FORWARD-LOOKING STATEMENTS
This prospectus supplement contains “forward-looking statements” or “forward-looking information” within the meaning of applicable securities laws (we collectively refer to these items as “forward-looking statements”). Forward-looking statements are generally identifiable by use of the words “believes,” “may,” “plans,” “will,” “anticipates,” “intends,” “budgets,” “could,” “estimates,” “expects,” “forecasts,” “projects” and similar expressions that are not based on historical fact or that are predictions of or indicate future events and trends, and the negative of such expressions. Forward-looking statements in this prospectus supplement, including the documents incorporated by reference, include statements about, among other things:
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our strategy, future operations, pre-clinical research, pre-clinical studies, clinical trials, prospects and the plans of management;
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the potential impact of the COVID-19 pandemic on our business and clinical trials;
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the discovery, development and commercialization of a curative combination regimen for chronic hepatitis B infection, a disease of the liver caused by the hepatitis B virus (“HBV”);
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our beliefs and development path and strategy to achieve a curative combination regimen for HBV;
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obtaining necessary regulatory approvals;
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obtaining adequate financing through a combination of financing activities and operations;
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using the results from our HBV clinical trials to adaptively design additional clinical trials to test the efficacy of combination therapies and the duration of the result in patients;
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the expected timing of and amount for payments related to the Enantigen Therapeutics, Inc.’s transaction and its programs;
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the potential of our product candidates to improve upon the standard of care and contribute to a functional curative combination treatment regimen;
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the potential benefits of the reversion of the Ontario Municipal Employees Retirement System (“OMERS”) royalty monetization transaction for our ONPATTRO® (Patisiran) (“ONPATTRO”) royalty interest;
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developing a suite of products that intervene at different points in the viral life cycle, with the potential to reactivate the host immune system;
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using pre-clinical results to adaptively design clinical trials for additional cohorts of patients, testing the combination and the duration of therapy;
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selecting combination therapy regimens and treatment durations to conduct Phase 3 clinical trials intended to ultimately support regulatory filings for marketing approval;
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the potential of substantially increasing diagnosis and treatment rates for people with chronic HBV through the introduction of an HBV curative regimen with a finite duration;
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expanding our HBV product candidate pipeline through internal development, acquisitions and
in-licenses;
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our expectation for additional data from ongoing cohorts of the Phase 1a/1b trial of AB-729 to be available in the second half of 2021 (including initial data from the 90 mg every 12-week dosing interval cohort in HBV DNA negative subjects and initial data from the 90 mg every 8-week dosing interval cohort in HBV DNA positive subjects);
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our expectation that AB-729 could be combined with our lead capsid inhibitor candidate, AB-836, and approved NAs, in our first combination therapy for HBV patients;
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our expectations regarding the anticipated trial design, timing, number of patients and dosing of our Phase 2a clinical trial of Assembly Biosciences, Inc.’s investigational HBV core inhibitor candidate, also known as a capsid inhibitor, vebicorvir, in combination with our proprietary GalNAc delivered RNAi therapeutic candidate, AB-729, and standard-of-care nucleos(t)ide reverse transcriptase inhibitor (NrtI) therapy for the treatment of patients with chronic HBV infection;
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our expectation to initiate two Phase 2a proof-of-concept clinical trials of AB-729 with Peg-IFNα-2a and Antios Therapeutics, Inc.’s ATI-2173 in the second half of 2021;