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 second quarter ended June 30, 2023.
“In the last year, we have successfully focused our
resources to drive value across three main pillars: (1) moving our
EB613 program along the right path to a Phase 3 registrational
study, (2) developing a potential new generation for EB612 and (3)
expanding our technological capabilities and platform. Our 2022
R&D plan resulted in pre-clinical validation of proprietary new
generations of our oral peptide delivery platform. These are
primarily designed to modify pharmacokinetic (PK)/ pharmacodynamic
(PD) parameters, optimize bioavailability and curb oral dosing
regimens across more complex peptides and therapeutic proteins.
They are also designed to develop novel, proprietary life cycle
extension candidates for our own first-in-class PTH(1-34) mini
tablet treatments for osteoporosis and hypoparathyroidism. We view
this as crucial given current pharmacoeconomic debates across our
industry. We are determined to develop a simple, oral mini tablet
format of peptides and therapeutic proteins in the most efficient
manner to facilitate access to millions of patients globally. We
expect to announce data from our Phase 1B study of our new
generation platform in the second half of 2023. Likewise, we
anticipate critical updates related to the FNIH-BQP qualification
process, which has a direct implication to the potential initiation
of our pivotal Phase 3 program for EB613,” said Miranda Toledano,
Entera’s Chief Executive Officer.
Corporate Updates:
- EB613: The
First and Only Once Daily PTH(1-34) Mini Tablet Treatment for
Post-Menopausal Women with High Risk
Osteoporosis. Alignment continues across our
CMC/supply chain, clinical operations, and strategic discussions to
potentially initiate the Phase 3 registrational study for EB613. A
critical milestone is anticipated with FDA’s review and potential
qualification of the FNIH-ASBMR SABRE BQP.1
- EB612: Next
Generation Oral Peptide Platform Data Read-Outs Expected in
H2’2023. In May 2023, Entera initiated a 45 subject, three
cohort, Phase 1B study comparing the safety, PK and early PD
outcomes for several novel PTH(1-34) tablet formulations versus our
current tablet formulations. The Company is expected to read out
data from the first two cohorts of the study in H2’2023. The
outcome of this study will serve to (1) validate the new platform
using PTH(1-34) as our model molecule, (2) provide a lifecycle
management candidate for EB613 once daily tablets for osteoporosis,
(3) provide a next generation for EB612 as the first PTH hormone
replacement therapy in daily tablet form, and (4) expand the
development of additional targeted and potentially more complex
oral peptides and therapeutic proteins independently and in
collaboration with strategic partners.
- Expansion
of IP Estate. Over the past quarter we have continued to
expand and deepen our global patent portfolio. Prosecution of
patent applications pertaining to treatment of osteoporosis or
hypoparathyroidism by oral administration of PTH-containing tablets
resulted in additional granted patents worldwide. New
international patent applications, pertaining to the next
generations of our base technology were filed, and additional
patent applications covering additional modifications to our
technology are expected to be filed later this year.
Financial Results for the Six Months Ended
June 30, 2023
As of June 30, 2023, Entera had cash and cash
equivalents of $9.1 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 R&D
and the completion of the Phase 1B PK study related to our new
generation platform and potential new formulations for EB612.
Research and development expenses for the
six months ended June 30, 2023 were $2.1 million, as compared to
$3.1 million for the six months ended June 30, 2022. The decrease
of $1.0 million was primarily due to a decrease of $0.4 million in
pre-clinical activity and a decrease of $0.6 million in share-based
compensation and a one-time payment made to a former employee
pursuant to the terms of his separation agreement.
General and administrative expenses for
the six months ended June 30, 2023 were $2.4 million, as compared
to $4.1 million for the six months ended June 30, 2022. The
decrease of $1.7 million was mainly attributable to a decrease of
$0.8 million in employee compensation, including share-based
compensation, a decrease of $0.6 million in professional fees and
other consultants and a decrease of $0.3 million in D&O
insurance costs.
Operating expenses for the six months ended June
30, 2023 were $4.5 million, as compared to $7.1 million for the six
months ended June 30, 2022.
Net loss was $4.5 million, or $0.16 per ordinary
share (basic and diluted), for the six months ended June 30, 2023,
as compared to $7.0 million, or $0.24 per ordinary share (basic and
diluted), for the six months ended June 30, 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®. 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 was initiated in H1 2023 to ascertain
feasibility of a new hypo candidate (a prior formulation had
positive Phase 2a data announced in 2015 and published in the JBMR
in 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 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) |
|
|
|
|
|
|
|
|
|
June 30, |
|
December 31, |
|
|
2023 |
|
2022 |
|
|
(Unaudited) |
|
(Audited) |
|
|
|
|
Cash and
cash equivalents |
9,135 |
|
12,309 |
|
Accounts
receivable and other current assets |
679 |
|
540 |
|
Property
and equipment, net |
122 |
|
139 |
|
Other
assets, net |
509 |
|
139 |
|
Total assets |
10,445 |
|
13,127 |
|
|
|
|
|
|
|
|
|
Accounts
payable and other current liabilities |
1,865 |
|
1,341 |
|
Total
non-current liabilities |
348 |
|
32 |
|
Total
liabilities |
2,213 |
|
1,373 |
|
Total
shareholders' equity |
8,232 |
|
11,754 |
|
|
|
|
|
|
Total liabilities and shareholders' equity |
10,445 |
|
13,127 |
|
|
|
|
|
|
ENTERA BIO
LTD. |
CONSOLIDATED
STATEMENTS OF OPERATIONS |
(U.S. dollars in
thousands, except share and per share data) |
(Unaudited) |
|
|
Six Months
Ended |
|
|
June 30, |
|
|
2023 |
|
2022 |
|
|
|
|
|
|
REVENUES |
- |
|
112 |
|
COST OF REVENUES |
- |
|
87 |
|
GROSS PROFIT |
- |
|
25 |
|
OPERATING EXPENSES: |
|
|
|
|
Research and development |
2,140 |
|
3,084 |
|
General and administrative |
2,429 |
|
4,052 |
|
Other income |
(27) |
|
(27) |
|
TOTAL OPERATING EXPENSES |
4,542 |
|
7,109 |
|
OPERATING LOSS |
4,542 |
|
7,084 |
|
|
|
|
|
|
FINANCIAL INCOME, NET |
(27) |
|
(104) |
|
LOSS BEFORE INCOME TAX |
4,515 |
|
6,980 |
|
INCOME TAX BENEFIT |
- |
|
(11) |
|
NET LOSS |
4,515 |
|
6,969 |
|
|
|
|
|
|
LOSS PER SHARE BASIC AND DILUTED |
0.16 |
|
0.24 |
|
|
|
|
|
|
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING USED IN
COMPUTATION OF BASIC AND DILUTED LOSS PER SHARE |
28,811,162 |
|
28,806,217 |
|
|
|
|
|
|
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)
Contact:
Entera Bio:
Ms. Miranda Toledano
Chief Executive Officer
Entera Bio
Email: miranda@enterabio.com
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