Benzinga | Jan 25, 2021 07:38AM EST

Arbutus Announces 2021 Corporate Objectives And Provides Financial Update

2021 objectives leverage positive momentum in Arbutus' Hepatitis B research and development programs

WARMINSTER, Pa., Jan. 25, 2021 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (NASDAQ:ABUS), a clinical-stage biopharmaceutical company primarily focused on developing a cure for people with chronic hepatitis B virus (HBV) infection, as well as therapies to treat coronaviruses (including COVID-19), today announced its 2021 corporate objectives and provided a financial update.

William Collier, President and CEO, stated, "We begin 2021 on solid footing from both a pipeline and financial perspective. Our lead clinical asset, AB-729, continues to demonstrate positive data in an ongoing Phase 1a/b clinical trial and we look forward to initiating several Phase 2a clinical trials in 2021. We believe AB-729 could become a cornerstone drug in future combination regimens to cure chronic hepatitis B." Mr. Collier added, "AB-836, our oral capsid inhibitor, is expected to enter a Phase 1a/1b clinical trial in the first half of this year."

Summary of 2021 Corporate Objectives

* Provide additional data from ongoing cohorts of the Phase 1a/1b clinical trial of AB-729 in the first half of 2021 (except for initial data from the 90 mg every 12 week cohort which is expected in the second half of 2021).

* Initiate a Phase 2a combination clinical trial to evaluate AB-729 in combination with Assembly Biosciences' lead core/capsid inhibitor candidate vebicorvir (VBR) and a nucleos(t)ide reverse transcriptase inhibitor (NrtI) for the treatment of subjects with chronic HBV infection in the first half of 2021.

* Initiate two Phase 2a combination clinical trials in HBV subjects, both including AB-729 with one or more approved or investigational agents, in the second half of 2021.

* Initiate a Phase 1a/1b clinical trial of AB-836, our next-generation oral capsid inhibitor, in the first half of 2021.

* The company expects to continue to advance its research in the oral PD-L1 inhibitor, RNA-destabilizer and coronavirus programs.

Financial Update:

* Arbutus had approximately $123.3 million (unaudited) in cash, cash equivalents and investments as of December 31, 2020. The preliminary cash, cash equivalents and investments as of December 31, 2020 were calculated prior to the completion of a review by Arbutus' independent registered public accounting firm and are therefore subject to adjustment.

* We expect our net cash burn to range from $70 to $75 million in 2021 and therefore our cash runway extends to mid-2022.

About AB-729

AB-729 is an RNA interference (RNAi) therapeutic targeted to hepatocytes using Arbutus' novel covalently conjugated N-acetylgalactosamine (GalNAc) delivery technology that enables subcutaneous delivery. AB-729 inhibits viral replication and reduces all HBV antigens, including hepatitis B surface antigen in preclinical models. Reducing hepatitis B surface antigen is thought to be a key prerequisite to enable reawakening of a patient's immune system to respond to the virus. Based upon clinical data generated thus far in an ongoing single- and multi-dose Phase 1a/1b clinical trial, AB-729 has demonstrated positive safety and tolerability data and meaningful reductions in hepatitis B surface antigen.

About AB-836

AB-836 is an oral HBV capsid inhibitor. HBV core protein assembles into a capsid structure, which is required for viral replication. The current standard-of-care therapy for HBV, primarily nucleos(t)ide analogues that work by inhibiting the viral polymerase, significantly reduce virus replication, but not completely. Capsid inhibitors inhibit replication by preventing the assembly of functional viral capsids. They also have been shown to inhibit the uncoating step of the viral life cycle thus reducing the formation of new covalently closed circular DNA (cccDNA), the genetic reservoir which the virus uses to replicate itself.