Entera Bio Ltd. (NASDAQ: ENTX), (“Entera” or the “Company”), a
leader in the development of orally delivered peptides and small
therapeutic proteins, today reported corporate updates and
financial results for the third quarter ended September 30th,
2023.
“Today, after over a year of steadfast
transformation and execution, Entera stands as a premier oral
peptide company. It is our goal to potentially move five high
value, first-in-class programs, Phase 1 through Phase 3, into the
clinic by the end of 2025.”
“Our disruptive and proprietary technology
simultaneously inhibits gastrointestinal enzymatic degradation and
consistently produces bioavailability of peptides, via a simple
tablet format (around 6mm in diameter). Each of our oral peptide
programs has been carefully selected based on platform alignment
and our mission to successfully develop treatments that stand to
become the number one choice for patients. Importantly Entera has
sufficient cash on hand to enable key read-outs from our
significant pipeline expansion efforts over the coming year,” said
Miranda Toledano, Chief Executive Officer of Entera.
“With our Phase 3 ready EB613 (oral PTH (1-34)
peptide), we aim to transform the lives of osteoporosis patients,
starting with the estimated 200 million women globally at-risk of
fracture. We are also exploring the potential use of EB613 to
accelerate stress fracture healing due to high intensity athletic
or military training. Our EB612 program aimed at the development of
a once-a-day (oral PTH (1- 34) peptide) replacement therapy for
patients suffering from hypoparathyroidism, a disease which also
disproportionately afflicts women, is being tested using a new
generation of our platform. In September 2023, we announced a
transformative collaboration with OPKO Health, Inc. (“OPKO”) that
expands our oral delivery technology across two additional
peptides: GLP-2 for the treatment of short bowel syndrome, and
oxyntomodulin, a dual targeted GLP-1 / glucagon agonist, for the
treatment of obesity,” said Ms. Toledano
“On a separate note, we would like to thank our
collaborators, partners, and shareholders around the world for
reaching out during the last six weeks since the war in Israel
erupted to ensure the safety of our team and loved ones. Entera
houses R&D, some manufacturing and key personnel across Israel,
alongside our clinical, supply chain, regulatory and other
functions in the U.S., UK and the EU. While our entire team at
Entera is “safe” and continues to meet goals; we are all deeply
affected by the current situation. Entera stands with Israel and
its right to protect its diverse population of Jewish, Muslim,
Druze and Christian citizens and residents. All of us are united in
the protection and preservation of our heterogeneous and democratic
country,” said Ms. Toledano.
Entera Q3 2023 Updates and Goals for 5
Oral Peptide Programs:
EB613: First Oral PTH (1-34) Daily
Osteoanabolic Tablets for Osteoporosis EB613 (oral PTH
(1-34), teriparatide), is being developed as the first oral,
osteoanabolic (bone building) once-daily tablet treatment for
osteoporosis. Entera is prepared to initiate a pivotal phase 3
study in post-menopausal women with high-risk osteoporosis and no
prior fracture. Entera successfully completed a phase 2, 6-month,
161-patient, placebo-controlled study. EB613 produced rapid
dose-proportional increases in biochemical markers of bone
formation, reductions in markers of bone resorption, and increased
lumbar spine, total hip, and femoral neck BMD in postmenopausal
women with low mass or osteoporosis and no prior fracture. In
October 2022, following a Type C meeting and in March 2023
following a Type D meeting, Entera announced the U.S. Food and Drug
Administration’s (FDA) concurrence that a 2-year,
placebo-controlled phase 3 (registrational) study with Total Hip
Bone Mineral Density (BMD) as primary endpoint could support an NDA
for EB613. On November 9th, 2023, Entera reported that the American
Society for Bone and Mineral Research (ASBMR) announced that the
SABRE (Strategy to Advance BMD as a Regulatory Endpoint) project
team had submitted to its full qualification plan to FDA for the
use of BMD as a surrogate endpoint for fractures in future trials
of new anti-osteoporosis drugs. EB613 stands as the first program
to potentially avail itself of the ASBMR-SABRE BMD endpoint.
