 CG-806 Phase 1 ab Study in B Cell Malignancies Advances to Fifth 750mg Dose CohortFDA Allows IND for Phase 1 ab Study of CG-806 in AML to Initiate at 450mg Dose LevelAPTO-253 Phase 1b Study in AML MDS Advances to Fifth 150mgm2 Dose CohortConference Call and Webcast at 5pm EDT TodaySAN DIEGO and TORONTO, Aug. 04, 2020 GLOBE NEWSWIRE -- Aptose Biosciences Inc. Aptose or the Company NASDAQ: APTO, TSX: APS, a clinical-stage company developing highly differentiated agents that target the underlying mechanisms of cancer, today announced financial results and corporate update for the three months ended June 30, 2020.The net loss for the quarter ended June 30, 2020 was 15.8 million 0.21 per share compared with 6.2 million 0.13 per share for the quarter ended June 30, 2019. Total cash and cash equivalents and investments as of June 30, 2020 were 82.7 million. Based on current operations, we expect that cash on hand and proceeds from the recent public offering provide the Company with sufficient resources to fund all planned operations including research and development into 2023.Aptoses two distinctive clinical assets, CG-806 and APTO-253, are advancing well through dose escalation in their respective clinical trials, both with signs of pharmacologic activity and favorable safety and tolerability to date, said William G. Rice, Ph.D., Chairman, President and Chief Executive Officer. For CG-806 in particular, we believe these higher doses provide momentum toward the goal of delivering responses in RR-CLL patients. Plus, with the FDAs recent allowance of our IND for CG-806 in AML patients at a potentially therapeutic starting dose of 450 mg BID, we continue to execute on our broad strategic plan and are hopeful that CG-806 will deliver benefit to yet another fragile patient population in great need of new therapies.Key Corporate Highlights CG-806 Phase 1 ab B-cell Malignancy Clinical Study Aptose has completed dose level four 600 mg BID dose cohort of the CG-806 trial in patients with CLL and other B-cell malignancies. The safety review committee then advanced CG-806 to the fifth dose level of 750 mg BID, and potential patients are being screened for enrollment into this cohort. To date, CG-806 continues to be well-tolerated, and initial indications of desired pharmacologic activity continue to be observed, including strong inhibition of multiple oncogenic driver kinases and a robust increase in peripheral blood lymphocytes - or lymphocytosis - classically ascribed as a response to the inhibition of BTK. Currently, 23 U.S. sites are open for screening and enrolling patients for the study, and more information is available at FDA Allowance of IND for CG-806 in AML In June, Aptose announced that the U.S. Food and Drug Administration FDA allowed the companys Investigational New Drug IND application for the initiation of a Phase 1ab clinical study of CG-806, the companys highly potent, oral FLT3BTK inhibitor, in patients with acute myeloid leukemia AML. Importantly, the desired starting dose of 450mg BID was allowed, as this dose is expected to be pharmacologically active in patients with FLT3 mutated AML. Aptose is working with key AML sites to start enrollment for this study NCT04477291 in late Q3. Despite recent advances in the treatment of AML, many patients continue to have a poor overall prognosis. CG-806 is the only BTK inhibitor that also possesses strong FLT3 inhibitory activity and is applicable therefore to both lymphoid and myeloid malignancies. APTO-253 Phase 1b Clinical Study Aptose recently completed dose level four 100 mgm2 of the APTO-253 study in patients with AML and MDS and the safety review committee then escalated dosing to 150 mgm2. Approval of the current protocol amendment with accelerated dosing will allow enrollment at 8 sites. APTO-253 is the only known clinical-stage molecule that can directly target and inhibit expression of the MYC oncogene, shown to reprogram survival signaling pathways and contribute to drug resistance in many malignancies, including AML and B cell malignancies. In the ongoing Phase 1b trial, Aptose has observed MYC suppression in the peripheral blood mononuclear cells PBMCs from treated patients with AML and MDS. More information is available at Public Offering of Common Shares In July, Aptose completed an underwritten public offering of 10,500,000 common shares the Offering at the public offering price of US5.25 per share. Piper Sandler Co. acted as the sole active book-running manager for the Offering and has been granted a 30-day option to purchase up to an additional 1,575,000 common shares in the Offering, under the same terms and conditions. Gross proceeds