therapy (TUS+VEN+HMA) for newly diagnosed AML patients, aiming to establish a new standard of care[93](index=93&type=chunk)[94](index=94&type=chunk)[95](index=95&type=chunk) - The TUSCANY Phase 1/2 trial of the TUS+VEN+AZA triplet has shown early positive results, achieving complete remissions in difficult-to-treat AML patients at the initial **40 mg dose** of tuspetinib, leading to dose escalation to **80 mg**[95](index=95&type=chunk)[107](index=107&type=chunk)[108](index=108&type=chunk) - Development of the luxeptinib program has been paused to conserve funds and prioritize the advancement of tuspetinib[100](index=100&type=chunk)[132](index=132&type=chunk) - Aptose entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) to collaborate on the clinical development of tuspetinib in NCI-sponsored myeloMATCH trials[104](index=104&type=chunk) [Results of Operations](index=33&type=section&id=Results%20of%20Operations) The company reported a net loss of **$5,543 thousand** for Q1 2025, a significant decrease from Q1 2024, primarily due to reduced Research and Development expenses Comparison of Operating Results (Q1 2025 vs Q1 2024) | (In thousands of US dollars) | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | Net Loss | $5,543 | $9,640 | $(4,097) | | Research & Development Expenses | $2,364 | $6,445 | $(4,081) | | General & Administrative Expenses | $3,097 | $3,315 | $(218) | - R&D expenses decreased by **$4,081 thousand** year-over-year, mainly due to reduced activity in the tuspetinib APTIVATE clinical trial, lower manufacturing costs, and a reduction in R&D personnel headcount[179](index=179&type=chunk)[183](index=183&type=chunk) - G&A expenses decreased by **$218 thousand**, primarily due to a **$300 thousand** reduction in stock-based compensation expense, partially offset by a **$100 thousand** increase in legal and consulting fees[182](index=182&type=chunk)[184](index=184&type=chunk) [Liquidity and Capital Resources](index=29&type=section&id=Liquidity%20and%20Capital%20Resources) The company's financial position is precarious, with cash reserves projected to last only through May 2025, raising substantial doubt about its ability to continue as a going concern - The company has sufficient liquidity to support operations only through **May 2025**, which raises substantial doubt about its ability to continue as a going concern[142](index=142&type=chunk)[148](index=148&type=chunk)[150](index=150&type=chunk) Key Liquidity Metrics | (In thousands of US dollars) | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $4,743 | $6,152 | | Working capital | $651 | $5,053 | | Stockholders' deficit | $(7,393) | $(4,543) | - The company was delisted from the Nasdaq Stock Market effective **April 2, 2025**, for failing to regain compliance with the minimum stockholders' equity requirement. Its shares continue to trade on the TSX and OTC markets[88](index=88&type=chunk)[141](index=141&type=chunk) - In Q1 2025, the company raised net proceeds of **$829 thousand** through its 2025 At-The-Market (ATM) facility by issuing **137,000 common shares**[152](index=152&type=chunk)[174](index=174&type=chunk) [Qualitative and Quantitative Disclosures about Market Risk](index=36&type=section&id=Item%203%20%E2%80%93%20Qualitative%20and%20Quantitative%20Disclosures%20about%20Market%20Risk) As a 'smaller reporting company' under SEC rules, the company is not required to provide disclosures about market risk - Aptose Biosciences is not required to provide information on market risk because it qualifies as a 'smaller reporting company' under SEC regulations[191](index=191&type=chunk) [Controls and Procedures](index=36&type=section&id=Item%204%20%E2%80%93%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were ineffective as of March 31, 2025, due to a material weakness in internal control over financial reporting, with a remediation plan underway - Management concluded that disclosure controls and procedures were not effective as of **March 31, 2025**[192](index=192&type=chunk) - The ineffectiveness is due to a material weakness in internal control over financial reporting related to the accounting for complex financial instruments, specifically warrants[192](index=192&type=chunk) - A remediation plan is underway to address the material weakness, involving engaging specialists for technical accounting analysis and providing additional training to employees[195](index=195&type=chunk) PART II—OTHER INFORMATION [Legal Proceedings](index=37&type=section&id=Item%201%20%E2%80%93%20Legal%20Proceedings) The company is not currently involved in any material active legal proceedings, though it may be subject to ordinary course legal actions - As of the filing date, the company is not involved in any material active legal actions[198](index=198&type=chunk) [Risk Factors](index=37&type=section&id=Item%201A%20%E2%80%93%20Risk%20Factors) This section supplements annual 10-K risk factors, emphasizing the immediate 'Going Concern Risk' due to limited cash runway, imminent bankruptcy risk, and urgent funding needs - The company's financial statements have been prepared