Aptose Biosciences(APTO)

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Aptose to Report Fourth Quarter and Year End 2023 Financial Results and Provide Corporate Update on Tuesday, March 26, 2024
Newsfilter· 2024-03-18 20:30
Core Viewpoint - Aptose Biosciences Inc. is set to report its financial results for Q4 and the full year of 2023 on March 26, 2024, along with a corporate update [1]. Group 1: Financial Reporting - The financial results will be disclosed after the market closes on March 26, 2024 [1]. - Analysts can participate in a Q&A session by pre-registering for the conference call [3]. Group 2: Company Overview - Aptose Biosciences is a clinical-stage biotechnology company focused on developing precision medicines for oncology, particularly in hematology [4]. - The company has a pipeline of small molecule cancer therapeutics aimed at providing single-agent efficacy and enhancing the effectiveness of other anti-cancer therapies without overlapping toxicities [4]. - Two clinical-stage oral kinase inhibitors are under development: tuspetinib (HM43239) for relapsed or refractory acute myeloid leukemia (AML) and luxeptinib (CG-806) for relapsed or refractory hematologic malignancies [4].
Aptose Announces Closing of $9.7 Million Public Offering and Concurrent $4 Million Private Placement with Hanmi Pharmaceutical, Including Full Exercise of Over-Allotment Option
Newsfilter· 2024-01-31 21:01
SAN DIEGO and TORONTO, Jan. 31, 2024 (GLOBE NEWSWIRE) -- Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ:APTO, TSX:APS), a clinical-stage precision oncology company developing highly differentiated targeted agents to treat hematologic malignancies, today announced the closing of the previously announced public offering (the "Public Offering") of 5,649,122 common shares of the Company (the "Common Shares") and warrants at a combined offering price of US $1.71 per share. This includes 736,842 Com ...
Why Is Aptose Biosciences (APTO) Stock Down Today?
InvestorPlace· 2024-01-26 13:36
Aptose Biosciences (NASDAQ:APTO) stock is on the move Friday after announcing details for a public offering of the clinical-stage biotechnology company’s shares.Aptose Biosciences is selling 4,912,280 shares of its common stock at a price of $1.71 per share. That has it expecting gross proceeds of $8.4 million from the stock offering.To go along with this, each share of APTO stock sold in the offering comes with one warrant. These warrants are for the purchase of another share of the company’s stock. The ex ...
Aptose Announces Pricing of $8.4 Million Public Offering and a Concurrent $4 Million Private Placement with Hanmi Pharmaceutical
Newsfilter· 2024-01-26 13:00
Core Viewpoint - Aptose Biosciences Inc. has announced a public offering of approximately 4.9 million common shares at a price of $1.71 per share, aiming to raise about $8.4 million before expenses [1][3] Group 1: Public Offering Details - The public offering consists of 4,912,280 common shares priced at $1.71 each, with warrants included for the same price [1] - Gross proceeds from the public offering are expected to be around $8.4 million, with underwriters having a 30-day option to purchase an additional 736,842 shares and/or warrants [1][3] - The public offering is anticipated to close on or about January 30, 2024, pending customary closing conditions [3] Group 2: Private Placement Details - A concurrent private placement of $4 million with Hanmi Pharmaceutical will occur, with Hanmi acquiring 19.97% of Aptose's outstanding shares post-placement at a price of $1.90 per share, an 11% premium over the public offering price [2] - Hanmi will also receive warrants to purchase common shares at $1.71 per share [2] - The private placement is expected to close on or about January 31, 2024, subject to customary closing conditions [3] Group 3: Use of Proceeds - The net proceeds from both the public offering and private placement will be utilized to support clinical trials for tuspetinib, manufacture clinical supplies, and for working capital and general corporate purposes [3] Group 4: Company Overview - Aptose Biosciences is a clinical-stage biotechnology company focused on developing precision medicines for oncology, particularly in hematology [7] - The lead product, tuspetinib, is being studied as a treatment for relapsed or refractory acute myeloid leukemia (AML) [7]
Aptose Biosciences(APTO) - 2023 Q3 - Earnings Call Transcript
2023-11-10 00:22
Aptose Biosciences Inc. (NASDAQ:APTO) Q3 2023 Earnings Conference Call November 9, 2023 5:00 PM ET Company Participants Susan Pietropaolo - Managing Director-Corporate Communications & Investor Relations William Rice - Chairman, President & Chief Executive Officer Rafael Bejar - Senior Vice President & Chief Medical Officer Conference Call Participants John Newman - Canaccord Genuity Operator Good afternoon. My name is Hope, and I will be your conference operator today. I would like to welcome everyone to t ...
Aptose Biosciences(APTO) - 2023 Q3 - Quarterly Report
2023-11-08 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Transition Period from to Commission File Number: 1-32001 APTOSE BIOSCIENCES INC. (Exact Name of Registrant as Specified in Its Charter) Canada (State or other jurisdiction of incorporatio ...
