Benitec Biopharma Provides Operational Update and Releases its 2020 Fiscal Year-End Financial Results
Benitec Biopharma Inc. (NASDAQ: BNTC) reported a significant decline in total revenues for FY 2020, totaling $102,000 compared to $12.2 million in FY 2019, primarily due to the termination of the Axovant Sciences Agreement. Net loss increased to $8.27 million, or $8.10 per share, compared to a profit of $2.6 million in 2019. The company concluded the fiscal year with $9.8 million in cash. Despite these challenges, Benitec is optimistic about the ongoing development of its BB-301 program for Oculopharyngeal Muscular Dystrophy, having initiated pivotal studies in 2020.
- Initiation of BB-301 Tissue Transduction Study in large animal subjects for Oculopharyngeal Muscular Dystrophy.
- Optimism expressed by management regarding the BB-301 program's prospects.
- Total revenues dropped to $102,000 from $12.2 million in FY 2019.
- Net loss increased to $8.27 million compared to profit of $2.6 million in the previous year.
- Decrease in government R&D grants from $648,000 to $5,000 due to re-domiciliation.
HAYWARD, Calif., Sept. 23, 2020 /PRNewswire/ -- Benitec Biopharma Inc. (NASDAQ: BNTC) ("Benitec" or "the Company"), a development-stage, gene therapy-focused, biotechnology company developing novel genetic medicines based on the proprietary DNA-directed RNA interference ("ddRNAi") platform, today provided an operational update and announced the financial results for its fiscal year ended June 30, 2020. The Company has filed its annual report on Form 10-K for the year ended June 30, 2020 with the U.S. Securities and Exchange Commission.
Operational Updates
The key milestones related to the investigational agents under development by the company and other corporate updates are outlined below:
BB-301(Oculopharyngeal Muscular Dystrophy Program)
- On June 6, 2019, Benitec announced the termination of its License and Collaboration Agreement with Axovant Sciences with the termination effective during September 3, 2019. The Company simultaneously announced its plans to conduct several additional exploratory analyses prior to the initiation of the BB-301 clinical study in order to potentially improve the biological efficacy of the compound via further optimization of the proprietary delivery method employed to dose the target tissues.
- On September 16, 2019, Benitec announced its plans to complete two non-clinical studies with the goal of improving the biological efficacy of BB-301 via optimization of the proprietary delivery method employed to dose the target tissues. These studies will help to facilitate the filing of an Investigational New Drug (IND) application and the formal initiation of a Phase I clinical trial in patients suffering from Oculopharyngeal Muscular Dystrophy (OPMD).
- On July 8, 2020 the company announced the initiation of the BB-301 Tissue Transduction Study in large animal subjects. The BB-301 Tissue Transduction Study is the first of three planned IND-enabling studies that will be conducted in large animals. The 8-week Tissue Transduction Study conducted in Beagle dogs will look to confirm the transduction efficiency of BB-301 upon administration via direct intramuscular injection into specific anatomical regions of the pharynx through the use of an open surgical procedure. Interim data for the BB-301 Tissue Transduction Study is expected in late Q4 2020 or early Q1 2021.
Corporate Updates
- On September 30, 2019, the company announced the closing of an equity financing that raised
$2.25 million .
- On April 15, 2020, the Company completed the re-domiciliation of the Company from Australia to the United States. As a result, the Company is now incorporated in the United States and its common stock is listed on Nasdaq. Also on April 15, 2020, Edward Smith, CFO of Marinus Pharmaceuticals, Inc., was appointed to the Company's board of directors.
Jerel A. Banks, M.D., Ph.D., Executive Chairman and Chief Executive Officer of Benitec Biopharma commented, "This has been a transformative year for Benitec. Our team has worked diligently to thoughtfully navigate the key development hurdles present for BB-301, and we are optimistic about the prospects for the success of this program."
