Benitec Biopharma(US:BNTC)2024-09-26 20:30Revenue 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].