Aptose Biosciences(APTO) - 2023 Q2 - Earnings Call Transcript
2023-08-11 03:01
Aptose Biosciences Inc. (NASDAQ:APTO) Q2 2023 Earnings Conference Call August 10, 2023 5:00 PM ET Company Participants Susan Pietropaolo - Corporate Communications and Investor Relations William Rice - Chairman, President and Chief Executive Officer Rafael Bejar - Senior Vice President and Chief Medical Officer Fletcher Payne - Senior Vice President and Chief Financial Officer Conference Call Participants Edward Tenthoff - Piper Sandler Matthew Biegler - Oppenheimer Li Watsek - Cantor Fitzgerald Soumit Roy ...
Aptose Biosciences(APTO) - 2023 Q2 - Quarterly Report
2023-08-09 16:00
Financial Performance - The net loss for the three months ended June 30, 2023, was $14,129 thousand, compared to a net loss of $10,565 thousand for the same period in 2022, indicating a 34% increase in losses [19]. - The net loss for the six months ended June 30, 2023, was $27.81 million, compared to a net loss of $22.05 million for the same period in 2022, indicating a 26% increase in losses [19]. - Basic and diluted loss per common share for the three months ended June 30, 2023, was $2.27, compared to $1.72 for the same period in 2022, reflecting a 32% increase in loss per share [19]. - The company reported a net loss per share of $4.47 for the six months ended June 30, 2023, compared to $3.59 for the same period in 2022, indicating a worsening loss per share [62]. - The company reported total operating expenses of $14,452 thousand for the three months ended June 30, 2023, which is a 35% increase from $10,673 thousand in the same period of 2022 [19]. Assets and Liabilities - Total assets decreased from $51,027 thousand as of December 31, 2022, to $26,575 thousand as of June 30, 2023, representing a decline of approximately 48% [16]. - Total current assets decreased from $49.52 million as of December 31, 2022, to $25.26 million as of June 30, 2023, a decline of 49% [15]. - Total liabilities decreased slightly from $13,286 thousand as of December 31, 2022, to $12,789 thousand as of June 30, 2023, a reduction of approximately 4% [16]. - Shareholders' equity fell from $37,741 thousand to $13,786 thousand, a decline of about 64% [16]. - Cash and cash equivalents dropped significantly from $36,970 thousand to $8,400 thousand, a decrease of about 77% [15]. Cash Flow and Funding - The company used $13.5 million in operating activities during the three months ended June 30, 2023, compared to $7.0 million in the same period in 2022 [25]. - The company utilized $24.8 million in cash for operating activities during the six months ended June 30, 2023, compared to $16.7 million for the same period in 2022 [25]. - The company plans to raise additional funds to support its operations, but there is no assurance that such funds will be available on acceptable terms [29]. - The company is evaluating strategies to obtain additional funding for future operations due to substantial doubt about its ability to continue as a going concern [36]. - The company has entered into a committed equity facility with Keystone Capital Partners, allowing for the sale of up to $25.0 million of common shares over a 24-month term [58]. Research and Development - Research and development expenses for the three months ended June 30, 2023, were $10,582 thousand, up 44% from $7,341 thousand in the same period of 2022 [19]. - The company has two clinical-stage investigational products for hematological malignancies: tuspetinib and luxeptinib [28]. - The company expects negative cash flow to continue until regulatory approval is received for its products or revenue exceeds expenses [30]. Stock and Equity - The company issued common shares under the 2022 ATM Facility, raising $1.1 million during the three months ended June 30, 2023 [25]. - A reverse stock split at a ratio of 1-for-15 was approved and took effect on June 6, 2023 [33]. - The company granted 215,000 stock options during the six months ended June 30, 2023, with a weighted average exercise price of $9.93 [68]. - The company recorded share-based payment expense of $2,643,000 for the six months ended June 30, 2023, down from $3,293,000 in the same period of 2022, reflecting a 20% decrease [79]. - The company has a maximum of 113,333 common shares available for sale under the Employee Stock Purchase Plan (ESPP) [67]. Accumulated Deficit - As of June 30, 2023, the company reported an accumulated deficit of approximately $492.1 million, up from $464.3 million as of December 31, 2022 [32]. - The company had working capital of approximately $13.3 million as of June 30, 2023, down from $37.2 million as of December 31, 2022 [32]. - Accrued liabilities increased to $8.084 million as of June 30, 2023, compared to $5.657 million on December 31, 2022 [51].
Aptose Biosciences(APTO) - 2023 Q1 - Earnings Call Transcript
2023-05-09 01:22
Aptose Biosciences Inc. (NASDAQ:APTO) Q1 2023 Earnings Conference Call May 8, 2023 5:00 PM ET Company Participants Susan Pietropaolo – Corporate Communications & Investor Relations William G. Rice – Chairman, President and Chief Executive Officer Rafael Bejar – Senior Vice President and Chief Medical Officer Fletcher Payne – Senior Vice President and Chief Financial Officer Conference Call Participants Edward Tenthoff – Piper Sandler & Co. Li Watsek – Cantor Fitzgerald Joseph Pantginis – H.C. Wainwright Ope ...
