Corporate Presentation
NASDAQ: ABUS
www.arbutusbio.com
May 2, 2024
© 2024 Arbutus Biopharma, Inc.
Forward-LookingStatements
This presentation contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and Canadian securities laws. All statements that are not historical facts are hereby identified as forward-lookingstatements for this purpose and include, among others, statements relating to: the potential market opportunity for HBV; Arbutus' ability to meet a significant unmet medical need; the sufficiency of Arbutus' cash and cash equivalents for the anticipated durations; the expected cost, timing and results of Arbutus' clinical development plans and clinical trials, including its clinical collaborations with third parties; the potential for Arbutus' product candidates to achieve their desired or anticipated outcomes; Arbutus' expectations regarding the timing and clinical development of Arbutus' product candidates, including its articulated clinical objectives; the timeline to a combination cure for HBV;
Arbutus' expectations regarding its technology licensed to third parties; the expected timing and payments associated with strategic and/or licensing agreements; the patent infringement
lawsuits; and other statements relating to Arbutus' future operations, future financial performance, future financial condition, prospects or other future events.
With respect to the forward-looking statements contained in this presentation, Arbutus has made numerous assumptions regarding, among other things: the timely receipt of expected payments; the effectiveness and timeliness of pre-clinical 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 patent litigation matters. Forward-looking statements herein involve known and unknown risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from any future results, events or developments expressed
or implied by such forward-looking statements. Such factors include, among others: anticipated pre-clinical 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 drug candidate; changes in Arbutus' 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; market shifts may require a change in strategic focus; and the parties may never realize the expected benefits of the collaborations. A more complete discussion of the risks and uncertainties facing Arbutus appears in Arbutus' Annual Report on Form 10-K, Quarterly Report on Form 10-Q and Arbutus' periodic disclosure filings, which are available at www.sec.gov and at www.sedar.com. 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.
© 2024 Arbutus Biopharma, Inc. | 2 |
Our Strategy for Value Creation
Leverage the proven track record of success established with our team's expertise in understanding and treating viral infections by discovering and developing a differentiated pipeline of therapies targeting chronic HBV.
Develop a combination therapy that includes antivirals and immunologics to provide a finite duration treatment for people with cHBV that results ≥20% functional cure rate.
HBV: Hepatitis B Virus | cHBV: chronic HBV | © 2024 Arbutus Biopharma, Inc. | 3 |
Investment Highlights
Indications with | Team | Portfolio | |||||||
significant unmet | with virology | of internally | |||||||
medical need & large | expertise and proven | discovered assets with | |||||||
market opportunities | track record | distinct MOAs | |||||||
Focused on | Discovered, | RNAi therapeutic |
developing a functional | developed & | PD-L1 inhibitor |
cure for HBV | commercialized | |
multiple drugs |
Lead HBV compound -
imdusiran (AB-729) RNAi therapeutic in multiple Phase 2a combination clinical trials
Data shows imdusiran is
generally safe
and well-tolerated and has shown meaningful suppression
of HBsAg while on- or off- treatment
Strong | Patented |
financial position | LNP |
technology |
Receiving licensing royalties | ||
Cash runway | arising from Alnylam's | |
Onpattro® and seeking | ||
through Q2 2026 | ||
damages from patent | ||
