Full Press Release Details
Benitec Biopharma Releases First Quarter 2024 Financial Results and Provides Operational Update
19 subjects enrolled in the OPMD Natural History Study, with multiple subjects entering the eligibility period this year for entry into the BB-301 Phase 1b/2a Clinical Treatment Study
HAYWARD, Calif., November 13,
2023 Benitec Biopharma Inc. (NASDAQ: BNTC) ( Benitec or Company ), a clinical-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 First Fiscal Quarter ended September 30, 2023. The Company has filed its quarterly report on Form 10-Q for the quarter ended September 30, 2023, with the U.S. Securities and Exchange Commission.
receipt of FDA clearance for the BB-301 IND application this year and the pace of enrollment into the OPMD Natural History Study continuing to exceed our expectations, we are well positioned to begin the
evaluation of BB-301 in subjects diagnosed with Oculopharyngeal Muscular Dystrophy, said Jerel A. Banks, M.D., Ph.D., Executive Chairman and Chief Executive Officer of Benitec. The Principal
Investigator and the clinical team at the U.S. clinical trial site are finalizing the plan to dose the first study subject with BB-301 in December 2023 or January 2024. The strong interest from members of the
Oculopharyngeal Muscular Dystrophy community, and the exceptional clinical trial execution by the U.S. clinical trial site, will support the generation of robust safety and efficacy data for BB-301 over the
The key milestones related to the development of BB-301 for the treatment of Oculopharyngeal Muscular Dystrophy
(OPMD)-related Dysphagia, along with other corporate updates, are outlined below:
Development Program Overview:
Regulatory Updates for
the Clinical Development Program:
Financial Highlights
First Quarter 2024 Financial Results
the quarter ended September 30, 2023, were $0 compared to $0 for the quarter ended September 30, 2022.
Total Expenses for the quarter ended
September 30, 2023 were $5.9 million compared to $4.6 million for the quarter ended September 30, 2022. For the quarter ended September 30, 2023, the Company received royalties and license fee credits of $106 thousand
compared to $0 for the three months ended September 30, 2022. The credit to expense during the quarter ended September 30, 2023, reflects the reversal of an accrual for license fees no longer due. The Company incurred $4.4 million of
research and development expenses compared to $2.7 million for the comparable quarter ended September 30, 2022. Research and development expenses relate primarily to ongoing clinical development of
BB-301 for the treatment of OPMD. General and administrative expenses were $1.6 million compared to $1.9 million for the quarter ended September 30, 2022.
The loss from operations for the quarter ended September 30, 2023, was $5.9 million compared to a
loss of $4.6 million for the quarter ended September 30, 2022. Net loss attributable to shareholders for the quarter ended September 30, 2023, was $6 million, or $2.76 per basic and diluted share, compared to a net loss of
$5.1 million, or $7.98 per basic and diluted share for the quarter ended September 30, 2022. As of September 30, 2023, the Company had $25.9 million in cash and cash equivalents.
BENITEC BIOPHARMA INC.
Consolidated Balance Sheets
thousands, except par value and share amounts)
| September 30, 2023 | June 30, 2023 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 25,864 | $ | 2,477 | ||||
| Restricted cash | 13 | 13 | ||||||
| Trade and other receivables | 53 | 55 | ||||||
| Prepaid and other assets | 482 | 1,184 | ||||||
| Total current assets | 26,412 | 3,729 | ||||||
| Property and equipment, net | 68 | 87 | ||||||
| Deposits | 25 | 25 | ||||||
| Prepaid and other assets | 85 | 97 | ||||||
| Right-of-use assets | 463 | 526 | ||||||
| Total assets | $ | 27,053 | $ | 4,464 | ||||
| Liabilities and stockholders equity | ||||||||
| Current liabilities: | ||||||||
| Trade and other payables | $ | 3,794 | $ | 3,231 | ||||
| Accrued employee benefits | 460 | 472 | ||||||
| Lease liabilities, current portion | 280 | 275 | ||||||
| Total current liabilities | 4,534 | 3,978 | ||||||
| Lease liabilities, less current portion | 211 | 284 | ||||||
| Total liabilities | 4,745 | 4,262 | ||||||
| Commitments and contingencies (Note 10) | ||||||||
| Stockholders equity: | ||||||||
| Common stock, $0.0001 par value-160,000,000 shares authorized; 2,547,434 shares and 1,671,485 shares issued and outstanding at September 30, 2023 and June 30, 2023, respectively | ||||||||
| Additional paid-in capital | 196,931 | 168,921 | ||||||
| Accumulated deficit | (173,843 | ) | (167,889 | ) | ||||
| Accumulated other comprehensive loss | (780 | ) | (830 | ) | ||||
| Total stockholders equity | 22,308 | 202 | ||||||
| Total liabilities and stockholders equity | $ | 27,053 | $ | 4,464 |
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 September 30, | ||||||||
| 2023 | 2022 | |||||||
| Revenue: | ||||||||
| Licensing revenues from customers | ||||||||
| Total revenues | $ | $ | ||||||
| Operating expenses: | ||||||||
| Royalties and license fees | (106 | ) | ||||||
| Research and development | 4,429 | 2,660 | ||||||
| General and administrative | 1,551 | 1,920 | ||||||
| Total operating expenses | 5,874 | 4,580 | ||||||
| Loss from operations | (5,874 | ) | (4,580 | ) | ||||
| Other income (loss): | ||||||||
| Foreign currency transaction loss | (56 | ) | (507 | ) | ||||
| Interest expense, net | (6 | ) | (9 | ) | ||||
| Other expense, net | (18 | ) | ||||||
| Unrealized gain on investment | 3 | |||||||
| Total other loss, net | (80 | ) | (513 | ) | ||||
| Net loss | $ | (5,954 | ) | $ | (5,093 | ) | ||
| Other comprehensive income: | ||||||||
| Unrealized foreign currency translation gain | 50 | 507 | ||||||
| Total other comprehensive income | 50 | 507 | ||||||
| Total comprehensive loss | $ | (5,904 | ) | $ | (4,586 | ) | ||
| Net loss | $ | (5,954 | ) | $ | (5,093 | ) | ||
| Net loss per share: basic and diluted | $ | (2.76 | ) | $ | (7.98 | ) | ||
| Weighted average number of shares outstanding: basic and diluted | 2,157,065 | 638,572 |
The accompanying notes are an integral part of these consolidated financial statements.
BB-301 is a novel, modified AAV9 capsid expressing a unique, single bifunctional construct promoting co-expression of both codon-optimized
Poly-A Binding Protein Nuclear-1 (PABPN1) and two small inhibitory RNAs (siRNAs) against mutant PABPN1. The two siRNAs are modeled into microRNA backbones to silence
expression of faulty mutant PABPN1, while allowing expression of the codon-optimized PABPN1 to replace the mutant with a functional version of the protein. We believe BB-301 s silence and replace
mechanism is uniquely positioned for the treatment of OPMD by halting mutant expression while providing a functional replacement protein.
Benitec Biopharma Inc.
Benitec Biopharma Inc. ( Benitec or the Company ) is a clinical-stage biotechnology company focused on
the advancement of novel genetic medicines with headquarters in Hayward, California. The proprietary DNA-directed RNA interference Silence and Replace platform combines RNA interference, or RNAi,
with gene therapy to create medicines that simultaneously facilitate sustained silencing of disease-causing genes and concomitant delivery of wildtype replacement genes following a single administration of the therapeutic construct. The Company is
developing Silence and Replace-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
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 COVID-19 pandemic, the disease caused by the SARS-CoV-2 virus and similar events, 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