Aptose Biosciences(APTO) - 2023 Q1 - Quarterly Report
2023-05-07 16:00
[PART I—FINANCIAL INFORMATION](index=5&type=section&id=PART%20I%E2%80%94FINANCIAL%20INFORMATION) This section presents Aptose Biosciences Inc.'s unaudited interim financial statements and management's discussion for Q1 2023 [Item 1 – Financial Statements](index=5&type=section&id=Item%201%20%E2%80%93%20Financial%20Statements) Presents Aptose Biosciences Inc.'s unaudited condensed consolidated interim financial statements and related notes for Q1 2023 and 2022 [Condensed Consolidated Interim Statements of Financial Position](index=6&type=section&id=Condensed%20Consolidated%20Interim%20Statements%20of%20Financial%20Position) Summarizes Aptose Biosciences Inc.'s financial position, including assets, liabilities, and equity, as of March 31, 2023, and December 31, 2022 **Condensed Consolidated Interim Statements of Financial Position (in thousands of US dollars)** | Metric | March 31, 2023 | December 31, 2022 | | :---------------------------- | :------------- | :---------------- | | Total Assets | $39,330 | $51,027 | | Cash and Cash Equivalents | $22,762 | $36,970 | | Investments | $12,958 | $9,989 | | Total Current Assets | $37,929 | $49,519 | | Total Liabilities | $13,337 | $13,286 | | Total Shareholders' Equity | $25,993 | $37,741 | | Deficit | $(478,006) | $(464,330) | [Condensed Consolidated Interim Statements of Loss and Comprehensive Loss](index=7&type=section&id=Condensed%20Consolidated%20Interim%20Statements%20of%20Loss%20and%20Comprehensive%20Loss) Details Aptose Biosciences Inc.'s revenue, expenses, net loss, and loss per share for the three months ended March 31, 2023 and 2022 **Condensed Consolidated Interim Statements of Loss and Comprehensive Loss (in thousands of US dollars, except per share data)** | Metric | Three months ended March 31, 2023 | Three months ended March 31, 2022 | | :---------------------------------- | :-------------------------------- | :-------------------------------- | | Revenue | $— | $— | | Research and Development Expenses | $8,811 | $7,393 | | General and Administrative Expenses | $5,285 | $4,107 | | Operating Expenses | $14,096 | $11,500 | | Interest Income | $422 | $22 | | Net Loss | $(13,676) | $(11,481) | | Basic and Diluted Loss Per Common Share | $(0.15) | $(0.12) | [Condensed Consolidated Interim Statements of Changes in Shareholders' Equity](index=8&type=section&id=Condensed%20Consolidated%20Interim%20Statements%20of%20Changes%20in%20Shareholders%27%20Equity) Outlines changes in Aptose Biosciences Inc.'s shareholders' equity, including net loss and share issuances, for Q1 2023 **Condensed Consolidated Interim Statements of Changes in Shareholders' Equity (in thousands of US dollars)** | Metric | Balance, December 31, 2022 | Balance, March 31, 2023 | | :------------------------- | :------------------------- | :---------------------- | | Total Shareholders' Equity | $37,741 | $25,993 | | Net Loss | $(13,676) | $(13,676) | | Common Shares Issued (2022 ATM Facility) | $34 | $34 | | Common Shares Issued (ESPP plan) | $16 | $16 | | Stock-based Compensation | $1,874 | $1,874 | [Condensed Consolidated Interim Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Interim%20Statements%20of%20Cash%20Flows) Presents Aptose Biosciences Inc.'s cash flows from operating, investing, and financing activities for Q1 2023 and 2022 **Condensed Consolidated Interim Statements of Cash Flows (in thousands of US dollars)** | Cash Flow Activity | Three months ended March 31, 2023 | Three months ended March 31, 2022 | | :------------------------------------------------ | :-------------------------------- | :-------------------------------- | | Net cash used in operating activities | $(11,302) | $(9,645) | | Net cash from/(used in) investing activities | $(2,960) | $7,505 | | Net cash from financing activities | $50 | $15 | | Net decrease in cash and cash equivalents | $(14,208) | $(2,123) | | Cash and cash equivalents, end of period | $22,762 | $36,991 | [1. Reporting entity](index=10&type=section&id=1.%20Reporting%20entity) Provides an overview of Aptose Biosciences Inc.'s business, product pipeline, and going concern status - Aptose is a science-driven clinical-stage biotechnology company focused on developing precision medicines for oncology, with an initial focus on hematology[34](index=34&type=chunk) - The company has two clinical-stage investigational products for hematological malignancies: tuspetinib (myeloid kinase inhibitor) and luxeptinib (dual lymphoid and myeloid kinase inhibitor)[35](index=35&type=chunk) - Aptose has an accumulated deficit of approximately **$478.0 million** as of March 31, 2023, and faces substantial doubt about its ability to continue as a going concern, requiring additional financing[36](index=36&type=chunk)[39](index=39&type=chunk) [2. Significant accounting policies](index=11&type=section&id=2.