Full Press Release Details
Benitec Biopharma Releases Q3 2022 Financial Results
HAYWARD, Calif., May 16, 2022 Benitec Biopharma Inc. (NASDAQ: BNTC) ( Benitec or the Company ), a
development-stage, gene therapy-focused, biotechnology company developing novel genetic medicines based on its proprietary DNA-directed RNA interference ( ddRNAi ) platform, today announced financial
results for its Fiscal Year Q3 ended March 31, 2022. The Company has filed its quarterly report on Form 10-Q for the quarter ended March 31, 2022, with the U.S. Securities and Exchange Commission.
With our key submission to the Central Ethics Committee in France completed in April, we are well-positioned to begin the clinical development
program this year, said Jerel A. Banks, M.D., Ph.D., Executive Chairman and Chief Executive Officer of Benitec Biopharma. The Benitec team remains committed to initiating the clinical development program for BB-301 and improving the lives of patients suffering from OPMD.
The key milestones related to the investigational agent under development by the Company and other corporate updates are outlined below:
BB-301 Clinical Development Program Overview:
Operational and Regulatory Updates for the Clinical Development Program in France:
Operational and Regulatory Updates for the Clinical Development Program in North America:
Trial Application (CTA) and Investigational New Drug (IND) Application Filing Timelines and Phase 1b/2a Treatment Study Initiation:
Financial Highlights
the three months ended March 31, 2022 were $48 thousand compared to $1 thousand in total revenue for three months ended March 31, 2021. The increase in revenues from customers is due to the increase in licensing revenue in the
Total Operating Expenses were $3.5 million for the quarter ended March 31, 2022 compared to $3.79 million for the
comparable period in 2021. For the three months ended March 31, 2022, Benitec did not incurr any royalties and license fees, compared to $7 thousand for the three months ended March 31, 2021. During the three months ended
March 31, 2022, the Company incurred $2.17 million in research and development expenses, compared to $2.75 million for the three months ended March 31, 2021. The decrease in research and development expenses is primarily related
to the BB-301 Regulatory Toxicology Study in Beagles at Charles River Laboratories in Evreux, France. As milestones were reached, the Company began incurring lower costs related to the execution of two large
nonclinical studies in Beagles, along with the commercial-scale GMP-grade manufacturing of BB-301, all of which are required to facilitate the CTA filing and the IND
filing for BB-301. For the three months ended March 31, 2022, general and administrative expenses were $1.3 million compared to $1 million for the three months ended March 31, 2021. The
increase during this period was due to increases in insurance, consultants, legal and accounting fees, and share-based compensation.
BENITEC BIOPHARMA INC.
Consolidated Balance Sheets
thousands, except par value and share amounts)
| March 31, 2022 | June 30, 2021 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 8,630 | $ | 19,769 | ||||
| Trade and other receivables | 5 | 25 | ||||||
| Prepaid and other assets | 206 | 814 | ||||||
| Total current assets | 8,841 | 20,608 | ||||||
| Property and equipment, net | 214 | 375 | ||||||
| Deposits | 25 | 9 | ||||||
| Other assets | 156 | 185 | ||||||
| Right-of-use assets | 828 | 202 | ||||||
| Total assets | $ | 10,064 | $ | 21,379 | ||||
| Liabilities and Stockholders Equity | ||||||||
| Current liabilities: | ||||||||
| Trade and other payables | $ | 1,320 | $ | 880 | ||||
| Accrued employee benefits | 357 | 276 | ||||||
| Lease liabilities, current portion | 232 | 213 | ||||||
| Total current liabilities | 1,909 | 1,369 | ||||||
| Lease liabilities, less current portion | 635 | |||||||
| Total liabilities | 2,544 | 1,369 | ||||||
| Commitments and contingencies (Note 10) | ||||||||
| Stockholders equity: | ||||||||
| Common stock, $0.0001 par value-40,000,000 shares authorized; 8,171,690 shares issued and outstanding at March 31, 2022 and June 30, 2021 | 1 | 1 | ||||||
| Additional paid-in capital | 152,285 | 151,583 | ||||||
| Accumulated deficit | (143,260 | ) | (130,119 | ) | ||||
| Accumulated other comprehensive loss | (1,506 | ) | (1,455 | ) | ||||
| Total stockholder equity | 7,520 | 20,010 | ||||||
| Total liabilities and stockholders equity | $ | 10,064 | $ | 21,379 |
BENITEC BIOPHARMA INC.
Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except
share and per share amounts)
| Three Months Ended March 31, | Nine Months Ended March 31, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Revenue: | ||||||||||||||||
| Licensing revenues from customers | $ | 48 | $ | 1 | $ | 73 | $ | 57 | ||||||||
| Total revenues | 48 | 1 | 73 | 57 | ||||||||||||
| Operating expenses | ||||||||||||||||
| Royalties and license fees | 7 | 122 | ||||||||||||||
| Research and development | 2,171 | 2,758 | 8,096 | 4,700 | ||||||||||||
| General and administrative | 1,337 | 1,029 | 5,093 | 4,976 | ||||||||||||
| Total operating expenses | 3,508 | 3,794 | 13,189 | 9,798 | ||||||||||||
| Loss from operations | (3,460 | ) | (3,793 | ) | (13,116 | ) | (9,741 | ) | ||||||||
| Other income (loss): | ||||||||||||||||
| Foreign currency transaction gain (loss) | 229 | (112 | ) | 36 | (167 | ) | ||||||||||
| Interest expense, net | (10 | ) | (2 | ) | (22 | ) | (5 | ) | ||||||||
| Other income (expense), net | (29 | ) | (29 | ) | 37 | |||||||||||
| Unrealized loss on investment | (5 | ) | (2 | ) | (10 | ) | (3 | ) | ||||||||
| Total other income (loss), net | 185 | (116 | ) | (25 | ) | (138 | ) | |||||||||
| Net loss | $ | (3,275 | ) | $ | (3,909 | ) | $ | (13,141 | ) | $ | (9,879 | ) | ||||
| Other comprehensive income: | ||||||||||||||||
| Unrealized foreign currency translation (loss) gain | (233 | ) | (24 | ) | (51 | ) | 362 | |||||||||
| Total other comprehensive (loss) income | (233 | ) | (24 | ) | (51 | ) | 362 | |||||||||
| Total comprehensive loss | $ | (3,508 | ) | $ | (3,933 | ) | $ | (13,192 | ) | $ | (9,517 | ) | ||||
| Net loss | $ | (3,275 | ) | $ | (3,909 | ) | $ | (13,141 | ) | $ | (9,879 | ) | ||||
| Net loss per share: | ||||||||||||||||
| Basic and diluted | $ | (0.40 | ) | $ | (0.82 | ) | $ | (1.61 | ) | $ | (2.93 | ) | ||||
| Weighted average number of shares outstanding: basic and diluted | 8,171,690 | 4,747,059 | 8,171,690 | 3,375,228 |
About Benitec Biopharma Inc.
Benitec Biopharma Inc. ( Benitec or the Company ) is a development-stage biotechnology company focused on the advancement of novel
genetic medicines with headquarters in Hayward, California. The proprietary platform, called DNA-directed RNA interference, or ddRNAi, combines RNA interference, or RNAi, with gene therapy to create medicines
that facilitate sustained silencing of disease-causing genes following a single administration. The Company is developing ddRNAi-based therapeutics for chronic and life-threatening human conditions including Oculopharyngeal Muscular Dystrophy
(OPMD). A comprehensive overview of the Company can be found on Benitec s website at www.benitec.com.
Forward Looking Statements
Except for the historical information set forth herein, the matters set forth in this press release include forward-looking statements, including statements
regarding Benitec s plans to develop and commercialize its product candidates, the timing of the initiation and completion of pre-clinical and clinical trials, the timing of patient enrolment and dosing
in clinical trials, the timing of expected regulatory filings, the clinical utility and potential attributes and benefits of ddRNAi and Benitec s product candidates, potential future out-licenses and
collaborations, the intellectual property position and the ability to procure additional sources of financing, and other forward-looking statements.
These forward-looking statements are based on the Company s current expectations and subject to risks and uncertainties that may cause actual results to
differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory
standards or warrant continued
development; the ability to enroll sufficient numbers of subjects in clinical trials; determinations made by the FDA and other governmental authorities; the Company s ability to protect and
enforce its patents and other intellectual property rights; the Company s dependence on its relationships with its collaboration partners and other third parties; the efficacy or safety of the Company s products and the products of the
Company s collaboration partners; the acceptance of the Company s products and the products of the Company s collaboration partners in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements;
greater than expected expenses; expenses relating to litigation or strategic activities; the Company s ability to satisfy its capital needs through increasing its revenue and obtaining additional financing; the impact of the current COVID-19 pandemic, the disease caused by the SARS-CoV-2 virus, which may adversely impact the Company s business and pre-clinical and future clinical trials; the impact of local, regional, and national and international economic conditions and events; and other risks detailed from time to time in the Company s reports filed
with the Securities and Exchange Commission. The Company disclaims any intent or obligation to update these forward-looking statements.
Investor Relations Contact:
Email: wwindham@soleburytrout.com