Benitec Biopharma Releases Third Quarter 2025 Financial Results
- Strong cash position of $103.6 million as of March 31, 2025
- Successful completion of Cohort 1 low-dose BB-301 treatment
- Progression to higher dose cohort planned for later in 2025
- Net loss increased to $9.4 million from $4.3 million year-over-year
- Total expenses more than doubled to $10.2 million from $4.1 million
- R&D expenses increased significantly to $6.0 million from $2.6 million
Insights
Benitec reports wider losses as R&D costs rise 132% for OPMD therapy BB-301, but maintains strong $103.6M cash position through clinical progression.
Benitec Biopharma's Q3 2025 financial results reveal significant escalation in operating expenses as the company advances its gene therapy program for Oculopharyngeal Muscular Dystrophy (OPMD). Research and development costs more than doubled to
The completion of dosing for the final subject in Cohort 1 represents a crucial milestone in the BB-301 clinical development program. This "Silence and Replace" therapy utilizes DNA-directed RNA interference (ddRNAi) technology with a bifunctional approach - simultaneously silencing the mutant PABPN1 gene while providing a functional replacement protein. This dual-action mechanism is particularly suited for OPMD, where dysphagia (difficulty swallowing) is a primary symptom.
Despite the accelerated cash burn rate, with total quarterly expenses reaching
The planned progression to a higher dosing cohort later this year, coupled with forthcoming clinical updates in Q4, signals confidence in the safety profile observed thus far and suggests the program remains on track. The close engagement with the OPMD patient community mentioned by CEO Dr. Banks highlights the company's patient-centric approach to drug development, which is essential for orphan disease therapies.
Benitec's quarterly loss widened to $9.4M despite strong $103.6M cash position; costs doubled while advancing OPMD therapy through clinical trials.
Benitec Biopharma's financial performance for Q3 2025 shows a company in active clinical development phase with significantly increased expenditures. The quarterly net loss widened to
The cash position remains strong at
General and administrative expenses also increased significantly to
The weighted average number of shares outstanding more than doubled to 38.6 million from 18.3 million in the comparable period, indicating substantial dilution for existing shareholders. However, this dilution has secured a considerably stronger financial position that supports continued development of the company's gene therapy platform without immediate financing concerns.
HAYWARD, Calif., May 14, 2025 (GLOBE NEWSWIRE) -- Benitec Biopharma Inc. (NASDAQ: BNTC) (“Benitec” or “Company”), a clinical-stage, gene therapy-focused, biotechnology company developing novel genetic medicines based on its proprietary “Silence and Replace” DNA-directed RNA interference (“ddRNAi”) platform, today announced financial results for its third fiscal quarter ended March 31, 2025. The Company has filed its quarterly report on Form 10-Q with the U.S. Securities and Exchange Commission.
“We are profoundly honored to be closely engaged with the OPMD patient community and are thankful for the support of the Subjects and their families as we remain focused on the continued development of BB-301 for the treatment of dysphagia in OPMD patients,” said Jerel A. Banks, M.D., Ph.D., Executive Chairman and Chief Executive Officer of Benitec. “The sixth and final Subject of Cohort 1 was safely treated with the low dose of BB-301 in April 2025. We look forward to enrolling additional Subjects at the next, higher dose of BB-301 later this year. Additional clinical study updates for Subjects enrolled in Cohort 1 are planned for the fourth calendar quarter of this year.”
Financial Highlights
Third Fiscal Quarter 2025 Financial Results
Total Expenses for the quarter ended March 31, 2025, were
The loss from operations for the quarter ended March 31, 2025, was
BENITEC BIOPHARMA INC. | |||||||||
Consolidated Balance Sheets | |||||||||
(in thousands, except par value and share amounts) | |||||||||
March 31, | June 30, | ||||||||
2025 | 2024 | ||||||||
(Unaudited) | |||||||||
Assets | |||||||||
Current assets: | |||||||||
Cash and cash equivalents | $ | 103,583 | $ | 50,866 | |||||
Restricted Cash | 63 | 63 | |||||||
Trade and other receivables | 3 | 229 | |||||||
Prepaid and other assets | 361 | 516 | |||||||
Total current assets | 104,010 | 51,674 | |||||||
Property and equipment, net | 145 | 179 | |||||||
Deposits | 55 | 25 | |||||||
Other assets | 35 | 62 | |||||||
Right-of-use assets | 964 | 270 | |||||||
Total assets | $ | 105,209 | $ | 52,210 | |||||
Liabilities and Stockholders’ Equity | |||||||||
Current liabilities: | |||||||||
Trade and other payables | $ | 6,254 | $ | 4,165 | |||||
Accrued employee benefits | 426 | 475 | |||||||
Lease liabilities, current portion | 346 | 284 | |||||||
Total current liabilities | 7,026 | 4,924 | |||||||
Non-current accrued employee benefits | - | 38 | |||||||
Lease liabilities, less current portion | 613 | - | |||||||
Total liabilities | 7,639 | 4,962 | |||||||
Stockholders’ equity: | |||||||||
