Concentrations of Risk Financial instruments that potentially subject the Company to significant concentration of credit risk consist primarily of cash and cash equivalents. The Company maintains deposits at federally insured financial institutions in excess of federally insured limits. The Company has not experienced any losses in such accounts, and management believes that the Company is not exposed to significant credit risk due to the financial position of the depository institutions in which those depo ...

-First efficacy signals demonstrated for a gene therapy under development for Oculopharyngeal Muscular Dystrophy (OPMD) which affects ~15,000 patients worldwide- - BB-301 facilitated improvements across multiple measures of swallowing function in the first Phase 1b/2a clinical study subject as compared to pretreatment assessments conducted during the observational natural history portion of the study- -Virtual R&D Day being held today at 9:00 am EDT, details below- HAYWARD, Calif., April 18, 2024 (GLOBE NEW ...

-First Subject Dosed with BB-301 in Phase 1b/2a Clinical Treatment Study (NCT06185673) in November 2023- -Data Safety Monitoring Board Review for First Subject Completed After Day 28 Study Visit- -Second Subject Scheduled to Receive BB-301 in February 2024- -23 Subjects Enrolled into the Oculopharyngeal Muscular Dystrophy Natural History Study with Multiple Subjects Eligible for entry into the Phase 1b/2a Clinical Treatment Study in 2024- HAYWARD, Calif., Feb. 13, 2024 (GLOBE NEWSWIRE) -- Benitec Biopharma ...

[PART I - FINANCIAL INFORMATION](index=5&type=section&id=PART%20I-FINANCIAL%20INFORMATION) This section presents the company's financial statements, management's discussion and analysis, market risk disclosures, and controls and procedures [Item 1. Financial Statements](index=5&type=section&id=ITEM%201.%20Financial%20Statements) The financial statements for the period ended December 31, 2023, reflect a substantial increase in cash and cash equivalents to $20.4 million due to financing activities, alongside a widened net loss of $12.8 million driven by increased research and development expenses [Consolidated Balance Sheets](index=5&type=section&id=Consolidated%20Balance%20Sheets) As of December 31, 2023, cash and cash equivalents significantly increased to $20.4 million, driving total assets to $21.4 million and stockholders' equity to $15.5 million, primarily due to capital raises Consolidated Balance Sheet Highlights (in thousands) | Balance Sheet Item | Dec 31, 2023 (Unaudited) | June 30, 2023 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $20,374 | $2,477 | | Total current assets | $20,796 | $3,729 | | Total assets | $21,353 | $4,464 | | **Liabilities & Equity** | | | | Total current liabilities | $5,746 | $3,978 | | Total liabilities | $5,883 | $4,262 | | Total stockholders' equity | $15,470 | $202 | [Consolidated Statements of Operations and Comprehensive Loss](index=6&type=section&id=Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) For the six months ended December 31, 2023, the company reported no revenue, with net loss widening to $12.8 million due to increased research and development expenses Statement of Operations Summary (in thousands, except per share data) | Metric | Six Months Ended Dec 31, 2023 | Six Months Ended Dec 31, 2022 | | :--- | :--- | :--- | | Total revenues | $0 | $14 | | Research and development | $9,531 | $6,421 | | General and administrative | $3,375 | $3,783 | | Loss from operations | $(12,801) | $(10,190) | | Net loss | $(12,752) | $(10,504) | | Net loss per share (Basic & Diluted) | $(5.39) | $(9.30) | [Consolidated Statements of Stockholders' Equity](index=7&type=section&id=Consolidated%20Statements%20of%20Stockholders'%20Equity) Stockholders' equity significantly increased from $0.2 million to $15.5 million for the six months ended December 31, 2023, primarily driven by $27.9 million in capital raised from stock and warrant issuances - Total stockholders' equity increased from **$202 thousand** at June 30, 2023, to **$15.47 million** at December 31, 2023[122](index=122&type=chunk) - The company raised **$27.9 million** from the issuance of common stock and warrants, net of **$2.96 million** in offering costs, during the six months ended December 31, 2023[122](index=122&type=chunk) [Consolidated Statements of Cash Flows](index=8&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) For the six months ended December 31, 2023, net cash used in