Arbutus Announces 2024 Corporate Objectives and Provides Financial Update
08 Januar 2024 - 1:30PM
Arbutus Biopharma Corporation (Nasdaq: ABUS) (“Arbutus” or the
“Company”), a clinical-stage biopharmaceutical company leveraging
its extensive virology expertise to develop a cure for people with
chronic hepatitis B virus (cHBV) infection, today announced its
2024 business outlook including its clinical development milestones
to advance its HBV pipeline and a financial update.
“As we enter 2024, our strong balance sheet and
anticipated clinical trial readouts position us well towards
achieving our mission of developing a functional cure for patients
with cHBV,” said Michael J. McElhaugh, Interim President and Chief
Executive Officer of Arbutus Biopharma. “Our Phase 2a program for
imdusiran, our RNAi therapeutic, consisting of three separate
trials, reinforces the potential role of imdusiran as a cornerstone
in a treatment regimen to functionally cure patients with cHBV.
Additionally, AB-101, our oral PD-L1 inhibitor, continues to
progress and we look forward to preliminary data from the ongoing
Phase 1a/1b clinical trial. We remain committed to continuing
discovery research in HBV and we are confident that we have the
talent and resources to execute our mission.”
2024 Clinical Development Milestones
Imdusiran (AB-729, RNAi
Therapeutic)
- AB-729-201 is a Phase 2a clinical
trial that is evaluating the safety, tolerability and antiviral
activity of the combination of imdusiran, nucleos(t)ide analogue
(NA) therapy and pegylated interferon alfa-2a (IFN) in patients
with cHBV. Preliminary data presented at the EASL Congress in June
2023 suggest that the addition of IFN to imdusiran was generally
well-tolerated and appears to result in continued HBsAg declines in
some patients. Arbutus plans to announce end-of-treatment data from
this trial in the first half of 2024.
- AB-729-202 is a
Phase 2a clinical trial that is evaluating the safety and
immunogenicity of imdusiran, NA therapy and Barinthus Bio’s
(formerly Vaccitech plc) VTP-300, an HBV antigen-specific
immunotherapy. Preliminary data presented at AASLD – The
Liver Meeting in November 2023 showed that the combination of
imdusiran and VTP-300 provided a meaningful reduction of HBsAg
levels that are maintained well below baseline. In addition, a
subset of patients given imdusiran and then VTP-300 showed early
signs of immune activation. Arbutus plans to announce
end-of-treatment data from this portion of the trial in the first
half of 2024.
- AB-729-202 was
amended to include an additional cohort of 20 patients who will
receive imdusiran plus NA therapy for 24 weeks followed by VTP-300
plus up to two low doses of nivolumab, an approved anti-PD-1
monoclonal antibody. Enrollment is complete in this additional
cohort with preliminary data expected in the second half of
2024.
- AB-729-203 is a
Phase 2a clinical trial that will initiate in the first half of
2024 and will evaluate the safety, tolerability and antiviral
activity of intermittent low doses of durvalumab, an approved PD-L1
monoclonal antibody in combination with imdusiran and NA
therapy.
AB-101 (Oral PD-L1
Inhibitor)
- AB-101-001 is a
Phase 1a/1b double-blind, randomized, placebo-controlled clinical
trial designed to investigate the safety, tolerability,
pharmacokinetics (PK), and pharmacodynamics (PD) of single- and
multiple-ascending oral doses of AB-101 for up to 28 days in
healthy subjects and patients with cHBV. AB-101 continues to be
evaluated at higher single doses in healthy subjects in part one of
the Phase 1a/1b clinical trial, which was initiated in September
2023. Arbutus expects to report preliminary data from the healthy
subject portion of this clinical trial, including target engagement
and receptor occupancy data, in the first half of 2024.
