Entera Bio Ltd. (NASDAQ: ENTX), (“Entera” or the “Company”) a
leader in the development of orally delivered peptides and
therapeutic proteins, today reported corporate updates and
financial results for the first quarter ended March 31, 2023.
“Our primary objectives for 2023 are to finalize
our discussion with the FDA regarding our registrational phase 3
study for EB613 in post-menopausal women with low bone mineral
density (BMD) and osteoporosis, and to update on our PK study which
will assess the potential for a novel oral PTH(1-34) candidate for
the treatment of hypoparathyroidism,” said Miranda Toledano,
the Company’s Chief Executive Officer. “We also remain focused on
our earlier stage R&D initiatives with peptides that best align
to our technology, such as GLP-2.”
Corporate Updates for First Quarter
2023:
- Concluded Type D Meeting with the FDA Related to
EB613. Entera previously reported that it will continue
discussions with the agency until final guidance is received on the
proposed statistical evaluation of its primary endpoint. This is
likely to occur pursuant to the FDA’s evaluation and qualification
of the Foundation for the National Institutes of Health Bone
Quality Project (FNIH BQP)1. Entera plans to provide an update on
its discussions with the FDA as the year progresses. Meanwhile, the
Company continues to strengthen its ecosystem of endocrinology and
women’s health advisory board for EB613 with the addition of Dr.
Steve Goldstein, a global leader in menopause health and former
President of the North American and International Menopause
Society.
- Institutional Review Board (IRB) Accepted and the
Company Plans to Initiate Next Generation Platform PK Study in
H1’2023. Topline results expected in H2’2023 including the
potential for a novel candidate to treat hypoparathyroidism with
once or twice a day oral PTH(1-34) tablets. This initiative builds
on prior PK and Phase 2 results of an earlier generation of EB612
in hypoparathyroidism patients.
- Entera Oral GLP-2 Pre-Clinical Manuscript Accepted for
Publication by the International Journal of Peptide Research and
Therapeutics. Based on this work, Entera believes GLP-2
represents a strong candidate for its oral delivery platform and
warrants further development as an injection free alternative to
patients suffering from short bowel syndrome and other disorders
requiring parenteral nutrition.
- Amgen Research Collaboration. After over four
years of collaborative pre-clinical work evaluating the use of
Entera’s delivery technology with one molecule selected by Amgen,
both collaborators have agreed to discontinue the Research
Collaboration and License Agreement entered into in 2018 out of
mutual convenience.
_______________1 FNIH BQP is also knows as the
ASBMR FNIH-SABRE, American Society for Bone and Mineral
Research-Foundation for the National Institutes of Health (FNIH)
Strategy to Advance BMD as a Regulatory Endpoint (SABRE)
Financial Results for the Three Months
Ended March 31, 2023
As of March 31, 2023, Entera had cash and cash
equivalents of $10.7 million. Entera expects that its existing cash
resources are sufficient to meet its projected operating
requirements into the third quarter of 2024, which includes the
capital required to fund our ongoing operations, including R&D
and the completion of the Phase 1 PK study related to the new
formulation of EB612.
Research and development expenses for the three
months ended March 31, 2023 were $0.9 million, as compared to $1.7
million for the three months ended March 31, 2022. The decrease of
$0.8 million was primarily due to a decrease of $0.6 million in
materials and production costs and a decrease of $0.2 million in
employee compensation, including share-based compensation.
General and administrative expenses for the
three months ended March 31, 2023 were $1.3 million, as compared to
$2.2 million for the three months ended March 31, 2022. The
decrease of $0.9 million was mainly attributable to a decrease of
$0.6 million in employee compensation, including share-based
compensation, a decrease of $0.2 million in professional fees and a
decrease of $0.1 million in D&O insurance costs.
Operating expenses for the quarter ended March
31, 2023 were $2.2 million, as compared to $3.8 million for the
quarter ended March 31, 2022. Entera’s operating loss was $2.2
million for quarter ended March 31, 2023, as compared to $3.8
million for the quarter ended March 31, 2022.
