Item 2. Managements Discussion and Analysis of Financial Condition
and Results of Operations
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
You should read the following discussion and analysis of financial condition and operating results together with our consolidated financial statements and
the related notes and other financial information included elsewhere in this document.
We endeavor to become the leader in discovery, development, and commercialization of therapeutic agents capable of addressing significant unmet
medical needs via the application of the silence and replace approach to the treatment of genetic disorders.
Benitec Biopharma Inc.
(Benitec or the Company or in the third person, we or our) is a development-stage biotechnology company focused on the advancement of novel genetic medicines with headquarters in Hayward,
California. The proprietary platform, called DNA-directed RNA interference, or ddRNAi, combines RNA interference, or RNAi, with gene therapy to create medicines that facilitate sustained silencing of
disease-causing genes following a single administration. The Company is developing ddRNAi-based therapeutics for chronic and life-threatening human conditions including Oculopharyngeal Muscular Dystrophy (OPMD), and Chronic Hepatitis B.
BB-301 is the most advanced ddRNAi-based genetic medicine currently under development by Benitec. BB-301 is an internally optimized, AAV-based gene therapy agent that is designed to both silence the expression of mutated, disease-causing genes
(to slow, or halt, the underlying mechanism of disease progression) and replace the mutant genes with normal, wild type genes (to drive restoration of function in diseased cells). This fundamental approach to disease management is
called silence and replace and this biological mechanism offers the potential to restore the underlying physiology of the treated tissues and, in the process, improve treatment outcomes for patients suffering from the chronic and,
potentially, fatal effects of Oculopharyngeal Muscular Dystrophy (OPMD). BB-301 has been granted Orphan Drug Designation in the United States and the European Union.
Through the combination of the targeted gene silencing effects of RNAi and the durable transgene expression achievable via the use of modified
viral vectors, the silence and replace approach has the potential to produce long-term silencing of disease-causing genes along with simultaneous replacement of wild type gene function following a single administration of the proprietary genetic
medicine. We believe this novel attribute of the investigational agents under development by Benitec may facilitate the achievement of robust clinical activity while greatly reducing the dosing frequencies traditionally expected for medicines
employed for the management of chronic diseases. Additionally, the establishment of chronic gene silencing and gene replacement may significantly reduce the risk of patient non-compliance during
the course of medical management of potentially fatal clinical disorders.
Unless otherwise indicated, all dollar amounts in this section
are provided in thousands.
On April 15, 2020, (the Implementation Date), the re-domiciliation of
Benitec Limited (the Re-domiciliation), a public company incorporated under the laws of the State of Western Australia, or Benitec Limited, was completed in accordance with the Scheme
Implementation Agreement, as amended and restated as of January 30, 2020, between Benitec Limited and us. As a result of the Re-domiciliation, the jurisdiction of incorporation was changed from
Australia to Delaware, and Benitec Limited became our wholly owned subsidiary.
The Re-domiciliation was effected pursuant to a statutory scheme of arrangement under
Australian law, or the Scheme, whereby on the Implementation Date, all of the issued and outstanding ordinary shares of Benitec Limited were exchanged for newly issued shares of our common stock, on the basis of one share of our common stock, par
value $0.0001 per share, for every 300 ordinary shares of Benitec Limited issued and outstanding. Holders of Benitec Limiteds American Depository Shares, or ADSs (each of which represented 200 ordinary shares), received two shares of our
common stock for every three ADSs held.