PART I—FINANCIAL INFORMATION [Financial Statements](index=5&type=section&id=ITEM%201.%20Financial%20Statements) The company reported a **$13.1 million net loss** for the nine months ended March 31, 2022, with cash and equity significantly declining, raising going concern doubts [Consolidated Balance Sheets](index=5&type=section&id=Consolidated%20Balance%20Sheets) As of March 31, 2022, total assets decreased to **$10.1 million**, driven by a reduction in cash, while total stockholders' equity fell sharply to **$7.5 million** Consolidated Balance Sheet Highlights (in thousands) | Balance Sheet Item | March 31, 2022 (Unaudited) | June 30, 2021 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $8,630 | $19,769 | | Total current assets | $8,841 | $20,608 | | Total assets | $10,064 | $21,379 | | **Liabilities & Equity** | | | | Total current liabilities | $1,909 | $1,369 | | Total liabilities | $2,544 | $1,369 | | Total stockholders' equity | $7,520 | $20,010 | | Total liabilities and stockholders' equity | $10,064 | $21,379 | [Consolidated Statements of Operations and Comprehensive Loss](index=6&type=section&id=Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) For the nine months ended March 31, 2022, the net loss increased to **$13.1 million**, primarily due to a rise in research and development expenses to **$8.1 million** Statement of Operations Summary (in thousands, except per share data) | Metric | Nine Months Ended March 31, 2022 | Nine Months Ended March 31, 2021 | | :--- | :--- | :--- | | Total revenues | $73 | $57 | | Research and development | $8,096 | $4,700 | | General and administrative | $5,093 | $4,976 | | Total operating expenses | $13,189 | $9,798 | | Loss from operations | ($13,116) | ($9,741) | | Net loss | ($13,141) | ($9,879) | | Net loss per share (Basic and diluted) | ($1.61) | ($2.93) | [Consolidated Statements of Stockholders' Equity](index=7&type=section&id=Consolidated%20Statements%20of%20Stockholders'%20Equity) Total stockholders' equity decreased from **$20.0 million** to **$7.5 million**, primarily due to the **$13.1 million net loss** incurred during the period Changes in Stockholders' Equity (in thousands) | Description | Nine Months Ended March 31, 2022 | | :--- | :--- | | Balance at June 30, 2021 | $20,010 | | Net loss | ($13,141) | | Share-based compensation | $702 | | Foreign currency translation | ($51) | | Balance at March 31, 2022 | $7,520 | [Consolidated Statements of Cash Flows](index=9&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities increased to **$11.0 million** for the nine months ended March 31, 2022, leading to a **$11.1 million decrease** in cash and cash equivalents Net Cash Flow Summary (in thousands) | Cash Flow Activity | Nine Months Ended March 31, 2022 | Nine Months Ended March 31, 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | ($11,044) | ($7,675) | | Net cash used in investing activities | $0 | ($362) | | Net cash provided by financing activities | $0 | $9,854 | | Net (decrease) increase in cash | ($11,139) | $2,187 | | Cash and cash equivalents, end of period | $8,630 | $11,988 | [Notes to Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) The notes detail the company's ddRNAi platform, accounting policies, and a critical 'Going Concern' note highlighting insufficient liquidity for the next 12 months - The company's business focuses on developing novel genetic medicines using its proprietary DNA-directed RNA interference (ddRNAi) platform, which combines RNA interference with gene therapy[31](index=31&type=chunk) - There is substantial doubt about the company's ability to continue as a going concern. As of March 31, 2022, the company had **$8.6 million in cash** and does not have adequate liquidity to fund operations for the next 12 months without raising additional funds[75](index=75&type=chunk) - In December 2021, stockholders approved an increase in authorized shares of common stock from **10,000,000 to 40,000,000**[88](index=88&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=19&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses BB-301 development, positive preclinical data, and planned 2022 clinical trials, while reiterating going concern risks due to increased net loss and cash burn [Overview and Development Programs](index=19&type=section&id=Overview%20and%20Development%20Programs) The company focuses on its ddRNAi platform, with lead candidate BB-301 for OPMD showing significant preclinical improvements and planning for a Phase 1b/2a clinical trial in 2022 - The company's lead candidate is **BB-301**, a ddRNAi-based therapeutic for Oculopharyngeal Muscular Dystrophy (OPMD), which has been granted Orphan Drug Designation in the United States and the European Union[105](index=105&type=chunk)[106](index=106&type=chunk) - A pilot dosing study for BB-301 in Beagle dogs demonstrated significant methodological improvements, leading to a **228-fold improvement** in transduction of the HP muscle and a **113-fold improvement** in the TP muscle compared to studies by a former licensee[122](index=122&type=chunk) - The company has completed pre-CTA and pre-IND meetings with regulators in France, Canada, and the U.S., and plans to begin the BB-301 clinical development program in 2022, starting with a Natural History Study followed by a Phase 1b/2a treatment study[125](index=125&type=chunk)[126](index=126&type=chunk)[127](index=127&type=chunk) [Results of Operations](index=28&type=section&id=Results%20of%20Operations) Revenues remained minimal, while