LNP Litigation Update:
- Arbutus will
continue to protect and defend its intellectual property, which is
the subject of the on-going lawsuits against Moderna and
Pfizer/BioNTech. The Company is seeking fair compensation for
Moderna’s and Pfizer/BioNTech’s use of its patented LNP technology
that was developed with great effort and at a great expense,
without which Moderna and Pfizer/BioNTech’s COVID-19 vaccines would
not have been successful. With respect to the Moderna lawsuit, fact
discovery is currently on-going with the claim construction hearing
scheduled for February 8, 2024. According to the Court Scheduling
Order, which was issued on March 21, 2023, the court is expected to
issue its claim construction order within 60 days of conclusion of
the claim construction hearing. Expert testimony and
depositions will then follow. A trial date has not been set, but
the trial is expected to commence in the first half of 2025. The
lawsuit against Pfizer/BioNTech is ongoing and a date for a claim
construction hearing has not been set.
Financial Update:
- The Company had
cash, cash equivalents and investments in marketable securities
totaling approximately $132 million as of December 31, 2023.
- The Company expects
to significantly reduce its net cash burn in 2024 when compared to
2023. The Company expects net cash burn in 2024 to range from $63
to $67 million versus a 2023 net cash burn of approximately $85
million. The Company believes its cash, cash equivalents and
investments in marketable securities of approximately $132 million
as of December 31, 2023, are sufficient to fund its operations into
the first quarter of 2026.
- The preliminary
cash, cash equivalents and investments as of December 31, 2023 and
its preliminary 2023 net cash burn were calculated prior to the
completion of an audit by Arbutus’ independent registered public
accounting firm and are therefore subject to adjustment.
About imdusiran
(AB-729)
Imdusiran is an RNA interference (RNAi)
therapeutic specifically designed to reduce all HBV viral proteins
and antigens including hepatitis B surface antigen, which is
thought to be a key prerequisite to enable reawakening of a
patient’s immune system to respond to the virus. Imdusiran targets
hepatocytes using Arbutus’ novel covalently conjugated
N-Acetylgalactosamine (GalNAc) delivery technology enabling
subcutaneous delivery. Clinical data generated thus far has shown
single and multiple doses of imdusiran to be generally safe and
well-tolerated, while also providing meaningful reductions in
hepatitis B surface antigen and hepatitis B DNA. Imdusiran is
currently in multiple Phase 2a clinical trials.
About AB-101
AB-101 is our oral PD-L1 inhibitor candidate
that we believe will allow for controlled checkpoint blockade while
minimizing the systemic safety issues typically seen with
checkpoint antibody therapies. Immune checkpoints such as
PD-1/PD-L1 play an important role in the induction and maintenance
of immune tolerance and in T-cell activation. Preclinical data
generated thus far indicates that AB-101 mediates re-activation of
exhausted HBV-specific T-cells from cHBV patients. We believe
AB-101, when used in combination with other approved and
investigational agents, could potentially lead to a functional cure
in patients chronically infected with HBV. AB-101 is currently
being evaluated in a Phase 1a/1b clinical trial.
About HBV
Hepatitis B is a potentially life-threatening
liver infection caused by the hepatitis B virus (HBV). HBV can
cause chronic infection which leads to a higher risk of death from
cirrhosis and liver cancer. Chronic HBV infection represents a
significant unmet medical need. The World Health Organization
estimates that over 290 million people worldwide suffer from
chronic HBV infection, while other estimates indicate that
approximately 2.4 million people in the United States suffer from
chronic HBV infection. Approximately 820,000 people die every year
from complications related to chronic HBV infection despite the
availability of effective vaccines and current treatment
options.
About Arbutus
Arbutus Biopharma Corporation (Nasdaq: ABUS) is
a clinical-stage biopharmaceutical company leveraging its extensive
virology expertise to identify and develop novel therapeutics with
distinct mechanisms of action, which can be combined to provide a
functional cure for patients with chronic hepatitis B virus (cHBV).
