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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
_________________
FORM 8-K
_________________
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): January 13, 2025
_______________________________
Arbutus Biopharma Corporation
(Exact name of registrant as specified in its charter)
_______________________________
| British Columbia, Canada | 001-34949 | 98-0597776 |
| (State or Other Jurisdiction of Incorporation) | (Commission File Number) | (I.R.S. Employer Identification No.) |
701 Veterans Circle
Warminster, Pennsylvania 18974
(Address of Principal Executive Offices) (Zip Code)
(267) 469-0914
(Registrant's telephone number, including area code)
(Former name or former address, if changed since last report)
_______________________________
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
| Common Shares, without par value | ABUS | The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02. Results of Operations and Financial Condition.
On January 13, 2025, Arbutus Biopharma Corporation (the "Company") issued a press release (the "Press Release") announcing its 2025 corporate update and providing certain estimated financial information, including its estimated cash, cash equivalents and investments as of December 31, 2024 and its estimated 2024 cash burn. The amounts included in the Press Release are preliminary, have not been audited and are subject to change upon completion of the Company's audited financial statements for the year ended December 31, 2024. Additional information and disclosures would be required for a more complete understanding of the Company's financial position and results of operations as of December 31, 2024. A copy of the press release is filed herewith as Exhibit 99.1 and is incorporated by reference herein.
On January 13, 2025, the Company posted an updated corporate presentation on its website at www.arbutusbio.com (the "Corporate Presentation"), which included the Company's estimated cash, cash equivalents and investments as of December 31, 2024. A copy of the Corporate Presentation is filed herewith as Exhibit 99.2 and is incorporated by reference herein.
Item 8.01. Other Events.
On January 13, 2025, the Company issued the Press Release, a copy of which is filed herewith as Exhibit 99.1 hereto and is incorporated by reference herein.
A copy of the Corporate Presentation is filed herewith as Exhibit 99.2 hereto and is incorporated by reference herein.
Item 9.01. Financial Statements and Exhibits.
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| | Arbutus Biopharma Corporation |
| | | |
| | | |
| Date: January 13, 2025 | By: | /s/ David C. Hastings |
| | | David C. Hastings |
| | | Chief Financial Officer |
| | | |
EXHIBIT 99.1
Arbutus Provides 2025 Corporate and Financial Update
Initiating Phase 2b clinical trial in first half of 2025 after achieving a meaningful functional cure rate in cHBV patients treated with imdusiran and interferon
WARMINSTER, Pa., Jan. 13, 2025 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (Nasdaq: ABUS) (“Arbutus” or the “Company”), a clinical-stage biopharmaceutical company leveraging its extensive virology expertise to develop a functional cure for people with chronic hepatitis B virus (cHBV) infection, today announced its 2025 corporate objectives and provided a financial update.
“We enter 2025 with solid financial footing and strong momentum in achieving our mission of developing a functional cure for cHBV, a disease that affects more than 250 million people worldwide and is a leading cause of liver cancer,” said Michael J. McElhaugh, Interim President and Chief Executive Officer of Arbutus. “The data we reported late last year from our IM-PROVE I Phase 2a clinical trial showed a meaningful functional cure rate and immune activation in cHBV patients that were treated with our RNAi therapeutic, imdusiran, interferon and nucleos(t)ide analogue (NA) therapy. These data support our belief that imdusiran is differentiated from other RNAi therapeutics in development for HBV. Therefore, we plan to initiate a Phase 2b clinical trial combining imdusiran, interferon and NA therapy in the first half of 2025.”
Imdusiran (RNAi therapeutic)
- At the American Association for the Study of Liver Diseases (AASLD) – The Liver Meeting® in November 2024, the Company presented new data from its IM-PROVE I Phase 2a clinical trial showing that six doses of imdusiran and 24 weeks of pegylated interferon alfa-2α (IFN), a standard-of-care immunomodulator, added to ongoing NA therapy led to a functional cure rate of 50% (3/6) in HBeAg-negative patients with baseline HBsAg levels less than 1000 IU/mL, and an overall functional cure rate of 25% (3/12). Those patients that achieved a functional cure also seroconverted with high anti-HBs antibody levels. The combination of imdusiran, IFN and NA therapy was generally safe and well-tolerated.