Preferred stock, | |||||||||
and outstanding at March 31, 2025 and June 30, 2024, respectively | - | - | |||||||
Common stock, | |||||||||
and outstanding at March 31, 2025 and June 30, 2024, respectively | 2 | 1 | |||||||
Additional paid-in capital | 310,313 | 238,398 | |||||||
Accumulated deficit | (212,029 | ) | (190,259 | ) | |||||
Accumulated other comprehensive loss | (716 | ) | (892 | ) | |||||
Total stockholders’ equity | 97,570 | 47,248 | |||||||
Total liabilities and stockholders’ equity | $ | 105,209 | $ | 52,210 |
BENITEC BIOPHARMA INC. | ||||||||||||||||||
Consolidated Statements of Operations and Comprehensive Loss | ||||||||||||||||||
(in thousands, except share and per share amounts) | ||||||||||||||||||
Three Months Ended March 31, | Nine Months Ended March 31, | |||||||||||||||||
2025 | 2024 | 2025 | 2024 | |||||||||||||||
Revenues | $ | - | $ | - | $ | - | $ | - | ||||||||||
Operating expenses | ||||||||||||||||||
Royalties and license fees | - | (3 | ) | - | (108 | ) | ||||||||||||
Research and development | 5,980 | 2,566 | 14,637 | 12,097 | ||||||||||||||
General and administrative | 4,208 | 1,578 | 9,952 | 4,953 | ||||||||||||||
Total operating expenses | 10,188 | 4,141 | 24,589 | 16,942 | ||||||||||||||
Loss from operations | (10,188 | ) | (4,141 | ) | (24,589 | ) | (16,942 | ) | ||||||||||
Other income (loss): | ||||||||||||||||||
Foreign currency transaction gain (loss) | 11 | (118 | ) | (190 | ) | (22 | ) | |||||||||||
Interest income (expense), net | 823 | (4 | ) | 2,250 | (16 | ) | ||||||||||||
Other income (expense), net | - | (16 | ) | (5 | ) | (50 | ) | |||||||||||
Gain on extinguishment of liabilities | - | - | 764 | - | ||||||||||||||
Unrealized gain (loss) on investment | - | - | - | (1 | ) | |||||||||||||
Total other income (loss), net | 834 | (138 | ) | 2,819 | (89 | ) | ||||||||||||
Net loss | $ | (9,354 | ) | $ | (4,279 | ) | $ | (21,770 | ) | $ | (17,031 | ) | ||||||
Other comprehensive income: | ||||||||||||||||||
Unrealized foreign currency translation gain (loss) | (28 | ) | 117 | 176 | (5 | ) | ||||||||||||
Total other comprehensive income | (28 | ) | 117 | 176 | (5 | ) | ||||||||||||
Total comprehensive loss | $ | (9,382 | ) | $ | (4,162 | ) | $ | (21,594 | ) | $ | (17,036 | ) | ||||||
Net loss | $ | (9,354 | ) | $ | (4,279 | ) | $ | (21,770 | ) | $ | (17,031 | ) | ||||||
Deemed dividends | - | - | - | (619 | ) | |||||||||||||
Net loss attributable to common shareholders | $ | (9,354 | ) | $ | (4,279 | ) | $ | (21,770 | ) | $ | (17,650 | ) | ||||||
Net loss per share: | ||||||||||||||||||
Basic and diluted | $ | (0.24 | ) | $ | (0.23 | ) | $ | (0.63 | ) | $ | (1.11 | ) | ||||||
Weighted average number of shares outstanding: basic and diluted | 38,599,453 | 18,281,896 | 34,559,870 | 15,876,753 |
About BB-301
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 causative gene for OPMD). 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 the silence and replace mechanism of BB-301 is uniquely positioned for the treatment of OPMD by halting mutant expression while providing a functional replacement protein.
About 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 “Silence and Replace” DNA-directed RNA interference 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 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 completion of pre-clinical and clinical trials, the timing of the availability of data from our clinical trials, the timing and sufficiency of patient enrollment and dosing in clinical trials, the timing of expected regulatory filings, and the clinical utility and potential attributes and benefits of ddRNAi and Benitec’s product candidates, 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: the success of our plans to develop and potentially commercialize our product candidates; the timing of the completion of preclinical studies and clinical trials; the timing and sufficiency of patient enrollment and dosing in any future clinical trials; the timing of the availability of data from our clinical trials; the timing and outcome of regulatory filings and approvals; the development of novel AAV vectors; our potential future out-licenses and collaborations; the plans of licensees of our technology; the clinical utility and potential attributes and benefits of ddRNAi and our product candidates, including the potential duration of treatment effects and the potential for a “one shot” cure; our intellectual property position and the duration of our patent portfolio; expenses, ongoing losses, future revenue, capital needs and needs for additional financing, and our ability to access additional financing given market conditions and other factors, including our capital structure; the length of time over which we expect our cash and cash equivalents to be sufficient to execute on our business plan; 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 and other regulatory developments; 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 impact of, and our ability to remediate, the identified material weakness in our internal controls over financial reporting; 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:
Irina Koffler
LifeSci Advisors, LLC
(917) 734-7387
ikoffler@lifesciadvisors.com
