Entera Bio Ltd. (NASDAQ: ENTX), a leader in the development of
orally delivered large molecule therapeutics, announced financial
and operating results for the quarter ended June 30, 2020 as well
as 6-month interim biomarker and bone mineral density (BMD) data
from the first 50% of the projected enrollment in the ongoing Phase
2 clinical trial of EB613. EB613, Entera’s clinical compound,
is an orally delivered human parathyroid hormone (1-34), or PTH,
program positioned as the first potential oral bone building
product to treat osteoporosis patients.
Based on the 6-month data, EB613 generated a
mean placebo adjusted increase in lumbar spine BMD of 2.15% (p =
0.08) for the 14 patients in the 1.5 mg treatment arm, as compared
to 16 patients in the placebo arm. The placebo-adjusted increase
was comprised of a mean BMD increase of 1.44% in the 1.5 mg
treatment arm compared to a mean decrease of 0.71% in the placebo
arm. An additional analysis of BMD changes in all EB613 treatment
groups showed a significant dose-dependent trend in the percentage
change in lumbar spine BMD. This dose response supports the use of
a higher dose to potentially increase efficacy. As expected and
consistent with published data from subcutaneous teriparatide, an
analysis of BMD of the total femur and femoral neck did not show a
significant effect from treatment with EB613. Increases in and
maintenance of BMD are widely accepted by clinicians throughout the
world as indicators of an overall improvement of osteoporosis and a
change in lumbar spine BMD is typically accepted by the United
States Food and Drug Administration as a phase 3 study efficacy
endpoint for a novel oral formulation intended to treat
osteoporosis using the 505 (b)(2) regulatory pathway. This is due
to the fact that PTH (1-34) (teriparatide for injection) has been
shown to reduce the risk of fractures.
The 6-month Placebo Adjusted Lumbar Spine BMD
results are summarized below (mean, standard error):
https://www.globenewswire.com/NewsRoom/AttachmentNg/43b00428-a38a-41e8-a645-2627ad3fdd9a
“We are highly encouraged by the dose dependent
improvement in lumbar spine BMD as seen in the interim data from
the first half of the patients in the EB613 Phase 2 dose ranging
clinical trial, especially given the small sample size of only 14
patients in the 1.5 mg treatment group. While the data reported
today include favorable results from the 1.5 mg treatment arm, we
believe that 1.5 mg may not be the maximum effective dose. This
belief which is supported by the 3-month biomarker data we reported
earlier this year, led us to amend the protocol in July to add a
2.5 mg treatment arm to the trial,” stated Roger Garceau, MD,
Director and Interim CEO of Entera. “Given the results we saw in
the 1.5mg treatment group, we are very much looking forward to
seeing the performance of the 2.5 mg treatment arm,” continued Dr.
Garceau.
6-Month Interim Results from Phase 2
Study of EB613 in Osteoporosis
The Phase 2 clinical trial of EB613 is a
dose-ranging, placebo-controlled, study in postmenopausal female
subjects with osteoporosis, or low BMD, and is being conducted at
four leading medical centers in Israel. Phase 2 dose-ranging
studies are utilized to determine the best dose to move into later
stage clinical trials. Based on the three-month interim biochemical
marker and safety data from the first 80 subjects randomized, the
Phase 2 protocol was amended in July 2020 to discontinue the two
lower doses (0.5 mg and 1.0 mg) and add a 2.5 mg dose of EB613. The
clinical trial is currently enrolling subjects in the 2.5 mg, 1.5
mg and placebo groups, with completion of enrollment for the
targeted 160 patients expected by the end of the third quarter.
There are currently 131 subjects enrolled in the trial.
Of the first 80 subjects who were enrolled in
the trial, 72 completed their 3-month visit and 68 completed their
6-month visit. Bone biomarker data at 6-months including P1NP,
Osteocalcin and CTX were consistent with the results seen after
three months of treatment at the 1.5 mg dose. There were no
significant changes in any of these bone biomarkers after treatment
with EB613 for 6 months, versus placebo. The demographics for the
EB613 Phase 2 clinical trial such as age, BMI and baseline levels
of bone markers were generally consistent with demographics from
similar osteoporosis studies in the literature.