from the Offering, before deducting underwriting discounts and commissions and estimated offering expenses payable by Aptose, are approximately US55.125 million. A summary of the results of operations for the three-month and six-month periods ended June 30, 2020 and 2019 is presented below: Three months ended June 30,Six months ended June 30, in thousands2020 2019 2020 2019 Revenues- - - - Research and development expenses 6,866 3,491 12,800 6,831 General and administrative expenses 9,015 2,855 14,915 5,115 Net finance income 131 128 439 222 Net loss15,750 6,21827,276 11,724 Other comprehensive gainloss 15 9 15 18 Total comprehensive loss15,765 6,20927,291 11,706 Basic and diluted loss per common share0.21 0.130.36 0.27 The net loss for the three-month period ended June 30, 2020 increased by 9.5 million to 15.8 million as compared with 6.2 million for the comparable period in 2019, primarily as a result of an increase of 7.1 million in stock-based compensation in the current period, a combined increase in program costs and related labor costs of approximately 2.6 million on our CG-806 and APTO-253 development programs, and offset by lower general and administrative expenses, after adjusting for stock option compensation, of 185 thousand.The net loss for the six-month period ended June 30, 2020 increased by 15.6 million to 27.3 million as compared with 11.7 million for the comparable period, primarily as a result of an increase of 10.9 million in stock-based compensation in the current period, a combined increase in program costs and related labor costs of approximately 4.5 million on our CG-806 and APTO-253 development programs, and higher cash-based general and administrative expenses of 384 thousand. These expenses were partially offset by an increase in net finance income of 217 thousand in the current period compared to the comparative period, mostly as a result of higher interest earned on larger balances of cash equivalents and investments held during the six-month period ended June 30, 2020.Research and Development The research and development expenses for the three-month and six-month periods ended June 30, 2020 and 2019 were as follows: Three months ended June 30,Six months ended June 30, in thousands2020 20192020 2019 Program costs CG-8063,755 1,678 6,700 3,064 Program costs APTO-253 856 722 1,735 1,850 Personnel related expenses 1,317 925 2,620 1,624 Stock-based compensation 933 157 1,733 275 Depreciation of equipment 5 9 12 18 6,866 3,491 12,800 6,831 Research and development expenses increased by 3.4 million to 6.9 million for the three-month period ended June 30, 2020 as compared with 3.5 million for the comparative period. Changes to the components of our research and development expenses presented in the table above are primarily as a result of the following events: Program costs for CG-806 increased by approximately 2.1 million, mostly as a result of higher manufacturing costs, including costs to scale up manufacturing and research costs associated with optimizing the formulation, higher costs associated with the CG-806 Phase 1ab trial, and the costs associated with start-up for the CG-806 AML trial. Personnel-related expenses increased by 392 thousand, mostly related to new positions hired since the second quarter of 2019 to support the conduct of the CC-806 Phase 1ab and APTO-253 Phase 1b clinical trials, and start-up of the CG-806 AML Phase 1 ab clinical trial. Stock-based compensation increased by approximately 776 thousand in the three months ended June 30, 2020, compared with the three months ended June 30, 2019, mostly related to an increase in the number of options granted during the six months ended June 30, 2020 and a higher grant date fair value of options as compared with the six months ended June 30, 2019.Research and development expenses increased by 6.0 million to 12.8 million for the six-month period ended June 30, 2020 as compared with 6.8 million for the comparative period for the same reasons as described above for the three-month period ended June 30, 2020.General and Administrative The general and administrative expenses for the three-month and six-month periods ending June 30, 2020 and 2019 were as follows: Three months ended June 30,Six months ended June 30, in thousands2020 2019 2020 2019 General and administrative, excluding items below2,214 2,399 4,479 4,095 Stock-based compensation 6,768 411 10,369 955 Depreciation of equipment 33 45 67 65 9,015 2,855 14,915 5,115 General and administrative expenses for the three-month period ended June 30, 2020 were 9.0 million as compared with 2.9 million for the comparative period, an increase of approximately 6.2 million. 