Multiple data presentations upcoming at AASLD – The Liver Meeting®, including preliminary data from Phase 2a clinical trial combining imdusiran, our RNAi therapeutic, with VTP-300, an HBV antigen-specific immunotherapy
Dosing continues in two Phase 2a combination clinical trials with imdusiran and in a Phase 1a/1b clinical trial with AB-101, our oral PD-L1 checkpoint inhibitor
Reducing workforce by 24% as a result of recent pipeline optimization
Cash runway extended into first quarter 2026
Conference Call and Webcast Today at
“We are looking forward to our upcoming data presentations at the
Pipeline Updates and Key Milestones
Imdusiran (AB-729, RNAi Therapeutic)
- Arbutus will be presenting preliminary data at AASLD from the first group of patients in its Phase 2a clinical trial (AB-729-202) that is evaluating imdusiran, nucleos(t)ide analogue (NA) therapy and Barinthus Bio’s (formerly
Vaccitech plc ) VTP-300, an HBV antigen-specific immunotherapy.
Enrollment is ongoing in the expanded cohort of the AB-729-202 clinical trial that is designed to enroll 20 patientswho will receive imdusiran (60mg every 8 weeks) plus NA therapy for 24 weeks followed by VTP-300 plus up to two doses of low-dose nivolumab. Preliminary data from this additional treatment arm are expected in 2024.
- Follow-up is continuing in the Company’s on-going Phase 2a clinical trial (AB-729-201), evaluating the safety, tolerability and antiviral activity of the combination of imdusiran and pegylated interferon alfa-2a (IFN) in patients with cHBV. Preliminary data presented at the
EASL Congress inJune 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 provide updates from this clinical trial in 2024.
AB-101 (Oral PD-L1 Inhibitor)
- In September, the Company dosed the first subject in its Phase 1a/1b double-blind, randomized, placebo-controlled, clinical trial (AB-101-001) designed to investigate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple oral doses of AB-101 for up to 28 days in healthy subjects and patients with cHBV. The trial will be conducted in three parts starting with single ascending doses in healthy subjects, followed by multiple ascending doses in healthy subjects and culminating with multiple doses in patients with cHBV. Safety and PK/PD assessments will be performed prior to dose escalation in all trial parts. Initial data from part one of the trial are expected in the first half of 2024.
Corporate Updates
In connection with the Company’s decision in September to focus its pipeline on its HBV clinical stage compounds and discontinue its research programs, Arbutus has taken steps to streamline its organization and has reduced its workforce by 24%, effective
With the organizational changes announced today and its ongoing cost management efforts, the Company now expects its current cash, cash equivalents and investments will be sufficient to fund its operations into the first quarter of 2026. The Company remains committed to continuing discovery research in chronic HBV.
In a separate press release issued today, Arbutus announced that
The above corporate updates do not affect the Company’s pending litigations. 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. Document production is currently on-going in the lawsuit against Moderna with the claim construction hearing scheduled for
Financial Results
Cash, Cash Equivalents and Investments
As of
Revenue
Total revenue was
Operating Expenses
Research and development expenses were
Net Loss
For the three months ended
Outstanding Shares
As of
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF LOSS
(in thousands, except share and per share data)
Three Months Ended | Nine Months Ended | ||||||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||||||
Revenue | |||||||||||||||
Collaborations and licenses | $ | 3,935 | $ | 3,607 | $ | 13,329 | $ | 27,381 | |||||||
Non-cash royalty revenue | 723 | 2,345 | 2,667 | 5,393 | |||||||||||
Total revenue | 4,658 | 5,952 | 15,996 | 32,774 | |||||||||||
Operating expenses | |||||||||||||||
Research and development | 20,169 | 20,055 | 56,136 | 61,459 | |||||||||||
General and administrative | 5,842 | 3,493 | 17,374 | 13,585 | |||||||||||
Change in fair value of contingent consideration | 205 | 215 | (158 | ) | 624 | ||||||||||
Total operating expenses | 26,216 | 23,763 | 73,352 | 75,668 | |||||||||||
