Full Press Release Details
Benitec Biopharma Releases Second Quarter 2023 Financial Results and Provides Operational Update
First subject enrolled into the OPMD clinical development program
HAYWARD, Calif., February 13, 2023 Benitec Biopharma Inc. (NASDAQ: BNTC)
( Benitec or 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 Second Fiscal Quarter ended December 31, 2022. The Company has filed its quarterly report on Form 10-Q for the quarter ended
December 31, 2022 with the U.S. Securities and Exchange Commission.
In January, we were excited to announce the enrollment of the first OPMD
patient into the natural history phase of the BB-301 development program, and the screening process has continued at a rapid pace. The enrollment of the first patient supports our central clinical development
goal of administering the first dose of BB-301 and reporting interim clinical results in 2023, said Jerel A. Banks, M.D., Ph.D., Executive Chairman and Chief Executive Officer of Benitec.
Dr. Banks continued, The OPMD Natural History (NH) Study represents the 6-month pre-treatment observation period for each OPMD subject prior to the administration of BB-301 for the treatment of OPMD-related dysphagia. Upon the completion of 6-months of radiographic and clinical assessments required for the NH Study, participants will be eligible for enrollment into the BB-301 Phase 1b/2a treatment study in which BB-301 will be administered.
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:
Regulatory Updates for the Clinical Development Program:
Second Quarter 2023 Financial Results
Revenue for the quarter ended December 31, 2022, was $14,000 compared to $25,000 for the quarter ended December 31, 2021.
Operating expenses for the quarter ended December 31, 2022, were $5.6 million compared to $4.9 million for the quarter ended December 31,
2021. The Company incurred $3.8 million of research and development expenses compared to $3.1 million for the comparable quarter ended December 31, 2021. Research and development expenses relate primarily to the OPMD project. The
year-over-year increases for the six-month period reflect conclusion of the BB-301 Regulatory Toxicology Study and the Parallel Assay Method Development, Qualification,
and Validation project, and the continuation of the GMP manufacturing project and Natural History Study. For the quarter ended December 31, 2022, general and administrative expenses were $1.9 million compared to $1.7 million for the
quarter ended December 31, 2021. The year-over-year increase for the three-month periods ended December 31 relates to higher bonuses and legal fees, partially offset by lower listing and filing fees and stock-based compensation.
The loss from operations for the quarter ended December 31, 2022, was $5.6 million compared to a
loss of $4.8 million for the quarter ended December 31, 2021. Net loss attributable to stockholders for the quarter ended December 31, 2022, was $5.4 million, or $0.20 per basic and diluted share, compared to a net loss of
$4.8 million, or $0.59 per basic and diluted share for the quarter ended December 31, 2021. As of December 31, 2022, the Company had $10.5 million in cash and cash equivalents.
BENITEC BIOPHARMA INC.
Consolidated Balance Sheets
thousands, except par value and share amounts)
| December 31, 2022 | June 30, 2022 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 10,537 | $ | 4,062 | ||||
| Restricted cash | 14 | 14 | ||||||
| Trade and other receivables | 68 | 3 | ||||||
| Prepaid and other assets | 356 | 741 | ||||||
| Total current assets | 10,975 | 4,820 | ||||||
| Property and equipment, net | 139 | 222 | ||||||
| Deposits | 25 | 25 | ||||||
| Other assets | 116 | 135 | ||||||
| Right-of-use assets | 650 | 771 | ||||||
| Total assets | $ | 11,905 | $ | 5,973 | ||||
| Liabilities and stockholders equity | ||||||||
| Current liabilities: | ||||||||
| Trade and other payables | $ | 1,830 | $ | 1,880 | ||||
| Accrued employee benefits | 396 | 400 | ||||||
| Lease liabilities, current portion | 263 | 252 | ||||||
| Total current liabilities | 2,489 | 2,532 | ||||||
| Lease liabilities, less current portion | 422 | 559 | ||||||
| Total liabilities | 2,911 | 3,091 | ||||||
| Commitments and contingencies (Note 11) | ||||||||
| Stockholders equity: | ||||||||
| Common stock, $0.0001 par value-160,000,000 shares authorized; 27,981,161 shares and 8,171,690 shares issued and outstanding at December 31, 2022 and June 30, 2022, respectively | 3 | 1 | ||||||
| Additional paid-in capital | 168,720 | 152,453 | ||||||
| Accumulated deficit | (158,831 | ) | (148,327 | ) | ||||
| Accumulated other comprehensive loss | (898 | ) | (1,245 | ) | ||||
| Total stockholders equity | 8,994 | 2,882 | ||||||
| Total liabilities and stockholders equity | $ | 11,905 | $ | 5,973 |
The accompanying notes are an integral part of these consolidated financial statements
BENITEC BIOPHARMA INC.
Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except
share and per share amounts)
| Three Months Ended | Six Months Ended | |||||||||||||||
| December 31, | December 31, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Revenue: | ||||||||||||||||
| Licensing revenues from customers | $ | 14 | $ | 25 | $ | 14 | $ | 25 | ||||||||
| Total revenues | 14 | 25 | 14 | 25 | ||||||||||||
| Operating Expenses | ||||||||||||||||
| Research and development | 3,761 | 3,146 | 6,421 | 5,926 | ||||||||||||
| General and admininstrative | 1,863 | 1,714 | 3,783 | 3,756 | ||||||||||||
| Total operating expenses | 5,624 | 4,860 | 10,204 | 9,682 | ||||||||||||
| Loss from operations | (5,610 | ) | (4,835 | ) | (10,190 | ) | (9,657 | ) | ||||||||
| Other income (loss): | ||||||||||||||||
| Foreign currency transaction gain (loss) | 161 | 48 | (346 | ) | (193 | ) | ||||||||||
| Interest expense, net | (9 | ) | (11 | ) | (18 | ) | (12 | ) | ||||||||
| Other income, net | 50 | 50 | ||||||||||||||
| Unrealized loss on investment | (3 | ) | (23 | ) | (5 | ) | ||||||||||
| Total other income (loss), net | 199 | 14 | (314 | ) | (210 | ) | ||||||||||
| Net loss | $ | (5,411 | ) | $ | (4,821 | ) | $ | (10,504 | ) | $ | (9,867 | ) | ||||
| Other comprehensive income: | ||||||||||||||||
| Unrealized foreign currency translation (loss) gain | (160 | ) | (57 | ) | 347 | 182 | ||||||||||
| Total other comprehensive (loss) income | (160 | ) | (57 | ) | 347 | 182 | ||||||||||
| Total comprehensive loss | $ | (5,571 | ) | $ | (4,878 | ) | $ | (10,157 | ) | $ | (9,685 | ) | ||||
| Net loss | $ | (5,411 | ) | $ | (4,821 | ) | $ | (10,504 | ) | $ | (9,867 | ) | ||||
| Net loss per share: | ||||||||||||||||
| Basid and diluted | $ | (0.20 | ) | $ | (0.59 | ) | $ | (0.55 | ) | $ | (1.21 | ) | ||||
| Weighted average number of shares outstanding: basic and diluted | 27,561,766 | 8,171,690 | 19,208,738 | 8,171,690 |
The accompanying notes are an integral part of these consolidated financial statements.
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