EB613: First Oral PTH (1-34)
Osteoanabolic Tablets to Treat Intense Sport and Military Stress
InjuriesEntera’s ability to consistently deliver its oral
PTH (1-34) peptide in a simple mini tablet format with
reproduceable, dose dependent pharmacokinetics and rapid biological
responses across gender, age, and health status was highlighted as
part of two poster sessions at the Annual Society of Bone and
Mineral Research (ASBMR) 2023 Annual Meeting held on October 13-16,
2023. This work also builds the foundation for Entera’s oral PTH
(1-34) tablets to potentially treat diverse patient populations
including younger men and women athletes at risk of stress
fractures. The Company is working towards a potential Phase 2 study
for EB613 in this important indication.
EB612: First Oral PTH (1-34) Peptide
Replacement Therapy Tablets for HypoparathyroidismEB612,
is the first oral formulation of PTH (1-34), as a hormone
replacement treatment for hypoparathyroidism. An open-label Phase
2a multicenter Phase 2A study, evaluating the safety, tolerability
and PK of EB612 in 19 patients with hypoparathyroidism, achieved
its primary and secondary endpoints, including a significant
reduction in calcium supplementation (42% reduction from baseline,
(p=0.001), a decline of 23% (p=0.0003) in median serum phosphate
levels two hours following the first dose that was maintained for
the duration of the study, improvement in quality of life score and
maintenance of median calcium levels above the lower target level
for hypoparathyroidism patients (>7.5 mg/dL) throughout the
study. There were no treatment emergent adverse events of
hypercalcemia reported and no treatment-emergent serious adverse
events. Entera is currently evaluating its hypoparathyroidism
program with improved formulations of EB612 based on new
intellectual property, tailored to optimize its PK profile and the
potential for reduced daily dosing as well as by potentially
combining Entera’s platform with alternative PTH analogues. Updates
from the ongoing PK/PD study are expected by the end of 2023.
First GLP-2 Peptide Tablets for Short
Bowel SyndromeUnder our collaboration agreement with OPKO,
OPKO will supply its proprietary long-acting GLP-2 peptide to
combine with Entera’s oral peptide platform for the development of
the first potential daily oral GLP-2 for the treatment of short
bowel syndrome. Treatment with Glucagon-Like Peptide-2 (GLP-2)
analogs has been shown to improve the absorption of nutrients in
patients with short bowel syndrome (SBS) and reduce parenteral
support requirements. Teduglutide, the only approved GLP-2 analog,
requires daily subcutaneous injections. In SBS patients, oral drug
delivery is particularly challenging because the site of
absorption, the intestine, is short and less functional. Entera
published pre-clinical data in May 2023 demonstrating that its oral
peptide delivery platform enables gastric absorption of
teduglutide, as a convenient potential tablet alternative to daily
injections. OPKO and Entera expect to update on the program in the
first half of 2024.
First GLP-1/Glucagon Agonist
(Oxyntomodulin) Peptide Tablets for ObesityOxyntomodulin
is a naturally occurring peptide hormone found in the colon, with
glucagon-like-peptide 1 (GLP-1) and glucagon dual agonist activity
which suppresses appetite and induces weight loss. OPKO has
developed several proprietary, modified OXM analogs as potential
candidates for treating obesity, including an injectable pegylated
peptide which demonstrated significant reductions in weight loss
and decreased plasma triglyceride levels with cardioprotective
benefits in a 420 patient phase 2 study. Under the collaboration
agreement, OPKO will supply certain OXM analogs to combine with
Entera’s oral peptide platform. OPKO and Entera expect to update on
the program in the first half of 2024.
Financial Results for the
Three Months Ended September 30,
2023
As of September 30, 2023, Entera had cash and
cash equivalents of $7.6 million. The Company 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 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 three months ended September 30,
2023 and 2022 were approximately $1.4 million. For the quarter
ended September 30, 2023, there was an increase of $0.4 million in
clinical expenses for our Phase 1 PK study related to our new
generation platform and new formulations for EB612, which was
offset by a decrease of $0.3 million materials and production costs
and a decrease of $0.1 million in share-based compensation
expense.