on a going concern basis, but its ability to continue is in substantial doubt as current cash is only projected to support operations through **May 2025**[199](index=199&type=chunk) - As of the filing date, the company's cash-on-hand was approximately **$2.2 million**, and it had a working capital deficiency[201](index=201&type=chunk) - Newly highlighted risks include the risk of imminent bankruptcy, the need to obtain substantial funding immediately, and potential work stoppages or contract changes from key suppliers[200](index=200&type=chunk) - A single contract research organization represented **43%** of the company's accounts payable as of **March 31, 2025**[200](index=200&type=chunk) [Exhibits](index=39&type=section&id=Item%206%20%E2%80%93%20Exhibits) This section lists exhibits filed with the Form 10-Q, including certifications of Principal Executive and Financial Officers and Inline XBRL financial statements List of Filed Exhibits | Exhibit Number | Description | | :--- | :--- | | 31.1 | Certification of Principal Executive Officer (Section 302) | | 31.2 | Certification of Principal Financial Officer (Section 302) | | 32.1 | Certification of Principal Executive Officer (Section 906) | | 32.2 | Certification of Principal Financial Officer (Section 906) | | 101 | Inline XBRL Financial Statements | [Signatures](index=40&type=section&id=Signatures) The quarterly report was officially signed by William G. Rice, Ph.D., President and CEO of Aptose Biosciences Inc., on May 8, 2025 - The report was duly signed by **William G. Rice, Ph.D.**, President and Chief Executive Officer, on **May 8, 2025**[205](index=205&type=chunk)[206](index=206&type=chunk)

[Report Overview & Highlights](index=1&type=section&id=Report%20Overview%20%26%20Highlights) [TUSCANY Clinical Trial Progress](index=1&type=section&id=TUSCANY%20Clinical%20Trial%20Progress) The TUSCANY trial for frontline AML with tuspetinib, venetoclax, and azacitidine shows robust safety and response, with all six patients achieving complete remissions across escalated doses up to 80 mg, including those with adverse mutations - The TUSCANY trial is evaluating a tuspetinib (TUS)-based triple drug frontline therapy (TUS+VEN+AZA) for newly diagnosed AML patients[2](index=2&type=chunk) - The tuspetinib dose was escalated from an initial **40 mg to 80 mg** in the triplet therapy[3](index=3&type=chunk) - All **six patients** treated in the first two cohorts (three at **40 mg** and three at **80 mg**) achieved Complete Remissions (CRs) and remain on treatment[3](index=3&type=chunk) - In the **40 mg cohort**, **three of four patients** achieved CRs, and all three were reported as MRD-negative[4](index=4&type=chunk) - In the **80 mg cohort**, all **three patients** achieved CRs, with no safety concerns or dose-limiting toxicities (DLTs) reported to date[5](index=5&type=chunk) - The therapy has shown effectiveness in patients with diverse and adverse mutation profiles, including **TP53**, **FLT3-ITD**, **IDH2**, and **DDX41** mutations[3](index=3&type=chunk)[4](index=4&type=chunk)[5](index=5&type=chunk) [Corporate Updates](index=1&type=section&id=Corporate%20Updates) Aptose common shares were delisted from Nasdaq due to non-compliance and now trade on OTC Markets under "APTOF" to enhance U.S. investor accessibility and liquidity, while maintaining TSX listing - Aptose common shares now trade on the OTC Markets under the ticker "**APTOF**" in addition to the Toronto Stock Exchange (TSX) under "**APS**"[5](index=5&type=chunk) - The company's common shares were delisted from The Nasdaq Stock Market effective **April 2, 2025**, because of non-compliance with the exchange's equity requirements[5](index=5&type=chunk) - The move to OTC is part of a strategy to increase visibility and participation from the U.S. investment community and enhance overall share liquidity[5](index=5&type=chunk) [Completed and Planned Value-Creating Milestones](index=1&type=section&id=Completed%20and%20Planned%20Value-Creating%20Milestones) Aptose reported initial safety and efficacy data for TUS+VEN+AZA cohorts, with plans to present maturing data at EHA and ASH in 2025, aiming to select the optimal tuspetinib dose for pivotal Phase 2/3 trials - Reported initial safety and efficacy data for both the **40mg and 80mg TUS+VEN+AZA cohorts**[12](index=12&type=chunk) - Plan to report maturing data from the triplet study at the European Hematology Association (EHA) in **1H 2025**[7](index=7&type=chunk) - Plan to report response rate and durability data at the American Society of Hematology (ASH) in **2025**[8](index=8&type=chunk)[12](index=12&type=chunk) - Future goals include selecting the tuspetinib dose for pivotal Phase 2/3 trials and preparing for their initiation[12](index=12&type=chunk) [Financial Results of Operations](index=2&type=section&id=FINANCIAL%20RESULTS%20OF%20OPERATIONS) [Financial Summary (Statements of Operations)](index=2&type=section&id=Financial%20Summary%20(Statements%20of%20Operations)) Aptose reported a Q1 2025 net loss of **$5.5 million**, a significant improvement from **$9.6 million** in Q1 