Benitec Biopharma(BNTC) - 2022 Q3 - Quarterly Report

PART I—FINANCIAL INFORMATION Financial Statements 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 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 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 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 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 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] - 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] - In December 2021, stockholders approved an increase in authorized shares of common stock from 10,000,000 to 40,000,000[88] Management's Discussion and Analysis of Financial Condition and Results of Operations 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 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][106] - 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] - 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][126][127] Results of Operations 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] Liquidity and Capital Resources 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] - 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] 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 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][165] - 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] Quantitative and Qualitative Disclosures About Market Risk 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] Controls and Procedures 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] - 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] PART II—OTHER INFORMATION Legal Proceedings 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] Risk Factors 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] Unregistered Sales of Equity Securities and Use of Proceeds No unregistered sales of equity securities or use of proceeds were reported for the period - None[178] Defaults Upon Senior Securities No defaults upon senior securities were reported - None[179] Mine Safety Disclosures Mine safety disclosures are not applicable to the company - None[180] Other Information No other information was reported for the period - None[181] Exhibits 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][183]