research and development expenses significantly increased to **$8.1 million**, primarily due to costs for the BB-301 Regulatory Toxicology Study and GMP manufacturing Operating Expenses Comparison (in thousands) | Expense Category | Nine Months Ended March 31, 2022 | Nine Months Ended March 31, 2021 | | :--- | :--- | :--- | | Royalties and license fees | $0 | $122 | | Research and development | $8,096 | $4,700 | | General and administrative | $5,093 | $4,976 | | **Total operating expenses** | **$13,189** | **$9,798** | - The increase in R&D expenses for the nine-month period was primarily related to the BB-301 Regulatory Toxicology Study in Beagles and commercial-scale GMP manufacturing of BB-301[145](index=145&type=chunk) [Liquidity and Capital Resources](index=31&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2022, cash and cash equivalents were **$8.6 million**, with **$11.0 million** used in operations, indicating insufficient liquidity for the next 12 months and raising going concern doubts - The company had cash and cash equivalents of approximately **$8.6 million** as of March 31, 2022[150](index=150&type=chunk) - The company does not have adequate liquidity to fund its operations for the next 12 months without raising additional funds, which raises substantial doubt about its ability to continue as a going concern[157](index=157&type=chunk) Net Cash Flow Activity (in thousands) | Activity | Nine Months Ended March 31, 2022 | Nine Months Ended March 31, 2021 | | :--- | :--- | :--- | | Operating activities | $(11,044) | $(7,675) | | Investing activities | $0 | $(362) | | Financing activities | $0 | $9,854 | [Critical Accounting Policies](index=32&type=section&id=Critical%20Accounting%20Policies) Critical accounting policies include Research and Development Expense and Share-based Compensation Expense, both requiring significant judgments and estimates for third-party costs and fair value determinations - Critical accounting policies include Research and Development Expense, which involves significant estimates for costs of activities conducted by third-party service providers[164](index=164&type=chunk)[165](index=165&type=chunk) - Share-based Compensation Expense is also a critical policy, requiring the use of the Black-Scholes Option Pricing Model to determine the fair value of awards, which is then expensed over the service or vesting period[166](index=166&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=34&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, the company is not required to provide quantitative and qualitative disclosures about market risk - The company is a smaller reporting company and is not required to provide information regarding quantitative and qualitative disclosures about market risk[170](index=170&type=chunk) [Controls and Procedures](index=34&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective, with no material changes in internal controls over financial reporting during the quarter - Based on an evaluation as of the end of the reporting period, the principal executive officer and principal financial officer concluded that the company's disclosure controls and procedures are effective[171](index=171&type=chunk) - No changes in internal controls over financial reporting occurred during the quarter ended March 31, 2022, that have materially affected, or are reasonably likely to materially affect, internal control over financial reporting[172](index=172&type=chunk) PART II—OTHER INFORMATION [Legal Proceedings](index=35&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings - The company is not currently a party to any material legal proceedings[176](index=176&type=chunk) [Risk Factors](index=35&type=section&id=Item%201A.%20Risk%20Factors) No material changes have occurred to the risk factors previously disclosed in the company's Annual Report on Form 10-K - No material changes have occurred to the risk factors disclosed in the company's Annual Report on Form 10-K for the fiscal year ended June 30, 2021[177](index=177&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=35&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities or use of proceeds were reported for the period - None[178](index=178&type=chunk) [Defaults Upon Senior Securities](index=35&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) No defaults upon senior securities were reported - None[179](index=179&type=chunk) [Mine Safety Disclosures](index=35&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) Mine safety disclosures are not applicable to the company - None[180](index=180&type=chunk) [Other Information](index=35&type=section&id=Item%205.%20Other%20Information) No other information was reported for the period - None[181](index=181&type=chunk) [Exhibits](index=35&type=section&id=Item%206.%20Exhibits) The report lists exhibits filed, including CEO and CFO certifications and Inline XBRL documents - Exhibits filed include CEO and CFO certifications under Sections 302 and 906 of the Sarbanes-Oxley Act, as well as various Inline XBRL documents[182](index=182&type=chunk)[183](index=183&type=chunk)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 Title of each classTrading Symbol(s)Name of each exchange on which registered Common Stock, par value $0.0001 BNTC The Nasdaq Stock Market LLC Large accelerated filer ☐ Accelerated filer ☐ Non-accelerated filer ☒ Smaller reporting company ☒ FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended December 31, 2021 ☐ TRANSITION REPORT PURSUANT TO SECTION ...

