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     409  0 Kommentare Arbutus Announces 2024 Corporate Objectives and Provides Financial Update - Seite 2

    • 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. AB-101 continues to be evaluated at higher single doses in healthy subjects in part one of the Phase 1a/1b clinical trial, which was initiated in September 2023. 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 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. With respect to the Moderna lawsuit, fact discovery is currently on-going with the claim construction hearing scheduled for 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 not been set, but the trial is expected to commence in the first half of 2025. The lawsuit against Pfizer/BioNTech is ongoing and a date for a claim construction hearing has not been set. 

    Financial Update:

    • The Company had cash, cash equivalents and investments in marketable securities totaling approximately $132 million as of December 31, 2023.
    • The Company expects to significantly reduce its net cash burn in 2024 when compared to 2023. The Company expects net cash burn in 2024 to range from $63 to $67 million versus a 2023 net cash burn of approximately $85 million. The Company believes its cash, cash equivalents and investments in marketable securities of approximately $132 million as of December 31, 2023, are sufficient to fund its operations into the first quarter of 2026.
    • The preliminary cash, cash equivalents and investments as of December 31, 2023 and its preliminary 2023 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.

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