On-track to report key clinical data in 2024 from two on-going Phase 2a clinical trials with imdusiran and the Phase 1a/1b clinical trial with AB-101
Plans to initiate a third Phase 2a clinical trial with imdusiran in first half of 2024 Claim Construction for Moderna LNP litigation occurred on February 8, 2024; trial date set for April 21, 2025 Strong financial position with cash and investments of $132M; cash runway into Q1 2026 Conference Call and Webcast Today at 8:45 am ET
WARMINSTER, Pa., Feb. 29, 2024 (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 reports fourth quarter and year end 2023 financial results and provides a corporate update.
“I anticipate that 2024 will be a productive year for Arbutus as we continue to advance the development of our HBV assets: imdusiran, our RNAi therapeutic, and AB-101, our oral checkpoint inhibitor,” said Michael J. McElhaugh, Interim President and Chief Executive Officer of Arbutus Biopharma. “To date, we have dosed more than 170 HBV patients with imdusiran and continue to see notable and sustained reductions in surface antigen. We believe that a combination therapy that reduces surface antigen, suppresses HBV DNA and boosts the host immune response will be necessary to functionally cure HBV. We are currently evaluating imdusiran with other immune modulators and expect multiple data readouts this year, including the potential to see undetectable surface antigen at end of treatment. These trials, in addition to our plans to initiate an imdusiran + durvalumab clinical trial, will help inform our later stage clinical development program in addition to the dose and dosing duration for AB-101, potentially expediting imdusiran + AB-101 combinations.” 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. Preliminary data from this additional cohort are expected in the second half of 2024.
- AB-729-203 is a Phase 2a clinical trial that Arbutus intends to initiate in the first half of 2024 to evaluate the safety, tolerability and antiviral activity of intermittent low doses of durvalumab, an approved anti-PD-L1 monoclonal antibody in combination with imdusiran and NA therapy. Insights gained from this clinical trial and the amended portion of the AB-729-202 clinical trial with nivolumab, may inform dosing for the planned imdusiran plus AB-101 Phase 2 clinical trial.
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. Arbutus is advancing AB-101 into part two of this clinical trial which involves dosing healthy subjects with multiple-ascending doses of AB-101. 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 continues 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 on-going and the claim construction hearing occurred on 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 been set for April 21, 2025 and is subject to the Court’s availability. The lawsuit against Pfizer/BioNTech is ongoing and a date for a claim construction hearing has not been set.
Financial Results Cash, Cash Equivalents and Investments As of December 31, 2023, the Company had cash, cash equivalents and investments in marketable securities of $132.3 million compared to $184.3 million as of December 31, 2022. During the year ended December 31, 2023, the Company used $85.9 million in operating activities, which was partially offset by $29.9 million of net proceeds from the issuance of common shares under its “at-the-market” offering program. The Company expects its 2024 net cash burn to range from between $63 million to $67 million, excluding any proceeds received from its “at the market” offering program. The Company believes its cash, cash equivalents and investments in marketable securities of $132.3 million as of December 31, 2023, are sufficient to fund its operations into the first quarter of 2026. Revenue Total revenue was $18.1 million for the year ended December 31, 2023, compared to $39.0 million for the same period in 2022. The decrease of $20.9 million was due primarily to a decrease in revenue recognition from the Company’s license agreement with Qilu, the Company’s collaboration partner in China, Hong Kong, Macau and Taiwan, based on a decrease in employee labor hours expended by the Company during 2023 compared to 2022 to perform its manufacturing obligations under the license agreement. Additionally, license royalty revenues decreased in 2023 compared to 2022 due to a decrease in Alnylam’s sales of ONPATTRO. Operating Expenses Research and development expenses were $73.7 million for the year ended December 31, 2023 compared to $84.4 million for the same period in 2022. The decrease of $10.7 million was due primarily to: (i) a decrease in manufacturing expenses associated with supplying drug for the Company’s clinical trials; and (ii) a decrease in clinical expenses due to the discontinuation of the Company’s AB-836 program in 2022; partially offset by (iii) an increase in clinical expenses for the Company’s ongoing AB-101 Phase 1a/1b clinical trial in 2023. General and administrative expenses were $22.5 million for the year ended December 31, 2023, compared to $17.8 million for the same period in 2022. This increase was due primarily to an increase in legal fees, non-cash stock-based compensation expense and employee compensation costs. Net Loss For the year ended December 31, 2023, our net loss was $72.8 million, or a loss of $0.44 per basic and diluted common share, as compared to a net loss of $69.5 million, or a loss of $0.46 per basic and diluted common share, for the year ended December 31, 2022. Outstanding Shares As of December 31, 2023, the Company had 169.9 million common shares issued and outstanding, as well as 20.4 million stock options and unvested restricted stock units outstanding. Roivant Sciences Ltd. owned approximately 23% of the Company’s outstanding common shares as of December 31, 2023.
