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(State or other jurisdiction
of incorporation) |
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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: March 8, 2022
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By:
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/s/ Spiros Jamas
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Name: Spiros Jamas
Title: Chief Executive Officer
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• |
Successful End of Phase 2 Meeting with FDA: Entera met with the
U.S. Food and Drug Administration (FDA), presented Phase 2 results, and reviewed the development plan of EB613 including the design of a Phase 3 registration trial expected to commence in 2022. Entera believes that the meeting was positive
and confirmed the use of bone mineral density (BMD) as the primary endpoint. The study design is being adjusted to incorporate FDA’s input and we intend to maintain close communication with the FDA to support our EB613 Osteoporosis program.
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Osteoporosis Phase 2 study meets endpoints: Entera effectively
executed the clinical development of EB613 for osteoporosis, as the Company’s lead drug candidate met its Phase 2 primary and key secondary endpoints. EB613 significantly increased lumbar spine BMD, in addition to the femoral neck, and total
hip BMD when compared to placebo after six months of treatment. EB613 demonstrated a safety profile consistent with Forteo®, a drug that has generated peak worldwide sales of $1.9 billion. Study results were shared with the
osteoporosis community in two presentations including being selected for a prestigious Late Breaking Oral Presentation at the American Society for Bone and Mineral Research (ASBMR) Annual Meeting in October 2021.
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• |
Entera engaged Torreya Capital, LLC, a global investment bank, to serve as their exclusive financial advisor for Entera’s business development activities to secure
non-dilutive funding through strategic alliances for our lead asset, EB613 for Osteoporosis.
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• |
EB612 Hypoparathyroidism Successful Phase 2a Data Published, Next Trial
Expected to Commence in 2022: Entera’s Phase 2a clinical results from its EB612 program, an oral parathyroid hormone (PTH) for the treatment of hypoparathyroidism, were published in February 2021 in the Journal of Bone and Mineral Research. The trial achieved its primary and
secondary endpoints with published data showing that when added to the standard of care, EB612 led to a statistically significant decrease in supplemental calcium usage. EB612 has the potential to have a major impact on compliance, adherence,
therapeutic impact, and quality of life for patients living with Hypoparathyroidism, a rare condition in which a person produces an abnormally low level of PTH. It also causes a heavy disease burden due to its impact on a patient’s
cardiovascular, neurologic, renal, and skeletal systems. Entera is currently working on an improved formulation of EB612 and is designing its next clinical trial, which it expects to commence in 2022. EB612 has Orphan Drug status with both
the FDA and the European Medicines Agency for Hypoparathyroidism.
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• |
Advanced Platform Technology: As a leader in the oral delivery of large proteins, Entera further advanced its platform technology in 2021 by identifying potential new treatment indications, filing
new patents, and receiving a foundational patent in the European Union, representing new intellectual property with an extended patent life. Entera’s platform technology continues to gain recognition for its applications in transforming
injectable biologics into oral pills. A study in collaboration with researchers at the University of East Anglia in the UK, describing the platform’s dual mechanism of action, was published in the peer-reviewed International Journal of Pharmaceutics:X in October 2021.
Additionally, new data were announced1 suggesting Entera’s platform orally delivers human growth hormone, and these data were shared in a poster presentation at the 31st Annual European
Pharma Congress in London in 2021.
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Biopharma Collaborations Continue: While Entera continues its
long-term collaboration with Amgen, the Company entered additional new material transfer agreements in 2021 with other companies in the biopharma industry. Working closely with the new collaborators, Entera has been generating proof of
principle data on its platform’s applications to large molecules, which may lead to additional new deals.
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ENTERA BIO LTD.
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CONSOLIDATED BALANCE SHEETS AUDITED
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(U.S. dollars in thousands, except share data)
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December 31
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|||||||
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2021
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2020
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||||||
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||||||||
Cash and cash equivalents
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24,892
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8,593
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||||||
Accounts receivable and other current assets
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437
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516
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Property and equipment, net
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156
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192
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Other assets, net
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502
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421
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Total assets
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25,987
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9,722
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||||||
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||||||||
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Accounts payable and other current liabilities
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3,161
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1,841
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||||||
Total non current liabilities
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261
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371
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Total liabilities
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3,422
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2,212
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Total shareholders' equity
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22,565
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7,510
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||||||
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Total liabilities and shareholders' equity
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25,987
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9,722
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Year ended December 31
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|||||||
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2021
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2020
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||||||
REVENUES
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571
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365
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COST OF REVENUES
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373
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300
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||||||
GROSS PROFIT
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198
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65
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||||||
OPERATING EXPENSES:
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||||||||
Research and development
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6,771
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6,382
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General and administrative
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5,690
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4,851
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||||||
Other income
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(46
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)
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-
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|||||
TOTAL OPERATING EXPENSES
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12,415
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11,233
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||||||
OPERATING LOSS
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12,217
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11,168
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FINANCIAL EXPENSES, net
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29
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28
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LOSS BEFORE INCOME TAX
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12,246
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11,196
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INCOME TAX ָ(BENEFIT) EXPENSE
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(59
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)
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20
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NET LOSS
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12,187
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11,216
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LOSS PER SHARE BASIC AND DILUTED
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0.47
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0.67
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WEIGHTED-AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER SHARE
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26,133,770
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18,417,093
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