Table of Contents Title of each classTrading Symbol(s)Name of each exchange on which registered Common Stock, par value $0.0001 BNTC The Nasdaq Stock Market LLC UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period f ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ Annual Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the fiscal year ended June 30, 2021 ☐ Transition Report under Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from to Commission File Number: 001-39267 Benitec Biopharma Inc. (Exact name of registrant as specified in its charter) Delaware 84-462-0206 (State or other jurisd ...

Table of Contents Title of each classTrading Symbol(s)Name of each exchange on which registered Common Stock, par value $0.0001 BNTC The Nasdaq Stock Market LLC UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2021 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ...

Table of Contents Title of each classTrading Symbol(s)Name of each exchange on which registered Common Stock, par value $0.0001 BNTC The Nasdaq Stock Market LLC UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended December 31, 2020 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period fr ...

PART I - FINANCIAL INFORMATION [Item 1. Financial Statements](index=5&type=section&id=ITEM%201.%20Financial%20Statements) This section presents the unaudited consolidated financial statements for the quarterly period ended September 30, 2020, reflecting the company's financial position, performance, and cash flows during the period [Consolidated Balance Sheets](index=6&type=section&id=Consolidated%20Balance%20Sheets) The Consolidated Balance Sheet as of September 30, 2020, shows a decrease in total assets to **$8,916 thousand** from **$11,587 thousand** at June 30, 2020, primarily driven by a reduction in cash and cash equivalents, with total stockholders' equity declining from **$10,238 thousand** to **$7,736 thousand** Consolidated Balance Sheet Highlights (in thousands) | Account | Sep 30, 2020 | Jun 30, 2020 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $7,450 | $9,801 | | Total current assets | $8,056 | $10,809 | | **Total assets** | **$8,916** | **$11,587** | | **Liabilities & Equity** | | | | Total current liabilities | $1,019 | $1,136 | | **Total liabilities** | **$1,180** | **$1,349** | | **Total stockholders' equity** | **$7,736** | **$10,238** | [Consolidated Statements of Operations and Comprehensive Loss](index=7&type=section&id=Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) For the three months ended September 30, 2020, the company reported a net loss of **$2,718 thousand**, a significant increase from the **$1,147 thousand** net loss in the same period of 2019, driven by a substantial rise in operating expenses, particularly in general and administrative costs, which grew from **$750 thousand** to **$1,837 thousand** Statement of Operations Summary (in thousands, except per share data) | Metric | Three Months Ended Sep 30, 2020 | Three Months Ended Sep 30, 2019 | | :--- | :--- | :--- | | Total revenues | $55 | $33 | | Research and development | $774 | $423 | | General and administrative | $1,837 | $750 | | **Total operating expenses** | **$2,745** | **$1,199** | | **Loss from operations** | **($2,690)** | **($1,166)** | | **Net loss** | **($2,718)** | **($1,147)** | | **Net loss per share (Basic and diluted)** | **($2.45)** | **($1.34)** | [Consolidated Statements of Stockholders' Equity](index=8&type=section&id=Consolidated%20Statements%20of%20Stockholders'%20Equity) Stockholders' equity decreased from **$10,238 thousand** at June 30, 2020, to **$7,736 thousand** at September 30, 2020, primarily due to the net loss of **$2,718 thousand** incurred during the quarter, partially offset by a **$178 thousand** positive foreign currency translation adjustment - Total stockholders' equity decreased from **$10,238 thousand** at the beginning of the period to **$7,736 thousand** at the end of the period[25](index=25&type=chunk) - The primary drivers for the change in equity were a net loss of **$2,718 thousand** and a foreign currency translation gain of **$178 thousand**[25](index=25&type=chunk) [Consolidated Statements of Cash Flows](index=9&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) The company used **$2,360 thousand** in cash for operating activities during the three months ended September 30, 2020, a significant increase from the **$545 thousand** used in the prior-year period, with no financing activities compared to **$1,770 thousand** provided in 2019, resulting in a **$2,533 thousand** decrease in cash and cash equivalents Cash Flow Summary (in thousands) | Activity | Three Months Ended Sep 30, 2020 | Three Months Ended Sep 30, 2019 | | :--- | :--- | :--- | | Net cash used in operating activities | ($2,360) | ($545) | | Net cash (used in) provided by investing activities | ($173) | $1 | | Net cash provided by financing activities | $0 | $1,770 | | **Net (decrease) increase in cash** | **($2,533)** | **$1,226** | | **Cash and cash equivalents, end of period** | **$7,450** | **$16,631** | [Notes to Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) The notes provide crucial context to the financial statements, detailing the company's business, re-domiciliation, basis of presentation, significant accounting policies, and key disclosures regarding funding sufficiency and financial details - The company focuses on developing novel genetic medicines using its proprietary DNA-directed RNA interference (ddRNAi) platform[33](index=33&type=chunk) - On **April 15, 2020**, the company completed its re-domiciliation from