Entera Bio Ltd. (NASDAQ: ENTX), (“Entera” or the “Company”) a
leader in the development of orally delivered peptides, today
reported financial results and key business updates for the fourth
quarter and year ended December 31, 2023.
“2023 was an inflection point for Entera, with
consistent validation of our disruptive N-Tab™ oral peptide
technology platform and the unveiling of our goal to advance five
potential first-in-class oral peptide programs, Phase 1 through
Phase 3, into the clinic by the end of 2025. Each of these programs
has been carefully selected to align with our platform and our
mission to develop treatments that stand to become the number one
choice for patients requiring peptide therapies, in a simple and
convenient tablet format. Each of these programs is expected to
have important catalysts during 2024. Following our December 2023
financing, we expect to have sufficient cash to fund operations
through the first half of 2025,” said Miranda Toledano, CEO
of Entera.
EB613: First Oral PTH(1-34) Daily
Osteoanabolic Tablets for Osteoporosis
- In March 2023, a Type D meeting between Entera and the U.S.
Food and Drug Administration (FDA) re-affirmed that a
placebo-controlled phase 3 study design with Bone Mineral Density
(BMD) and not fracture as primary endpoint could support a New Drug
Application for EB613
- In November 2023, Entera echoed the American Society for Bone
and Mineral Research (ASBMR) announcement that the Strategy to
Advance BMD as a Regulatory Endpoint (SABRE) team had submitted its
final qualification plan to the FDA
- At the Annual ASBMR Meeting in October 2023, Entera presented
the differentiated pharmacokinetic profile of EB613, versus Forteo®
PTH(1-34) 20 µg which requires a daily subcutaneous injection.
EB613 consistently shows an increased Cmax and shorter duration of
systemic exposure versus Forteo®. Furthermore, EB613’s brief
“pulsatile” action appears to simultaneously stimulate both a dual
bone formation and a mild anti-resorptive effect, as compared to
Forteo®
- During the fourth quarter of 2023, Entera submitted its Phase 2
manuscript for potential publication in a major medical journal
related to its phase 2, 6-month, 161-patient, placebo-controlled
study in post-menopausal women with low bone mass and osteoporosis
which met primary and secondary endpoints
“We expect an update on the qualification
process of SABRE and BMD as the surrogate endpoint for fracture in
2024. We view this as the final de-risking event from a regulatory
standpoint to move EB613 to Phase 3. We believe EB613 stands as the
first program to potentially avail itself of the landmark SABRE
initiative which is also the first biomarker to potentially be
approved as part of the 2016 21st Century Cures Act. As the
first potential oral tablet osteoanabolic treatment, EB613 holds
the potential to address the treatment chasm in this severe,
potentially lethal disease which remains significantly undertreated
despite efficacious injectable treatments. Fracture rates continue
to rise globally, and we have not seen any new drugs approved for
osteoporosis since 2019 due to the ethical concerns and the costs
of fracture endpoint studies. Our discussions with key clinicians
and patient advocacy groups and other key stakeholders in this
ecosystem indicate that an oral anabolic treatment is absolutely
warranted and a potential ‘game changer’ for the estimated 200
million women with osteoporosis globally. We continue to hold
strategic discussions related to EB613 and look forward to
initiating our pivotal phase 3 study once the final qualification
of the SABRE endpoint is announced by FDA,” said Miranda Toledano,
CEO of Entera.
EB612: First Oral PTH(1-34) Peptide
Replacement Therapy Tablets for HypoparathyroidismEB612,
is being developed as the first oral PTH(1-34) peptide replacement
treatment for hypoparathyroidism. Entera is currently evaluating
its hypoparathyroidism program with an improved formulation of
EB612 using the naked PTH(1-34) peptide and new intellectual
property, tailored to optimize its PK profile and the potential for
reduced daily dosing. Entera is also combining its N-Tab™ platform
with an alternative PTH receptor agonist in a third party
collaboration. Entera expects to submit data from the Phase 1 of
its next generation EB612 program using the naked PTH(1-34) peptide
in the first half of 2024.