2024, driven by reduced operating expenses, with net loss per share improving to **$2.61** from **$22.02** Q1 2025 vs Q1 2024 Statement of Operations ($ in thousands) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Research and development | $2,364 | $6,445 | | General and administrative | $3,097 | $3,315 | | **Operating expenses** | **$5,461** | **$9,760** | | **Net loss** | **$(5,543)** | **$(9,640)** | | Net loss per share | $(2.61) | $(22.02) | | Weighted average shares | 2,126,287 | 437,750 | [Balance Sheet Summary](index=2&type=section&id=Balance%20Sheet%20Summary) As of March 31, 2025, Aptose reported **$4.7 million** in cash, **$7.5 million** in total assets, and a shareholders' deficit of **$7.4 million**, reflecting a decrease in cash and an increased deficit from year-end 2024 Balance Sheet Data ($ in thousands) | Metric | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash, cash equivalents and restricted cash | $4,743 | $6,707 | | Working capital | $651 | $5,053 | | Total assets | $7,467 | $10,127 | | Long-term liabilities | $8,542 | $10,193 | | Accumulated deficit | $(546,510) | $(540,967) | | Shareholders' deficit | $(7,393) | $(4,543) | [Research and Development Expenses](index=3&type=section&id=RESEARCH%20AND%20DEVELOPMENT%20EXPENSES) Q1 2025 R&D expenses significantly decreased to **$2.4 million** from **$6.4 million** in Q1 2024, primarily due to reduced tuspetinib program costs, lower personnel expenses, and the discontinuation of the APTO-253 program R&D Expense Breakdown - Q1 2025 vs Q1 2024 ($ in thousands) | Program | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Tuspetinib | $1,479 | $3,923 | | Luxeptinib | $98 | $208 | | APTO-253 | $- | $22 | | Personnel related expenses | $646 | $1,924 | | Stock-based compensation | $141 | $328 | | **Total R&D Expenses** | **$2,364** | **$6,445** | - Tuspetinib program costs decreased by **$2.4 million** due to reduced activity in the APTIVATE clinical trial and lower manufacturing expenses[16](index=16&type=chunk) - Personnel-related expenses decreased by **$1.3 million** due to lower R&D headcount[16](index=16&type=chunk) - The APTO-253 program was discontinued, eliminating its associated costs[16](index=16&type=chunk) [Liquidity and Capital Resources](index=3&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2025, Aptose held **$4.7 million** in cash, projecting funding only until May 2025, and is actively pursuing financing and cost-reduction strategies to extend its cash runway - Total cash, cash equivalents and restricted cash equivalents were **$4.7 million** as of March 31, 2025[15](index=15&type=chunk) - The company expects its current cash on hand to fund operations only until the end of **May 2025**[15](index=15&type=chunk) - Aptose is proactively implementing financing and cost reduction efforts to extend its cash runway[15](index=15&type=chunk) - As of May 1, 2025, the company had **2,552,429** common shares issued and outstanding[15](index=15&type=chunk) [Corporate Information & Disclosures](index=3&type=section&id=Corporate%20Information%20%26%20Disclosures) [About Aptose](index=3&type=section&id=About%20Aptose) Aptose Biosciences is a clinical-stage biotechnology company developing precision oncology medicines, with its lead compound, tuspetinib, an oral kinase inhibitor, targeting frontline acute myeloid leukemia - Aptose is a clinical-stage biotechnology company developing precision medicines for oncology, with a focus on hematology[15](index=15&type=chunk) - The company's lead clinical-stage compound is **tuspetinib (TUS)**, an oral kinase inhibitor for acute myeloid leukemia (AML)[17](index=17&type=chunk) [Forward-Looking Statements](index=4&type=section&id=Forward%20Looking%20Statements) This section serves as a legal disclaimer for forward-looking statements, highlighting risks like capital acquisition, drug development efficacy, and market conditions, with no obligation to update unless legally required - The press release contains forward-looking statements that are subject to significant risks, uncertainties, and assumptions[18](index=18&type=chunk) - Key risks include the ability to obtain required capital, drug development efficacy, regulatory approval processes, clinical trial progress, and changing economic conditions[18](index=18&type=chunk) - Aptose does not assume any obligation to update these forward-looking statements, except as required by law[19](index=19&type=chunk)

