Revenue and Sales - In the fiscal year ended June 30, 2024, the company generated no revenues from product sales, compared to $75 thousand in the fiscal year ended June 30, 2023, indicating a decrease in licensing revenue [373][374]. - The Company has not generated any revenue from product sales and does not expect to do so until regulatory approval is obtained for its product candidates [389]. - The company reported no revenues from customers for the year ended June 30, 2024, down from $75,000 in the previous year [419]. - The company recognized no licensing revenue for the fiscal year ended June 30, 2024, as performance obligations were not satisfied [467]. Financial Performance - The company incurred net losses of $21.8 million and $19.6 million for the years ended June 30, 2024, and 2023, respectively, with cumulative losses reaching $190.3 million as of June 30, 2024 [383]. - The net loss for the year ended June 30, 2024, was $21,751,000, compared to a net loss of $19,562,000 in 2023, reflecting a 11% increase in losses [419]. - The company anticipates continued losses as it develops product candidates, with expected losses increasing as commercialization efforts begin [390]. - The company has not established a source of revenue to cover its full operating costs and is dependent on capital financing activities [464]. Expenses - Research and development expenses for the year ended June 30, 2024, were $15.6 million, up from $12.8 million in the previous year, primarily due to ongoing clinical development of BB-301 for OPMD [380][381]. - Total expenses for the year ended June 30, 2024, were $22.5 million, compared to $19.2 million for the year ended June 30, 2023, reflecting increased research and development and general administrative costs [380][381]. - Total operating expenses rose to $22,490,000 in 2024, an increase of 17% from $19,156,000 in 2023 [419]. - The company anticipates an increase in general and administrative expenses as it continues to develop its clinical programs and comply with regulatory requirements [378]. Cash and Financing - As of June 30, 2024, the company had cash and cash equivalents of $50.9 million, with net cash used in operating activities amounting to $19.4 million for the year [384][385]. - Net cash provided by financing activities was $68.0 million for the year ended June 30, 2024, significantly higher than $16.0 million for the previous year, driven by capital raises [387]. - The company completed an underwritten public offering in August 2023, raising gross proceeds of approximately $30.9 million, and another in April 2024, raising approximately $40.0 million [371][372]. - The Company closed a private investment in public equity (PIPE) financing on April 22, 2024, resulting in net proceeds of $37.1 million [388]. Assets and Equity - Total current assets increased significantly to $51,674,000 as of June 30, 2024, compared to $3,729,000 in the previous year, representing a growth of 1,284% [417]. - Total stockholders' equity increased to $47,248,000 as of June 30, 2024, from $202,000 in the previous year, indicating a significant rise in equity [418]. - Cash and cash equivalents at the end of the year were $50,866,000, a substantial increase from $2,477,000 in the previous year, marking a growth of 1,952% [421]. Research and Development - BB-301, a silence and replace-based genetic medicine, is under development for the treatment of Oculopharyngeal Muscular Dystrophy (OPMD) and has received Orphan Drug Designation in the U.S. and EU [364]. - Research and development expenses increased to $15,609,000 in 2024, up from $12,774,000 in 2023, representing a growth of 22% [419]. - Research and development expenses primarily relate to clinical and pre-clinical trials, with accrued liabilities recorded for estimated costs [455][456]. Accounting and Compliance - The Company adopted ASU 2016-13 effective July 1, 2023, which requires immediate recognition of expected credit losses, with an immaterial impact on financial statements [402]. - The Company is evaluating the impact of recently issued accounting standards on its disclosures, including ASU No. 2023-09 and ASU No. 2023-07 [404]. - The Company adopted ASC 326 for estimating expected credit losses on trade and other receivables starting July 1, 2023 [443]. - The company’s financial statements are prepared in accordance with US GAAP and reflect the historical results of BBL and its subsidiaries [428]. Stock and Warrants - A 1-for-17 reverse stock split was executed on July 26, 2023, affecting the number of outstanding shares and stock options [427]. - The company had 1,182,140 stock options outstanding as of June 30, 2024, with a weighted average exercise price of $6.58 [488]. - The weighted-average grant-date fair value of stock options granted during the fiscal year ended June 30, 2024, was $4.39, compared to $3.34 for the fiscal year ended June 30, 2023 [489]. - The exercise price of the Series 2 Warrants was adjusted from $11.22 to $1.9299 due to a public offering on August 11, 2023, resulting in a deemed dividend of $618,987 [505]. Risks and Challenges - The company is subject to risks typical of early-stage biotechnology firms, including competition and regulatory approval challenges [434]. - Future funding requirements will depend on various factors, including clinical trial costs and regulatory approval timelines [391].