operating activities was $9.9 million, offset by $28.0 million provided by financing activities, resulting in a $17.9 million net increase in cash Cash Flow Summary (in thousands) | Cash Flow Activity | Six Months Ended Dec 31, 2023 | Six Months Ended Dec 31, 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(9,942) | $(9,888) | | Net cash provided by financing activities | $27,958 | $16,015 | | Net increase in cash | $17,898 | $6,475 | | Cash at end of period | $20,388 | $10,551 | [Notes to Consolidated Financial Statements (Unaudited)](index=9&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements%20(Unaudited)) The notes detail the company's genetic medicine focus, a 1-for-17 reverse stock split, and the impact of a $27.9 million public offering on liquidity, which is expected to fund operations for at least twelve months - The company's business focuses on developing novel genetic medicines using its proprietary DNA-directed RNA interference (ddRNAi) platform[125](index=125&type=chunk) - A **1-for-17 reverse stock split** of common stock was effected on July 26, 2023. All share and per-share amounts in the report reflect this split[127](index=127&type=chunk) - As of December 31, 2023, the company had **$20.4 million** in cash and cash equivalents, which is estimated to be sufficient to fund operations for at least the next twelve months[167](index=167&type=chunk) - In August 2023, the company closed an underwritten public offering, raising net proceeds of **$27.9 million** through the sale of common stock, pre-funded warrants, and common warrants[174](index=174&type=chunk) [Item 2. 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 the company's clinical-stage biotechnology focus, the advancement of its lead program BB-301 for OPMD, and the significant strengthening of its financial condition by a $27.9 million capital raise, providing a cash runway for at least 12 months [Company Overview and Strategy](index=19&type=section&id=Company%20Overview%20and%20Strategy) Benitec is a clinical-stage biotechnology company focused on developing genetic medicines using its proprietary ddRNAi and "silence and replace" technology, aiming to develop and commercialize treatments for genetic disorders - Benitec is a clinical-stage biotechnology company focused on advancing novel genetic medicines using its proprietary DNA-directed RNA interference (ddRNAi) platform[210](index=210&type=chunk) - The company's unique "silence and replace" approach combines RNA interference (RNAi) with gene therapy to silence disease-causing genes while simultaneously delivering wildtype replacement genes[210](index=210&type=chunk) - The company's strategy is to develop proprietary programs, explore partnerships with large biopharmaceutical companies, and actively protect its intellectual property[239](index=239&type=chunk) [Our Pipeline: BB-301 for OPMD](index=25&type=section&id=Our%20Pipeline%3A%20BB-301%20for%20OPMD) BB-301, the company's lead AAV-based gene therapy for OPMD, received FDA IND approval in June 2023, with the first patient dosed in its Phase 1b/2a clinical trial in November 2023, alongside an ongoing Natural History study - BB-301 is the lead investigational agent for Oculopharyngeal Muscular Dystrophy (OPMD), a degenerative muscle disorder[15](index=15&type=chunk)[16](index=16&type=chunk) - The Investigational New Drug (IND) application for BB-301 was approved by the FDA in June 2023[15](index=15&type=chunk)[27](index=27&type=chunk) - The first subject in the BB-301 Phase 1b/2a clinical trial was dosed in November 2023[15](index=15&type=chunk)[29](index=29&type=chunk) - The clinical development program includes a Natural History (NH) study to establish baseline dysphagia progression before subjects are enrolled into the treatment study. As of January 2024, **23 subjects** are enrolled in the NH study[29](index=29&type=chunk)[282](index=282&type=chunk) [Intellectual Property, Manufacturing, and Competition](index=37&type=section&id=Intellectual%20Property%2C%20Manufacturing%2C%20and%20Competition) Benitec's intellectual property for OPMD includes five patent families, the company relies on third-party CMOs for manufacturing, and despite intense competition, it is unaware of other gene therapy approaches specifically for OPMD - The patent portfolio for OPMD includes **five patent families** covering the therapeutic candidate BB-301, the 'silence and replace' treatment strategy, and the AAV delivery system[31](index=31&type=chunk) - The