- Based on this data, the Company is planning to initiate a placebo-controlled Phase 2b clinical trial with this treatment regimen in the first half of 2025. Subject to regulatory approval, the clinical trial is anticipated to enroll approximately 170 HBeAg-negative cHBV patients with baseline HBsAg ≤1000 IU/mL. Additional details will be provided by the Company after regulatory approval.
- The Company also presented data from its IM-PROVE II Phase 2a clinical trial showing that the addition of low dose nivolumab increased rates of HBsAg loss in cHBV patients that were first treated with imdusiran, ongoing NA therapy and Barinthus Biotherapeutics’ VTP-300. In this clinical trial, 23% (3/13) of patients that received imdusiran, VTP-300, NA therapy and nivolumab achieved HBsAg loss by week 48. The Company is evaluating functional cure in these patients and anticipates reporting data in the first half of 2025.
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 doses of AB-101, the Company’s oral PD-L1 inhibitor, in healthy subjects and patients with cHBV.
- Based on data from Part 2 of this clinical trial reported in November 2024 showing that AB-101 was generally well-tolerated with evidence of dose-dependent receptor occupancy, Arbutus has moved into Part 3 which evaluates repeat doses of AB-101 for 28 days in patients with cHBV. Data from the 10 mg cohort is expected in the first half of 2025. Next steps for AB-101 will be determined after Arbutus evaluates data from Part 3 of this clinical trial.
LNP Litigation
- 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’s and Pfizer/BioNTech’s COVID-19 vaccines would not have been successful.
- The claim construction hearing for the lawsuit against Pfizer/BioNTech occurred on December 18, 2024. The court is expected to provide its ruling on the claim construction and issue the scheduling order in the first half of 2025.
- The Moderna trial date is scheduled for September 24, 2025, and is subject to the court’s availability. Expert reports and expert depositions continue in this lawsuit.
Financial Update:
- The Company had cash, cash equivalents and investments in marketable securities totaling approximately $123 million as of December 31, 2024 (unaudited).
- The Company expects to significantly reduce its net cash burn in 2025 when compared to 2024. Net cash burn is expected to range from $47 to $50 million in 2025 versus a 2024 net cash burn of approximately $65 million (unaudited). The Company believes its cash, cash equivalents, investments in marketable securities and anticipated contractual milestones from Qilu Pharmaceutical, its strategic partner in Greater China, are sufficient to fund its operations through the first quarter of 2028. This includes fully funding the imdusiran Phase 2b clinical trial.
- The preliminary cash, cash equivalents and investments as of December 31, 2024 and the estimated 2024 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.
- With its current cash balance and anticipated 2025 net cash burn, the Company does not anticipate utilizing its “at-the-market” program (ATM) this year.
About Imdusiran
Imdusiran is an 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. In a Phase 2a clinical trial, imdusiran achieved meaningful functional cure rates in patients with cHBV when combined with pegylated interferon (IFN) alfa-2α and nucleos(t)ide analogue (NA) therapy. Clinical data generated thus far has shown imdusiran to be generally safe and well-tolerated, while also providing meaningful reductions in hepatitis B surface antigen and hepatitis B DNA. In the first half of 2025, the Company is planning to initiate a Phase 2b clinical trial of imdusiran combined with IFN and NA therapy.
