Aptose Biosciences(APTO) - 2020 Q1 - Earnings Call Transcript

Financial Data and Key Metrics Changes - The company ended the quarter with approximately $90 million in cash and cash equivalents, down from $97 million at December 31, 2019 [28] - The net loss for the quarter was $11.5 million, or $0.15 per share [28] - Research and Development expenses increased to $5.9 million from $3.3 million in the same quarter last year, primarily due to activities related to CG-806 [28][29] Business Line Data and Key Metrics Changes - The company is developing two main clinical candidates: CG-806, a treatment for hematologic cancers, and APTO-253, a MYC inhibitor for AML and MDS [7][25] - CG-806 is in a Phase I clinical trial for B-cell malignancies, with ongoing patient enrollment and dose escalation [11][19] - APTO-253 is also in a Phase Ia/b trial, with completed dosing in the first three cohorts and ongoing enrollment [25][26] Market Data and Key Metrics Changes - The market for AML appears competitive, with several recently approved drugs, but none offer cures, indicating a potential opportunity for CG-806 [20] - The company is focusing on enrolling patients from specialty regional cancer centers rather than large hospitals to mitigate COVID-19 risks [10][11] Company Strategy and Development Direction - The company aims to continue the development of CG-806 and APTO-253, with a focus on addressing unmet needs in hematologic cancers [7][25] - There is a strategic pivot to enroll patients from regional cancer centers to ensure safety and maintain trial progress during the pandemic [10][11] - The company plans to submit a new IND for CG-806 in AML patients, consolidating all preclinical and clinical data gathered to date [22][23] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence that COVID-19 has not significantly impacted the company's timelines, referring to challenges as "crosswinds" rather than headwinds [55] - The company anticipates presenting additional data at the ASH conference later in the year, with hopes of demonstrating responses in patients with AML [48][50] Other Important Information - The company entered into a new At-The-Market agreement for $75 million, providing strategic flexibility for funding operations and R&D [29][30] - Management emphasized the importance of safety and tolerability in ongoing trials, with all dose levels thus far being well-tolerated [22][26] Q&A Session Summary Question: Clarification on CG-806 dose level three plasma exposure - Management confirmed that plasma exposure levels were around one micromolar and consistent among patients [32] Question: Expectations for EHA data presentation - Management indicated that safety, pharmacokinetic, and pharmacodynamic data from Cohorts 1 through 4 would be presented at EHA [40] Question: Concerns about BTK inhibition and clinical activity - Management acknowledged the skepticism and explained that while BTK inhibition is crucial, it is not solely responsible for killing CLL cells; other pathways must also be targeted [68]