company does not own or operate manufacturing facilities and relies on contract manufacturing organizations for the production of its product candidates under cGMP conditions[36](index=36&type=chunk) - The company faces intense competition but is not aware of any other companies developing a gene therapy or gene silencing approach for OPMD[290](index=290&type=chunk) [Government Regulation](index=41&type=section&id=Government%20Regulation) The company's gene therapy products are subject to extensive FDA regulation, requiring IND and BLA submissions, with BB-301 having received Orphan Drug Designation in the U.S. and E.U., and post-approval regulations including cGMP - Gene therapy products are regulated as biologics by the FDA's Center for Biologics Evaluation and Research (CBER)[67](index=67&type=chunk) - The approval process requires submitting an Investigational New Drug (IND) application before human trials and a Biologics License Application (BLA) for marketing approval[68](index=68&type=chunk)[263](index=263&type=chunk) - The FDA has created the Regenerative Medicine Advanced Therapy (RMAT) designation to expedite the development of certain gene therapies[67](index=67&type=chunk) - BB-301 has received **Orphan Drug Designation** in the United States and the European Union, which provides benefits such as market exclusivity upon approval[16](index=16&type=chunk)[215](index=215&type=chunk)[325](index=325&type=chunk) [Results of Operations](index=53&type=section&id=Results%20of%20Operations) For the six months ended December 31, 2023, the company reported no revenue, with research and development expenses increasing to $9.5 million due to BB-301 clinical development, resulting in a total operating loss of $12.8 million Operating Expenses (in thousands) | Expense Category | Six Months Ended Dec 31, 2023 | Six Months Ended Dec 31, 2022 | | :--- | :--- | :--- | | Royalties and License Fees | $(105) | $0 | | Research and development | $9,531 | $6,421 | | General and administrative | $3,375 | $3,783 | | **Total operating expenses** | **$12,801** | **$10,204** | - The increase in R&D expenses is primarily related to the ongoing clinical development of BB-301 for the treatment of OPMD[344](index=344&type=chunk) - The decrease in G&A expenses for the six-month period was mainly due to lower stock-based compensation (**$70k**) and legal fees (**$396k**)[103](index=103&type=chunk) [Liquidity and Capital Resources](index=56&type=section&id=Liquidity%20and%20Capital%20Resources) As of December 31, 2023, the company had $20.4 million in cash and cash equivalents, with liquidity significantly bolstered by a $28.0 million public offering, which management believes is sufficient to fund operations for at least the next twelve months - As of December 31, 2023, the company had cash and cash equivalents of approximately **$20.4 million**[346](index=346&type=chunk) - Net cash used in operating activities was **$9.9 million** for the six months ended December 31, 2023[91](index=91&type=chunk) - Net cash provided by financing activities was **$28.0 million** for the six months ended December 31, 2023, primarily from the August 2023 public offering[360](index=360&type=chunk) - The company estimates that its current cash and cash equivalents will be sufficient to fund operations for at least the next twelve months from the date of the report[92](index=92&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=59&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[111](index=111&type=chunk) [Item 4. Controls and Procedures](index=59&type=section&id=ITEM%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of December 31, 2023, with no material changes to internal control over financial reporting during the quarter - Based on an evaluation as of the end of the period, the principal executive officer and principal financial officer concluded that the company's disclosure controls and procedures are effective[95](index=95&type=chunk) - There were no changes in internal controls over financial reporting during the quarter ended December 31, 2023, that have materially affected, or are reasonably likely to materially affect, internal control over financial reporting[353](index=353&type=chunk) [PART II - OTHER INFORMATION](index=60&type=section&id=PART%20II%20-%20OTHER%20INFORMATION) This section covers legal proceedings, risk factors, equity sales, defaults, mine safety, other information, and exhibits [Item 1. Legal