Australia to the **United States (Delaware)**[34](index=34&type=chunk)[36](index=36&type=chunk) - Subsequent to the quarter end, on October 6, 2020, the company closed an underwritten public offering with gross proceeds of approximately **$11.5 million**[120](index=120&type=chunk) - Management estimates that existing cash, including proceeds from the October 2020 offering, will be sufficient to fund operations for **at least the next twelve months** from the filing date[97](index=97&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=23&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's business overview, operational and financial impacts, results of operations, liquidity, capital resources, and critical accounting policies for the quarter [Overview](index=23&type=section&id=MD%26A%20Overview) Benitec is a development-stage biotechnology company advancing genetic medicines via its proprietary DNA-directed RNA interference (ddRNAi) platform, with its lead program BB-301 for OPMD utilizing a 'silence and replace' approach, and completed re-domiciliation to the U.S. in April 2020 - The company's core technology is a proprietary platform called DNA-directed RNA interference (ddRNAi), which combines RNAi with gene therapy[125](index=125&type=chunk) - The most advanced program is BB-301 for Oculopharyngeal Muscular Dystrophy (OPMD), which uses a 'silence and replace' mechanism and has received **Orphan Drug Designation** in the **U.S. and EU**[126](index=126&type=chunk) - The company completed a re-domiciliation from Australia to Delaware on **April 15, 2020**, becoming a **U.S. domestic public company**[129](index=129&type=chunk)[130](index=130&type=chunk) [COVID-19 Impact](index=24&type=section&id=COVID-19%20Impact) The COVID-19 pandemic has caused delays to the company's preclinical development timelines, particularly for the BB-301 program, with a key tissue transduction study delayed but now commenced - The company has experienced delays in the timeline for its BB-301 IND-enabling development work due to the COVID-19 pandemic[132](index=132&type=chunk) - A key BB-301 tissue transduction study was delayed but has recently been initiated, with initial dosing proceeding without incident[132](index=132&type=chunk) [Results of Operations](index=26&type=section&id=Results%20of%20Operations) For the three months ended September 30, 2020, revenues were minimal at **$55 thousand**, while operating expenses increased to **$2,745 thousand** from **$1,199 thousand** in the prior-year period, mainly due to higher G&A and R&D costs, resulting in a net loss of **$2,718 thousand**, more than double the **$1,147 thousand** loss from the same quarter in 2019 Comparison of Operating Results (in thousands) | Metric | Q3 2020 | Q3 2019 | | :--- | :--- | :--- | | Total Revenues | $55 | $33 | | Royalties and license fees | $134 | $26 | | Research and development | $774 | $423 | | General and administrative | $1,837 | $750 | | **Total operating expenses** | **$2,745** | **$1,199** | | **Net Loss** | **($2,718)** | **($1,147)** | - The increase in R&D expenses was primarily due to the impact of being reimbursed **$618 thousand** by Axovant Sciences in the prior year period and the termination of the AMD program[152](index=152&type=chunk) - The increase in G&A expense was due to increases in corporate and office costs[153](index=153&type=chunk) [Liquidity and Capital Resources](index=28&type=section&id=Liquidity%20and%20Capital%20Resources) As of September 30, 2020, the company had **$7.5 million** in cash and cash equivalents, with net cash used in operations of **$2.4 million** for the quarter, and a subsequent public offering in October 2020 raised approximately **$9.9 million** in net proceeds, which management believes are sufficient to support operations for at least the next twelve months - The company held **$7.5 million** in cash and cash equivalents as of September 30, 2020[160](index=160&type=chunk) - Net cash used in operating activities for the quarter was **$2.36 million**[160](index=160&type=chunk)[162](index=162&type=chunk) - On October 6, 2020, the company completed a public offering, raising approximately **$11.5 million** in gross proceeds and **$9.9 million** in net proceeds[165](index=165&type=chunk) - Management estimates that its cash and cash equivalents are sufficient to fund operations for **at least the next twelve months**[160](index=160&type=chunk)[168](index=168&type=chunk) [Critical Accounting Policies and Significant Accounting Estimates](index=30&type=section&id=Critical%20Accounting%20Policies%20and%20Significant%20Accounting%20Estimates) This section details the accounting policies that require significant management judgment and estimation, primarily Revenue Recognition (**ASC 606**) and Share-Based Compensation (**ASC 718**) - Critical accounting policies require management to make difficult, subjective, or complex judgments[173](index=173&type=chunk) - Key policies include Revenue Recognition (**ASC 606**) and Share-Based Compensation (**ASC 718**)[176](index=176&type=chunk)[183](index=183&type=chunk) - For revenue recognition, management applies judgment in identifying performance obligations and determining transaction prices, especially for licensing agreements[177](index=177&type=chunk)[178](index=178&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=33&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a **smaller reporting company**, Benitec Biopharma Inc. is **not required** to provide the information requested under this item - The company is **not required** to provide information for this item as it qualifies as a **smaller reporting company**[188](index=188&type=chunk) [Item 4. Controls and Procedures](index=33&type=section&id=Item%204.