Aptose Biosciences(APTO)

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Aptose Biosciences(APTO) - 2019 Q4 - Earnings Call Transcript
2020-03-11 02:51
Financial Data and Key Metrics Changes - The company ended the quarter with approximately $97.6 million in cash, cash equivalents, and investments, compared to $15.7 million at December 31, 2018, and $30.2 million at September 30, 2019 [37] - The net loss was $7.7 million for the quarter and $26.3 million or $0.52 per share for the year [38] Business Line Data and Key Metrics Changes - Research and development expenses were $5.3 million for the quarter and $16.8 million for the year, while general and administrative expenses were $2.6 million for the quarter and $10 million for the year [38] Market Data and Key Metrics Changes - The company has opened 18 U.S. clinical sites for screening and enrolling patients for the ongoing clinical trials [22] Company Strategy and Development Direction - The company is focused on advancing its two hematology compounds, CG-806 and APTO-253, into clinical trials, with CG-806 being positioned as a mutation-agnostic agent targeting multiple oncogenic signaling pathways [15][16] - The company plans to submit documents to the FDA for a new AML trial during the first half of the year, focusing on relapsed and refractory AML patients [25] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the ongoing clinical trials and the potential of CG-806 to benefit patients who have failed other therapies, highlighting the urgent need for new treatments in AML [30] - The management is closely monitoring the impact of COVID-19 on operations but currently does not foresee any delays in clinical trials or manufacturing [39][56] Other Important Information - The company has strengthened its management team with the addition of key personnel in clinical operations and business development [13][14] - A $200 million shelf registration statement was filed in late December, which was declared effective in early January [38] Q&A Session Summary Question: Update on the second patient at the 300 mg BID dose cohort - The patient was taken off the study due to extensive bone marrow involvement, but the drug was well tolerated, and lymphocytosis was observed [44][46] Question: Safety and pharmacokinetics for the next cohort - Safety is the primary focus, and pharmacokinetics data is being analyzed to ensure minimal variability and effective drug levels [50][52] Question: Impact of COVID-19 on clinical trials - No direct impact has been observed on clinical operations, but the situation is being monitored closely [58][59] Question: Appetite for AML side of 806's potential - The company is aggressive in pursuing both CLL and AML opportunities, aiming to demonstrate activity in both patient populations [61][62] Question: Responses in CLL and imaging requirements - Responses in CLL can take time, and imaging is typically evaluated every two cycles to confirm responses [70][72] Question: Criteria for determining active dose in AML - The company is looking for safety, pharmacokinetics around one micromolar, and pharmacodynamic responses to recommend moving into AML trials [75][76]
Aptose Biosciences(APTO) - 2019 Q4 - Annual Report
2020-03-10 21:01
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark one) ☒ ANNUAL REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2019. ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number 001-3200 APTOSE BIOSCIENCES INC. (Exact name of registrant as specified in its charter) Canada (State or other jurisdiction of incorporation or organization) 98-1136802 (I.R.S. Employer ...
Aptose Biosciences(APTO) - 2019 Q3 - Quarterly Report
2019-11-05 22:01
[PART I—FINANCIAL INFORMATION](index=4&type=section&id=PART%20I%E2%80%94FINANCIAL%20INFORMATION) This section provides the interim financial statements and management's analysis of the company's financial performance and position [Financial Statements](index=4&type=section&id=ITEM%201%20%E2%80%93%20FINANCIAL%20STATEMENTS) This section details the company's interim financial position, comprehensive loss, equity changes, and cash flows for the reported periods [Condensed Consolidated Interim Statements of Financial Position](index=4&type=section&id=Condensed%20Consolidated%20Interim%20Statements%20of%20Financial%20Position) Total assets nearly doubled to $32.46 million by September 2019, driven by increased cash and investments from financing activities Condensed Consolidated Interim Statements of Financial Position (in thousands of US dollars) | | September 30, 2019 | December 31, 2018 | | :--- | :--- | :--- | | **Total current assets** | $30,608 | $16,486 | | **Total assets** | $32,460 | $16,870 | | **Total current liabilities** | $3,908 | $2,789 | | **Total liabilities** | $5,032 | $2,789 | | **Total shareholders' equity** | $27,428 | $14,081 | [Condensed Consolidated Interim Statement of Loss and Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Interim%20Statement%20of%20Loss%20and%20Comprehensive%20Loss) Net loss decreased to $18.57 million for the nine months ended September 2019, primarily due to lower R&D and G&A expenses Statement of Loss and Comprehensive Loss Highlights (in thousands of US dollars, except per share data) | | Nine months ended Sep 30, 2019 | Nine months ended Sep 30, 2018 | | :--- | :--- | :--- | | **Revenue** | $0 | $0 | | **Research and development** | $11,582 | $14,549 | | **General and administrative** | $7,391 | $8,233 | | **Operating Expenses** | $18,973 | $22,782 | | **Net loss** | $(18,568) | $(22,607) | | **Basic and diluted loss per common share** | $(0.39) | $(0.71) | [Condensed Consolidated Interim Statements of Changes in Shareholders' Equity](index=7&type=section&id=Condensed%20Consolidated%20Interim%20Statements%20of%20Changes%20in%20Shareholders%27%20Equity) Shareholders' equity significantly increased to $27.43 million, driven by public offerings and share purchase agreements, offset by net loss - Total shareholders' equity increased to **$27,428 thousand** at September 30, 2019, from **$14,081 thousand** at December 31, 2018[8](index=8&type=chunk) - Key drivers of the equity increase include proceeds from a public offering (**$19.6 million**) and a share purchase agreement (**$10.0 million**), which were partially offset by the period's net loss (**$18.6 million**)[8](index=8&type=chunk) [Condensed Consolidated Interim Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Interim%20Statements%20of%20Cash%20Flows) Cash and equivalents increased by $5.39 million, with financing activities providing $29.81 million, offsetting operating and investing outflows Cash Flow Summary (in thousands of US dollars) | | Nine months ended Sep 30, 2019 | Nine months ended Sep 30, 2018 | | :--- | :--- | :--- | | **Cash used in operating activities** | $(15,327) | $(17,705) | | **Cash provided by (used in) investing activities** | $(9,092) | $98 | | **Cash provided by financing activities** | $29,808 | $22,032 | | **Increase in cash and cash equivalents** | $5,387 | $4,425 | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=19&type=section&id=ITEM%202%20-%20MANAGEMENT%27S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS) Management provides an overview of clinical programs, financial condition, and operational results, highlighting progress and funding into 2021 [Overview and Program Updates](index=19&type=section&id=Overview%20and%20Program%20Updates) Aptose advances two oncology drug candidates, CG-806 and APTO-253, through Phase 1 trials, securing global rights and patents - CG-806 is in a Phase 1a/b study for B-cell malignancies (CLL/SLL/NHL), with patient enrollment completed for the first two dose levels and escalation to the third dose level (450mg BID) approved[58](index=58&type=chunk)[64](index=64&type=chunk)[65](index=65&type=chunk) - APTO-253 is in a Phase 1b trial for R/R AML and high-risk MDS. The trial has successfully completed the first three dose cohorts, and the company plans to begin enrollment for the fourth cohort at **100mg/m2**[61](index=61&type=chunk)[79](index=79&type=chunk)[80](index=80&type=chunk) - The company secured worldwide rights to CG-806 (excluding Korea) and has obtained patents in the U.S., Japan, Europe, and Australia, providing protection until **late 2033**[69](index=69&type=chunk)[70](index=70&type=chunk)[71](index=71&type=chunk) - The clinical hold on APTO-253, related to manufacturing issues, was lifted by the FDA in **June 2018**, allowing the Phase 1b trial to be re-initiated[83](index=83&type=chunk)[84](index=84&type=chunk) [Liquidity and Capital Resources](index=24&type=section&id=Liquidity%20and%20Capital%20Resources) The company holds $30.2 million in cash and investments, with financing activities providing $29.8 million, sufficient to fund operations into 2021 Liquidity Position (in thousands) | | Sep 30, 2019 | Dec 31, 2018 | | :--- | :--- | :--- | | Cash and cash equivalents | $20,686 | $15,299 | | Investments | $9,528 | $440 | | **Total** | **$30,214** | **$15,739** | | **Working capital** | **$26,700** | **$13,697** | - The company believes its current cash, investments, and available financing facilities will be sufficient to fund planned operations into **2021**[100](index=100&type=chunk) - In **June 2019**, the company completed a public offering, raising gross proceeds of approximately **$21.3 million**[113](index=113&type=chunk) - The company established a new **$40 million** At-The-Market (ATM) facility in **May 2019** and a new **$20 million** share purchase agreement with Aspire Capital[97](index=97&type=chunk)[98](index=98&type=chunk) [Results of Operations](index=28&type=section&id=Results%20of%20Operations) Net loss decreased to $18.6 million due to the absence of a 2018 license fee and lower stock-based compensation, despite increased program costs