Net loss was $2.2 million, or $0.08 per ordinary
share (basic and diluted), for the quarter ended March 31, 2023, as
compared to $3.8 million, or $0.13 per ordinary share (basic and
diluted), for the quarter ended March 31, 2022.
About Entera Bio
Entera is a leader in the development of orally
delivered macromolecules, including peptides and other therapeutic
proteins. The Company focuses on significant unmet medical needs
where a daily mini tablet form of a peptide treatment or
replacement therapy holds the potential to transform the standard
of care. The Company’s most advanced product candidates, EB613 for
the treatment of high risk, post-menopausal osteoporosis and EB612
for the treatment of hypoparathyroidism, are in clinical
development. EB613 is the first oral, once daily mini tablet
presentation of synthetic hPTH (1-34), (teriparatide), consisting
of the exact same 34 amino acid sequence as daily subcutaneous
teriparatide injection, Forteo®, which requires daily SC
injections. A placebo controlled, dose ranging Phase 2 study of
EB613 tablets (n= 161) met primary (PD/biomarker) and secondary
endpoints (BMD) in a dose dependent manner and was presented at the
ASBMR 2021 Annual Conference. A phase 1 PK study of novel PTH
formulations is planned for H1 2023 to ascertain feasibility of a
new hypo candidate (a prior formulation had positive Phase 2a data
announced in 2015 and published in JBMR 2019) and for another
potential indication. For more information on Entera Bio, visit
www.enterabio.com.
Cautionary Statement Regarding Forward
Looking Statements
Various statements in this press release are
“forward-looking statements” within the meaning of the Private
Securities Litigation Reform Act of 1995. All statements (other
than statements of historical facts) in this press release
regarding our prospects, plans, financial position, business
strategy and expected financial and operational results may
constitute forward-looking statements. Words such as, but not
limited to, “anticipate,” “believe,” “can,” “could,” “expect,”
“estimate,” “design,” “goal,” “intend,” “may,” “might,”
“objective,” “plan,” “predict,” “project,” “target,” “likely,”
“should,” “will,” and “would,” or the negative of these terms and
similar expressions or words, identify forward-looking statements.
Forward-looking statements are based upon current expectations that
involve risks, changes in circumstances, assumptions and
uncertainties. Forward-looking statements should not be read as a
guarantee of future performance or results and may not be accurate
indications of when such performance or results will be
achieved.
Important factors that could cause actual
results to differ materially from those reflected in Entera’s
forward-looking statements include, among others: changes in the
interpretation of clinical data; results of our clinical trials;
the FDA’s interpretation and review of our results from and
analysis of our clinical trials; unexpected changes in our ongoing
and planned preclinical development and clinical trials, the timing
of and our ability to make regulatory filings and obtain and
maintain regulatory approvals for our product candidates; the
potential disruption and delay of manufacturing supply chains; loss
of available workforce resources, either by Entera or its
collaboration and laboratory partners; impacts to research and
development or clinical activities that Entera is contractually
obligated to provide, such as those pursuant to Entera’s agreement
with Amgen; overall regulatory timelines; the size and growth of
the potential markets for our product candidates; the scope,
progress and costs of developing Entera’s product candidates;
Entera’s reliance on third parties to conduct its clinical trials;
Entera’s expectations regarding licensing, business transactions
and strategic collaborations; Entera’s operation as a development
stage company with limited operating history; Entera’s ability to
continue as a going concern absent access to sources of liquidity;
Entera’s ability to obtain and maintain regulatory approval for any
of its product candidates; Entera’s ability to comply with Nasdaq’s
minimum listing standards and other matters related to compliance
with the requirements of being a public company in the United
States; Entera’s intellectual property position and its ability to
protect its intellectual property; and other factors that are
described in the “Cautionary Statements Regarding Forward-Looking
Statements,” “Risk Factors” and “Management’s Discussion and
Analysis of Financial Condition and Results of Operations” sections
of Entera’s most recent Annual Report on Form 10-K filed with the
SEC, as well as the company’s subsequently filed Quarterly Reports
on Form 10-Q and Current Reports on Form 8-K. There can be no
assurance that the actual results or developments anticipated by
Entera will be realized or, even if substantially realized, that
they will have the expected consequences to, or effects on, Entera.