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 250 million people worldwide suffer from chronic HBV infection, while other estimates indicate that approximately 2 million people in the United States suffer from chronic HBV infection. Approximately 1.1 million 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 develop novel therapeutics with distinct mechanisms of action, which can potentially be combined to provide a functional cure for patients with chronic hepatitis B virus (cHBV). Arbutus believes the key to success in developing a functional cure involves suppressing HBV DNA, reducing surface antigen, and boosting HBV-specific immune responses. Arbutus’ pipeline of internally developed, proprietary compounds includes an RNAi therapeutic, imdusiran (AB-729), and an oral PD-L1 inhibitor, AB-101. Imdusiran has achieved meaningful functional cure rates in patients with cHBV when administered as combination therapy. In the first half of 2025, Arbutus is planning to initiate a Phase 2b clinical trial with imdusiran. 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: the potential to lead to a functional cure for HBV; Arbutus’ future development plans for its product candidates; the expected timing, cost and results of Arbutus’ clinical development plans and clinical trials with respect to its product candidates; Arbutus’ expectations with respect to the cost, initiation and the release of data from its clinical trials and the expected timing thereof; the potential for Arbutus’ product candidates to achieve success in clinical trials; Arbutus’ expectations with respect to utilizing its ATM program; Arbutus’ plans with respect to the ongoing patent litigation matters; and Arbutus’ expected financial condition, including the anticipated duration of its cash runway, its expectations regarding its 2025 cash burn and the timing and need 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 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. 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: ongoing and anticipated 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; uncertainties associated with litigation generally and patent litigation specifically; economic and market conditions may worsen; market shifts may require a change in strategic focus; Arbutus and its collaborators may never realize the expected benefits of the collaborations; Arbutus may need to utilize its ATM program based on changes in its business; 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
EXHIBIT 99.2
NASDAQ: ABUS www.arbutusbio.com January 13, 2025 Corporate Presentation © 2025 Arbutus Biopharma, Inc.
Forward - Looking Statements 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 - looking statements 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 ; Arbutus' expectations with respect to utilizing its ATM program ; the patent infringement lawsuits ; and other statements relating to Arbutus’ future operations, future financial performance, f uture 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 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 : ongoing and anticipated 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 ; Arbutus may need to utilize its ATM program based on changes in its business ; 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, 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 . 2 © 2025 Arbutus Biopharma, Inc.
Arbutus Biopharma (ABUS) Overview ~250M 1 people have cHBV with current treatment options for most patients limited to life - long suppressive therapy, representing a need for a finite curative regimen. HBV Represents a Large Commercial Opportunity ` Phase 2a clinical trial data with imdusiran shows that it is generally safe, well - tolerated and significantly reduces HBsAg. Imdusiran in combination with a short course of interferon achieves functional cure. Achieved Functional Cure in Phase 2a – Advancing into Phase 2b Cash runway* through Q1 2028 fully funding the Phase 2b clinical trial. Seeking damages from patent litigation filed against Moderna & Pfizer/BioNTech for COVID - 19 vaccine sales. Strong Financial Position HBV: Hepatitis B Virus | cHBV: chronic HBV | HBsAg : HBV Surface Antigen 3 © 2025 Arbutus Biopharma, Inc. 1 https://www.who.int/news - room/fact - sheets/detail/hepatitis - b * Cash runway assumes receipt of contractual milestones anticipated from Qilu. Leveraging virology expertise and proven track record in success to address global health issue. Focused on Developing a Functional Cure for Patients with Chronic HBV