%20Controls%20and%20Procedures) Based on an evaluation conducted by management, including the principal executive and financial officers, the company's disclosure controls and procedures were deemed **effective** as of September 30, 2020, with no material changes to internal controls over financial reporting during the quarter - Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures are **effective** as of the end of the period covered by the report[189](index=189&type=chunk) - **No changes** in internal controls over financial reporting occurred during the quarter that have **materially affected**, or are reasonably likely to materially affect, these controls[190](index=190&type=chunk) PART II - OTHER INFORMATION [Item 1. Legal Proceedings](index=34&type=section&id=Item%201.%20Legal%20Proceedings) The company reports that it is **not currently a party to any material legal proceedings** - The company is **not currently a party to any material legal proceedings**[194](index=194&type=chunk) [Item 1A. Risk Factors](index=34&type=section&id=Item%201A.%20Risk%20Factors) There have been **no material changes** to the risk factors previously disclosed in the company's Annual Report on Form 10-K for the fiscal year ended June 30, 2020 - **No material changes** to the risk factors disclosed in the Annual Report on Form 10-K for the period ended June 30, 2020, have occurred[195](index=195&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=34&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported **no unregistered sales of equity securities or use of proceeds** during the reporting period - **None reported**[196](index=196&type=chunk) [Item 3. Defaults Upon Senior Securities](index=34&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported **no defaults upon senior securities** - **None reported**[197](index=197&type=chunk) [Item 4. Mine Safety Disclosures](index=34&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is **not applicable** to the company - **None reported**[198](index=198&type=chunk) [Item 5. Other Information](index=34&type=section&id=Item%205.%20Other%20Information) The company reported **no other information** for this period - **None reported**[199](index=199&type=chunk) [Item 6. Exhibits](index=34&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, which include certifications by the CEO and CFO pursuant to the Sarbanes-Oxley Act and XBRL data files - Exhibits filed include **CEO and CFO certifications** (31.1, 31.2, 32.1, 32.2) and **XBRL Instance Documents**[200](index=200&type=chunk)

Part I [Business](index=5&type=section&id=Item%201.%20Business) Benitec Biopharma is a development-stage biotechnology company focused on genetic medicines using its proprietary ddRNAi "silence and replace" platform, with lead candidate BB-301 for OPMD [Company Overview](index=5&type=section&id=Company%20Overview) Benitec Biopharma, based in Hayward, California, develops genetic medicines using its ddRNAi platform for OPMD (BB-301) and Chronic Hepatitis B, having re-domiciled to Delaware in April 2020 - The company's core technology is DNA-directed RNA interference (ddRNAi), which combines RNA interference with gene therapy to achieve long-term silencing of disease-causing genes from a single administration[22](index=22&type=chunk) - Benitec's lead candidate, BB-301 for Oculopharyngeal Muscular Dystrophy (OPMD), employs a "silence and replace" strategy, designed to silence the mutated gene while simultaneously replacing it with a normal, functional gene to restore cell function[23](index=23&type=chunk) - On April 15, 2020, the company completed a re-domiciliation, changing its jurisdiction of incorporation from Australia to Delaware and making the Australian entity (Benitec Limited) a wholly owned subsidiary[29](index=29&type=chunk) [Our Technology and Approach](index=6&type=section&id=Our%20Technology%20and%20Approach) The company's ddRNAi and "silence and replace" technologies use AAV vectors for single-dose, long-term gene silencing and functional protein replacement, addressing limitations of traditional siRNA therapies - The ddRNAi approach uses viral vectors (like AAV) to deliver a DNA construct into the cell's nucleus, which continuously produces short hairpin RNAs (shRNAs) processed into siRNAs to silence the target disease-causing gene[40](index=40&type=chunk)[41](index=41&type=chunk) - The "silence and replace" approach enhances ddRNAi by including a wildtype transgene in the DNA construct, allowing for simultaneous silencing of the mutant gene and continuous production of the normal protein, aiming to restore native biological processes[39](index=39&type=chunk)[42](index=42&type=chunk) - This approach aims to overcome key limitations of traditional siRNA therapies, including the need for repeat dosing, patient compliance challenges, and the inability to replace defective genes[37](index=37&type=chunk)[38](index=38&type=chunk) [Our Pipeline](index=11&type=section&id=Our%20Pipeline) Benitec's pipeline prioritizes BB-301 for OPMD, currently in IND-enabling studies, while actively seeking strategic partners for its BB-103 HBV program due to funding limitations Product Candidate Development Status | Product Candidate | Indication | Development Stage | | :--- | :--- | :--- | | BB-301 | Oculopharyngeal Muscular Dystrophy (OPMD) | Late-Stage Nonclinical (IND-enabling studies) | | BB-103 | Chronic Hepatitis B Virus (HBV) | Nonclinical (Seeking partners for IND-enabling studies) | - The company