Proceedings](index=60&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[113](index=113&type=chunk)[354](index=354&type=chunk) [Item 1A. Risk Factors](index=60&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, 2023 - There have been no material changes to the risk factors disclosed in the Company's Annual Report on Form 10-K for the fiscal year ended June 30, 2023[366](index=366&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=60&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section was noted in the table of contents but no specific information regarding unregistered sales was provided in the corresponding text - The report indicates this item but does not provide specific details on unregistered sales of equity securities in the reviewed chunks[9](index=9&type=chunk)[115](index=115&type=chunk) [Item 3. Defaults Upon Senior Securities](index=60&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reports that there were no defaults upon senior securities during the period - None reported[97](index=97&type=chunk)[369](index=369&type=chunk) [Item 4. Mine Safety Disclosures](index=60&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[100](index=100&type=chunk) [Item 5. Other Information](index=60&type=section&id=Item%205.%20Other%20Information) The company reports that none of its directors or officers adopted, modified, or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement during the quarter ended December 31, 2023 - During the quarter ended December 31, 2023, none of the company's directors or officers adopted, modified, or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement[367](index=367&type=chunk) [Item 6. Exhibits](index=60&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including amendments to compensation plans, CEO/CFO certifications pursuant to the Sarbanes-Oxley Act, and Inline XBRL documents - Exhibits filed include the Second Amendment to the 2020 Equity and Incentive Compensation Plan, CEO and CFO certifications (Sections 302 and 906), and various Inline XBRL documents[368](index=368&type=chunk)

Title of each classTrading Symbol(s)Name of each exchange on which registered UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 For the quarterly period ended September 30, 2023 Delaware 84-462-0206 (State or other jurisdiction of incorporation or organization)(IRS Employer Identification No.) Table of Contents Emerging growth company ☐ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to 3940 Trust Way, ...

PART I [Business](index=5&type=section&id=Item%201.%20Business) Benitec Biopharma is a clinical-stage biotechnology company developing genetic medicines, with lead candidate BB-301 for OPMD, utilizing proprietary ddRNAi and "silence and replace" platforms [Company Overview and Technology](index=5&type=section&id=Company%20Overview%20and%20Technology) Benitec Biopharma develops genetic medicines using proprietary DNA-directed RNA interference (ddRNAi) and "silence and replace" platforms for sustained gene silencing and functional gene replacement - The company's core technology is DNA-directed RNA interference (ddRNAi), which combines RNAi with gene therapy for sustained gene silencing from a single administration[27](index=27&type=chunk) - Benitec's proprietary "silence and replace" approach is designed to both silence the expression of a disease-causing mutant gene and simultaneously replace it with a normal, wildtype gene to restore function[13](index=13&type=chunk)[15](index=15&type=chunk)[34](index=34&type=chunk) - The company's lead therapeutic candidate, BB-301, is being developed for Oculopharyngeal Muscular Dystrophy (OPMD) and has received Orphan Drug Designation in the U.S. and European Union[13](index=13&type=chunk)[27](index=27&type=chunk) [Our Pipeline and Lead Candidate BB-301](index=11&type=section&id=Our%20Pipeline%20and%20Lead%20Candidate%20BB-301) The company's pipeline focuses on BB-301, a first-in-class AAV-based gene therapy for OPMD, which demonstrated restored muscle strength in preclinical models - BB-301 is an AAV9-based gene therapy designed to silence the mutant PABPN1 gene and replace it with a codon-optimized, functional version to treat OPMD[48](index=48&type=chunk)[73](index=73&type=chunk) - In the A17 mouse model of OPMD, a single dose of BB-301 led to full restoration of muscle strength, clearance of intranuclear inclusions (INIs), and a reduction of fibrosis[76](index=76&type=chunk) - A pilot dosing study in Beagle dogs using an optimized