PHASE 1 PHASE 2 PHASE 3 Strategy for Value Creation Develop a combination therapy that includes antivirals and immunomodulators to provide a finite, curative treatment for people with chronic HBV Imdusiran (IDR) RNAi Therapeutic (Subcutaneous) AB - 101 PD - L1 Inhibitor (Oral) cHBV Program AB - 101 in healthy subjects & cHBV patients AB - 101 - 001 IM - PROVE I IM - PROVE II Functional cure rate goal exceeded Functional Cure Sustained HBsAg loss and HBV DNA <LLOQ 24 weeks off all treatment, with or without anti - HBs . ≥ 20% NA: Nucleoside Analogue | LLOQ : Lower Limit of Quantification | anti - HBs : hepatitis B surface antibodies 4 © 2025 Arbutus Biopharma, Inc. Imdusiran + Peg - IFN α - 2a + NA Imdusiran + vaccine +NA +/ - nivolumab
Chronic HBV (2M in U.S.) >250M HBV: A Global Public Health Threat with a Significant Unmet Medical Need Treated 7M 3% Diagnosed 32M 13% 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/ Pegasys , PEG - Intron, Baraclude and Viread Package Inserts 5 © 2025 Arbutus Biopharma, Inc. HIV : Human Immunodeficiency Virus | HCV: Hepatitis C Virus | HCC: Hepatocellular carcinoma • Most common serious liver infection • 100x more infectious than HIV & 10x more infectious than HCV • Primary cause of liver cancer (HCC, second - leading cause of cancer deaths globally ) • Limitations with current treatments, including <10% functional cure rate • “Silent infection” that is transmittable through body fluids and from mother to child • Significant patient stigma that can impact employment and family Million DEATHS/YEAR ~ 1.1 40 - 50% HBsAg<1000 IU/mL at baseline Terrault NA, et al. Incidence and prediction of HBsAg seroclearance in a prospective multi - ethnic HBeAg - negative chronic hepatitis B cohort. Hepatology. 2022 Mar;75(3):709 - 723 Yeo YH, et al. Incidence, Factors, and Patient - Level Data for Spontaneous HBsAg Seroclearance : A Cohort Study of 11,264 Patients. Clin Transl Gastroenterol. 2020 Sep;11(9):e00196 Hu RWH, et al. Quantitative hepatitis B surface antigen levels and determinants in chronic hepatitis B: Implications for novel drug development. 2024. EA SL Congress. Milan, Italy https://www.mdpi.com/1999 - 4915/14/12/2668
6 © 2025 Arbutus Biopharma, Inc. Rationale for a Functional Cure in HBV Prevent complications of disease progression - HBsAg loss is strongly associated with a reduced risk of long - term adverse clinical outcomes observed among cHBV patients regardless of the presence of cirrhosis. 1, 2, 3 Decrease HBV burden by minimizing patient stigma 3 Address the need for finite and more efficacious HBV treatments that further improve long - term outcomes and lead to earlier treatment to prevent progression of disease and associated healthcare costs. 4, 5 Benefits of a Functional Cure for Patients 1 Yip, Terry Cheuk - Fung et al, Journal of Hepatology, 2018; Vol 70, Issue 3, 361 - 370 2 Moini , M. HBsAg Loss as a Treatment for Chronic HBV Infection: HBV Cure. Viruses 2022 , 14, 657 3 Smith - Palmer J, et al. Impactof Stigma on People Living with ChronicHepatitis B.Patient RelatOutcomeMeas. 2020;11:95 - 107 4 Chahal, et al, Open Forum Infectious Diseases 2019 Jan; 61(1) 5 Razavi - Shearer, et al, J Viral Hepat. 2023; 00:1 - 9 HBsAg Loss Further Reduces HCC Risk After Complete Viral Suppression with NA 1
Suppress Reduce Boost Viral DNA Viral Antigen - HBsAg Host Immune System Leading to an HBV Functional Cure 3 - Pronged Approach to Therapeutic Success Therapeutic success will require a combination of agents with complementary MOAs. Suppress HBV DNA Reduce viral antigens Boost host immune response 7 NA RNAi RNAi RNAi PD - L1 Inhibitor Interferon Therapeutic Vaccines © 2025 Arbutus Biopharma, Inc.
