Arbutus Biopharma(US:ABUS)2019-08-05 19:08Financial Data and Key Metrics Changes - As of June 30, 2019, the company had a cash and investments balance of $95.3 million, down from $124.6 million at December 31, 2018 [13] - Cash used in operating activities during the first half of 2019 was $34.1 million, and the company believes its cash balance plus net proceeds from a recent royalty monetization is sufficient to fund operations into the second half of 2020 [14][15] Business Line Data and Key Metrics Changes - The company is focused on advancing two lead compounds, AB-506 and AB-729, through clinical trials, with preliminary results expected in early 2020 [6][12] - AB-506 showed a decrease in mean HBV DNA and HBV RNA at the end of treatment, with reductions ranging from minus 2 logs for the 160-milligram dose to minus 2.8 logs for the 400-milligram dose [8][10] Market Data and Key Metrics Changes - The company is targeting chronic hepatitis B patients for its clinical trials, with plans to initiate a combination proof-of-concept Phase II trial in the second half of 2020 if both lead compounds progress as expected [12][16] Company Strategy and Development Direction - The company's objective is to improve the existing standard of care in hepatitis B by developing a curative combination regimen that includes multiple mechanisms of action [6] - The combination of AB-506 and AB-729 is believed to have the potential for profound inhibition of HBV replication and higher rates of sustained S-antigen loss compared to current treatments [12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to advance its pipeline and achieve significant clinical milestones, with results from ongoing trials expected later in the year [16][30] - The management highlighted the importance of the upcoming data from the Phase Ia/Ib trials for both AB-506 and AB-729 in shaping the future direction of the company's clinical development [12][16] Other Important Information - A severance charge of $4.5 million was recorded in the second quarter of 2019 due to the retirement of the former CEO, impacting general and administrative expenses [14][15] Q&A Session Summary Question: How many chronic hepatitis B patients will have data by the end of the year? - The company expects to have data from 24 chronic hepatitis B patients, divided into two cohorts of 12 [18] Question: Any update on the progress for the RNA destabilizer? - The company is conducting a 90-day study in two species, with data expected by the first quarter of 2020 to inform future decisions [20] Question: Update on AB-506 and its Phase I trial on safety and efficacy? - The company reported satisfactory results with HBV DNA drops of 2 logs and 2.9 logs, with plans to continue dosing based on the outcomes of the healthy volunteer study [22][23] Question: Is seeing a surface antigen response a competitive advantage? - The company believes its capsid inhibitor may be unique in showing drops in surface antigen and e-antigen, but more data is needed to confirm any competitive advantage [24][25] Question: Will there be protocol amendments for AB-729 to include hep-B patients? - The protocol already includes plans for single ascending doses in chronic hepatitis B patients, so no amendments are necessary [26][27]