Full Press Release Details
Benitec Biopharma Releases Third Quarter 2023 Financial Results and Provides Operational Update
9 subjects enrolled into the OPMD clinical development program
HAYWARD, Calif., May 15, 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 Third Fiscal Quarter ended March 31, 2023. The Company has filed its quarterly report on Form 10-Q for the quarter ended March 31, 2023 with the U.S.
Securities and Exchange Commission.
We continue to screen and enroll OPMD subjects into the Natural History Study at the U.S. clinical study site,
and enrollment is proceeding at a rapid pace, said Jerel A. Banks, M.D., Ph.D., Executive Chairman and Chief Executive Officer of Benitec. With 9 subjects enrolled to date, the current pace of enrollment supports our central clinical
development goals of administering BB-301 to OPMD subjects in 2H2023 and disclosing interim safety and efficacy data in 2H2023 for one or more subjects that have received
Dr. Banks continued, We remain focused on opening additional clinical study sites in
Canada and France, pending ongoing discussions with Institutional Review Boards and regional regulators. While those discussions progress, we continue to advance the development of BB-301 in the
United States and expect to receive a response from the U.S. FDA regarding the Investigational New Drug (IND) application for BB-301 in the Second Calendar Quarter of 2023.
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:
Financial Highlights
Third Quarter 2023 Financial Results
quarter ended March 31, 2023, was $54 thousand compared to $48 thousand for the quarter ended March 31, 2022.
Operating expenses for
the quarter ended March 31, 2023, were $4.4 million compared to $3.5 million for the quarter ended March 31, 2022. The Company incurred $3.17 million of research and development expenses compared to $2.17 million for
the comparable quarter ended March 31, 2022. Research and development expenses relate primarily to the OPMD project. The year over year increase in research and development costs for the period relates primarily to the continuation of the GMP
manufacturing project and the Natural History Study. For the quarter ended March 31, 2023, general and administrative expenses were $1.2 million compared to $1.3 million for the quarter ended March 31, 2022. The year over year
decrease for the three-month periods ended March 31 relates to lower listing and filing fees and stock-based compensation.
The loss from operations
for the quarter ended March 31, 2023, was $4.4 million compared to a loss of $3.5 million for the quarter ended March 31, 2022. Net loss attributable to stockholders for the quarter ended March 31, 2023, was
$4.4 million, or $0.16 per basic and diluted share, compared to a net loss of $3.3 million, or $0.40 per basic and diluted share for the quarter ended March 31, 2022. As of March 31, 2023, the Company had $6.6 million in
cash and cash equivalents.
BENITEC BIOPHARMA INC.
Consolidated Balance Sheets
thousands, except par value and share amounts)
| March 31, 2023 | June 30, 2022 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 6,551 | $ | 4,062 | ||||
| Restricted cash | 14 | 14 | ||||||
| Trade and other receivables | 56 | 3 | ||||||
| Prepaid and other assets | 774 | 741 | ||||||
| Total current assets | 7,395 | 4,820 | ||||||
| Property and equipment, net | 106 | 222 | ||||||
| Deposits | 25 | 25 | ||||||
| Other assets | 105 | 135 | ||||||
| Right-of-use assets | 589 | 771 | ||||||
| Total assets | $ | 8,220 | $ | 5,973 | ||||
| Liabilities and stockholders equity | ||||||||
| Current liabilities: | ||||||||
| Trade and other payables | $ | 2,455 | $ | 1,880 | ||||
| Accrued employee benefits | 429 | 400 | ||||||
| Lease liabilities, current portion | 269 | 252 | ||||||
| Total current liabilities | 3,153 | 2,532 | ||||||
| Lease liabilities, less current portion | 354 | 559 | ||||||
| Total liabilities | 3,507 | 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 March 30, 2022 and June 30, 2022, respectively | 3 | 1 | ||||||
| Additional paid-in capital | 168,791 | 152,453 | ||||||
| Accumulated deficit | (163,228 | ) | (148,327 | ) | ||||
| Accumulated other comprehensive loss | (853 | ) | (1,245 | ) | ||||
| Total stockholders equity | 4,713 | 2,882 | ||||||
| Total liabilities and stockholders equity | $ | 8,220 | $ | 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 | Nine Months Ended | |||||||||||||||
| March 31, | March 31, | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| Revenue: | ||||||||||||||||
| Licensing revenues from customers | $ | 54 | $ | 48 | $ | 68 | $ | 73 | ||||||||
| Total revenues | 54 | 48 | 68 | 73 | ||||||||||||
| Operating Expenses | ||||||||||||||||
| Research and development | 3,167 | 2,171 | 9,588 | 8,096 | ||||||||||||
| General and admininstrative | 1,228 | 1,337 | 5,011 | 5,093 | ||||||||||||
| Total operating expenses | 4,395 | 3,508 | 14,599 | 13,189 | ||||||||||||
| Loss from operations | (4,341 | ) | (3,460 | ) | (14,531 | ) | (13,116 | ) | ||||||||
| Other income (loss): | ||||||||||||||||
| Foreign currency transaction gain (loss) | (45 | ) | 229 | (391 | ) | 36 | ||||||||||
| Interest expense, net | (7 | ) | (10 | ) | (25 | ) | (22 | ) | ||||||||
| Other income, net | (29 | ) | 50 | (29 | ) | |||||||||||
| Unrealized loss on investment | (4 | ) | (5 | ) | (4 | ) | (10 | ) | ||||||||
| Total other income (loss), net | (56 | ) | 185 | (370 | ) | (25 | ) | |||||||||
| Net loss | $ | (4,397 | ) | $ | (3,275 | ) | $ | (14,901 | ) | $ | (13,141 | ) | ||||
| Other comprehensive income: | ||||||||||||||||
| Unrealized foreign currency translation gain (loss) | 45 | (233 | ) | 392 | (51 | ) | ||||||||||
| Total other comprehensive income (loss) | 45 | (233 | ) | 392 | (51 | ) | ||||||||||
| Total comprehensive loss | $ | (4,352 | ) | $ | (3,508 | ) | $ | (14,509 | ) | $ | (13,192 | ) | ||||
| Net loss | $ | (4,397 | ) | $ | (3,275 | ) | $ | (14,901 | ) | $ | (13,141 | ) | ||||
| Net loss per share: | ||||||||||||||||
| Basid and diluted | $ | (0.16 | ) | $ | (0.40 | ) | $ | (0.67 | ) | $ | (1.61 | ) | ||||
| Weighted average number of shares outstanding: basic and diluted | 27,981,161 | 8,171,690 | 22,090,191 | 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.
Strategic Communications
Email: wwindham@soleburystrat.com