Benitec Biopharma Inc.

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 10-Q

(Mark One)

For the quarterly period ended September 30,2026

For the transition period from to

Commission File Number 001-39267

(Exact name of registrant as specified in its charter)

3940 Trust Way, Hayward, California 94545

(Address of principal executive offices & zip code)

(510)780-0819

(Registrant’s telephone number, including area code)

Securities registered pursuant to Section 12(b) of the Act:

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ or No☒

We had 36,119,043 shares of our common stock outstanding as of the close of business on November 9, 2026.

INDEX TO FORM 10-Q

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Report contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended, 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 Report, regarding our strategy, future operations, development of BB-301 and other medicines, preclinical and clinical trial data, financial position, projected costs, prospects, plans and objectives of management are forward-looking statements. When used in this 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 adeno-associated viral (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 DNA-directed RNA interferences (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;

•

unanticipated delays;

•

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;

•

reliance on third-party manufacturers and suppliers, and the risks associated with manufacturing complexity, supply interruptions, and compliance with current good manufacturing practices;

•

sales, marketing, and distribution requirements for our product candidates;

•

greater than expected expenses, including expenses relating to litigation or strategic activities;

•

our incurrence of significant losses and the uncertainty of our ability to achieve or sustain profitability or generate any revenue;

•

our ability to satisfy our capital needs through increasing revenue and obtaining additional financing;

•

the impact of local, regional, national and international economic conditions and events, including geopolitical instability, and risks associated with conducting business and seeking regulatory approvals in international markets;

•

our ability to attract and retain key management, scientific, and technical personnel;

•

cyber-security threats and vulnerabilities in our and our third parties' information technology systems;

•

the impact of legislative and regulatory reforms affecting drug pricing and reimbursement, including Medicare drug-price negotiation and government pricing frameworks;

•

potential product liability claims arising from the use of our product candidates in clinical trials or following any future marketing approval;

•

physicians, patients, third-party payers, or others in the medical community may not be receptive to our product candidates, and we may not generate any future revenue from the sale or licensing of our product candidates; and

•

disruptions to U.S. government agency operations, including FDA staffing changes.

These as well as other risks are detailed under the caption “Risk Factors” in the Company’s Annual Report on Form 10-K for the fiscal year ended June 30, 2026, 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 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 Report on information available to us on the date of this 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 Report.