General and administrative expenses for the
three months ended September 30, 2023 were $1.0 million, as
compared to $1.5 million for the three months ended September 30,
2022. The decrease of $0.5 million was mainly attributable to a
decrease of $0.3 million in professional fees and other consultants
and a decrease of $0.2 million in D&O insurance costs.
Operating expenses for the three months ended
September 30, 2023 were $2.4 million, as compared to $2.9 million
for the three months ended September 30, 2022.
Net loss was $2.4 million, or $0.08 per ordinary
share (basic and diluted), for the three months ended September 30,
2023, as compared to $3.1 million, or $0.11 per ordinary share
(basic and diluted), for the three months ended September 30,
2022.
About Entera Bio
Entera focuses on significant unmet medical
needs where an oral tablet form of a peptide treatment or protein
replacement therapy holds the potential to transform the standard
of care. The Company’s oral PTH (1-34) teriparatide mini tablets
have been administered to a total of 240 subjects (153 patients)
across Phase 1 and Phase 2 studies, with demonstrated
bioavailability and clinical benefit across two distinct diseases.
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. EB612 is being developed as
the first tablet peptide replacement therapy for the treatment of
hypoparathyroidism. The Company is currently conducting a phase 1
PK study of novel PTH formulations using its proprietary, next
generation oral delivery platform with data expected in the second
half of 2023. Entera is also developing oral GLP-2 peptide as an
injection-free alternative for patients suffering from short bowel
syndrome and other severe intestinal and malabsorption metabolic
conditions and oral Oxyntomodulin (GLP1/glucagon) peptide for
obesity in collaboration with OPKO Health. 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 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) |
|
|
|
|
|
|
September 30 |
|
December 31 |
|
2023 |
|
2022 |
|
(Unaudited) |
|
(Audited) |
|
|
Cash and cash equivalents |
7,585 |
|
12,309 |
Accounts receivable and other current assets |
431 |
|
540 |
Property and equipment, net |
108 |
|
139 |
Other assets, net |
441 |
|
139 |
Total assets |
8,565 |
|
13,127 |
|
|
|
|
|
|
Accounts payable and other current liabilities |
2,027 |
|
1,341 |
Total non-current liabilities |
302 |
|
32 |
Total liabilities |
2,329 |
|
1,373 |
Total shareholders' equity |
6,236 |
|
11,754 |
|
|
|
|
Total liabilities and shareholders' equity |
8,565 |
|
13,127 |
|
ENTERA BIO LTD. CONSOLIDATED STATEMENTS OF
OPERATIONS (U.S. dollars in thousands, except share and
per share data)(Unaudited) |
|
|
|
Three Months Ended September
30, |
|
|
2023 |
|
2022 |
|
|
|
|
|
REVENUES |
|
- |
|
8 |
COST OF
REVENUES |
|
- |
|
6 |
GROSS
PROFIT |
|
- |
|
2 |
OPERATING
EXPENSES: |
|
|
|
|
Research and
development |
|
1,370 |
|
1,413 |
General and
administrative |
|
1,028 |
|
1,460 |
Other
income |
|
(12) |
|
(6) |
TOTAL OPERATING
EXPENSES |
|
2,386 |
|
2,867 |
OPERATING
LOSS |
|
2,386 |
|
2,865 |
FINANCIAL EXPENSES
(INCOME), NET |
|
(36) |
|
8 |
LOSS BEFORE INCOME
TAX |
|
2,350 |
|
2,873 |
INCOME
TAX |
|
29 |
|
194 |
NET LOSS |
|
2,379 |
|
3,067 |
|
|
|
|
|
BASIC AND DILUTED LOSS
PER SHARE |
|
0.08 |
|
0.11 |
|
|
|
|
|
WEIGHTED AVERAGE
NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND
DILUTED LOSS PER SHARE |
|
28,813,952 |
|
28,809,922 |
Contact:
Entera Bio:
Ms. Miranda Toledano
Chief Executive Officer
Email: miranda@enterabio.com
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