litigation suits filed | ||
against Moderna & | ||
Pfizer/BioNTech for COVID- | ||
19 vaccine sales |
MOA: Mechanism of Action | PD-L1: Programmed death-ligand 1 | HBsAg: Hepatitis B surface antigen
© 2024 Arbutus Biopharma, Inc. | 4 |
Pipeline
TherapeuticRNAi | Imdusiran (AB-729) | cHBV |
Inhibitor | AB-101 | cHBV |
PD-L1 | ||
Pre-Clinical | Phase 1 | Phase 2 |
AB-729-201 Combo trial (imdusiran + Peg-IFNα-2a + NA)
AB-729-202 Combo trial (imdusiran + vaccine + NA +/- nivolumab)
AB-729-203 Combo trial (imdusiran + NA + durvalumab)
AB-101-001single-/multiple- ascending dose
Phase 3
Marketed
NA: Nucleoside Analogue | © 2024 Arbutus Biopharma, Inc. | 5 |
HBV Overview
Cause & Symptoms | Diagnosis |
Life-threatening liver infection | HBsAg detection |
caused by hepatitis B virus (HBV) | Additional biomarkers necessary |
Transmitted through body fluids and | to determine stage of disease |
from mother to child |
Long-term chronic infection (cHBV) leads to higher risk of cirrhosis and/or liver cancer
Treatments
NA therapy - lifelong daily therapy, aimed at reducing HBV DNA and risk of cirrhosis and/or
HCC
Peg-IFNα - administered weekly; poorly tolerated
<5% of patients achieve functional cure
Rationale
Need for finite and more efficacious HBV treatments that further improve long-term outcomes and increase functional cure rate
Combination therapy with different MOAs will be required to reduce HBsAg, suppress HBV DNA, and boost immune system
Sources for all data on slide:
- Hepatitis B Fact Sheet, WHOhttps://www.who.int/news-room/fact-sheets/detail/hepatitis-b; Hep B Foundation link https://www.hepb.org/what-is-hepatitis-b/what-is-hepb/facts-and-figures/; Kowdley et al. Hepatology (2012) Prevalence of Chronic Hepatitis B Among Foreign-Born Persons Living in the US by Country of Origin
- Pegasys, PEG-Intron, Baraclude and Viread Package Inserts
HBsAg: HBV Surface Antigen | HCC: Hepatocellular carcinoma | © 2024 Arbutus Biopharma, Inc. | 6 |
HBV Presents a Significant Unmet Medical Need
>290M
people are chronically infected with HBV, globally.
Americas
7M
2M
USA
~820k
people die every year as a consequence despite the availability of effective vaccines
and antivirals.
SOC: Standard of Care
>290M Chronic
HBV
15M
EU | Europe | 10.5% | ||
Diagnosed | 30M | |||
15M | ||||
E Mediterranean | W Pacific | |||
SE Asia | 115M | |||
21M | 2.3% | |||
39M | 6.6M | |||
90M | Treated | |||
Africa | Low due to sub-optimal | |||
60M | China | |||
SOC cure rate and | ||||
asymptomatic nature of disease.
Sources:https://www.who.int/news-room/fact-sheets/detail/hepatitis-b | ||
https://www.hepb.org/what-is-hepatitis-b/what-is-hepb/facts-and-figures/ | © 2024 Arbutus Biopharma, Inc. | 7 |
3-Pronged Approach to
Therapeutic Success
Suppress HBV DNA
Reduce viral antigens
Boost host immune response
Therapeutic success will
require a combination of agents with
complementary MOAs.
Suppress | Reduce |
Viral DNA and | Viral Antigen - HBsAg |
cccDNA Pool | |
NA | RNAi |
RNAi |
Leading to an HBV Cure
Boost
Host Immune System
RNAi
PD-L1 Inhibitor
Interferon
Therapeutic Vaccines
© 2024 Arbutus Biopharma, Inc. | 8 |
RNAi Therapeutic
© 2024 Arbutus Biopharma, Inc. | 9 |
Imdusiran
RNAi
Therapeutic
Proprietary GalNAc-conjugate delivery technology provides
liver targeting and enables subcutaneous
dosing
GalNAc | Linker |
n |
Single trigger RNAi agent targeting all HBV transcripts
Inhibits HBV replication and lowers all HBV antigens
Pan-genotypic activity across HBV genotypes
Demonstrated complementarity with other agents
Actively targets the liver
Active against cccDNA derived and integrated HBsAg transcripts Clean profile in long term preclinical safety studies
HBx
sAg
sAg
Polymerase, Core Ag, eAg, pgRNA
© 2024 Arbutus Biopharma, Inc. 10
Attachments
- Original Link
- Original Document
- Permalink
Disclaimer
Arbutus Biopharma Corp. published this content on 02 May 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 02 May 2024 12:58:29 UTC.