Summary of Aptose Biosciences Conference Call Company Overview - **Company**: Aptose Biosciences - **Focus**: Clinical stage precision oncology company developing Tuspitinib for acute myeloid leukemia (AML) treatment [2][12] Industry Context - **Disease**: Acute Myeloid Leukemia (AML) - **Characteristics**: Aggressive cancer of the bone marrow and blood, primarily affecting patients aged 65 and older [5][6] - **Current Treatment**: Standard of care is a two-drug cocktail (Venaza: Venetoclax and Azacitidine) [6][9] - **Survival Rates**: Five-year survival rate for patients aged 65+ is approximately 9% [6] Core Points and Arguments - **Need for Improved Therapy**: - Current therapies have high rates of refractoriness (one-third of patients do not respond) and limited overall survival (median of 14.7 months for responders) [7][8] - Need for therapies that are broadly active across all genetic subtypes of AML [9][12] - **Tuspitinib's Role**: - Described as a safe, mutation-agnostic third drug to be added to the Venaza backbone [12][48] - Demonstrated excellent safety profile, convenient administration (once daily oral tablets), and broad activity against various AML mutations [13][48] - Potential market opportunity exceeding $1 billion annually [14] - **Clinical Trials**: - **Tuscany Trial**: Focused on newly diagnosed AML patients, aiming to select optimal dosing for pivotal studies [19][38] - Initial dosing started at 40 mg, escalated to 80 mg, with promising results in terms of complete remissions and minimal toxicity [20][22][24] - Patients achieving complete remission (CR) and minimal residual disease (MRD) negativity, indicating potential for durable responses [26][37] - **Regulatory Status**: - Orphan drug designation and fast track status received from the FDA [18] - Required to start trials in relapsed/refractory patients before moving to newly diagnosed patients [16] Important but Overlooked Content - **Patient Case Studies**: - Multiple case studies presented showing diverse mutation profiles and successful outcomes with Tuspitinib [30][34][36] - Highlighted the drug's effectiveness in patients with challenging mutations like TP53, which are often excluded from clinical trials [29][34] - **Upcoming Milestones**: - Data presentation at the European Hematology Association meeting and the American Society of Hematology meeting planned for later in the year [40][42] - Selection of pivotal trial dose expected within the year [38][49] - **Company Structure**: - Small team of 15 full-time employees, with a strong advisory board including key opinion leaders in AML and MDS [43][45] Conclusion - Aptose Biosciences is positioned to address significant unmet needs in AML treatment with its lead drug Tuspitinib, supported by promising clinical data and a strategic focus on broad applicability across genetic subtypes. The company is on track for pivotal trials and has garnered interest from major pharmaceutical companies.

Core Insights - Aptose Biosciences is developing a unique triple drug therapy (TUS+VEN+AZA) for newly diagnosed acute myeloid leukemia (AML) patients, aiming for a safe and mutation-agnostic frontline treatment [1][6] - Initial data from the Phase 1/2 TUSCANY trial shows promising safety and efficacy, with complete remissions and measurable residual disease (MRD) negativity observed in patients with diverse mutations [1][4] Group 1: Clinical Trial Details - The TUSCANY trial has initiated dosing with tuspetinib (TUS) at 40 mg and 80 mg in combination with venetoclax (VEN) and azacitidine (AZA), demonstrating safety and antileukemic activity [2][4] - The trial is designed to evaluate various doses and schedules of TUS for AML patients who cannot receive induction chemotherapy, with a target enrollment of 18-24 patients by mid-late 2025 [7] Group 2: Patient Outcomes - In the first cohort, a patient with biallelic TP53 mutations achieved complete remission and MRD-negative status, while another FLT3-wildtype patient also achieved complete remission [4] - In the second cohort receiving 80 mg of TUS, all three patients showed blast reductions meeting criteria for complete remissions or complete remission with incomplete blood count recovery (CRi) [4] Group 3: Company Overview - Aptose Biosciences focuses on developing precision medicines for oncology, with tuspetinib as a lead candidate showing activity in relapsed or refractory AML and being advanced as a frontline therapy [9]

Core Viewpoint - Aptose Biosciences Inc. announced that KPMG LLP will not stand for re-appointment as the independent registered public accounting firm for the 2025 annual audit, while KPMG will continue to review the company's quarterly interim financial results through the first two fiscal quarters of 2025 [1]. Group 1: Company Announcement - KPMG did not seek the company's consent regarding its decision not to stand for re-appointment, and neither the Board of Directors nor the Audit Committee participated in this decision [2]. - KPMG issued unqualified reports on the company's consolidated financial statements for the fiscal years ended December 31, 2024, and 2023 [3]. - There were no disagreements or reportable events between the company and KPMG during the fiscal years ended December 31, 2024, and 2023, except for a communicated material weakness in internal control over financial reporting related to complex financial instruments [4]. Group 2: Company Overview - Aptose Biosciences is a clinical-stage biotechnology company focused on developing precision medicines for oncology, particularly in hematology [6]. - The company's lead compound, tuspetinib (TUS), is an oral kinase inhibitor being developed as a frontline triplet therapy for newly diagnosed acute myeloid leukemia (AML) [6].