surgical delivery method demonstrated a **248-fold improvement** in transduction of the hypopharyngeal muscle compared to a previous licensee's study[113](index=113&type=chunk) [Clinical Development and Regulatory Status](index=21&type=section&id=Clinical%20Development%20and%20Regulatory%20Status) The FDA cleared BB-301's IND in June 2023, enabling a Phase 1b/2a treatment study following a natural history study with 15 enrolled subjects as of September 2023 - The U.S. FDA cleared the Investigational New Drug (IND) application for BB-301 in June 2023, allowing the Phase 1b/2a treatment study to proceed[115](index=115&type=chunk) - The clinical program involves a 6-month Natural History (NH) study to establish a baseline, followed by a 52-week Phase 1b/2a treatment study with a primary endpoint of safety[141](index=141&type=chunk)[92](index=92&type=chunk) - As of September 2023, **15 subjects** have been enrolled in the NH study in the U.S., with initial interim safety and efficacy data for treated subjects expected within the next **12 months**[92](index=92&type=chunk) [Intellectual Property, Manufacturing, and Competition](index=23&type=section&id=Intellectual%20Property%2C%20Manufacturing%2C%20and%20Competition) Benitec protects its BB-301 and 'silence and replace' technology with five patent families, relies on third-party manufacturing, and faces broad biopharmaceutical competition but no direct OPMD gene therapy competitors - The OPMD patent portfolio consists of **five patent families** covering the BB-301 construct, specific shRNA target regions, the 'silence and replace' concept for OPMD, and the AAV delivery system[118](index=118&type=chunk)[94](index=94&type=chunk)[95](index=95&type=chunk) - The company does not own or operate manufacturing facilities and relies on contract manufacturing organizations (CMOs) for the production of its product candidates[122](index=122&type=chunk)[149](index=149&type=chunk) - Benitec is not aware of any other companies developing a gene therapy or gene silencing approach for OPMD, though it faces competition from larger companies in the broader gene therapy space[153](index=153&type=chunk)[124](index=124&type=chunk) [Government Regulation](index=27&type=section&id=Government%20Regulation) The company's gene therapy products are subject to extensive FDA regulation, with BB-301 benefiting from Orphan Drug Designation and potential RMAT pathways for expedited review - Gene therapy products are regulated as biologics by the FDA's Center for Biologics Evaluation and Research (CBER) and require a Biologics License Application (BLA) for marketing approval[134](index=134&type=chunk)[140](index=140&type=chunk) - The FDA's RMAT designation offers an expedited pathway for gene therapies that address unmet medical needs in serious conditions, providing increased access to the FDA during development[158](index=158&type=chunk)[132](index=132&type=chunk) - Orphan Drug Designation, which BB-301 has received in the U.S. and EU, provides **seven and ten years** of market exclusivity, respectively, upon approval for the designated rare disease[170](index=170&type=chunk)[183](index=183&type=chunk) [Risk Factors](index=39&type=section&id=Item%201A.%20Risk%20Factors) The company faces substantial risks including financial losses, the unproven nature of its novel technologies, complex regulatory pathways, reliance on third parties, and intellectual property challenges [Financial and Operational Risks](index=39&type=section&id=Financial%20and%20Operational%20Risks) The company has a history of significant financial losses, with an accumulated deficit of **$167.9 million** as of June 30, 2023, and relies on future capital raises, including **$28.6 million** from an August 2023 offering, to fund operations - The company has incurred significant losses since inception, with an accumulated deficit of **$167.9 million** as of June 30, 2023[224](index=224&type=chunk) - Benitec will need to raise additional funding to continue operations; failure to do so may negatively impact its ability to continue as a going concern[223](index=223&type=chunk)[256](index=256&type=chunk) - A public offering in August 2023 raised net proceeds of **$28.6 million**, which is estimated to be sufficient to fund operations for at least the next **twelve months**[257](index=257&type=chunk) [Product Development and Regulatory Risks](index=43&type=section&id=Product%20Development%20and%20Regulatory%20Risks) Product development