Benitec Biopharma Releases Q3 2022 Financial Results
May 16 2022 - 8:15AM
Benitec Biopharma Inc. (NASDAQ: BNTC) (“Benitec” or “the 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 Fiscal Year Q3 ended March 31, 2022. The
Company has filed its quarterly report on Form 10-Q for the quarter
ended March 31, 2022, with the U.S. Securities and Exchange
Commission.
“With our key submission to the Central Ethics
Committee in France completed in April, we are well-positioned to
begin the clinical development program this year,” said Jerel A.
Banks, M.D., Ph.D., Executive Chairman and Chief Executive Officer
of Benitec Biopharma. “The Benitec team remains committed to
initiating the clinical development program for BB-301 and
improving the lives of patients suffering from OPMD.”
Operational Updates
The key milestones related to the
investigational agent under development by the Company and other
corporate updates are outlined below:
BB-301 Clinical Development Program
Overview:
- The BB-301 clinical development
program will be conducted in France, Canada, and the United States,
and the primary elements of the clinical development plan are
summarized below.
- The Clinical development plan will
begin in 2022 and comprise approximately 76 weeks of follow-up:
- 6 month pre-treatment observation
periods for the evaluation of baseline disposition and natural
history of OPMD-derived dysphagia in each study participant.
- 1 day of BB-301 dosing to initiate
participation in the Phase 1b/2a single-arm, open-label,
sequential, dose-escalation cohort study.
- 52 weeks of post-dosing follow-up
for conclusive evaluation of the primary and secondary endpoints of
the Phase 1b/2a BB-301 treatment study.
- The OPMD Natural History (NH) Study
will facilitate the characterization of OPMD patient disposition at
baseline and assess subsequent rates of progression of dysphagia
(swallowing impairment) via the use of the following quantitative
radiographic measures of global swallowing function and pharyngeal
constrictor muscle function inclusive of Videofluoroscopic
Swallowing Studies (VFSS):
- Total Pharyngeal Residue
%(C2-4)2
- Pharyngeal Area at Maximum
Constriction (PhAMPC)
- Dynamic Imaging Grade of Swallowing
Toxicity Scale (DIGEST)
- Vallecular Residue %(C2-4)2,
Pyriform Sinus Residue %(C2-4)2, and Other Pharyngeal Residue
%(C2-4)2
- Normalized Residue Ratio Scale
(NRRSv, NRRSp)
- Pharyngeal Construction Ratio
(PCR)
- Clinical measures of global
swallowing capacity and oropharyngeal dysphagia
- Patient-reported measures of
oropharyngeal dysphagia
- Upon the achievement of 6 months of
follow-up in the NH Study, participants will be eligible for
enrollment onto the Phase 1b/2a treatment study.
- BB-301 Phase 1b/2a Treatment Study:
- This first-in-human study (FIH) will be a Phase 1b/2a,
open-label, dose-escalation study to evaluate the safety and
clinical activity of intramuscular doses of BB-301 administered to
subjects with OPMD.
- Upon rollover onto the Phase 1b/2a BB-301 treatment study, the
follow-up of OPMD study participants will continue for 52
weeks.
- The primary endpoints will be safety and tolerability, with
secondary endpoints comprising quantitative radiographic measures
of global swallowing function and pharyngeal constrictor muscle
function as well as clinical assessments equivalent to those
employed for the NH study. These endpoints will be evaluated during
each 90-day period following BB-301 intramuscular injection (Day
1).
- The natural history of dysphagia observed for each OPMD study
participant, as characterized by the quantitative measures and
clinical assessments carried out during the NH Study, will serve as
the baseline for comparative assessment of safety and efficacy of
BB-301 upon rollover from the NH Study onto the Treatment
Study.
Operational and Regulatory Updates for the
Clinical Development Program in France:
- The NH Study Protocol, the Informed
Consent Form (ICF), the patient-facing documents and the
physician-facing documents have been completed.
- Primary clinical sites (staffed by
neurologists with decades of experience managing OPMD patients) and
auxiliary clinical sites (for the conduct of the NH Study-specific
videofluoroscopic swallowing studies) have been formally
qualified.
- Principal Investigators (PIs), and
sub-investigators, have been identified at the respective clinical
sites.
- The central reader for the
videofluoroscopic swallowing studies has been selected.