is prioritizing its cash and cash equivalents to advance BB-301 for OPMD[46](index=46&type=chunk) - For the BB-103 HBV program, Benitec is actively seeking a strategic partnership to support its development and complete IND-enabling studies due to current liquidity and funding limitations[46](index=46&type=chunk)[52](index=52&type=chunk)[60](index=60&type=chunk) [Intellectual Property](index=20&type=section&id=Intellectual%20Property) Benitec's IP strategy protects its ddRNAi and "silence and replace" technologies with patent families for BB-103 (HBV) and BB-301 (OPMD) extending through at least 2036, alongside registered trademarks - The patent portfolio for the HBV program (BB-103) consists of four patent families covering RNAi agents targeting the HBV genome and the AAV delivery system[101](index=101&type=chunk) - The patent portfolio for the OPMD program (BB-301) includes five patent families covering shRNA/shmiRs targeting the PABPN1 gene, the 'silence and replace' therapeutic concept, the specific BB-301 construct, and the AAV delivery system[105](index=105&type=chunk) - The company has a growing patent portfolio protecting its technology and product candidates through at least 2036, with potential for further patent life[54](index=54&type=chunk) Key Registered Trademarks | Trademark | Jurisdiction(s) | | :--- | :--- | | BENITEC ® | Australia, United States | | BENITEC BIOPHARMA ® | Australia, United States | | GIVING DISEASE THE SILENT TREATMENT ® | Australia, European Union | | SILENCING GENES FOR LIFE ® | Australia, United States | [Manufacturing, Competition, and Regulation](index=23&type=section&id=Manufacturing%2C%20Competition%2C%20and%20Regulation) Benitec relies on third-party manufacturers, faces strong competition in gene therapy, and is subject to extensive FDA regulation for its biologic products, with evolving pathways like RMAT - The company does not own or operate manufacturing facilities and relies on third-party contract manufacturing organizations (CMOs) to produce its product candidates under cGMP standards[118](index=118&type=chunk)[119](index=119&type=chunk) - Benitec faces competition from well-funded companies in the gene therapy and gene silencing space, with specific competitors in the hepatitis B field including Alnylam, Arbutus, and Arrowhead[122](index=122&type=chunk) - The company's products are subject to extensive regulation by the FDA as biologics, requiring a rigorous development process including nonclinical testing, an Investigational New Drug (IND) application, and multi-phase clinical trials before a Biologics License Application (BLA) can be submitted for marketing approval[128](index=128&type=chunk)[140](index=140&type=chunk) - The FDA has established specific guidance and an office (Office of Tissues and Advanced Therapies) for gene therapy products, and new regulations such as the Regenerative Medicine Advanced Therapy (RMAT) designation may provide expedited pathways for qualifying products[133](index=133&type=chunk)[134](index=134&type=chunk) [Risk Factors](index=36&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including historical losses, capital needs, unproven novel technologies, reliance on third parties, IP challenges, intense competition, and COVID-19 impacts - The company has a history of significant losses, with an accumulated deficit of **$116.6 million** as of June 30, 2020, and expects to incur further losses as it advances its research and development programs[195](index=195&type=chunk) - Benitec will require additional funding to advance its product candidates through clinical trials and to commercialization, and failure to secure this capital could force the company to delay or discontinue its development programs[205](index=205&type=chunk)[208](index=208&type=chunk) - The company's ddRNAi and silence and replace technologies are novel, with no products based on them yet approved for commercial sale, posing significant development, regulatory, and market acceptance risks[214](index=214&type=chunk) - Benitec relies on third parties for critical functions, including conducting preclinical studies and clinical trials, and for manufacturing its product candidates, making it vulnerable to delays or failures by these partners[280](index=280&type=chunk)[284](index=284&type=chunk) - The COVID-19 pandemic poses a risk to the business, potentially causing delays in clinical trials, disruptions to the supply chain, and negative impacts on the company's ability to raise capital[308](index=308&type=chunk)[311](index=311&type=chunk) [Unresolved Staff Comments](index=82&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports no unresolved staff comments from the SEC - None[432](index=432&type=chunk) [Properties](index=82&type=section&id=Item%202.%20Properties) The company's corporate headquarters and R&D facility are located in a leased 7,295 sq ft space in Hayward, California, with the lease expiring in June 2022 - The company's main facility is a leased 7,295 sq ft office and lab space in Hayward, California, with the lease expiring in June 2022[433](index=433&type=chunk) [Legal Proceedings](index=82&type=section&id=Item%203.