faces risks from novel, unapproved technologies, lengthy and uncertain regulatory processes for gene therapies, potential AAV vector issues, and challenges in patient enrollment for rare diseases - The company's core technologies, ddRNAi and silence and replace, are novel and have not yet resulted in an approved commercial product, making their development inherently risky[289](index=289&type=chunk)[235](index=235&type=chunk) - The regulatory approval process for gene therapies is complex and lengthy, and regulatory agencies have limited experience with ddRNAi-based therapeutics, creating uncertainty in development timelines and costs[294](index=294&type=chunk) - Potential issues with AAV delivery vectors, such as pre-existing patient immunity or adverse immunological side effects, could delay or halt clinical development[278](index=278&type=chunk)[268](index=268&type=chunk) - Difficulty enrolling a sufficient number of patients for clinical trials, a common challenge for rare diseases, could delay or prevent the completion of studies[270](index=270&type=chunk) [Risks Related to Reliance on Third Parties](index=55&type=section&id=Risks%20Related%20to%20Reliance%20on%20Third%20Parties) The company's operations are highly dependent on third-party contract research organizations, manufacturers, collaborators, and licensors, introducing risks related to performance, quality, and control - The company relies on third-party collaborators for research, development, and potential commercialization, and has no control over the resources they may devote to its programs[318](index=318&type=chunk) - Benitec is dependent on CROs to conduct its clinical trials and is responsible for ensuring their compliance with GCP and other regulatory requirements[321](index=321&type=chunk)[322](index=322&type=chunk) - The company relies on third-party partners for the manufacturing and supply of all materials for research and clinical studies and has not yet secured commercial-scale manufacturing capabilities[349](index=349&type=chunk)[328](index=328&type=chunk) [Risks Related to Intellectual Property](index=71&type=section&id=Risks%20Related%20to%20Intellectual%20Property) The company's success relies on uncertain and costly intellectual property protection, facing risks of patent challenges, infringement claims, and limited control over in-licensed IP - The company's ability to obtain and maintain patent protection is uncertain, and its patents may be challenged, narrowed, or invalidated[419](index=419&type=chunk)[421](index=421&type=chunk) - Benitec relies on license agreements with third parties for key technology and may not have control over the prosecution and enforcement of the in-licensed patents[452](index=452&type=chunk)[426](index=426&type=chunk) - The company may face claims of infringing third-party patents, which could lead to costly litigation, substantial damages, or the inability to commercialize its products[430](index=430&type=chunk)[456](index=456&type=chunk) - Changes in U.S. patent law, such as the Leahy-Smith Act, and recent Supreme Court rulings have created uncertainty regarding the scope and enforceability of biotechnology patents[466](index=466&type=chunk)[496](index=496&type=chunk) [Properties](index=82&type=section&id=Item%202.%20Properties) The company leases approximately **7,295 square feet** of office and lab space in Hayward, California, for its headquarters and R&D, with the lease expiring in June 2025 - The company leases approximately **7,295 square feet** of office and laboratory space in Hayward, California, with the lease expiring in June 2025[481](index=481&type=chunk) [Legal Proceedings](index=82&type=section&id=Item%203.%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[523](index=523&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 the symbol "BNTC", and the company has never paid or plans to pay cash dividends, retaining earnings for operations - The company's common stock trades on Nasdaq under the symbol "BNTC"[525](index=525&type=chunk) - Benitec has never paid cash dividends and does not plan to in the foreseeable future, retaining earnings for operations[511](index=511&type=chunk)[538](index=538&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=84&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) The company's net loss increased to **$19.6 million** in FY2023 due to higher R&D expenses, with **$2.5 million** in cash as of June 30, 2023, supplemented by a **$28.6 