%20Significant%20accounting%20policies) Details Aptose Biosciences Inc.'s critical accounting policies, going concern considerations, and financial risk management - Substantial doubt exists about the Company's ability to continue as a going concern due to an accumulated deficit of **$478.0 million**, cash and cash equivalents and investment balances of **$35.7 million**, and working capital of **$25.5 million** as of March 31, 2023[39](index=39&type=chunk)[43](index=43&type=chunk)[44](index=44&type=chunk) - The company is evaluating strategies for additional funding, including equity or debt financing, but there is no assurance of obtaining such liquidity when needed or under acceptable terms, if at all[44](index=44&type=chunk) - No changes to significant accounting policies were made during the three months ended March 31, 2023, and the functional and presentation currency of the Company is the US dollar[45](index=45&type=chunk)[47](index=47&type=chunk)[48](index=48&type=chunk) - Credit risk from cash and investments is managed by investing in highly rated corporations and treasury bills capable of prompt liquidation[49](index=49&type=chunk) [3. Cash and cash equivalents](index=12&type=section&id=3.%20Cash%20and%20cash%20equivalents) Provides a breakdown of Aptose Biosciences Inc.'s cash and cash equivalents as of March 31, 2023, and December 31, 2022 **Cash and Cash Equivalents (in thousands of US dollars)** | Metric | March 31, 2023 | December 31, 2022 | | :------------------------------------------------ | :------------- | :---------------- | | Cash | $1,132 | $596 | | Deposits (high interest savings, money market, term deposits < 90 days) | $21,630 | $36,374 | | Total Cash and Cash Equivalents | $22,762 | $36,970 | [4. Prepaid expenses](index=12&type=section&id=4.%20Prepaid%20expenses) Details Aptose Biosciences Inc.'s prepaid expenses, including R&D and insurance, as of March 31, 2023, and December 31, 2022 **Prepaid Expenses (in thousands of US dollars)** | Metric | March 31, 2023 | December 31, 2022 | | :---------------------------- | :------------- | :---------------- | | Prepaid Research and Development Expenses | $1,208 | $1,271 | | Prepaid Insurance | $684 | $893 | | Other Prepaid Expenses | $155 | $139 | | Total Prepaid Expenses | $2,047 | $2,303 | [5. Right-of-use assets](index=12&type=section&id=5.%20Right-of-use%20assets) Presents Aptose Biosciences Inc.'s right-of-use assets and accumulated amortization as of March 31, 2023, and December 31, 2022 **Right-of-Use Assets (in thousands of US dollars)** | Metric | March 31, 2023 | December 31, 2022 | | :------------------------- | :------------- | :---------------- | | Right-of-use assets, NBV | $1,218 | $1,297 | | Accumulated Amortization | $(1,906) | $(1,803) | [6. Investments](index=12&type=section&id=6.%20Investments) Summarizes Aptose Biosciences Inc.'s investment portfolio, including Treasury Bills and Commercial Notes, as of March 31, 2023 **Investments (Market Value in thousands of US dollars)** | Investment Type | March 31, 2023 | December 31, 2022 | | :-------------- | :------------- | :---------------- | | United States Treasury Bills | $9,985 | $9,989 | | Commercial Notes | $2,973 | $0 | | Total Investments | $12,958 | $9,989 | [7. Fair value measurements and financial instruments](index=12&type=section&id=7.%20Fair%20value%20measurements%20and%20financial%20instruments) Discusses Aptose Biosciences Inc.'s fair value measurements for financial assets, primarily classified as Level 2 inputs - All financial assets measured at fair value are classified as Level 2 inputs, indicating valuation based on observable market data other than quoted prices[59](index=59&type=chunk)[60](index=60&type=chunk) **Fair Value of Assets (in thousands of US dollars)** | Asset Type | March 31, 2023 | December 31, 2022 | | :----------------------------------------- | :------------- | :---------------- | | Money Market funds | $14,126 | $22,343 | | High interest savings account | $1,537 | $13,866 | | United States Treasury Bills (cash equivalents) | $5,967 | $0 | | United States Treasury Bills (short-term investments) | $9,985 | $9,989 | | Commercial Note | $2,973 | $0 | | Total Fair Value Assets | $34,588 | $46,363 | [8. Accrued liabilities](index=13&type=section&id=8.%20Accrued%20liabilities) Details Aptose Biosciences Inc.'s accrued liabilities, including personnel and R&D costs, as of March 31, 2023, and December 31, 2022 **Accrued Liabilities (in thousands of US dollars)** | Metric | March 31, 2023 | December 31, 2022 | | :-------------------------------- | :------------- | :---------------- | | Accrued Personnel Related Costs | $1,180 | $2,302 | | Accrued Research and Development Expenses | $5,005 | $3,122 | | Other Accrued Expenses | $409 | $233 | | Total Accrued Liabilities | $6,594 | $5,657 | [9. Lease liability](index=13&type=section&id=9.