Net Loss Summary (in thousands) | | Nine months ended Sep 30, 2019 | Nine months ended Sep 30, 2018 | | :--- | :--- | :--- | | Research and development expenses | $11,582 | $14,549 | | General and administrative expenses | $7,391 | $8,233 | | **Net loss** | **$(18,568)** | **$(22,607)** | Research and Development Expenses Breakdown (in thousands) | | Nine months ended Sep 30, 2019 | Nine months ended Sep 30, 2018 | | :--- | :--- | :--- | | License fees – CG-806 | $0 | $5,000 | | Program costs – CG-806 | $5,287 | $4,164 | | Program costs – APTO-253 | $3,296 | $3,085 | | Personnel related expenses | $2,666 | $1,448 | | Stock-based compensation | $309 | $826 | | **Total R&D Expenses** | **$11,582** | **$14,549** | General and Administrative Expenses Breakdown (in thousands) | | Nine months ended Sep 30, 2019 | Nine months ended Sep 30, 2018 | | :--- | :--- | :--- | | G&A, excluding non-cash items | $5,515 | $4,726 | | Aspire share purchase agreement fees | $360 | $600 | | Stock-based compensation | $1,425 | $2,869 | | **Total G&A Expenses** | **$7,391** | **$8,233** | [Critical Accounting Policies](index=30&type=section&id=Critical%20Accounting%20Policies) The company adopted new lease accounting standards, recognizing a right-of-use asset and lease liability, with no material impact on the statement of loss - Effective **January 1, 2019**, the company adopted the new lease accounting standard, ASU No. 2016-02 (Topic 842)[135](index=135&type=chunk) - Upon adoption, the company recorded a right-of-use asset of approximately **$1.570 million** and a lease liability of approximately **$1.647 million**[136](index=136&type=chunk) [Qualitative and Quantitative Disclosures About Market Risk](index=31&type=section&id=ITEM%203.%20QUALITATIVE%20AND%20QUANTITATIVE%20DISCLOSURES%20ABOUT%20MARKET%20RISK) The company is exempt from providing market risk disclosures as it qualifies as a smaller reporting company - The company is not required to provide this information as it qualifies as a smaller reporting company[140](index=140&type=chunk) [Controls and Procedures](index=31&type=section&id=ITEM%204.%20CONTROLS%20AND%20PROCEDURES) Management concluded that disclosure controls and procedures were effective as of September 30, 2019, with no material changes to internal controls - Management concluded that as of **September 30, 2019**, the company's disclosure controls and procedures were effective[141](index=141&type=chunk) - There were no changes in internal control over financial reporting during the quarter that have materially affected, or are reasonably likely to materially affect, internal controls[144](index=144&type=chunk) [PART II—OTHER INFORMATION](index=33&type=section&id=PART%20II%E2%80%94OTHER%20INFORMATION) This section provides information on legal proceedings, risk factors, and exhibits filed with the report [Legal Proceedings](index=33&type=section&id=ITEM%201.%20LEGAL%20PROCEEDINGS) The company is not currently involved in any material legal proceedings - The company is not currently party to any material legal proceedings[146](index=146&type=chunk) [Risk Factors](index=33&type=section&id=ITEM%201A.%20RISK%20FACTORS) The company is exempt from providing risk factor disclosures as it qualifies as a smaller reporting company - The company is not required to provide this information as it qualifies as a smaller reporting company[147](index=147&type=chunk) [Exhibits](index=33&type=section&id=ITEM%206.%20%E2%80%93%20EXHIBITS) This section lists the exhibits accompanying the quarterly report, including required Sarbanes-Oxley certifications - The report includes certifications from principal officers as required by the Sarbanes-Oxley Act of **2002**[148](index=148&type=chunk)
Aptose Biosciences(APTO) - 2019 Q2 - Quarterly Report
2019-08-06 21:11
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ý QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended June 30 , 2019 OR o 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: 1-35447 APTOSE BIOSCIENCES INC. (Exact Name of Registrant as Specified in Its Charter) Canada 98-1136802 (State or Other Jurisdiction of Incor ...
Aptose Biosciences(APTO) - 2019 Q1 - Quarterly Report
2019-05-07 20:47
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 March 31, 2019 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: 1-35447 APTOSE BIOSCIENCES INC. (Exact Name of Registrant as Specified in Its Charter) Canada 98-1136802 (State or Other Jurisdiction of Incor ...
Aptose Biosciences(APTO) - 2018 Q4 - Annual Report
2019-03-12 20:57
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark one) ☒ ANNUAL REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2018. ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number 001-3200 APTOSE BIOSCIENCES INC. (Exact name of registrant as specified in its charter) Canada (State or other jurisdiction of incorporation or organization) 98-1136802 (I.R.S. Employer ...