Arbutus Biopharma(US:ABUS)2024-05-02 17:15Financial Data and Key Metrics Changes - The company ended Q1 2024 with approximately $138 million in cash, cash equivalents, and investments, an increase from approximately $132 million as of December 31, 2023 [20] - During Q1 2024, the company received $21.8 million in net proceeds from the issuance of common shares, offset by $19.3 million used in operations [20] - The expected net cash burn for 2024 is projected to range between $63 million to $67 million, excluding any proceeds from the ATM program [20] Business Line Data and Key Metrics Changes - The company is advancing two proprietary clinical assets for HBV: imdusiran, an RNAi therapeutic, and AB-101, an oral small molecule PD-L1 checkpoint inhibitor [11] - Preliminary data from the Phase 1a/1b clinical trial of AB-101 is anticipated to be reported in the second half of 2024 [22] - The company has initiated patient screening for the AB-729-203 trial, evaluating imdusiran in combination with durvalumab [15] Market Data and Key Metrics Changes - Two abstracts from ongoing Phase 2a clinical trials were accepted for presentation at the EASL Congress in June 2024 [13] - The company is focused on developing a functional cure for chronic HBV, which involves reducing surface antigen, suppressing HBV DNA, and boosting the immune system [11][14] Company Strategy and Development Direction - The company aims to develop a functional cure for HBV through a combination of its clinical assets, with a focus on combination therapies [11][32] - The ongoing clinical trials are designed to evaluate the safety and efficacy of imdusiran in combination with various immunomodulatory approaches [14][15] - The company is also involved in ongoing patent infringement lawsuits to protect its intellectual property, including its LNP delivery technology [23][24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's path towards developing a functional cure for HBV, highlighting the importance of ongoing clinical trials [8][11] - The company believes its cash runway is sufficient to fund operations through the second quarter of 2026, allowing for continued advancement of its HBV assets [21] Other Important Information - Dr. Mike Sofia, the Chief Scientific Officer, announced his retirement effective at the end of 2024, after co-founding the company over 10 years ago [7][8] - The company is currently evaluating the potential of AB-101 in a Phase 1a/1b clinical trial, with a focus on its unique liver-centric properties [17][19] Q&A Session Summary Question: When can functional cure signals be expected from the pipeline? - Management indicated that functional cure signals cannot be assessed until subjects are at least six months off all treatment, with ongoing trials expected to provide data as it becomes available [29] Question: What is the gating factor for starting a Phase 3 trial? - Management stated that the decision to start a Phase 3 trial will depend on the data from ongoing studies, including the new durvalumab trial and existing trials [30] Question: Will the next Phase 2b or Phase 3 study evaluate imdusiran as a monotherapy or in combination? - Management confirmed that the next study will likely focus on combination therapy, as curing HBV requires a multi-faceted approach [32] Question: What is the rationale behind different dosing intervals for durvalumab? - The rationale is to evaluate the extent of checkpoint inhibition necessary to induce HBV-specific immunity while maintaining a safe profile for patients [34] Question: What are the next steps for the AB-101 program after the multi-ascending dose Phase? - The next goal is to combine AB-101 with imdusiran in a Phase 2 study as quickly as possible after completing the current Phase 1 study [37]