Core Insights - Benitec Biopharma Inc. reported positive interim clinical trial data for its gene therapy BB-301 targeting Oculopharyngeal Muscular Dystrophy (OPMD), showing significant improvements in swallowing efficiency in subjects [2][5][6] - The company successfully closed an oversubscribed private placement financing of $40 million, extending its cash runway through 2025 [1][9] - The second subject was dosed in February 2024, with a third subject expected to be dosed in Q4 2024 [1][7] Clinical Trial Results - The 90-day and 180-day interim results from the Phase 1b/2a clinical study indicated clinically meaningful improvements in key assessments, including Total Pharyngeal Residue (TPR) and the Sydney Swallow Questionnaire (SSQ) [2][4][5] - At the 90-day post-dose assessment, Subject 1 showed improvements in VFSS assessments and SSQ scores, indicating enhanced swallowing function [4][6] - At the 180-day post-dose assessment, TPR values remained significantly reduced compared to pre-dose averages, and SSQ scores continued to decline, reflecting ongoing improvements in swallowing ability [5][6] Safety and Tolerability - The safety profile of BB-301 has been favorable, with only transient Grade 2 Gastroesophageal Reflux Disease (GERD) reported, and no Serious Adverse Events (SAEs) observed in the subjects dosed so far [8] Financial Highlights - For the fiscal year ending June 30, 2024, total revenues were reported at $0 million, a decrease from $75,000 in the previous year [12] - Total expenses increased to $22.5 million from $19.2 million year-over-year, with R&D expenses rising to $15.6 million from $12.8 million [13][14] - The net loss attributable to shareholders for the year was $22.4 million, or $5.51 per share, compared to a net loss of $19.6 million, or $14.12 per share, in the prior year [15] Corporate Updates - The company appointed Kishen Mehta to its board of directors following the successful PIPE financing [9] - Benitec's proprietary "Silence and Replace" platform is designed to treat chronic conditions like OPMD by silencing disease-causing genes while delivering functional replacement genes [17]

Core Insights - Benitec Biopharma Inc. announced that a Late Breaking Abstract on its gene therapy BB-301 has been accepted for oral presentation at the 29th Annual Congress of the World Muscle Society in Prague from October 8-12, 2024 [1] Group 1: Company Overview - Benitec Biopharma Inc. is a clinical-stage biotechnology company focused on developing novel genetic medicines using its proprietary "Silence and Replace" DNA-directed RNA interference platform [6] - The company is headquartered in Hayward, California, and aims to create therapeutics for chronic and life-threatening conditions, including Oculopharyngeal Muscular Dystrophy (OPMD) [6] Group 2: Product Information - BB-301 is a modified AAV9 capsid gene therapy designed to co-express a functional version of the Poly-A Binding Protein Nuclear-1 (PABPN1) and two small inhibitory RNAs (siRNAs) targeting the mutant PABPN1 [5] - The mechanism of BB-301 aims to silence the expression of the faulty mutant PABPN1 while providing a functional replacement, positioning it uniquely for treating OPMD [5] Group 3: Disease Context - Oculopharyngeal Muscular Dystrophy (OPMD) is a rare, progressive muscle-wasting disease caused by mutations in the PABPN1 gene, leading to severe swallowing difficulties and other debilitating symptoms [4] - Currently, there are no effective drug therapies for OPMD, and existing clinical and surgical interventions are limited in their effectiveness [4]

-The post-dose average values for Total Pharyngeal Residue (i.e., the amount of solid food or liquid material remaining in the pharynx after the first swallow) remained meaningfully reduced at the 180-day post-dose assessment following the administration of the low dose of gene therapy BB-301 as compared to the pre-dose average values recorded for Subject 1 during the OPMD Natural History Study- -Critically, for three of the four food types evaluated during the radiographic swallowing study assessments for ...

-Key Opinion Leaders participating in the recent BB-301 Research and Development Day webcast (April 2024) highlighted radiographic swallowing study assessments of Total Pharyngeal Residue and the Subject-Reported Outcome SSQ Total Score as the central markers of value for the long-term evaluation of clinically meaningful improvement in subjects diagnosed with OPMD- The post-dose average values for TPR remained meaningfully reduced (i.e., smaller amounts of solid food and liquid material remained in the phar ...

Table of Contents As filed with the Securities and Exchange Commission on May 15, 2024 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Benitec Biopharma Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2834 84-462-0206 (Primary Standard Industrial Classification Code Number) Approximate date of commencement of propos ...

-Positive Interim Clinical Trial Data for the First Oculopharyngeal Muscular Dystrophy (OPMD) Subject Dosed with BB-301 in the Phase 1b/2a Clinical Treatment Study Reported in April- -The Second OPMD Subject was Safely Dosed with BB-301 in February- -Additional Interim Clinical Safety Data and Clinical Efficacy Data are Expected for Several Study Subjects in the Second Half of 2024- -23 OPMD Subjects have Enrolled into the OPMD Natural History Study with Multiple Subjects Eligible for Entry into the BB-301 ...

Exhibit 99.1 -Positive Interim Clinical Trial Data for the First Oculopharyngeal Muscular Dystrophy (OPMD) Subject Dosed with BB-301 in the Phase 1b/2a Clinical Treatment Study Reported in April- -Additional Interim Clinical Safety Data and Clinical Ef icacy Data are Expected for Several Study Subjects in the Second Half of 2024- HAYWARD, Calif., May 13, 2024 (GLOBE NEWSWIRE) — Benitec Biopharma Inc. (NASDAQ: BNTC) ("Benitec" or "Company"), a clinical-stage, gene therapy-focused, biotechnology company devel ...

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 ...