%20Lease%20liability) Outlines Aptose Biosciences Inc.'s lease liabilities and recent lease extensions for its office facilities - Aptose extended its San Diego office lease through May 31, 2026, and its Toronto office lease through June 30, 2024[63](index=63&type=chunk) **Lease Liability (in thousands of US dollars)** | Metric | March 31, 2023 | December 31, 2022 | | :------------------------- | :------------- | :---------------- | | Lease liability, current portion | $306 | $301 | | Lease liability, long-term portion | $918 | $1,002 | | Total Lease Liability | $1,224 | $1,303 | [10. Share capital](index=14&type=section&id=10.%20Share%20capital) Details Aptose Biosciences Inc.'s equity issuances and loss per share calculations for the periods presented [a. Equity issuances](index=14&type=section&id=a.%20Equity%20issuances) Summarizes Aptose Biosciences Inc.'s common share issuances under ATM facilities during Q1 2023 - Issued **46,427 common shares** under the 2022 ATM Facility for net proceeds of **$34 thousand** during the three months ended March 31, 2023[69](index=69&type=chunk) - The 2020 ATM Facility was terminated on October 31, 2022, having raised a cumulative total of **$86 thousand** net proceeds[70](index=70&type=chunk) [b. Loss per share](index=15&type=section&id=b.%20Loss%20per%20share) Presents Aptose Biosciences Inc.'s net loss and weighted-average common shares for loss per share calculation **Loss Per Share (in thousands of US dollars, except per share data)** | Metric | Three months ended March 31, 2023 | Three months ended March 31, 2022 | | :------------------------------------------------ | :-------------------------------- | :-------------------------------- | | Net Loss | $(13,676) | $(11,481) | | Weighted-average common shares (basic and diluted) | 92,562 | 92,226 | | Net Loss per share (basic and diluted) | $(0.15) | $(0.12) | [11. Stock‑based compensation](index=15&type=section&id=11.%20Stock%E2%80%91based%20compensation) Details Aptose Biosciences Inc.'s stock option plan, employee stock purchase plan, and share-based payment expenses [a. Stock option plan and employee stock purchase plan](index=15&type=section&id=a.%20Stock%20option%20plan%20and%20employee%20stock%20purchase%20plan) Provides an overview of Aptose Biosciences Inc.'s outstanding stock options, grants, and restricted stock units - As of March 31, 2023, **18.84 million stock options** were outstanding (weighted average exercise price **$3.11**, contractual life **7.01 years**)[80](index=80&type=chunk) - **3.22 million stock options** were granted in Q1 2023 with a weighted-average grant date fair value of **$0.44**[80](index=80&type=chunk)[82](index=82&type=chunk) - **570,000 restricted stock units (RSUs)** were granted, immediately vested, and redeemed for common shares in Q1 2023[85](index=85&type=chunk)[86](index=86&type=chunk) [b. Share-based payment expense](index=17&type=section&id=b.%20Share-based%20payment%20expense) Details Aptose Biosciences Inc.'s share-based payment expenses allocated to R&D and G&A for Q1 2023 and 2022 **Share-based Payment Expense (in thousands of US dollars)** | Expense Category | Three months ended March 31, 2023 | Three months ended March 31, 2022 | | :------------------------- | :-------------------------------- | :-------------------------------- | | Research and Development | $652 | $946 | | General and Administrative | $1,222 | $1,568 | | Total Share-based Payment Expense | $1,874 | $2,514 | [12. Subsequent events](index=17&type=section&id=12.%20Subsequent%20events) Reports on Aptose Biosciences Inc.'s additional share issuances under the 2022 ATM Facility after March 31, 2023 - Subsequent to March 31, 2023, up to May 8, 2023, Aptose issued an additional **648,384 shares** under the 2022 ATM Facility, generating **$319 thousand** in net proceeds[89](index=89&type=chunk) [Item 2 – Management's Discussion and Analysis of Financial Condition and Results of Operations](index=18&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, liquidity, capital resources, and financial results for Q1 2023 [OVERVIEW](index=18&type=section&id=OVERVIEW) Provides a general introduction to Aptose Biosciences Inc.'s clinical-stage biotechnology focus and product pipeline - Aptose is a clinical-stage biotechnology company developing precision medicines for oncology, specifically hematologic cancers[93](index=93&type=chunk) - The company's pipeline includes two clinical-stage investigational products: tuspetinib (myeloid kinase inhibitor) and luxeptinib (dual lymphoid and myeloid kinase inhibitor)[94](index=94&type=chunk)[95](index=95&type=chunk) [PROGRAM UPDATES](index=18&type=section&id=PROGRAM%20UPDATES) Details the progress and clinical activity of Aptose Biosciences Inc.'s investigational products, tuspetinib and luxeptinib [Tuspetinib](index=18&type=section&id=Tuspetinib) Provides updates on the Phase 1/2 clinical trial for tuspetinib in R/R AML, highlighting its activity and designations - Tuspetinib, an oral