|
|
N |
Mean |
Median |
|
Age |
72 |
61.10 |
61.00 |
|
Weight (Kg) |
72 |
64.65 |
61.50 |
|
BMI |
72 |
25.34 |
24.36 |
|
|
|
|
|
The placebo adjusted changes at 6-months in
lumbar spine BMD for each treatment arm are summarized in the table
below:
Difference in Mean % Change in Lumbar Spine BMD from
Baseline at Month 6 (EB613 Treatment – Placebo) * |
|
|
Mean |
Std Error |
p-value |
|
EB613 0.5 mg |
0.9168 |
1.0370 |
0.38 |
|
EB613 1.0 mg |
1.7218 |
1.0502 |
0.11 |
|
EB613 1.5 mg |
2.1533 |
1.1820 |
0.08 |
*Number of subjects: Placebo (16), 0.5 mg
treatment arm (19); 1.0 mg treatment arm (19); 1.5 mg treatment arm
(14)
“These interim data mark the first time Entera
has evaluated the BMD effect of EB613, and we are pleased with the
results to date. Given the small number of subjects evaluated and
our estimate that the 1.5-mg dose may not be maximally effective,
we did not expect to see statistically significant results, but
were very pleased with the p-value observed in the high dose
group. We were also pleased with the significant
dose-dependent trend in the change in lumbar spine BMD. As
potentially the first oral PTH to treat osteoporosis patients, we
note that EB613 has a bone biomarker profile that is different from
subcutaneous PTH,” stated Arthur Santora, MD, PhD, Chief Medical
Officer of Entera. “As a result, these interim lumbar spine BMD
data are supportive of the 2.5 mg dose we recently added to the
ongoing Phase 2 study. Based on guidance from the FDA, and given
positive final results from the current Phase 2 trial, we
anticipate one global pivotal Phase 3 505(b)(2) non-inferiority
study of EB613 as compared to Forteo®, with a primary endpoint of a
change in lumbar spine bone mineral density,” continued Dr.
Santora.
Second Quarter 2020 and Recent
Highlights
- Highly Encouraging Market Research Results Indicate Oral PTH’s
Potential to Significantly Expand a Multi-Billion Dollar Global
Market: Two primary market research studies of clinicians who treat
osteoporosis patients were conducted by a third-party firm with a
goal of gaining a better understanding of the perceived value and
potential market penetration of an orally-delivered PTH product in
the treatment of osteoporosis. Results included:
- Approximately 85% of clinicians
surveyed stated they were likely to prescribe oral PTH to treat
moderate to severe osteoporosis
- Oral PTH was described by
clinicians as a potential game-changer that addresses a substantial
unmet need with the possibility of improving patient compliance and
comfort
- More than half of clinicians are
likely to increase usage of PTH to treat osteoporosis if an
effective orally delivered product is available
- Continued Development of EB612:
Following the conclusion of a successful Phase 2a study of EB612 in
the treatment of hypoparathyroidism, Entera is developing
formulations of the drug with different release profiles with the
goal of selecting the optimal formulation to be used in a Phase 2b
or Phase 3 clinical trial in patients with hypoparathyroidism in
2021.
- Pipeline Update: Entera is making
progress towards its goal of building out two new targets each year
for preclinical development based on its oral drug delivery
platform. Several potential candidates are currently being
evaluated, and Entera expects to provide an update on target
selection by the end of 2020.
- European Patent for Oral PTH: The
European Trademark Office granted Entera a patent titled “Methods
and Compositions for Oral Administration of Proteins.” This
composition patent covers oral administration of proteins (up to
100kD) and specifically PTH, using Entera's oral delivery
technology.
- Amgen Collaboration Agreement:
Several studies have been completed using Entera’s technology to
evaluate different formulations of Amgen’s drug. While continuing
to work with Amgen, Entera is actively evaluating additional
business development opportunities to leverage the Company’s
technology platform.
“In the coming quarters, we expect to achieve
several additional milestones in the clinical development of EB613
for the treatment of osteoporosis including the completion of
patient enrollment for the Phase 2 study in the third quarter of
2020, efficacy results for the full three-month biomarker data in
the first quarter of 2021, and efficacy and safety results for the
full trial in the second quarter of 2021. We anticipate an
End-of-Phase 2 meeting with the FDA in the middle of 2021, followed
by the potential commencement of a global, pivotal Phase 3 study in
2021 or 2022. Given the highly encouraging results of two recent
market surveys with clinicians who treat osteoporosis, we believe
the value proposition of EB613 has been confirmed. An effective and
safe oral PTH may significantly expand the osteoporosis treatment
market, as only an estimated 5% of osteoporosis patients today are
opting in for the currently available injectable products,” added
Dr. Garceau.
Financial Results for the Six Months
Ended June 30, 2020
Revenues for the six months ended June 30, 2020
were $94,000 as compared to $74,000 in the first half of 2019, with
revenues in both years attributable to R&D services provided to
Amgen. The cost of revenues for the six months ended June 30, 2020
and 2019 were $73,000 and $62,000, respectively and were comprised
of salaries and related expenses in connection with the R&D
services provided to Amgen.