First GLP-2 Peptide Tablets for Short
Bowel SyndromeUnder a collaboration agreement with OPKO
Health (“OPKO”), Entera is combining its N-Tab™ technology with a
proprietary long-acting GLP-2 peptide for the development of the
first potential daily oral GLP-2 for the treatment of short bowel
syndrome and other GI disorders such as Crohn’s and Celiac disease
for which GLP-2 has relevance. Entera published pre-clinical data
in May 2023 demonstrating that its oral peptide delivery platform
enables gastric absorption of teduglutide (Gattex®), the only
approved GLP-2 treatment, as a convenient potential tablet
alternative to daily injections. Pre-IND in vivo PK data for oral
GLP-2 using OPKO’s long-acting analogue is expected in the first
half of 2024.
First GLP-1/Glucagon Agonist
(Oxyntomodulin) Peptide Tablets for ObesityUnder a
collaboration agreement with OPKO, Entera is combining its N-Tab™
technology with a proprietary long-acting Oxyntomodulin (OXM)
peptide for the development of the first potential daily OXM
treatment for obesity and other metabolic diseases. Previously, an
injectable pegylated version of this OXM peptide demonstrated
significant reductions in weight loss and decreased plasma
triglyceride levels with cardioprotective benefits in over 420
patients in phase 2/2B studies. Pre-IND in vivo PK data for oral
OXM using OPKO’s long acting, modified analogue is expected in
mid-2024.
EB613: First Oral PTH(1-34)
Osteoanabolic Tablets to Treat Intense Sport and Military Stress
InjuriesEntera is collaborating with leading researchers
in orthopedics and sports medicine to contribute its proprietary
oral PTH(1-34) tablets for an investigator sponsored Phase 2 Study
seeking to treat young women and men athletes that experience
stress fractures as a result of intense sports training. More
details on this study are expected in the second half of 2024.
Financial Results for the year Ended December 31,
2023
As of December 31, 2023, Entera had cash and
cash equivalents of $11.0 million. The Company believes that its
existing cash resources will be sufficient to meet its projected
operating requirements through the second quarter of 2025, which
includes the capital required to fund our ongoing operations,
including R&D, the completion of the Phase 1 PK study related
to our new generation platform and the GLP-2/OXM collaborative
research we are conducting with OPKO.
Research and development expenses for the year
ended December 31, 2023 were $4.5 million, as compared to $5.8
million for the year ended December 31, 2022. The decrease of $1.3
million was primarily due to a decrease of $1.5 million in
pre-clinical activity and materials costs and a decrease of $0.6
million in employee compensation, including a one-time payment made
to a former employee pursuant to the terms of his separation
agreement. The decrease was partially offset by an increase of $0.8
million in clinical expenses for our Phase 1 PK study related to
our new generation platform and new formulations for EB612.
General and administrative expenses for the year
ended December 31, 2023 were $4.4 million, compared to $7.3 million
for the year ended December 31, 2022. The decrease of $2.8 million
was mainly attributable to a decrease of $1.1 million in employee
compensation, including a one-time payment to our former employee
pursuant to the terms of his separation agreement, a decrease of
$0.8 million as part of a restructuring of professional fees and
other advisor expenses, a decrease in Board fees of $0.2 million
due to the Board’s forfeiture of their fees for the third and
fourth quarters of 2023 and a decrease of $0.7 million in D&O
insurance costs.
Operating expenses for year ended December 31,
2023 were $8.9 million, as compared to $13.0 million for the year
ended December 31, 2022.
Net loss was $8.9 million, or $0.31 per ordinary
share (basic and diluted), for the year ended December 31, 2023, as
compared to $13.1 million, or $0.45 per ordinary share (basic and
diluted), for the year ended December 31, 2022.