%20Legal%20Proceedings) The company is not currently involved in any material legal proceedings - The company is not currently involved in any material legal proceedings[435](index=435&type=chunk) [Mine Safety Disclosures](index=82&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[436](index=436&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=83&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) Benitec's common stock trades on Nasdaq under "BNTC", has never paid dividends, and recently issued shares related to its re-domiciliation - The company's common stock trades on Nasdaq under the symbol "BNTC"[440](index=440&type=chunk) - The company has never declared or paid cash dividends and intends to retain all available funds for future operations and growth[442](index=442&type=chunk) - In connection with the Re-domiciliation on April 15, 2020, the company issued **1,070,957 shares** of common stock in exchange for all outstanding ordinary shares of its Australian predecessor, Benitec Limited[445](index=445&type=chunk) [Selected Financial Data](index=84&type=section&id=Item%206.%20Selected%20Financial%20Data) As a smaller reporting company, Benitec is not required to provide selected financial data - The company is a smaller reporting company and is not required to provide selected financial data[450](index=450&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=85&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) FY2020 saw a sharp revenue decline to **$102 thousand** and a net loss of **$8.3 million** due to the Axovant agreement termination, with **$9.8 million** cash and a planned offering to fund operations [Results of Operations](index=88&type=section&id=Results%20of%20Operations) FY2020 total revenues declined to **$102 thousand** from **$12.2 million** in 2019 due to the Axovant agreement termination, resulting in an **$8.3 million** operating loss Revenue Comparison (FY 2020 vs. FY 2019) | Revenue Source | FY 2020 (in thousands) | FY 2019 (in thousands) | | :--- | :--- | :--- | | Revenues from customers | $97 | $11,551 | | Government R&D grants | $5 | $648 | | **Total revenues** | **$102** | **$12,199** | Expense Comparison (FY 2020 vs. FY 2019) | Expense Category | FY 2020 (in thousands) | FY 2019 (in thousands) | | :--- | :--- | :--- | | Royalties and license fees | $(185) | $435 | | Research and development | $3,001 | $4,567 | | General and Administrative | $5,567 | $4,614 | | **Total expenses** | **$8,383** | **$9,616** | - The significant decrease in customer revenue in FY2020 was due to the termination of the License and Collaboration Agreement with Axovant Sciences, which was effective September 3, 2019[480](index=480&type=chunk)[481](index=481&type=chunk) - The decrease in R&D expenses was primarily due to reimbursement of **$606 thousand** from Axovant for OPMD program costs and the termination of the AMD program[489](index=489&type=chunk) [Liquidity and Capital Resources](index=90&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2020, the company had **$9.8 million** in cash, a cumulative deficit of **$116.6 million**, and expects current cash plus a planned offering to fund operations for the next twelve months - The company had cash and cash equivalents of **$9.8 million** as of June 30, 2020[495](index=495&type=chunk) Net Cash Flow Summary (FY 2020 vs. FY 2019) | Activity | FY 2020 (in thousands) | FY 2019 (in thousands) | | :--- | :--- | :--- | | Operating activities | $(7,535) | $4,790 | | Investing activities | $(94) | $(400) | | Financing activities | $1,770 | $0 | | **Net (decrease) increase in cash** | **$(5,859)** | **$4,390** | - Management estimates that current cash and proceeds from a planned public offering will fund operations for at least the next twelve months, with the company having filed a registration statement on Form S-1 on August 14, 2020[503](index=503&type=chunk)[630](index=630&type=chunk) [Critical Accounting Policies and Significant Accounting Estimates](index=93&type=section&id=Critical%20Accounting%20Policies%20and%20Significant%20Accounting%20Estimates) Critical accounting policies involve significant judgment, including Revenue Recognition (ASC 606) for complex licensing and Share-Based Compensation (ASC 718) requiring fair value estimates - Revenue Recognition (ASC 606) is a critical policy, requiring management judgment to identify performance obligations and allocate transaction prices, especially for licensing revenues[511](index=511&type=chunk)[512](index=512&type=chunk) - Share-Based Compensation (ASC 718) is also critical, as it requires the use of the Black-Scholes model to determine the fair value of awards, which involves significant estimates for inputs like expected volatility and award life[519](index=519&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=95&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) As a smaller reporting company, Benitec is not required to provide quantitative and qualitative disclosures about market risk - The company is a smaller reporting company and is not required to provide this information[527](index=527&type=chunk) [Financial Statements and Supplementary Data](index=96&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section presents the company's audited consolidated financial statements for FY2020 and FY2019, including balance sheets, statements of operations, equity, cash flows, and accompanying notes Consolidated Balance Sheet Highlights (as of June 30) | Metric (in thousands) | 2020 | 2019 | | :--- | :--- | :--- | | Cash and cash equivalents | $9,801 | $15,718 | | Total assets | $11,587 | $19,235 | | Total liabilities | $1,349 | $2,641 | | Total stockholders' equity | $10,238 | $16,594 | Consolidated Statement of Operations Highlights (for the year ended June 30) | Metric (in thousands) | 2020 | 2019 | | :--- | :--- | :--- | | Total revenues | $102 | $12,199 | | Total operating expenses | $8,383 | $9,616 | | Net income (loss) | $(8,274) | $2,609 | [Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](index=123&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) Information