CG-806 Phase 1 a/b Study in B Cell Malignancies Advances to Fifth (750mg) Dose CohortFDA Allows IND for Phase 1 a/b Study of CG-806 in AML to Initiate at 450mg Dose LevelAPTO-253 Phase 1b Study in AML / MDS Advances to Fifth (150mg/m2) 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.“Aptose’s 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 R/R-CLL patients. Plus, with the FDA’s 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 HighlightsCG-806 Phase 1 a/b 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 www.clinicaltrials.gov.
FDA Allowance of IND for CG-806 in AML – In June, Aptose announced that the U.S. Food and Drug Administration (FDA) allowed the company’s Investigational New Drug (IND) application for the initiation of a Phase 1a/b clinical study of CG-806, the company’s highly potent, oral FLT3/BTK 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 mg/m2) of the APTO-253 study in patients with AML and MDS and the safety review committee then escalated dosing to 150 mg/m2. 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 www.clinicaltrials.gov.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 US$5.25 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 US$55.125 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: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:
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