About Entera Bio
Entera is a clinical stage company focused on
developing oral peptide or protein replacement therapies for
significant unmet medical needs where an oral tablet form holds the
potential to transform the standard of care. The Company leverages
on a disruptive and proprietary technology platform and its
pipeline includes five differentiated, first-in-class oral peptide
programs, expected to enter into the clinic (Phase 1 to Phase 3) by
2025. The Company’s most advanced product candidate, EB613 (oral
PTH(1-34), teriparatide), is being developed as the first oral,
osteoanabolic (bone building) once-daily tablet treatment for
post-menopausal women with low BMD and high-risk osteoporosis, with
no prior fracture. A placebo controlled, dose ranging Phase 2 study
of EB613 tablets (n=161) met primary (PD/bone turnover biomarker)
and secondary endpoints (BMD). Entera is preparing to initiate a
Phase 3 registrational study for EB613 pursuant to the FDA’s
qualification of a quantitative BMD endpoint which is expected to
occur in 2024. The EB612 program is being developed as the first
oral PTH(1-34) tablet peptide replacement therapy for
hypoparathyroidism. Entera is also developing the first oral
oxyntomodulin, a dual targeted GLP1/glucagon peptide, in tablet
form for the treatment of obesity; and first oral GLP-2 peptide
tablet as an injection-free alternative for patients suffering from
rare malabsorption conditions such as short bowel syndrome in
collaboration with OPKO Health. For more information on Entera Bio,
visit www.enterabio.com or follow us on LinkedIn, Twitter,
Facebook, Instagram.
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 may be contractually
obligated to provide; 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) |
|
|
|
|
|
|
December 31 |
|
December 31 |
|
2023 |
|
2022 |
|
(Unaudited) |
|
(Audited) |
|
|
Cash and cash equivalents |
11,019 |
|
12,309 |
Accounts receivable and other current assets |
238 |
|
540 |
Property and equipment, net |
100 |
|
139 |
Other assets, net |
408 |
|
139 |
Total assets |
11,765 |
|
13,127 |
|
|
|
|
|
|
Accounts payable and other current liabilities |
1,091 |
|
1,341 |
Total non-current liabilities |
288 |
|
32 |
Total liabilities |
1,379 |
|
1,373 |
Total shareholders' equity |
10,386 |
|
11,754 |
Total liabilities and shareholders' equity |
11,765 |
|
13,127 |
ENTERA BIO LTD. |
CONSOLIDATED STATEMENTS OF OPERATIONS |
(U.S. dollars in thousands, except share and per share data) |
|
(Unaudited) |
|
|
Year Ended December 31, |
|
2023 |
|
2022 |
|
|
|
|
REVENUES |
- |
|
134 |
COST OF
REVENUES |
- |
|
101 |
GROSS
PROFIT |
- |
|
33 |
OPERATING
EXPENSES: |
|
|
|
Research and development |
4,510 |
|
5,848 |
General and
administrative |
4,430 |
|
7,253 |
Other income |
(49) |
|
(51) |
TOTAL OPERATING
EXPENSES |
8,891 |
|
13,050 |
OPERATING
LOSS |
8,891 |
|
13,017 |
FINANCIAL INCOME,
NET |
(31) |
|
(83) |
LOSS BEFORE INCOME
TAX |
8,860 |
|
12,934 |
INCOME TAX
EXPENSES |
29 |
|
137 |
NET LOSS |
8,889 |
|
13,071 |
|
|
|
|
BASIC AND DILUTED LOSS
PER SHARE |
0.31 |
|
0.45 |
WEIGHTED AVERAGE
NUMBER OF SHARES |
|
|
|
OUTSTANDING USED IN
COMPUTATION OF |
29,007,794 |
|
28,808,090 |
BASIC AND DILUTED LOSS
PER SHARE |
|
|
|
Contact:
Entera Bio:
Ms. Miranda Toledano
Chief Executive Officer
Entera Bio
Email: miranda@enterabio.com
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