Arbutus gets FDA clinical hold lifted on AB-101, expands Pfizer/BioNTech patent suits

Arbutus Biopharma reported third quarter 2026 results on November 10, 2026. In October 2026, the FDA lifted the clinical hold on the IND application for AB-101, allowing the company to engage in additional clinical development of AB-101 in the United States.¹ Arbutus said it is evaluating next steps for the continued development of AB-101.¹ In the company's Phase 1a/1b clinical trial, AB-101 was generally well-tolerated with evidence of high receptor occupancy.¹

On the litigation front, Arbutus and Genevant filed additional lawsuits in Japan seeking to enforce patents protecting their lipid nanoparticle technology against Pfizer Japan Inc., and amended a previously filed Canadian lawsuit against Pfizer, BioNTech and affiliates to add a newly issued LNP patent, seeking monetary relief and injunctions against the companies' mRNA-LNP COVID-19 vaccines.¹ On November 5, 2026, expedited oral argument was held at the U.S. Court of Appeals for the Federal Circuit regarding the Moderna §1498 Appeal, with a decision pending.¹ That appeal concerns an additional $1.3 billion Moderna would pay Arbutus and Genevant contingent on an appellate ruling that a federal statute does not bar their infringement claims, except for doses the district court characterized as going to U.S. government employees.¹

On cash, as of September 30, 2026, the company had cash, cash equivalents and investments in marketable securities of $337.5 million, compared to $91.5 million at year-end 2025.¹ In early October 2026, Arbutus completed a modified "Dutch Auction" tender offer, returning $230 million to shareholders by purchasing 46 million common shares at $5.00 per share, about 23% of shares outstanding as of September 29, 2026.¹ Net income for the quarter was $59.1 million, or $0.30 per basic and diluted share, compared with a net loss of $7.7 million a year earlier.¹