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(State or other jurisdiction
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(Commission File Number)
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(I.R.S. Employer
Identification) |
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a -12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d -2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e -4(c))
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Title of each class
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Trading Symbol(s)
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Name of each exchange on which registered
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Exhibit
Number
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Description
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104
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Cover Page Interactive Data File (embedded within the Inline XBRL document)
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ENTERA BIO LTD.
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Date: November 10, 2022
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By:
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/s/ Miranda J. Toledano
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Name: Miranda J. Toledano
Title: Chief Executive Officer
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• |
On October 6th, 2022, Entera announced that it had successfully completed its Type C meeting and reached a record agreement with the U.S. Food and Drug Administration
(FDA) that a single pivotal Phase 3 placebo-controlled study could support a New Drug Application (NDA) submission for its lead clinical candidate, EB613 under the 505(b)(2) regulatory pathway.
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• |
Importantly, the FDA also agreed that total hip bone mineral density (BMD), not fracture, could serve as the primary endpoint for the registrational study of EB613;
and that Entera could enroll the same post-menopausal osteoporosis patient population that significantly benefited from EB613 treatment during Entera’s Phase 2 clinical study which was reported in 2021.
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• |
EB613 is the first oral, daily tablet formulation of synthetic hPTH (1-34), (teriparatide), consisting of the exact same 34 amino acid sequence as daily subcutaneous
teriparatide injection, Forteo® which has been the leading anabolic treatment of osteoporosis since 2002 with peak sales of $1.7 billion in 2018 prior to patent expiration. EB613 tablets are simple, small (~ 6 mm wide) and administered once
daily.
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Low BMD osteoporotic patients at high risk of fracture are often reluctant to initiate injectable anabolic (bone forming) therapy and represent an estimated 40% of
the 3 million currently treated patients across the United States, while current bone forming injections treat less than 10% of these patients1. As the first daily tablet PTH osteoanabolic treatment, EB613 could significantly
impact the osteoporosis treatment paradigm. Patient enrollment in the pivotal phase 3 study is expected to commence in 2023.
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New findings on EB613 were presented in a poster titled “A Six-month Phase 2 Study of Oral PTH (EBP05) in Postmenopausal Women with Low Bone Mass – Dose Proportional
Absorption and Effect on Lumbar Spine BMD (SUN-591)” at the American Society for Bone and Mineral Research (ASBMR) 2022 Annual Meeting in September.
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New analyses of hPTH concentration in blood shortly after a dose of EB613 tablets confirmed a strong, statistically significant correlation between mean blood level
and the dose of EB613 taken.
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These findings are consistent with the positive correlation between the change in lumbar spine BMD and EB613 dose after six months of treatment.
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ENTERA BIO LTD.
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CONSOLIDATED BALANCE SHEETS
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||||||||
(U.S. dollars in thousands, except share data)
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||||||||
(Unaudited)
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||||||||
September 30
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December 31
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|||||||
2022
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2021
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|||||||
Cash and cash equivalents
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14,323
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24,892
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||||||
Accounts receivable and other current assets
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867
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437
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||||||
Property and equipment, net
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152
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156
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||||||
Other assets, net
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198
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502
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||||||
Total assets
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15,540
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25,987
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||||||
Accounts payable and other current liabilities
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1,193
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3,161
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Total non current liabilities
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35
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261
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Total liabilities
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1,228
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3,422
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||||||
Total shareholders' equity
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14,312
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22,565
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Total liabilities and shareholders' equity
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15,540
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25,987
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Three Months ended
September 30,
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||||||||
2022
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2021
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|||||||
REVENUES
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8
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140
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||||||
COST OF REVENUES
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6
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65
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||||||
GROSS PROFIT
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2
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75
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||||||
OPERATING EXPENSES:
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||||||||
Research and development
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1,413
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1,771
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General and administrative
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1,460
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1,535
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||||||
Other income
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(6
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)
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(11
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)
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||||
TOTAL OPERATING EXPENSES
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2,867
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3,295
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||||||
OPERATING LOSS
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2,865
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3,220
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||||||
FINANCIAL EXPENSES, net
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8
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7
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LOSS BEFORE INCOME TAX
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2,873
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3,227
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INCOME TAX ָ(BENEFIT)
EXPENSE
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194
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(13
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)
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NET LOSS
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3,067
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3,214
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LOSS PER SHARE BASIC AND DILUTED
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0.11
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0.11
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WEIGHTED-AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER SHARE
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28,809,922
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28,680,833
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