8 © 20 25 Arbutus Biopharma, Inc. Imdusiran RNAi Therapeutic
Imdusiran: Key Differentiators 9 © 2025 Arbutus Biopharma, Inc. Unique Nucleotide Sequence Single trigger targeting all HBV transcripts including HBx from cccDNA and integrated DNA Specific Chemical Modifications Reduces off - target effects but maintains potency and provides durable liver exposure Proprietary GalNAc Display Provides highly efficient liver - targeted uptake and enables subcutaneous dosing Highest Functional Cure Rates When combined with a short course of IFN, a 50% functional cure rate was seen in patients with HBsAg <1000 IU/mL at baseline Immune Activation HBV - specific T - cell immune restoration and decrease of exhausted T - cells in key responder patients ` Low Dose and Dosing Frequency 60 mg dosed every 8 weeks leads to consistent HBsAg declines ` GalNAc n Linker Polymerase, Core Ag, eAg, pgRNA sAg sAg HBx
Phase 2a POC Clinical Trial Imdusiran in combination with ongoing NA therapy and short courses of Peg - IFN α - 2 a in cHBV patients IM - PROVE I: POC: Proof of Concept Primary objective : evaluate safety and tolerability of imdusiran in combination with Peg - IFN α - 2a in patients with NA - suppressed cHBV After completing IFN treatment and the 24 - week NA only follow - up period, patients who meet the criteria to discontinue NA therapy will be followed for an additional 48 weeks off therapy Multi - center, open - label Phase 2a 10 © 2025 Arbutus Biopharma, Inc. Weeks NA only Follow - up (24 weeks) A1: Imdusiran x 2 doses + NA + 24w IFN (n=12) A2: NA + 24w IFN (n=13) B1: Imdusiran x 1 dose + NA + 12w IFN (n=8) B2: NA + 12w IFN (n=10) Imdusiran x 4 doses + NA (60mg Q8W) n=43 HBeAg - Randomize NA only Follow - up (24 weeks) 1 52 28 24 40 Off Therapy Follow - up (24 - 48 weeks) Off Therapy Follow - up (24 - 48 weeks) 64 76 Data presented at EASL 2024 and AASLD 2024
IM - PROVE I: Imdusiran with Short Courses of IFN Leads to Functional Cure Data presented at AASLD 2024 *Subject to regulatory approval © 2025 Arbutus Biopharma, Inc. Patients with HBsAg Loss at Key Time Points A2: IDR (4 doses) + NA + IFN 24W N=13 A1: IDR (6 doses) + NA + IFN 24W N=12 Achieved HBsAg loss (≤0.05 IU/mL) at time point, n/N (%) 3/13 (23) 2/7 (29) 4/12 (33) 4/6 (67) EOT (WK 52) All BL HBsAg <1000 IU/mL 2/13 (15) 2/7 (29) 4/12 (33) 4/6 (67) 24W Post - EOT (WK 76) All BL HBsAg <1000 IU/mL 2/13 (15) 2/7 (29) 3/12 (25) 3/6 (50) Functional Cure All BL HBsAg <1000 IU/mL BL, baseline; EOT, end of IFN treatment; FC, functional cure; HBsAg, hepatitis B surface antigen; IDR, imdusiran; IFN, pegyla ted interferon alfa - 2a; NA, nucleos (t)ide analogue; W, week. 11 Next Steps: I nitiate placebo - controlled Phase 2 b clinical trial with imdusiran, IFN and NA therapy – 1 H 2025 n =~ 170 HBeAg - negative cHBV patients w/ baseline HBsAg ≤ 1000 IU/mL* anticipated costs to complete the trial are $ 30 - $ 40 M Key Findings from Cohort A1: 50 % ( 3 / 6 ) of patients with baseline HBsAg < 1000 IU/mL achieved a functional cure 25 % ( 3 / 12 ) of all patients achieved a functional cure Those patients that achieved a functional cure also seroconverted with high anti - HBs levels The combination of imdusiran and IFN was generally safe and well - tolerated, with no SAEs related to imdusiran or IFN, and no AEs leading to discontinuation SAEs : S erious Adverse Events | AEs : Adverse Events