Operating expenses were $6.4 million for the six
months ended June 30, 2020, compared to $5.1 million for the first
half of 2019. Entera’s operating loss was $(6.4) million for the
six months ended June 30, 2020, compared to $(5.1) million for the
first half of 2019.
Research and development expenses were $3.6
million for the six months ended June 30, 2020, compared to $3.4
million for the six months ended June 30, 2019. The increase was
primarily due to an increase in consulting fees related to the
preparation of an IND application for EB613 and an increase in
clinical trial expenses relating to the Phase 2 clinical trial of
EB613 which were partially offset by a reduction in material and
production expenses due to significant manufacturing activities to
support preclinical and clinical trials during the six months ended
June 30, 2019 that were not repeated in 2020.
General and administrative expenses were $2.8
million for the six months ended June 30, 2020, compared to $1.7
million for the six months ended June 30, 2019. The increase was
primarily due to increases in compensation related expenses,
professional fees and insurance costs that were partially offset by
a decline in investor relations and other expenses.
Net comprehensive loss was $(6.1) million for
the six months ended June 30, 2020, or $(0.34) per ordinary share,
compared to $(4.4) million, or $(0.38) per ordinary share for the
six months ended June 30, 2019. The change in net loss is primarily
due to the increase in overall operating expenses.
At June 30, 2020, Entera had cash and cash
equivalents of $9.8 million, compared to $15.2 million at December
31, 2019.
Entera expects an operating loss of at least
$11.4 million for the year ending December 31, 2020, and believes
its current cash position will be sufficient to fund its operations
into the second quarter of 2021.
Conference Call and Webcast
Information
Entera’s management will host a conference call
on Thursday, August 20, 2020 at 8:30 a.m. EDT. A
question-and-answer session will follow Entera’s remarks. To
participate on the live call, please dial (855) 547-3865 (US) or
(409) 217-8787 (international) and provide the conference ID
“5243229” five to ten minutes before the start of the call.
To access a live audio webcast of the
presentation on the “Investor Relations” page of Entera’s website,
please click here. A replay of the webcast will be archived on
Entera’s website for approximately 45 days following the
presentation.
About Entera Bio Ltd.
Entera is a leader in the development of orally
delivered macromolecule therapeutics for use in areas with
significant unmet medical need where adoption of injectable
therapies is limited due to cost, convenience and compliance
challenges for patients. The Company’s proprietary, oral drug
delivery technology is designed to address the technical challenges
of poor absorption, high variability, and the inability to deliver
large molecules to the targeted location in the body through the
use of a synthetic absorption enhancer to facilitate the absorption
of large molecules, and protease inhibitors to prevent enzymatic
degradation and support delivery to targeted tissues. The Company’s
most advanced product candidates, EB613 for the treatment of
osteoporosis and EB612 for the treatment of hypoparathyroidism are
in Phase 2 clinical development. Entera also licenses its
technology to biopharmaceutical companies for use with their
proprietary compounds and, to date, has established a collaboration
with Amgen Inc. For more information on Entera Bio, visit
www.enterabio.com.
Forward Looking Statements
Various statements in this release are
“forward-looking statements” under the securities laws. 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
our interpretation of the interim data from the ongoing Phase 2
clinical trial of EB613, 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; a possible
suspension of the Phase 2 clinical trial of EB613 for clinical or
data-related reasons; the impact of COVID-19 on Entera’s business
operations including enrollment in the Phase 2 clinical trial for
EB613 in patients with osteoporosis and the ability to collect the
necessary data from the Phase 2 trial of EB613; the potential
disruption and delay of manufacturing supply chains, loss of
available workforce resources, either by Entera or its
collaboration and laboratory partners, due to travel restrictions,
lay-offs or forced closures or repurposing of hospital facilities;
impacts to research and development or clinical activities that
Entera is contractually obligated to provide, such as pursuant to
Entera’s agreement with Amgen; overall regulatory timelines, if the
FDA or other authorities are closed for prolonged periods, choose
to allocate resources to review of COVID-19 related drugs or
believe that the amount of Phase 2 clinical data collected so far
are insufficient to initiate a Phase 3 trial, or a meaningful
deterioration of the current political, legal and regulatory
situation in Israel or the United States; the availability, quality
and timing of the data from the Phase 2 clinical trial of EB613 in
osteoporosis patients; the ability find a dose that demonstrates
the comparability of EB613 to FORTEO in the ongoing Phase 2
clinical trial of EB613; the size and growth of the potential
market for EB613 and Entera’s other product candidates including
any possible expansion of the market if an orally delivered option
is available in addition to an injectable formulation; 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 expectations regarding its expenses, revenue, cash
resources; Entera’s ability to raise additional capital; Entera’s
interpretation of FDA feedback and guidance and how such guidance
may impact its clinical development plans; 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 “Special Note Regarding Forward-Looking Statements,” “Risk
Factors” and “Management’s Discussion and Analysis of Financial
Condition and Results of Operations” sections of Entera’s annual
and current filings which are on file with the SEC and available
free of charge on the SEC’s website at http://www.sec.gov.