million** August 2023 offering to fund operations [Results of Operations](index=88&type=section&id=Results%20of%20Operations) The net loss for FY2023 increased to **$19.6 million** from **$18.2 million** in FY2022, primarily driven by a **$1.5 million** rise in research and development expenses for the OPMD program Fiscal Year 2023 vs 2022 Operating Results (in thousands) | Metric | FY 2023 | FY 2022 | | :--- | :--- | :--- | | Revenues from customers | $75 | $73 | | Research and development expenses | $12,774 | $11,272 | | General and administrative expenses | $6,382 | $6,646 | | Loss from operations | ($19,081) | ($17,854) | | Net loss | ($19,562) | ($18,208) | - The increase in research and development expenses in FY2023 was primarily related to the advancement of the OPMD project[846](index=846&type=chunk) - The decrease in general and administrative expenses in FY2023 was mainly due to lower listing and filing fees and reduced stock-based compensation[868](index=868&type=chunk) [Liquidity and Capital Resources](index=90&type=section&id=Liquidity%20and%20Capital%20Resources) The company reported **$2.5 million** in cash as of June 30, 2023, with **$18.0 million** used in operations for FY2023, and subsequently raised **$28.6 million** in August 2023 to fund operations for at least the next twelve months - As of June 30, 2023, the company had cash and cash equivalents of **$2.5 million**[871](index=871&type=chunk) - Net cash used in operating activities increased to **$18.0 million** in FY2023 from **$15.9 million** in FY2022[872](index=872&type=chunk)[873](index=873&type=chunk) - In August 2023, the company raised approximately **$28.6 million** in net proceeds from an underwritten public offering, which is expected to fund operations for at least the next **twelve months**[552](index=552&type=chunk)[861](index=861&type=chunk) [Critical Accounting Policies](index=92&type=section&id=Critical%20Accounting%20Policies) Critical accounting policies, including Research and Development Expenses and Share-Based Compensation, require significant management judgment and estimation, particularly for accruals and valuation models - The company accrues for R&D expenses based on estimates of work completed by third-party service providers, which requires significant judgment[879](index=879&type=chunk)[907](index=907&type=chunk) - Share-based compensation is valued using the Black-Scholes model, an approach that relies on several subjective assumptions[908](index=908&type=chunk) [Financial Statements and Supplementary Data](index=94&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section presents the audited consolidated financial statements for FY2023 and FY2022, with Baker Tilly US, LLP issuing an unqualified opinion while highlighting accrued R&D costs as a critical audit matter - The independent auditor, Baker Tilly US, LLP, issued an unqualified opinion on the financial statements[913](index=913&type=chunk) - The auditor identified Accrued Research and Development Costs as a Critical Audit Matter due to the high degree of judgment and subjectivity involved in management's estimates[916](index=916&type=chunk) Key Financial Data (in thousands) | Metric | As of/For the Year Ended June 30, 2023 | | :--- | :--- | | **Balance Sheet:** | | | Total Assets | $4,464 | | Total Liabilities | $4,262 | | Total Stockholders' Equity | $202 | | **Income Statement:** | | | Net Loss | ($19,562) | | Net Loss Per Share | ($14.12) | [Controls and Procedures](index=92&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of June 30, 2023, and as a non-accelerated filer, the company is exempt from an auditor's attestation on internal controls - Management concluded that the company's disclosure controls and procedures were effective as of June 30, 2023[698](index=698&type=chunk) - The company is a non-accelerated filer and therefore is not required to obtain an auditor's attestation on its internal control over financial reporting[666](index=666&type=chunk) PART III [Directors, Executive Officers and Corporate Governance](index=121&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) The company's five-member Board of Directors, with three independent members serving staggered terms, oversees governance through Audit, Compensation, and Nominating committees and a Code of Ethics - The Board of Directors is composed of **five members**, with **three** determined to be independent[672](index=672&type=chunk)[593](index=593&type=chunk) - The Board is classified, with directors serving staggered **three-year terms**[596](index=596&type=chunk) - The company has established Audit, Compensation, and Nominating and Corporate Governance committees, each composed of independent directors[711](index=711&type=chunk)[712](index=712&type=chunk) [Executive Compensation](index=125&type=section&id=Item%2011.