- Submission of the comprehensive NH
Study trial package to the Central Ethics Committee (CEC) was
completed in April 2022.
- Approval of the NH Study trial
package by the CEC allows for clinical site activation and OPMD
patient enrollment to begin in France.
- The final CEC decision is expected
in July 2022 (allowing for NH Study screening visits to begin in
July/August 2022).
Operational and Regulatory Updates for the
Clinical Development Program in North America:
- Primary clinical sites in Canada
and the United States and auxiliary clinical sites have been
identified.
- Formal site qualification has been
completed in Canada, and site qualifications are underway in the
United States.
- PIs have been identified at the
respective clinical sites.
- Submission of the comprehensive NH
Study trial package to the Research Ethics Board (REB) in Canada is
anticipated for June 2022, and submissions to the Independent
Ethics Committees (IECs) in the United States will follow.
Clinical Trial Application (CTA) and
Investigational New Drug (IND) Application Filing Timelines and
Phase 1b/2a Treatment Study Initiation:
- CTA and IND filings are anticipated
for January 2023 (required to initiate the Phase 1b/2a Treatment
Study in France, Canada, and the United States).
- The first NH study subject is
anticipated to be eligible for BB-301 administration in April 2023
(following 6-months of NH Study enrollment and follow-up and final
confirmation of eligibility for the BB-301 Phase 1b/2a Treatment
Study).
- Interim safety and efficacy data is
anticipated for release every 90-days following BB-301
administration.
- In preclinical proof-of-concept
studies for BB-301, the OPMD disease phenotype was reversed
14-to-20 weeks after the administration of BB-301 (with muscle
strength restored and microscopic signs of muscle damage
significantly improved).
Financial Highlights
Total Revenues for the three months ended March
31, 2022 were $48 thousand compared to $1 thousand in total revenue
for three months ended March 31, 2021. The increase in revenues
from customers is due to the increase in licensing revenue in the
third quarter.
Total Operating Expenses were $3.5 million for
the quarter ended March 31, 2022 compared to $3.79 million for the
comparable period in 2021. For the three months ended March 31,
2022, Benitec did not incur any royalties and license fees,
compared to $7 thousand for the three months ended March 31, 2021.
During the three months ended March 31, 2022, the Company incurred
$2.17 million in research and development expenses, compared to
$2.75 million for the three months ended March 31, 2021. The
decrease in research and development expenses is primarily related
to the BB-301 Regulatory Toxicology Study in Beagles at Charles
River Laboratories in Evreux, France. As milestones were reached,
the Company began incurring lower costs related to the execution of
two large nonclinical studies in Beagles, along with the
commercial-scale GMP-grade manufacturing of BB-301, all of which
are required to facilitate the CTA filing and the IND filing for
BB-301. For the three months ended March 31, 2022, general and
administrative expenses were $1.3 million compared to $1 million
for the three months ended March 31, 2021. The increase during this
period was due to increases in insurance, consultants, legal and
accounting fees, and share-based compensation.
BENITEC BIOPHARMA INC. |
Consolidated Balance Sheets |
(in thousands, except par value and share
amounts) |
|
|
|
|
|
|
March 31, |
|
June 30, |
|
2022 |
|
2021 |
|
(Unaudited) |
|
|
Assets |
|
|
|
|
|
Current assets: |
|
|
|
|
|
Cash and cash equivalents |
$ |
8,630 |
|
|
$ |
19,769 |
|
Trade and other receivables |
|
5 |
|
|
|
25 |
|
Prepaid and other assets |
|
206 |
|
|
|
814 |
|
Total current assets |
|
8,841 |
|
|
|
20,608 |
|
Property and equipment, net |
|
214 |
|
|
|
375 |
|
Deposits |
|
25 |
|
|
|
9 |
|
Other assets |
|
156 |
|
|
|
185 |
|
Right-of-use assets |
|
828 |
|
|
|
202 |
|
Total assets |
$ |
10,064 |
|
|
$ |
21,379 |
|
Liabilities and
Stockholders’ Equity |
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
Trade and other payables |
$ |
1,320 |
|
|
$ |
880 |
|
Accrued employee benefits |
|
357 |
|
|
|
276 |
|
Lease liabilities, current portion |
|
232 |
|
|
|
213 |
|
Total current liabilities |
|
1,909 |
|
|
|
1,369 |
|
Lease liabilities, less current
portion |
|
635 |
|
|
|
— |
|
Total liabilities |
|
2,544 |
|
|
|
1,369 |
|
Commitments and contingencies
(Note 10) |
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
Common stock, $0.0001 par value-40,000,000 shares authorized;
8,171,690 shares issued and outstanding at March 31, 2022 and
June 30, 2021 |
|
1 |
|
|
|
1 |
|
Additional paid-in capital |
|
152,285 |
|
|
|
151,583 |
|
Accumulated deficit |
|
(143,260 |
) |
|
|
(130,119 |
) |
Accumulated other comprehensive loss |
|
(1,506 |
) |
|
|
(1,455 |
) |
Total stockholders’ equity |
|
7,520 |
|
|
|
20,010 |
|
Total liabilities and
stockholders’ equity |
$ |
10,064 |
|
|
$ |
21,379 |
|
|
|
|
|
|
|
BENITEC BIOPHARMA INC.