myeloid kinase inhibitor, is in an international Phase 1/2 clinical trial for relapsed or refractory acute myeloid leukemia (R/R AML)[94](index=94&type=chunk)[96](index=96&type=chunk) - It has demonstrated robust clinical activity, including multiple complete responses in R/R AML patients with diverse disease genotypes (e.g., NPM1, MLL, TP53, RAS pathway mutations), and a favorable safety profile without prolonged myelosuppression or life-threatening toxicities[96](index=96&type=chunk)[101](index=101&type=chunk)[103](index=103&type=chunk)[105](index=105&type=chunk) - Tuspetinib received FDA Orphan Drug designation for AML (Oct 2018) and Fast Track designation for R/R AML with FLT3 mutation (May 2022)[98](index=98&type=chunk) - The APTIVATE Phase 1/2 expansion trial has initiated monotherapy and doublet combination treatment with venetoclax (TUS/VEN), showing brisk enrollment and early signs of antileukemic activity[100](index=100&type=chunk)[105](index=105&type=chunk) - Preclinical data show tuspetinib inhibits wild type and mutant FLT3, SYK, JAK1, JAK2, and mutant c-KIT, and can overcome acquired resistance to other FLT3 inhibitors[106](index=106&type=chunk)[107](index=107&type=chunk) [Luxeptinib](index=20&type=section&id=Luxeptinib) Details the Phase 1a/b studies for luxeptinib, including its new G3 formulation and clinical activity in various malignancies - Luxeptinib is an oral, dual lymphoid and myeloid kinase inhibitor in Phase 1a/b studies for R/R AML, high-risk MDS, and B-cell malignancies (CLL, SLL, NHL)[108](index=108&type=chunk)[109](index=109&type=chunk) - A 'third generation' (G3) formulation of luxeptinib is being developed, showing up to an **18-fold improvement** in plasma steady-state exposure compared to the original G1 formulation, with continuous dosing initiated in R/R AML patients[114](index=114&type=chunk)[115](index=115&type=chunk)[116](index=116&type=chunk) - Clinical activity includes a complete response in a diffuse large B-cell lymphoma patient and durable MRD-negative CR and blast reductions in FLT3-ITD mutated AML patients[110](index=110&type=chunk)[113](index=113&type=chunk) - Research indicates luxeptinib interferes with LYN-mediated activation of SYK and modulates BCR signaling, distinct from BTK inhibitors like ibrutinib[117](index=117&type=chunk) [Other corporate matters](index=21&type=section&id=Other%20corporate%20matters) Addresses Aptose Biosciences Inc.'s Nasdaq compliance status and potential strategies for regaining minimum bid price - Aptose received a Nasdaq deficiency letter on July 18, 2022, for not meeting the **$1.00 minimum bid price** requirement, with an extension until July 18, 2023[40](index=40&type=chunk)[41](index=41&type=chunk)[118](index=118&type=chunk) - The company is considering a reverse stock split (1-for-10 to 1-for-20) to regain Nasdaq compliance, pending shareholder and Board approval[42](index=42&type=chunk)[120](index=120&type=chunk) [LIQUIDITY AND CAPITAL RESOURCES](index=22&type=section&id=LIQUIDITY%20AND%20CAPITAL%20RESOURCES) Analyzes Aptose Biosciences Inc.'s financial position, funding sources, and cash flow activities, highlighting going concern risks - Aptose is an early-stage development company with no product revenues, dependent on equity financing and strategic partners[122](index=122&type=chunk) - The company faces substantial doubt about its ability to continue as a going concern and requires additional financing, which may be affected by market conditions or trial delays[125](index=125&type=chunk)[131](index=131&type=chunk) **Liquidity and Capital Resources (in thousands of US dollars)** | Metric | March 31, 2023 | December 31, 2022 | | :----------------------------------- | :------------- | :---------------- | | Cash and Cash Equivalents | $22,762 | $36,970 | | Investments | $12,958 | $9,989 | | Total Cash, Cash Equivalents & Investments | $35,720 | $46,959 | | Working Capital | $25,510 | $37,235 | [Sources of liquidity](index=22&type=section&id=Sources%20of%20liquidity) Identifies Aptose Biosciences Inc.'s primary funding mechanisms, including equity financing and interest income - Operations are financed primarily through equity financing, exercise of warrants and stock options, and interest income[35](index=35&type=chunk)[126](index=126&type=chunk) - Excess cash is invested in short-term, highly-rated financial instruments to manage credit risk[126](index=126&type=chunk)[136](index=136&type=chunk) [2022 Base Shelf](index=22&type=section&id=2022%20Base%20Shelf) Describes Aptose Biosciences Inc.'s $200 million base shelf prospectus for future equity or debt offerings - A **$200 million** base shelf prospectus was filed in October 2022, effective until October 2025, for distributing common shares, warrants, or units[127](index=127&type=chunk) [At-The-Market Facilities](index=22&type=section&id=At-The-Market%20Facilities) Summarizes Aptose Biosciences Inc.'s share issuances