%20Executive%20Compensation) Named Executive Officers' compensation for FY2023, totaling **$645,725** for Dr. Banks and **$352,529** for Ms. Boston, comprised base salary, bonuses, and equity awards FY2023 Summary Compensation Table | Named Executive Officer | Position | Total Compensation ($) | | :--- | :--- | :--- | | Dr. Jerel A. Banks | Executive Chairman & CEO | 645,725 | | Megan Boston | Executive Director | 352,529 | - The compensation program for NEOs consists of base salary, discretionary annual bonuses, and equity incentive awards (stock options)[720](index=720&type=chunk) - In June 2023, the Compensation Committee granted nonqualified stock options to Dr. Banks (**20,994 shares**) and Ms. Boston (**9,000 shares**) under the 2020 Equity and Incentive Compensation Plan[775](index=775&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=132&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) As of August 25, 2023, **four entities** beneficially owned **5%** or more of common stock, with Franklin Resources Inc. being the largest at **23.0%**, while all executive officers and directors collectively owned less than **1%** 5% or Greater Stockholders (as of August 25, 2023) | Name of Beneficial Owner | Percentage of Shares Beneficially Owned | | :--- | :--- | | Entities affiliated with Franklin Resources Inc. | 23.0% | | Entities affiliated with Janus Henderson Group plc | 8.0% | | Entities affiliated with Citadel Securities LLC | 7.0% | | Entities affiliated with Suvretta Capital Management, LLC | 6.5% | - All executive officers and directors as a group beneficially own less than **1%** of the company's outstanding common stock[795](index=795&type=chunk) [Principal Accountant Fees and Services](index=134&type=section&id=Item%2014.%20Principal%20Accountant%20Fees%20and%20Services) Baker Tilly US, LLP, the independent auditor, billed **$345,300** in aggregate fees for FY2023, primarily for audit and audit-related services, all pre-approved by the Audit Committee Accountant Fees (Fiscal Years 2023 & 2022) | Fee Category | 2023 | 2022 | | :--- | :--- | :--- | | Audit Fees | $251,640 | $222,696 | | Audit-Related Fees | $64,800 | $16,200 | | Tax Fees | $28,860 | $65,735 | | **Total** | **$345,300** | **$304,631** | - **100%** of all audit, audit-related, tax, and other services were pre-approved by the Audit Committee[821](index=821&type=chunk) PART IV [Exhibits and Financial Statement Schedules](index=135&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section indexes all exhibits filed with the Annual Report on Form 10-K, including corporate governance documents, securities forms, material contracts, and Sarbanes-Oxley certifications - The report includes a list of exhibits such as the Amended and Restated Certificate of Incorporation, employment agreements with NEOs, the 2020 Equity and Incentive Compensation Plan, and various warrant agreements[682](index=682&type=chunk)[802](index=802&type=chunk)[825](index=825&type=chunk)

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 For the quarterly period ended March 31, 2023 Commission File Number 001-39267 3940 Trust Way, Hayward, California 94545 (Address of principal executive offices & zip code) 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 pe ...

During the year ended June 30, 2021, the Company completed an organization restructuring as part of the commercial desire to provide a more efficient structure for the future as the Company transitioned its operations to the United States. 2. Basis of Presentation and Summary of Significant Accounting Policies Principles of Consolidation Table of Contents There can be no assurance that the Company's research and development will be successfully completed, that adequate protection for the Company's intellect ...

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 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, 2022 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission ...

Table of Contents Emerging Growth Company ☐ 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, 2022 ☐ 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 84-462-0 ...