Loss from operations | (21,558 | ) | (17,811 | ) | (57,356 | ) | (42,894 | ) | |||||||
Other income (loss) | |||||||||||||||
Interest income | 1,494 | 694 | 4,223 | 1,249 | |||||||||||
Interest expense | (46 | ) | (429 | ) | (415 | ) | (1,417 | ) | |||||||
Foreign exchange gain | 6 | (21 | ) | 11 | (18 | ) | |||||||||
Total other income (loss) | 1,454 | 244 | 3,819 | (186 | ) | ||||||||||
Loss before income taxes | (20,104 | ) | (17,567 | ) | (53,537 | ) | (43,080 | ) | |||||||
Income tax expense | — | — | — | (4,444 | ) | ||||||||||
Net loss | $ | (20,104 | ) | $ | (17,567 | ) | $ | (53,537 | ) | $ | (47,524 | ) | |||
Net loss per common share | |||||||||||||||
Basic and diluted | $ | (0.12 | ) | $ | (0.12 | ) | $ | (0.32 | ) | $ | (0.32 | ) | |||
Weighted average number of common shares | |||||||||||||||
Basic and diluted | 167,512,708 | 150,995,191 | 165,085,243 | 149,385,999 |
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
2023 | 2022 | ||||
Cash, cash equivalents and marketable securities, current | $ | 134,180 | $ | 146,913 | |
Accounts receivable and other current assets | 7,427 | 4,226 | |||
Total current assets | 141,607 | 151,139 | |||
Property and equipment, net of accumulated depreciation | 5,033 | 5,070 | |||
Investments in marketable securities, non-current | 10,496 | 37,363 | |||
Right of use asset | 1,502 | 1,744 | |||
Other non-current assets | 3 | 103 | |||
Total assets | $ | 158,641 | $ | 195,419 | |
Accounts payable and accrued liabilities | $ | 9,806 | $ | 16,029 | |
Deferred license revenue, current | 12,106 | 16,456 | |||
Lease liability, current | 412 | 372 | |||
Total current liabilities | 22,324 | 32,857 | |||
Liability related to sale of future royalties | 8,110 | 10,365 | |||
Deferred license revenue, non-current | — | 5,999 | |||
Contingent consideration | 7,373 | 7,531 | |||
Lease liability, non-current | 1,497 | 1,815 | |||
Total stockholders’ equity | 119,337 | 136,852 | |||
Total liabilities and stockholders’ equity | $ | 158,641 | $ | 195,419 |
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
Nine Months Ended | |||||||
2023 | 2022 | ||||||
Net loss | $ | (53,537 | ) | $ | (47,524 | ) | |
Non-cash items | 4,613 | 3,429 | |||||
Change in deferred license revenue | (10,349 | ) | 25,463 | ||||
Other changes in working capital | (9,371 | ) | 266 | ||||
Net cash (used in) operating activities | (68,644 | ) | (18,366 | ) | |||
Net cash provided by (used in) investing activities | 28,548 | (87,624 | ) | ||||
Issuance of common shares pursuant to Share Purchase Agreement | — | 10,973 | |||||
Issuance of common shares pursuant to the Open Market Sale Agreement | 26,000 | 9,241 | |||||
Cash provided by other financing activities | 840 | 516 | |||||
Net cash provided by financing activities | 26,840 | 20,730 | |||||
Effect of foreign exchange rate changes on cash and cash equivalents | 11 | (18 | ) | ||||
Decrease in cash and cash equivalents | (13,245 | ) | (85,278 | ) | |||
Cash and cash equivalents, beginning of period | 30,776 | 109,282 | |||||
Cash and cash equivalents, end of period | 17,531 | 24,004 | |||||
Investments in marketable securities | 127,145 | 166,150 | |||||
Cash, cash equivalents and marketable securities, end of period | $ | 144,676 | $ | 190,154 |
Conference Call and Webcast Today
Arbutus will hold a conference call and webcast today,
An archived webcast will be available on the Arbutus website after the event.
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. We have identified compounds in our internal PD-L1 portfolio that could also be used in oncology indications.
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
About Arbutus
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 expected financial condition, including the anticipated duration of cash runways and timing regarding needs for additional capital and our expected management changes.
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: the risk that the program updates may not materially extend the cash runway and may create a distraction or uncertainty that may adversely affect our operating results, business, or investor perceptions; 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; 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
Vice President, Investor Relations
Phone: 215-206-1822
Email: lcaperelli@arbutusbio.com
Source:
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