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| PART I |
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| Item 1. | Business | 3 |
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| Item 1A. | Risk Factors | 28 |
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| Item 1B. | Unresolved Staff Comments | 70 |
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| Item 1C. | Cybersecurity | 70 |
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| Item 2. | Properties | 70 |
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| Item 3. | Legal Proceedings | 70 |
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| Item 4. | Mine Safety Disclosures | 70 |
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| PART II |
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| Item 5. | Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities | 71 |
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| Item 6. | RESERVED | 71 |
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| Item 7. | Management’s Discussion and Analysis of Financial Condition and Results of Operations | 72 |
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| Item 7A. | Quantitative and Qualitative Disclosures about Market Risk | 80 |
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| Item 8. | Financial Statements and Supplementary Data | F-1 |
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| Item 9. | Changes in and Disagreements with Accountants on Accounting and Financial Disclosure | 81 |
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| Item 9A. | Controls and Procedures | 81 |
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| Item 9B. | Other Information | 83 |
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| Item 9C. | Disclosure Regarding Foreign Jurisdictions that Prevent Inspections. | 83 |
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| PART III |
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| Item 10. | Directors, Executive Officers and Corporate Governance | III-1 |
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| Item 11. | Executive Compensation | III-1 |
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| Item 12. | Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters | III-1 |
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| Item 13. | Certain Relationships and Related Transactions, and Director Independence | III-1 |
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| Item 14. | Principal Accountant Fees and Services | III-1 |
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| PART IV |
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| Item 15. | Exhibits and Financial Statement Schedules | IV-1 |
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| Signatures | IV-5 |
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PART I
ABOUT THIS ANNUAL REPORT
Unless the context otherwise requires, the terms “Benitec,” the “Company,” “we,” “us,” “our” and similar terms used in this Annual Report on Form 10-K refer to Benitec Biopharma Inc., a Delaware corporation, and its subsidiaries (including Benitec Limited). Any references to “Benitec Limited” or “BBL” refer to Benitec Biopharma Limited, an Australian corporation.
All references to “$” in this Annual Report refer to U.S. dollars. Any references to “A$” in this Annual Report mean Australian dollars. As of June 30, 2025, the rate of exchange of U.S. dollars to Australian dollars was 1.5265 AUD.
Our fiscal year-end is June 30. References to a particular “fiscal year” are to our fiscal year ended June 30 of that calendar year.
Except as otherwise stated, all share and earnings per share amounts presented in this Annual Report reflect the impact of the 1-for-17 reverse stock split of the Company’s common stock effective July 26, 2023.
INDUSTRY AND MARKET DATA
This Annual Report includes information with respect to market and industry conditions and market share from third-party sources or based upon estimates using such sources when available. We believe that such information and estimates are reasonable and reliable. We also believe the information extracted from publications of third- party sources has been accurately reproduced. However, we have not independently verified any of the data from third-party sources. Similarly, our internal research is based upon our understanding of industry conditions, and such information has not been verified by any independent sources.
TRADEMARKS AND TRADENAMES
We have proprietary and licensed rights to trademarks used in this Annual Report which are important to our business, many of which are registered under applicable intellectual property laws. Our trademarks include:
| • | GIVING DISEASE THE SILENT TREATMENT® |
| • | SILENCING GENES FOR LIFE® |
Solely for convenience, trademarks and trade names referred to in this Annual Report appear without the “®” or “™” symbols, but such references are not intended to indicate, in any way, that we will not assert, to the fullest extent possible under applicable law, our rights or the rights of the applicable licensor to these trademarks and trade names. We do not intend our use or display of other companies’ trade names, trademarks or service marks to imply a relationship with, or endorsement or sponsorship of us by, any other companies. Each trademark, trade name or service mark of any other company appearing in this Annual Report is the property of its respective holder.
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Annual Report contains forward-looking statements that are subject to a number of risks and uncertainties, many of which are beyond our control. All statements, other than statements of historical fact included in this Annual Report, regarding our strategy, future operations, financial position, projected costs, prospects, plans and objectives of management are forward-looking statements. When used in this Annual Report, the words “could,” “believe,” “anticipate,” “intend,” “estimate,” “expect,” “may,” “continue,” “predict,” “potential,” “project,” or the negative of these terms, and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain such identifying words. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. These risks, uncertainties and factors include:
| • | the success of our plans to develop and potentially commercialize our product candidates; |
| • | the timing of the completion of preclinical studies and clinical trials; |
| • | the timing and sufficiency of patient enrollment and dosing in any future clinical trials; |
| • | the timing of the availability of data from our clinical trials; |
| • | the timing and outcome of regulatory filings and approvals; |
| • | the development of novel AAV vectors; |
| • | our potential future out-licenses and collaborations; |
| • | the plans of licensees of our technology; |
| • | the clinical utility and potential attributes and benefits of ddRNAi and our product candidates, including the potential duration of treatment effects and the potential for a “one shot” cure; |
| • | our intellectual property position and the duration of our patent portfolio; |
| • | expenses, ongoing losses, future revenue, capital needs and needs for additional financing, and our ability to access additional financing given market conditions and other factors; |
| • | the length of time over which we expect our cash and cash equivalents to be sufficient to execute on our business plan; |
| • | further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; |
| • | the ability to enroll sufficient numbers of subjects in clinical trials; |
| • | determinations made by the U.S. Food and Drug Administration and other governmental authorities; |
| • | regulatory developments in the United States of America; |
| • | our ability to protect and enforce our patents and other intellectual property rights; |
| • | our dependence on our relationships with our collaboration partners and other third parties; |
| • | the efficacy or safety of our products and the products of our collaboration partners; |
| • | the acceptance of our products and the products of our collaboration partners in the marketplace and market competition; |
| • | sales, marketing, manufacturing and distribution requirements; |
| • | greater than expected expenses, expenses relating to litigation or strategic activities; |
| • | the impact of, and our ability to remediate, the identified material weakness in our internal controls over financial reporting; |
| • | our ability to satisfy our capital needs through increasing revenue and obtaining additional financing; and |
| • | the impact of local, regional and national and international economic conditions and events; |
as well as other risks detailed under the caption “Risk Factors” in this Annual Report and in other reports filed with the SEC. Although we believe that we have a reasonable basis for each forward-looking statement contained in this Annual Report, we caution you that these statements are based on a combination of facts and important factors currently known by us and our expectations of the future, about which we cannot be certain.
We have based the forward-looking statements included in this Annual Report on information available to us on the date of this Annual Report or on the date thereof. Except as required by law we undertake no obligation to revise or update any forward-looking statements, whether as a result of new information, future events or otherwise. You are advised to consult any additional disclosures that we may make directly to you or through reports that we, in the future, may file with the SEC, including annual reports on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K.
All forward-looking statements included herein or in documents incorporated herein by reference are expressly qualified in their entirety by the cautionary statements contained or referred to elsewhere in this Annual Report.
