Aptose Biosciences(APTO) - 2019 Q4 - Earnings Call Transcript

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]