ENTERA BIO LTD.
(Registrant)
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By:
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/s/ Dr. Roger Garceau
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Name: Roger Garceau
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Title: Chief Executive Officer
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N
|
Mean
|
Median
|
|
Age
|
72
|
61.10
|
61.00
|
Weight (Kg)
|
72
|
64.65
|
61.50
|
BMI
|
72
|
25.34
|
24.36
|
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
|
• |
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:
|
o |
Approximately 85% of clinicians surveyed stated they were likely to prescribe oral PTH to treat moderate to severe osteoporosis
|
o |
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
|
o |
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.
|
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
|
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
|