Financial Highlights
Total Revenues for the year ended June 30, 2020 were one hundred two thousand dollars compared to
Total expenses were
The Net loss from operations for fiscal 2020 was
BENITEC BIOPHARMA INC. Consolidated Statements of Operations and Comprehensive Income (Loss) (in thousands, except share and per share amounts) | ||||||||
Year Ended | ||||||||
June 30, | ||||||||
2020 | 2019 | |||||||
Revenue: | ||||||||
Revenues from customers | $ | 97 | $ | 11,551 | ||||
Government research and development grants | 5 | 648 | ||||||
Total revenues | 102 | 12,199 | ||||||
Operating expenses | ||||||||
Royalties and license fees | (185) | 435 | ||||||
Research and development | 3,001 | 4,567 | ||||||
General and administrative | 5,567 | 4,614 | ||||||
Total operating expenses | 8,383 | 9,616 | ||||||
Income (loss) from operations | (8,281) | 2,583 | ||||||
Other income (loss): | ||||||||
Foreign currency transaction loss | (88) | (75) | ||||||
Interest income, net | 62 | 122 | ||||||
Other income, net | 34 | - | ||||||
Unrealized loss on investment | (1) | (21) | ||||||
Total other income, net | 7 | 26 | ||||||
Net income (loss) | $ | (8,274) | $ | 2,609 | ||||
Other comprehensive loss: | ||||||||
Unrealized foreign currency translation loss | (89) | (531) | ||||||
Total other comprehensive loss | (89) | (531) | ||||||
Total comprehensive income (loss) | $ | (8,363) | $ | 2,078 | ||||
Net income (loss) | $ | (8,274) | $ | 2,609 | ||||
Net income (loss) per share: | ||||||||
Basic and diluted | $ | (8.10) | $ | 3.05 | ||||
Weighted-average shares outstanding: | ||||||||
Basic and diluted | 1,021,193 | 856,765 | ||||||
BENITEC BIOPHARMA INC. Consolidated Balance Sheets (in thousands, except par value and share amounts) | ||||||||
June 30, | June 30, | |||||||
2020 | 2019 | |||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 9,801 | $ | 15,718 | ||||
Trade and other receivables | 59 | 2,536 | ||||||
Other assets | 949 | 502 | ||||||
Total current assets | 10,809 | 18,756 | ||||||
Property and equipment, net | 374 | 470 | ||||||
Deposits | 9 | 9 | ||||||
Right-of-use assets | 395 | - | ||||||
Total assets | $ | 11,587 | $ | 19,235 | ||||
Liabilities and Stockholders' Equity | ||||||||
Current liabilities: | ||||||||
Trade and other payables | $ | 741 | $ | 2,494 | ||||
Accrued employee benefits | 203 | 147 | ||||||
Lease liabilities, current portion | 192 | - | ||||||
Total current liabilities | 1,136 | 2,641 | ||||||
Lease liabilities, less current portion | 213 | - | ||||||
Total liabilities | 1,349 | 2,641 | ||||||
Commitments and contingencies (Note 13) | ||||||||
Stockholders' equity: | ||||||||
Common stock, | 1 | 1 | ||||||
Additional paid-in capital | 128,826 | 127,327 | ||||||
Accumulated deficit | (116,636) | (108,870) | ||||||
Accumulated other comprehensive loss | (1,953) | (1,864) | ||||||
Total stockholders' equity | 10,238 | 16,594 | ||||||
Total liabilities and stockholders' equity | $ | 11,587 | $ | 19,235 | ||||
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), and Chronic Hepatitis B. 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 preclinical 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 preclinical 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.
Media & Investor Relations Contact:
Jay A. Morakis
CEO of M Group Strategic Communications (for Benitec Biopharma, Inc.)
Phone: 646-859-5951
Email: jmorakis@mgroupsc.com
View original content to download multimedia:http://www.prnewswire.com/news-releases/benitec-biopharma-provides-operational-update-and-releases-its-2020-fiscal-year-end-financial-results-301137053.html
SOURCE Benitec Biopharma Inc.