and net proceeds from its At-The-Market facilities - Raised **$34 thousand** net proceeds from the 2022 ATM Facility in Q1 2023 by issuing **46,427 shares**[129](index=129&type=chunk) - The 2020 ATM Facility was terminated on October 31, 2022, after raising a cumulative **$86 thousand** net proceeds[130](index=130&type=chunk) [Cash flows](index=23&type=section&id=Cash%20flows) Provides a detailed breakdown of Aptose Biosciences Inc.'s cash flow activities from operations, investing, and financing **Summary of Cash Flows (in thousands of US dollars)** | Cash Flow Activity | Three months ended March 31, 2023 | Three months ended March 31, 2022 | | :------------------------------------------------ | :-------------------------------- | :-------------------------------- | | Net cash provided by (used in) operating activities | $(11,302) | $(9,645) | | Net cash provided by (used in) investing activities | $(2,960) | $7,505 | | Net cash provided by (used in) financing activities | $50 | $15 | | Net decrease in cash and cash equivalents | $(14,208) | $(2,123) | [Cash used in operating activities](index=23&type=section&id=Cash%20used%20in%20operating%20activities) Analyzes the increase in cash used for Aptose Biosciences Inc.'s operating activities, driven by higher R&D expenses - Cash used in operating activities increased to **$11.3 million** in Q1 2023 (from **$9.6 million** in Q1 2022) due to higher operating expenses, including clinical studies, manufacturing, and professional fees[134](index=134&type=chunk) - Negative cash flow from operations is expected to continue until regulatory approval and commercialization of products, if ever[135](index=135&type=chunk) [Cash flow from (used in) investing activities](index=23&type=section&id=Cash%20flow%20from%20%28used%20in%29%20investing%20activities) Compares Aptose Biosciences Inc.'s cash flow from investing activities, shifting from net maturities to net acquisitions of investments - Investing activities resulted in **$3.0 million** cash used in Q1 2023 (net acquisition of investments) compared to **$7.5 million** cash provided in Q1 2022 (net maturities of investments)[136](index=136&type=chunk) [Cash flow from financing activities](index=24&type=section&id=Cash%20flow%20from%20financing%20activities) Details Aptose Biosciences Inc.'s cash generated from financing activities, primarily through ATM facilities and ESPP - Cash from financing activities was **$50 thousand** in Q1 2023 (2022 ATM Facility and ESPP) versus **$15 thousand** in Q1 2022 (stock option exercises)[139](index=139&type=chunk) [CONTRACTUAL OBLIGATIONS and commitments described under Item 7](index=24&type=section&id=CONTRACTUAL%20OBLIGATIONS%20and%20commitments%20described%20under%20Item%207) States that there are no material changes to Aptose Biosciences Inc.'s contractual obligations since the last annual report - No material changes to contractual obligations and commitments since the December 31, 2022 Annual Report on Form 10-K[140](index=140&type=chunk) [RESULTS OF OPERATIONS](index=24&type=section&id=RESULTS%20OF%20OPERATIONS) Analyzes Aptose Biosciences Inc.'s financial performance, focusing on changes in R&D, G&A expenses, and net loss **Summary of Results of Operations (in thousands of US dollars)** | Metric | Three months ended March 31, 2023 | Three months ended March 31, 2022 | | :---------------------------------- | :-------------------------------- | :-------------------------------- | | Net Loss | $13,676 | $11,481 | | Research and Development Expenses | $8,811 | $7,393 | | General and Administrative Expenses | $5,285 | $4,107 | | Other Income, net | $420 | $19 | [Research and Development](index=24&type=section&id=Research%20and%20Development) Discusses the increase in Aptose Biosciences Inc.'s R&D expenses, primarily driven by the tuspetinib program - R&D expenses increased by **$1.4 million** to **$8.8 million** in Q1 2023, primarily due to higher tuspetinib program costs[146](index=146&type=chunk) - Tuspetinib program costs increased to **$4.8 million** (from **$1.2 million** in Q1 2022) due to patient enrollment in the APTIVATE clinical trial[146](index=146&type=chunk) - Luxeptinib program costs decreased by **$1.5 million** due to lower manufacturing costs from a new formulation requiring less API, partially offset by higher clinical trial contractor costs[146](index=146&type=chunk) - Personnel-related expenses decreased by **$256 thousand**, and stock-based compensation decreased by **$294 thousand**[146](index=146&type=chunk) - R&D expenses are expected to be higher in the foreseeable future as tuspetinib advances into larger clinical trials[142](index=142&type=chunk) [General and Administrative](index=25&type=section&id=General%20and%20Administrative) Examines the increase in Aptose Biosciences Inc.'s G&A expenses, mainly due to higher salaries and professional fees - G&A expenses increased by **$1.2 million** to **$5.3 million** in Q1 2023, primarily due to higher salaries and professional fees[148](index=148&type=chunk) - Stock-based compensation within G&A decreased by **$346 thousand** due to lower grant date fair values[150](index=150&type=chunk) - G&A expenses are expected to increase in the foreseeable future to support pipeline expansion and intellectual property[147](index=147&type=chunk) [CRITICAL ACCOUNTING POLICIES](index=26&type=section&id=CRITICAL%20ACCOUNTING%20POLICIES) Reviews Aptose Biosciences Inc.'s critical accounting policies, estimates, and updated share information [Critical Accounting Policies and Estimates](index=26&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) Confirms no material changes to Aptose Biosciences Inc.'s critical accounting policies and estimates in Q1 2023 - No material changes to critical accounting policies and estimates occurred during the three months ended March 31, 2023[152](index=152&type=chunk) [Significant accounting judgments and estimates](index=26&type=section&id=Significant%20accounting%20judgments%20and%20estimates) Highlights management's judgments and estimates for R&D expenses and their potential impact on financial statements - Management makes significant judgments and estimates for R&D expenses based on contract progress, impacting accrued and prepaid balances[153](index=153&type=chunk) - A **10% variance** in R&D expense estimates could result in an over or understatement of approximately **$620 thousand** in R&D expenses[154](index=154&type=chunk) [Updated share information](index=26&type=section&id=Updated%20share%20information) Provides Aptose Biosciences Inc.'s common shares issued and outstanding, and shares issuable from stock options as of May 8, 2023 **Updated Share Information (as of May 8, 2023)** | Metric | Amount | | :----------------------------------- | :------------- | | Common Shares Issued and Outstanding | 93,653,652 | | Common Shares Issuable from Stock Options | 18,790,758 | [Item 3 – Qualitative and Quantitative Disclosures about Market Risk](index=27&type=section&id=Item%203%20%E2%80%93%20Qualitative%20and%20Quantitative%20Disclosures%20about%20Market%20Risk) Aptose Biosciences Inc., as a smaller reporting company, is exempt from market risk disclosures - As a smaller reporting company, Aptose is exempt from providing qualitative and quantitative disclosures about market risk[158](index=158&type=chunk) [Item 4 – Controls and Procedures](index=27&type=section&id=Item%204%20%E2%80%93%20Controls%20and%20Procedures) Management concluded Aptose Biosciences Inc.'s disclosure controls and procedures were effective as of March 31, 2023 - As of March 31, 2023, disclosure controls and procedures were deemed effective by management, including the CEO and CFO[159](index=159&type=chunk) - Control systems provide reasonable, not absolute, assurance and may not prevent all errors or fraud[160](index=160&type=chunk) [CHANGES IN INTERNAL CONTROL OVER FINANCIAL REPORTING](index=27&type=section&id=CHANGES%20IN%20INTERNAL%20CONTROL%20OVER%20FINANCIAL%20REPORTING) Confirms no material changes in Aptose Biosciences Inc.'s internal control over financial reporting during Q1 2023 - No material changes in internal control over financial reporting occurred during the fiscal quarter ended March 31, 2023[161](index=161&type=chunk) [PART II—OTHER INFORMATION](index=28&type=section&id=PART%20II%E2%80%94OTHER%20INFORMATION) This section provides additional information including legal proceedings, risk factors, exhibits, and signatures for the report [Item 1 – Legal Proceedings](index=28&type=section&id=Item%201%20%E2%80%93%20Legal%20Proceedings) Aptose Biosciences Inc. is not currently involved in any material active legal actions - The company is not involved in any material active legal actions[163](index=163&type=chunk) [Item 1A – Risk Factors](index=28&type=section&id=Item%201A%20%E2%80%93%20Risk%20Factors) No material changes to Aptose Biosciences Inc.'s risk factors since the December 31, 2022 Annual Report on Form 10-K - No material changes to risk factors since the December 31, 2022 Annual Report on Form 10-K[164](index=164&type=chunk) [Item 6 – Exhibits](index=29&type=section&id=Item%206%20%E2%80%93%20Exhibits) Lists exhibits filed with the Form 10-Q, including officer certifications and Inline XBRL financial statements - Includes certifications from Principal Executive Officer and Principal Financial Officer (Exhibits 31.1, 31.2, 32.1, 32.2)[166](index=166&type=chunk) - Contains Inline XBRL formatted financial statements and related taxonomy documents (Exhibit 101 and 101.INS, 101.SCH, 101.CAL, 101.DEF, 101.LAB, 101.PRE)[166](index=166&type=chunk) [Signatures](index=30&type=section&id=Signatures) The report was signed by Aptose Biosciences Inc.'s President and CEO on May 8, 2023 - Report signed by William G. Rice, Ph.D., President and CEO, on May 8, 2023[168](index=168&type=chunk)