Additional factors may be set forth in those sections of Entera’s
Quarterly Report on Form 6-K for the quarter ended June 30, 2020,
to be filed with the SEC in the third quarter of 2020. In addition
to the risks described above and in Entera’s annual report on Form
20-F and current reports on Form 6-K and other filings with the
SEC, other unknown or unpredictable factors also could affect
Entera’s results. 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 in such forward-looking
statements and estimates will be achieved.
All written and verbal forward-looking
statements attributable to Entera or any person acting on its
behalf are expressly qualified in their entirety by the cautionary
statements contained or referred to herein. Entera cautions
investors not to rely too heavily on the forward-looking statements
Entera makes or that are made on its behalf. The information
in this release is provided only as of the date of this release,
and Entera undertakes no obligation, and specifically declines any
obligation, to update or revise publicly any forward-looking
statements, whether as a result of new information, future events
or otherwise.
ENTERA BIO LTD.CONDENSED
CONSOLIDATED STATEMENTS OF COMPREHENSIVE
LOSS(UNAUDITED)(US$ in thousands,
except share and per share data)
|
|
|
|
Six months ended |
|
Three months ended |
|
|
June 30 |
|
June 30 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
REVENUE |
$ |
94 |
|
$ |
74 |
|
$ |
52 |
|
$ |
74 |
|
COST OF REVENUE |
|
73 |
|
|
62 |
|
|
31 |
|
|
62 |
|
RESEARCH AND DEVELOPMENT EXPENSES, NET |
|
3,616 |
|
|
3,448 |
|
|
2,011 |
|
|
1,413 |
|
GENERAL AND ADMINISTRATIVE EXPENSES |
|
2,827 |
|
|
1,684 |
|
|
1,537 |
|
|
628 |
|
OPERATING LOSS |
|
6,422 |
|
|
5,120 |
|
|
3,527 |
|
|
2,029 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
FINANCIAL INCOME: |
|
|
|
|
Income from change in fair value of financial liabilities at fair
value |
|
(318 |
) |
|
(794 |
) |
|
(366 |
) |
|
(682 |
) |
Other financial expenses, net |
|
6 |
|
|
35 |
|
|
29 |
|
|
19 |
|
FINANCIAL INCOME, NET |
|
(314 |
) |
|
(759 |
) |
|
(337 |
) |
|
(663 |
) |
NET COMPREHENSIVE LOSS FOR THE PERIOD |
$ |
6,108 |
|
$ |
4,361 |
|
$ |
3,190 |
|
$ |
1,366 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. dollars |
|
U.S.
dollars |
|
|
|
|
|
LOSS PER ORDINARY
SHARE: |
|
|
|
|
Basic and diluted |
$ |
0.34 |
|
$ |
0.38 |
|
$ |
0.17 |
|
$ |
0.12 |
|
|
|
|
|
|
|
|
|
|
|
|
WEIGHTED AVERAGE NUMBER OF SHARES
OUTSTANDING: |
|
|
|
|
Basic and diluted |
|
18,142,016 |
|
|
11,601,289 |
|
|
18,234,191 |
|
|
11,742,797 |
|
ENTERA BIO LTD.CONDENSED
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION(US$
in thousands)
|
|
|
|
|
|
|
|
|
June
30, |
|
December
31, |
|
|
|
2020 |
|
2019 |
|
|
|
(Unaudited) |
|
(Audited) |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
9,767 |
|
$ |
15,185 |
|
Accounts receivable and other current assets |
|
|
677 |
|
|
451 |
|
Property and equipment, net |
|
|
199 |
|
|
202 |
|
Other assets, net |
|
|
819 |
|
|
865 |
|
Total assets |
|
$ |
11,462 |
|
$ |
16,703 |
|
|
|
|
|
|
|
Accounts payable and other
current liabilities |
|
$ |
1,727 |
|
$ |
2,148 |
|
Warrant liabilities |
|
|
2,350 |
|
|
2,444 |
|
Total current liabilities |
|
|
4,077 |
|
|
4,592 |
|
Total Non-current
liabilities |
|
|
156 |
|
|
192 |
|
Total shareholders’ equity |
|
|
7,229 |
|
|
11,919 |
|
Total liabilities and shareholders’ equity |
|
$ |
11,462 |
|
$ |
16,703 |
|
|
|
|
|
|
|
|
Contact:
Jonathan Lieber, CFO
Tel: +001 617-362-3579
jon@enterabio.com
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