Consolidated Statements of Operations and Comprehensive
Loss (Unaudited) (in thousands,
except share and per share amounts)
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
March 31, |
|
March 31, |
|
2022 |
|
2021 |
|
2022 |
|
2021 |
Revenue: |
|
|
|
|
Licensing revenues from customers |
$ |
48 |
|
|
$ |
1 |
|
|
$ |
73 |
|
|
$ |
57 |
|
Total revenues |
|
48 |
|
|
|
1 |
|
|
|
73 |
|
|
|
57 |
|
Operating expenses |
|
|
|
|
Royalties and license fees |
|
— |
|
|
|
7 |
|
|
|
— |
|
|
|
122 |
|
Research and development |
|
2,171 |
|
|
|
2,758 |
|
|
|
8,096 |
|
|
|
4,700 |
|
General and administrative |
|
1,337 |
|
|
|
1,029 |
|
|
|
5,093 |
|
|
|
4,976 |
|
Total operating expenses |
|
3,508 |
|
|
|
3,794 |
|
|
|
13,189 |
|
|
|
9,798 |
|
Loss from operations |
|
(3,460 |
) |
|
|
(3,793 |
) |
|
|
(13,116 |
) |
|
|
(9,741 |
) |
Other income
(loss): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency transaction gain (loss) |
|
229 |
|
|
|
(112 |
) |
|
|
36 |
|
|
|
(167 |
) |
Interest expense, net |
|
(10 |
) |
|
|
(2 |
) |
|
|
(22 |
) |
|
|
(5 |
) |
Other income (expense), net |
|
(29 |
) |
|
|
— |
|
|
|
(29 |
) |
|
|
37 |
|
Unrealized loss on investment |
|
(5 |
) |
|
|
(2 |
) |
|
|
(10 |
) |
|
|
(3 |
) |
Total other income (loss),
net |
|
185 |
|
|
|
(116 |
) |
|
|
(25 |
) |
|
|
(138 |
) |
Net loss |
$ |
(3,275 |
) |
|
$ |
(3,909 |
) |
|
$ |
(13,141 |
) |
|
$ |
(9,879 |
) |
Other comprehensive
income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized foreign currency translation (loss) gain |
|
(233 |
) |
|
|
(24 |
) |
|
|
(51 |
) |
|
|
362 |
|
Total other comprehensive (loss)
income |
|
(233 |
) |
|
|
(24 |
) |
|
|
(51 |
) |
|
|
362 |
|
Total comprehensive loss |
$ |
(3,508 |
) |
|
$ |
(3,933 |
) |
|
$ |
(13,192 |
) |
|
$ |
(9,517 |
) |
Net loss |
$ |
(3,275 |
) |
|
$ |
(3,909 |
) |
|
$ |
(13,141 |
) |
|
$ |
(9,879 |
) |
Net loss per
share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
$ |
(0.40 |
) |
|
$ |
(0.82 |
) |
|
$ |
(1.61 |
) |
|
$ |
(2.93 |
) |
Weighted average number of shares
outstanding: basic and diluted |
|
8,171,690 |
|
|
|
4,747,059 |
|
|
|
8,171,690 |
|
|
|
3,375,228 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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; 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:
William WindhamVP, Solebury TroutPhone:
646-378-2946Email: wwindham@soleburytrout.com
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