on changes in and disagreements with accountants was previously disclosed in a Form 8-K filed on June 5, 2020, and amended on August 19, 2020 - The company refers to a previously filed Form 8-K for information on this topic[696](index=696&type=chunk) [Controls and Procedures](index=123&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that disclosure controls and internal control over financial reporting were effective as of June 30, 2020, with no material changes during the quarter - Management concluded that as of June 30, 2020, the company's disclosure controls and procedures were effective[697](index=697&type=chunk) - Management concluded that the company's internal control over financial reporting was effective as of June 30, 2020, based on the COSO framework[699](index=699&type=chunk) - No changes occurred during the quarter ended June 30, 2020, that materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[698](index=698&type=chunk) [Other Information](index=123&type=section&id=Item%209B.%20Other%20Information) The company reports no other information for this item - None[702](index=702&type=chunk) Part III [Directors, Executive Officers and Corporate Governance](index=124&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) The company's leadership includes CEO Dr. Jerel Banks, with a five-member staggered Board of Directors, three standing committees, and an adopted Code of Ethics and Business Conduct - The executive officers are Dr. Jerel Banks (CEO) and Megan Boston (Executive Director)[706](index=706&type=chunk) - The Board of Directors is classified into three staggered three-year terms and has standing Audit, Compensation, and Nominating and Corporate Governance committees[724](index=724&type=chunk)[726](index=726&type=chunk) - The company has adopted a Code of Ethics and Business Conduct, which is available on its website[734](index=734&type=chunk)[735](index=735&type=chunk) [Executive Compensation](index=128&type=section&id=Item%2011.%20Executive%20Compensation) In FY2020, CEO Dr. Jerel Banks received **$431,704** and Executive Director Megan Boston received **$238,205** in total compensation, with both having at-will employment agreements requiring six-month termination notice FY 2020 Named Executive Officer Compensation | Named Executive Officer | Position | Salary ($) | Total ($) | | :--- | :--- | :--- | :--- | | Dr. Jerel A. Banks | CEO | 400,000 | 431,704 | | Megan Boston | Executive Director | 221,430 | 238,205 | - Both NEOs have employment agreements that are "at will" but require the company to provide six months' prior notice or pay in lieu of notice for termination[747](index=747&type=chunk)[751](index=751&type=chunk) - Non-employee directors receive annual fees for their service, with Mr. Buchi's fee at **$51,432** and Mr. Smith's at **$50,000** annually[781](index=781&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=135&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) As of September 15, 2020, Nant Capital, LLC is the sole beneficial owner of over 5% of common stock at **26.4%**, while directors and executive officers collectively own **4.1%** Principal Stockholders (as of Sept 15, 2020) | Name of Beneficial Owner | Percentage of Shares Beneficially Owned | | :--- | :--- | | Nant Capital, LLC | 26.4% | | All Executive Officers and Directors As a Group (5 persons) | 4.1% | [Certain Relationships and Related Transactions, and Director Independence](index=137&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) The company has engaged in various transactions with its largest shareholder, Nant Capital, LLC, and its affiliates, with the Audit Committee responsible for reviewing related party transactions - The company has a strategic relationship with Nant Capital, LLC, its largest shareholder (**26.4%** ownership), which includes a prior equity investment and collaboration agreements[789](index=789&type=chunk)[786](index=786&type=chunk) - A sublicense agreement with NantWorks, LLC (an affiliate of Nant Capital) for the BB-401 program was terminated in June 2020 as the program was discontinued[789](index=789&type=chunk) - The Audit Committee reviews and approves any related party transaction that requires disclosure[792](index=792&type=chunk) [Principal Accountant Fees and Services](index=139&type=section&id=Item%2014.%20Principal%20Accountant%20Fees%20and%20Services) For FY2020, Squar Milner LLP billed the company **$206,800** for audit, audit-related, and tax services, all pre-approved by the Audit Committee Accountant Fees for Fiscal Year 2020 | Fee Category | Amount ($) | | :--- | :--- | | Audit Fees | $183,600 | | Audit-Related Fees | $16,200 | | Tax Fees | $7,000 | | **Total** | **$206,800** | - The Audit Committee pre-approves **100%** of all services rendered by the independent registered public accounting firm[796](index=796&type=chunk) Part IV [Exhibits and Financial Statement Schedules](index=140&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section indexes exhibits filed with Form 10-K, including corporate governance documents, executive employment agreements, and required SEC certifications - This section contains the index of all exhibits filed as part of the annual report[802](index=802&type=chunk) - Key filed exhibits include corporate governance documents, material contracts such as executive employment agreements, and required SEC certifications[798](index=798&type=chunk)[803](index=803&type=chunk) [Form 10-K Summary](index=142&type=section&id=Item%2016.%20Form%2010-K%20Summary) This item is not applicable - Not applicable[806](index=806&type=chunk)