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF LOSS
(in thousands, except share and per share data) |
| | | Year Ended December 31, | | | 2023 | | | 2022 | | | Revenue | | | | | | | Collaborations and licenses | $ | 14,274 | | | $ | 31,366 | | | Non-cash royalty revenue | | 3,867 | | | | 7,653 | | | Total revenue | | 18,141 | | | | 39,019 | | | Operating expenses | | | | | | | Research and development | | 73,700 | | | | 84,408 | | | General and administrative | | 22,475 | | | | 17,834 | | | Change in fair value of contingent consideration | | 69 | | | | 2,233 | | | Total operating expenses | | 96,244 | | | | 104,475 | | | Loss from operations | | (78,103 | ) | | | (65,456 | ) | | Other income (loss) | | | | | | | Interest income | | 5,688 | | | | 2,192 | | | Interest expense | | (459 | ) | | | (1,726 | ) | | Foreign exchange gain | | 25 | | | | (22 | ) | | Total other income | | 5,254 | | | | 444 | | | Loss before income taxes | | (72,849 | ) | | | (65,012 | ) | | Income tax expense | | — | | | | (4,444 | ) | | Net loss | $ | (72,849 | ) | | $ | (69,456 | ) | | Net loss per common share | | | | | | | Basic and diluted | $ | (0.44 | ) | | $ | (0.46 | ) | | Weighted average number of common shares | | | | | | | Basic and diluted | | 165,960,379 | | | | 150,939,337 | | | | | | | | | | |
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
| | | | | | December 31,
2023 | | December 31,
2022 | | Cash, cash equivalents and marketable securities, current | | $ | 126,003 | | $ | 146,913 | | Accounts receivable and other current assets | | | 6,024 | | | 4,226 | | Total current assets | | | 132,027 | | | 151,139 | | Property and equipment, net of accumulated depreciation | | | 4,674 | | | 5,070 | | Investments in marketable securities, non-current | | | 6,284 | | | 37,363 | | Right of use asset | | | 1,416 | | | 1,744 | | Other non-current assets | | | — | | | 103 | | Total assets | | $ | 144,401 | | $ | 195,419 | | | | | | | | | | Accounts payable and accrued liabilities | | $ | 10,271 | | $ | 16,029 | | Deferred license revenue, current | | | 11,791 | | | 16,456 | | Lease liability, current | | | 425 | | | 372 | | Total current liabilities | | | 22,487 | | | 32,857 | | Liability related to sale of future royalties | | | 6,953 | | | 10,365 | | Deferred license revenue, non-current | | | — | | | 5,999 | | Contingent consideration | | | 7,600 | | | 7,531 | | Lease liability, non-current | | | 1,343 | | | 1,815 | | Total stockholders’ equity | | | 106,018 | | | 136,852 | | Total liabilities and stockholders’ equity | | $ | 144,401 | | $ | 195,419 |
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
| | | | | | Twelve Months Ended December 31, | | | | 2023 | | | 2022 | | | Net loss | | $ | (72,849 | ) | | $ | (69,456 | ) | | Non-cash items | | | 5,146 | | | | 4,857 | | | Change in deferred license revenue | | | (10,664 | ) | | | 22,455 | | | Other changes in working capital | | | (7,569 | ) | | | 6,788 | | | Net cash used in operating activities | | | (85,936 | ) | | | (35,356 | ) | | Net cash provided by (used in) investing activities | | | 50,773 | | | | (74,942 | ) | | Issuance of common shares pursuant to Share Purchase Agreement | | | — | | | | 10,973 | | | Issuance of common shares pursuant to the Open Market Sale Agreement | | | 29,852 | | | | 20,324 | | | Cash provided by other financing activities | | | 795 | | | | 517 | | | Net cash provided by financing activities | | | 30,647 | | | | 31,814 | | | Effect of foreign exchange rate changes on cash and cash equivalents | | | 25 | | | | (22 | ) | | Decrease in cash and cash equivalents | | | (4,491 | ) | | | (78,506 | ) | | Cash and cash equivalents, beginning of period | | | 30,776 | | | | 109,282 | | |
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| Related companies: | Arbutus Biopharma Corporation |
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