12 Off Therapy Follow - up (24 - 48 weeks) Group A ( n=20) : VTP - 300 Group B (n=20): VTP - 300 placebo 1 IDR x 4 doses (60mg Q8W) n=40 Weeks IDR x 4 doses (60mg Q8W) n=22 24 Group C: VTP - 300 ± LDN 1 48 24 Weeks 48 Off Therapy Follow - up (24 - 48 weeks) © 2025 Arbutus Biopharma, Inc. Data presented at EASL 2024 and AASLD 2024 * P =0.017. ANCOVA adjusted for baseline HBsAg. Evaluating imdusiran in combination with Barinthus Bio’s immunotherapeutic, VTP - 300, and NA with or without low dose nivolumab (LDN) Preliminary Data : 23 % ( 3 / 13 ) of LDN - trea ted patients achieved HBsAg loss at week 48 The combination of imdusiran, VTP - 300 and LDN was generally safe and well - tolerated and did not result in any immune - related adverse events Subjects are being followed off NA therapy for assessment of functional cure Randomize All: Ongoing NA therapy All: Ongoing NA therapy IM - PROVE II Phase 2a Clinical Trial Mean HBsAg Change from Baseline by Treatment Group
Imdusiran: Key Takeaways from Clinical Trials to Date Imdusiran provided robust and comparable HBsAg declines (~1.5 - 2.0 log 10 ) regardless of dose, dosing interval, HBeAg or DNA status When combined with a short course of IFN, a 50% functional cure rate was seen in patients with HBsAg <1000 IU/mL at baseline Imdusiran was generally safe and well - tolerated after completing dosing in >200 cHBV patients Imdusiran resulted in HBV - specific T - cell immune restoration and decrease of exhausted T - cells in some patients 13 © 2024 Arbutus Biopharma, Inc. Data from Phase 1 and all Phase 2a clinical trials conducted to date with imdusiran.
Strategic Collaboration Exclusive Licensing* and Strategic Partnership Develop, manufacture and commercialize imdusiran in Greater China Imdusiran Upfront payment (received in 2022) $40M Equity investment (received in 2022) $15M Commercialization and milestone payments Up to $245M Tiered royalties on annual sales Double - digit up to low twenties % *ABUS retains the non - exclusive right to develop and manufacture in the Qilu territory for exploiting imdusiran in the rest of the world Deal economics for Arbutus: Qilu Pharmaceutical: One of the leading pharmaceutical companies in China, provides development, manufacturing, and commercialization expertise to this partnership China 14 © 2025 Arbutus Biopharma, Inc.
15 © 2025 Arbutus Biopharma, Inc. AB - 101 Oral PD - L1 Checkpoint Inhibitor
AB - 101: Oral PD - L1 Inhibitor for HBV Immune Reactivation PD - 1: Programmed death ligand protein | Abs: Antibodies Currently in a Phase 1a/1b clinical trial Rationale • HBV immune tolerance is a critical driver of cHBV infection • PD - 1:PD - L1 checkpoint axis plays a key role in immune tolerization in cHBV • PD - L1 expression upregulated during HBV infection • PD - 1 upregulated on HBV - specific T - and B - cells • Inhibition associated with HBsAg loss in some cHBV patients AB - 101 • Blocks PD - L1/PD - 1 interaction at sub - nM concentrations • Activates HBV - specific immune responses in T - cells from cHBV patients in vitro • Novel MOA identified • Demonstrates a robust checkpoint mediated in vivo effect • Improves HBV - specific T - and B - cell responses ex vivo Small - Molecule Inhibitor Approach • Allows controlled checkpoint blockade • Enables oral dosing • Designed to reduce systemic safety issues seen with Abs 16 © 2025 Arbutus Biopharma, Inc.