We believe the key to success in developing a functional cure
involves suppressing HBV DNA, reducing surface antigen, and
boosting HBV-specific immune responses. Our pipeline of internally
developed, proprietary compounds includes an RNAi therapeutic,
imdusiran (AB-729) and an oral PD-L1 inhibitor, AB-101. Imdusiran
has generated meaningful clinical data demonstrating an impact on
both surface antigen reduction and reawakening of the HBV-specific
immune response. Imdusiran is currently in two Phase 2a combination
clinical trials. AB-101 is currently being evaluated in a Phase
1a/1b clinical trial. For more information, visit
www.arbutusbio.com.
Forward-Looking Statements and
Information
This press release contains forward-looking
statements within the meaning of the Section 27A of the Securities
Act of 1933 and Section 21E of the Securities Exchange Act of 1934,
and forward-looking information within the meaning of Canadian
securities laws (collectively, forward-looking statements).
Forward-looking statements in this press release include statements
about our future development plans for our product candidates; our
program updates; our belief that checkpoint inhibitors may play a
key role in antiviral immune tolerance in cHBV; the expected cost,
timing and results of our clinical development plans and clinical
trials with respect to our product candidates; our expectations
with respect to clinical trial design and the release of data from
our clinical trials and the expected timing thereof; our
expectations and goals for our collaborations with third parties
and any potential benefits related thereto; the potential for our
product candidates to achieve success in clinical trials; our plans
with respect to the ongoing patent litigation matters; and our
expected financial condition, including the anticipated duration of
cash runways, our expectations regarding our 2024 cash burn and the
timing regarding our needs for additional capital.
With respect to the forward-looking statements
contained in this press release, Arbutus has made numerous
assumptions regarding, among other things: the effectiveness and
timeliness of preclinical studies and clinical trials, and the
usefulness of the data; the timeliness of regulatory approvals; the
continued demand for Arbutus’ assets; and the stability of economic
and market conditions. While Arbutus considers these assumptions to
be reasonable, these assumptions are inherently subject to
significant business, economic, competitive, market and social
uncertainties and contingencies, including uncertainties and
contingencies related to the ongoing patent litigation
matters.
Additionally, there are known and unknown risk
factors which could cause Arbutus’ actual results, performance or
achievements to be materially different from any future results,
performance or achievements expressed or implied by the
forward-looking statements contained herein. Known risk factors
include, among others: anticipated pre-clinical studies and
clinical trials may be more costly or take longer to complete than
anticipated, and may never be initiated or completed, or may not
generate results that warrant future development of the tested
product candidate; Arbutus may elect to change its strategy
regarding its product candidates and clinical development
activities; Arbutus may not receive the necessary regulatory
approvals for the clinical development of Arbutus’ products;
economic and market conditions may worsen; uncertainties associated
with litigation generally and patent litigation specifically; it
may take considerable time and expense to resolve the clinical hold
that has been placed on AB-101 by the FDA, and no assurance can be
given that the FDA will remove the clinical hold; Arbutus and its
collaborators may never realize the expected benefits of the
collaborations; and market shifts may require a change in strategic
focus; Arbutus’ plans to reduce its net cash burn may not
materially extend the cash runway and may create a distraction or
uncertainty that may adversely affect its operating results,
business, or investor perceptions; and risks related to the
sufficiency of Arbutus’ cash resources and its ability to obtain
adequate financing in the future for its foreseeable and
unforeseeable operating expenses and capital
expenditures. A more complete discussion of the
risks and uncertainties facing Arbutus appears in Arbutus’ Annual
Report on Form 10-K, Arbutus’ Quarterly Reports on Form 10-Q and
Arbutus’ continuous and periodic disclosure filings, which are
available at www.sedar.com and at www.sec.gov. All forward-looking
statements herein are qualified in their entirety by this
cautionary statement, and Arbutus disclaims any obligation to
revise or update any such forward-looking statements or to publicly
announce the result of any revisions to any of the forward-looking
statements contained herein to reflect future results, events or
developments, except as required by law.
Contact Information
Investors and Media
Lisa M. Caperelli Vice President,
Investor Relations Phone: 215-206-1822 Email:
lcaperelli@arbutusbio.com
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