Full Press Release Details
Benitec Biopharma Releases First Quarter 2023 Financial
Results and Provides Operational Update
HAYWARD, Calif., November 10, 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 First Quarter ended September 30, 2022. The Company has filed its quarterly report on Form 10-Q for the quarter ended September 30, 2022, with the U.S.
Securities and Exchange Commission.
Following the receipt of a favorable decision from the Institutional Review Board of the lead clinical site for
the OPMD Natural History Study in the United States and the formal completion of the Site Initiation Visit at this key clinical enrollment site, the screening of OPMD subjects for enrollment into the OPMD Natural History Study will begin this month.
The initiation of subject screening for the OPMD Natural History Study represents a major milestone for Benitec, and we look forward to enrolling the first subjects into the OPMD Natural History Study this year. The enrollment of subjects into the
OPMD Natural History Study in 2022 continues to support our central clinical development goal of administering the first dose of BB-301 in 2023, said Jerel A. Banks, M.D., Ph.D., Executive Chairman and
Chief Executive Officer of Benitec Biopharma. The Principal Investigator of the OPMD Natural History Study in the United States expects high enrollment interest for this incurable genetic disease with no approved treatments, and we continue to
work with regulators globally to open additional sites in geographies outside of the United States.
The key milestones related to the development of BB-301 for the treatment of Oculopharyngeal Muscular Dystrophy (OPMD),
along with other corporate updates, are outlined below:
BB-301 Clinical Development Program Overview:
Operational and Regulatory Updates for the Clinical Development Program:
BB-301 Phase 1b/2a Regulatory
Financial Highlights
First Quarter 2023 Financial Results
the quarter ended September 30, 2022, were $0 compared to $0 for the quarter ended September 30, 2021.
Total Expenses for the quarter ended
September 30, 2022, were $4.6 million compared to $4.8 million for the quarter ended September 30, 2021. The Company incurred $2.7 million of research and development expenses compared to $2.8 million for the comparable
quarter ended September 30, 2021. Research and development expenses relate primarily to the OPMD project. The Company continued with the GMP manufacturing project after concluding the BB-301 Regulatory
Toxicology Study and the Parallel Assay Method Development, Qualification, and Validation project. For the quarter ended September 30, 2022, general and administrative expenses were $1.9 million compared to $2.0 million for the
quarter ended September 30, 2021. The decrease was due to the decrease in salaries and wages, insurance, state and local taxes.
operations for the quarter ended September 30, 2022, was $4.6 million compared to a loss of $4.8 million for the quarter ended September 30, 2021. Net loss attributable to shareholders for the quarter ended September 30,
2022, was $5.1 million, or $0.47 per basic and diluted share, compared to a net loss of $5.0 million, or $0.62 per basic and diluted share for the quarter ended September 30, 2021. As of September 30, 2022, the Company had
$16.5 million in cash and cash equivalents.
BENITEC BIOPHARMA INC.
Consolidated Balance Sheets
thousands, except par value and share amounts)
| September 30, 2022 | June 30, 2022 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 16,534 | $ | 4,062 | ||||
| Restricted cash | 13 | 14 | ||||||
| Trade and other receivables | 3 | 3 | ||||||
| Prepaid and other assets | 531 | 741 | ||||||
| Total current assets | 17,081 | 4,820 | ||||||
| Property and equipment, net | 179 | 222 | ||||||
| Deposits | 25 | 25 | ||||||
| Other assets | 119 | 135 | ||||||
| Right-of-use assets | 711 | 771 | ||||||
| Total assets | $ | 18,115 | $ | 5,973 | ||||
| Liabilities and stockholders equity | ||||||||
| Current liabilities: | ||||||||
| Trade and other payables | $ | 2,368 | $ | 1,880 | ||||
| Accrued employee benefits | 385 | 400 | ||||||
| Lease liabilities, current portion | 258 | 252 | ||||||
| Total current liabilities | 3,011 | 2,532 | ||||||
| Lease liabilities, less current portion | 491 | 559 | ||||||
| Total liabilities | 3,502 | 3,091 | ||||||
| Commitments and contingencies (Note 10) | ||||||||
| Stockholders equity: | ||||||||
| Common stock, $0.0001 par value-40,000,000 shares authorized; 25,809,533 shares and 8,171,690 shares issued and outstanding at September 30, 2022 and June 30, 2022, respectively | 3 | 1 | ||||||
| Additional paid-in capital | 168,768 | 152,453 | ||||||
| Accumulated deficit | (153,420 | ) | (148,327 | ) | ||||
| Accumulated other comprehensive loss | (738 | ) | (1,245 | ) | ||||
| Total stockholders equity | 14,613 | 2,882 | ||||||
| Total liabilities and stockholders equity | $ | 18,115 | $ | 5,973 |
BENITEC BIOPHARMA INC.
Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except
share and per share amounts)
| Three months Ended September 30 | ||||||||
| 2022 | 2021 | |||||||
| Revenue: | ||||||||
| Licensing revenues from customers | ||||||||
| Total revenues | $ | $ | ||||||
| Operating expenses | ||||||||
| Research and development | 2,660 | 2,780 | ||||||
| General and administrative | 1,920 | 2,042 | ||||||
| Total operating expenses | 4,580 | 4,822 | ||||||
| Loss from operations | (4,580 | ) | (4,822 | ) | ||||
| Other income (loss): | ||||||||
| Foreign currency transaction loss | (507 | ) | (240 | ) | ||||
| Interest expense, net | (9 | ) | (1 | ) | ||||
| Unrealized gain on investment | 3 | 18 | ||||||
| Total other income (loss), net | (513 | ) | (223 | ) | ||||
| Net loss | $ | (5,093 | ) | $ | (5,045 | ) | ||
| Other comprehensive income: | ||||||||
| Unrealized foreign currency translation gain | 507 | 239 | ||||||
| Total other comprehensive income | 507 | 239 | ||||||
| Total comprehensive loss | $ | (4,586 | ) | $ | (4,806 | ) | ||
| Net loss | $ | (5,093 | ) | $ | (5,045 | ) | ||
| Net loss per share: basic and diluted | $ | (0.47 | ) | $ | (0.62 | ) | ||
| Weighted average number of shares outstanding: basic and diluted | 10,855,710 | 8,171,690 |
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; given market conditions and other factors,
including our capital structure; our ability to continue as a going concern; the length of time over which the Company expects its cash and cash equivalents to be sufficient to execute on its business plan; 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:
VP, Solebury Strategic Communications
Email: wwindham@soleburystrat.com