AB - 101: Small - Molecule Oral PD - L1 Inhibitor for HBV AB - 101 is highly potent and activates HBV specific immune cells from chronic HBV patients AB - 101 reinvigorates HBV - specific cHBV patient T - cells PBMCs N= cells from 9 cHBV patients *p< - 0.05 PBMC: P eripheral Blood Mononuclear Cells PDL1 * Inactive AB - 101 * 0 3 2 1 IFN - y Fold Increase Over HBV peptide alone 17 © 2025 Arbutus Biopharma, Inc. Once daily oral administration of AB - 101 resulted in statistically significant tumor reduction Study Day MC38 Tumor Mouse Model Tumor Volume (mm 3 ) Data presented at EASL 2022
18 © 2025 Arbutus Biopharma, Inc. Part 1: SAD (n=8/cohort – 6:2) 1C: 10 mg 1B: 3 mg 1A: 1 mg Part 2: MAD (n=10/cohort – 8:2) 2A: 10 mg daily x 7 days 2B: 25 mg daily x 7 days† 3A: 10 mg daily x 28d 3B: Dose/interval TBD x 28d AB - 101 - 001: Phase 1a/1b Clinical Trial with AB - 101 Parts 1 & 2 – Healthy Subjects ** Part 3 – cHBV Patients (n=12/cohort – 10:2) Virally suppressed ** Additional doses may be tested in Part 1 and Part 2 † In the 25mg cohort, preliminary data shows all subjects with evidence of receptor occupancy, with 7 of the 8 subjects demonstrating receptor occupancy >70% during the 7 - day dosing period. * Preliminary data shows AB - 101 is well tolerated and binds to the receptor target. In the 25mg cohort, all 5 evaluable subjects showed evidence of receptor occupancy between 50 - 100%. 1D: 25 mg * Preliminary data for Cohort 3A expected in 1H 2025 Next steps will be determined after evaluating data from Part 3.
LNP Litigation: Update Moderna - Trial date September 24, 2025 (subject to the Court’s availability)* • Markman Hearing occurred February 8, 2024 – judge heard arguments on claim construction. – Court provided ruling on April 3 and agreed with Arbutus’s position on the majority of the claims • Expert reports and expert depositions continue 80% to Genevant Arbutus owns 16% of Genevant 20% to Arbutus Royalties/litigation related damages *Above referenced date is included in the 8/15/2024 Stipulation to Extend Time. Pfizer • Lawsuit ongoing • Markman Hearing occurred on December 18, 2024. • Next steps: Court expected to provide ruling on claim construction & issue scheduling order in 1H 2025. 19 © 2025 Arbutus Biopharma, Inc.
2025 Key Milestones 20 Timing 2025 Milestone 1H Initiate Phase 2b clinical trial (imdusiran + IFN) 1H IM - PROVE II Phase 2a (imdusiran + VTP - 300 + nivolumab): Functional cure data 1H AB - 101 - 001: Preliminary data from Cohort 3A in cHBV patients 1H LNP Litigation: Outcome of PFE Markman Hearing * 2H LNP Litigation: Moderna Trial ** © 2025 Arbutus Biopharma, Inc. * subject to Court’s ruling ** subject to Court’s availability
Investment Highlights Strong financial position Indication with significant unmet medical need & large market opportunities Patented LNP technology Portfolio of internally discovered assets with distinct MOAs Lead HBV compound – imdusiran, RNAi therapeutic advancing into Phase 2b combination clinical trial Team with virology expertise and proven track record Focused on developing a functional cure for HBV Cash balance* of $123M as of 12/31/24, cash runway through Q1 2028**; Phase 2b fully funded, 2025 cash burn $47 - 50M. Data from Phase 2a shows imdusiran combined with interferon is generally safe, well - tolerated and functionally cured 50% of patients with HBsAg<1000 IU/mL at baseline RNAi therapeutic Oral PD - L1 inhibitor Receiving licensing royalties arising from Alnylam’s Onpattro ® and seeking damages from patent litigation suits filed against Moderna & Pfizer/BioNTech for COVID - 19 vaccine sales Discovered, developed & commercialized multiple drugs MOA: Mechanism of Action | PD - L1: Programmed death - ligand 1 | HBsAg: Hepatitis B surface antigen 21 © 2025 Arbutus Biopharma, Inc. *Unaudited; consists of cash, cash equivalents and marketable securities . ** Cash runway assumes receipt of contractual milestones anticipated from Qilu.
Thank You 22 © 2025 Arbutus Biopharma, Inc.
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Arbutus Biopharma (NASDAQ:ABUS)
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Arbutus Biopharma (NASDAQ:ABUS)
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