Bio-Path(US:BPTH)2020-08-14 15:56Financial Data and Key Metrics Changes - The company recorded a net loss of $2.0 million or $0.50 per share for Q2 2020, compared to a net loss of $2.5 million or $0.87 per share for Q2 2019, indicating an improvement in loss per share [38] - Research and development expenses decreased to $1.0 million in Q2 2020 from $1.5 million in Q2 2019, primarily due to the timing of activities related to the Phase II clinical trial of prexigebersen [38] - General and administrative expenses remained consistent at $1.0 million for Q2 2020 compared to the same period in 2019 [39] - Cash as of June 30, 2020, was $14.4 million, down from $20.4 million at December 31, 2019 [39] Business Line Data and Key Metrics Changes - The lead product candidate, prexigebersen, has progressed to stage two of its Phase II clinical trial for the treatment of Acute Myeloid Leukaemia (AML) [6][12] - The trial design includes cohorts for previously untreated AML, relapsed resistant AML, and patients intolerant to venetoclax, with a total of approximately 206 patients expected to be enrolled across all cohorts [58] Market Data and Key Metrics Changes - The evolving landscape for standard care in AML has prompted the company to adapt its trial design to include the combination of prexigebersen with decitabine and venetoclax, reflecting recent approvals and physician feedback [8][9] Company Strategy and Development Direction - The company aims to enhance the efficacy of frontline treatments for AML patients by adding prexigebersen to existing therapies [11][17] - Plans for BP-1002, targeting the Bcl-2 protein, and BP-1003, targeting the STAT3 protein, are underway, with expected IND filings and clinical trials in 2020 [24][36] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the progress in clinical trials despite challenges posed by COVID-19, noting that patient enrollment has been better than expected [45][50] - The company anticipates an increase in operating expenses as it begins dosing patients in the Phase II trial, but expects to maintain a manageable cash burn rate [59][62] Other Important Information - The company has signed up eight sites for the AML trial, with plans to expand to ten, indicating a robust infrastructure for patient enrollment [45] - The company is preparing for potential supply chain challenges but has reported good responses from patients in the relapse cohorts [49] Q&A Session Summary Question: Update on clinical trials affected by COVID-19 - Management confirmed that they have eight sites signed up for the AML trial and are working to expand to ten, with patient enrollment progressing well despite COVID-19 challenges [45][46] Question: Performance of specific AML cell lines in preclinical studies - Management acknowledged variability in responses among AML cell lines tested and indicated that not all cell lines perform uniformly [52] Question: Financial expectations regarding operating expenses - Management indicated that while operating expenses may increase due to patient costs and ongoing CRO expenses, the initial setup costs from earlier quarters would not recur, leading to a more stable expense outlook [59][62]