Therefore, no assurance can be given that the outcomes stated or
implied in such forward-looking statements and estimates will be
achieved. Entera cautions investors not to rely on the
forward-looking statements Entera makes in this press release. The
information in this press release is provided only as of the date
of this press release, and Entera undertakes no obligation to
update or revise publicly any forward-looking statements, whether
as a result of new information, future events or otherwise, except
to the extent required by law.
|
ENTERA BIO LTD. |
CONSOLIDATED BALANCE SHEETS |
(U.S. dollars in thousands, except share data) |
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
March 31 |
|
|
|
December 31 |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
Cash and cash equivalents |
|
10,691 |
|
|
|
12,309 |
|
Accounts receivable and other current assets |
|
682 |
|
|
|
540 |
|
Property and equipment, net |
|
136 |
|
|
|
139 |
|
Other assets, net |
|
97 |
|
|
|
139 |
|
Total assets |
|
11,606 |
|
|
|
13,127 |
|
|
|
|
|
|
|
|
|
|
|
Accounts payable and other current liabilities |
|
1,494 |
|
|
|
1,341 |
|
Total non-current liabilities |
|
32 |
|
|
|
32 |
|
Total liabilities |
|
1,526 |
|
|
|
1,373 |
|
Total shareholders' equity |
|
10,080 |
|
|
|
11,754 |
|
|
|
|
|
|
|
|
|
Total liabilities and shareholders' equity |
|
11,606 |
|
|
|
13,127 |
|
|
|
|
|
|
|
|
|
ENTERA BIO LTD.
CONSOLIDATED STATEMENTS OF OPERATIONS (U.S.
dollars in thousands, except share and per share data)
|
Three Months Ended March 31, |
|
|
2023 |
|
|
|
2022 |
|
|
|
|
|
|
|
|
|
REVENUES |
|
- |
|
|
|
68 |
|
COST OF REVENUES |
|
- |
|
|
|
54 |
|
GROSS PROFIT |
|
- |
|
|
|
14 |
|
OPERATING EXPENSES: |
|
|
|
|
|
|
|
Research and development |
|
931 |
|
|
|
1,690 |
|
General and administrative |
|
1,294 |
|
|
|
2,171 |
|
Other income |
|
(13 |
) |
|
|
(12 |
) |
TOTAL OPERATING EXPENSES |
|
2,212 |
|
|
|
3,849 |
|
OPERATING LOSS |
|
2,212 |
|
|
|
3,835 |
|
|
|
|
|
|
|
|
|
FINANCIAL INCOME, NET |
|
(22 |
) |
|
|
(44 |
) |
LOSS BEFORE INCOME TAX |
|
2,190 |
|
|
|
3,791 |
|
INCOME TAX BENEFIT |
|
- |
|
|
|
(7 |
) |
NET LOSS |
|
2,190 |
|
|
|
3,784 |
|
|
|
|
|
|
|
|
|
LOSS PER SHARE BASIC AND DILUTED |
|
0.08 |
|
|
|
0.13 |
|
|
|
|
|
|
|
|
|
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING USED IN
COMPUTATION OF BASIC AND DILUTED LOSS PER SHARE |
|
28,809,922 |
|
|
|
28,804,411 |
|
|
|
|
|
|
|
|
|
Contact:
Entera Bio:
Ms. Miranda Toledano
Chief Executive Officer
Entera Bio
Email: miranda@enterabio.com
Entera Bio (NASDAQ:ENTX)
Historical Stock Chart
From Apr 2024 to May 2024
Entera Bio (NASDAQ:ENTX)
Historical Stock Chart
From May 2023 to May 2024