Core Viewpoint - Aptose Biosciences Inc. is participating in the 2025 Bloom Burton & Co. Healthcare Investor Conference to present its developments in precision oncology, specifically focusing on its lead compound tuspetinib for treating acute myeloid leukemia [1][4]. Company Overview - Aptose Biosciences is a clinical-stage biotechnology company focused on developing precision medicines for oncology, with an emphasis on hematology [5]. - The company's lead product, tuspetinib (TUS), is an oral kinase inhibitor that has shown efficacy as both a monotherapy and in combination therapy for relapsed or refractory acute myeloid leukemia (AML) [5]. - Tuspetinib is being developed as a frontline triplet therapy for newly diagnosed AML patients [5]. Conference Details - The 2025 Bloom Burton & Co. Healthcare Investor Conference will take place on May 5-6, 2025, in Toronto [1][4]. - Dr. William G. Rice, Chairman, President, and CEO of Aptose, will present on May 5, 2025, at 3:00 p.m. EDT [2][3]. - The presentation will be available via webcast, and further details can be found on the Aptose website [3]. Investor Engagement - The conference provides an opportunity for investors to receive corporate updates from various Canadian healthcare companies through presentations and one-on-one meetings [4]. - Aptose is open to scheduling one-on-one meetings with interested investors during the conference [2].

Core Insights - Aptose Biosciences Inc. is a clinical-stage precision oncology company focused on developing tuspetinib (TUS) as a frontline therapy for newly diagnosed acute myeloid leukemia (AML) [1][5] - The company will participate in the 2025 Bloom Burton & Co. Healthcare Investor Conference in Toronto on May 5-6, 2025, where Dr. William G. Rice will present and host one-on-one meetings [1][2][4] Company Overview - Aptose is committed to developing precision medicines to address unmet medical needs in oncology, with a focus on hematology [5] - The company's pipeline includes small molecule cancer therapeutics designed for single-agent efficacy and to enhance the efficacy of other anti-cancer therapies without overlapping toxicities [5] - Tuspetinib (TUS) is an oral kinase inhibitor that has shown activity as both a monotherapy and in combination therapy for patients with relapsed or refractory AML, and is being developed as a triplet therapy for newly diagnosed AML [5] Conference Details - The 2025 Bloom Burton & Co. Healthcare Investor Conference will feature corporate updates from various Canadian healthcare companies, providing opportunities for investors to engage with company representatives [4] - Dr. William G. Rice's corporate presentation is scheduled for May 5, 2025, at 3:00 p.m. EDT, and will be available via webcast [3]

Core Viewpoint - Aptose Biosciences Inc. has been determined by the Nasdaq Hearings Panel to delist its common shares from Nasdaq due to non-compliance with the Exchange's equity requirement by the deadline of March 31, 2025 [1] Company Overview - Aptose Biosciences is a clinical-stage biotechnology company focused on developing precision medicines for oncology, particularly in hematology [3] - The company's lead compound, tuspetinib (TUS), is an oral kinase inhibitor aimed at treating acute myeloid leukemia (AML) and is being developed as a frontline triplet therapy for newly diagnosed AML patients [3] Delisting Details - The Nasdaq Hearings Panel's decision was based on Aptose's failure to demonstrate compliance with the equity requirement outlined in Listing Rule 5550(b)(1) by the specified date [1] - Trading of Aptose's common shares will be suspended effective April 2, 2025, following the Panel's determination [1] Future Plans - The company and its board are considering all available options, including an appeal against the delisting decision, while continuing to execute its business plan [2] - Aptose intends to seek a listing on a U.S. national Securities Exchange at an appropriate time [2]