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(State or other jurisdiction of
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(I.R.S. Employer
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incorporation or organization)
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Identification No.)
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(Address of principal executive offices)
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(Zip Code)
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Title of Each Class
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Trading Symbol
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Name of Each Exchange on Which Registered
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Warrants to purchase ordinary shares
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ENTXW
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Nasdaq Capital Market
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Large accelerated filer
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☐
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Accelerated filer
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☐
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☒
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Smaller reporting company
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Emerging growth company
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• |
the scope, progress and costs of developing our product candidates such as EB613 for osteoporosis and EB612 for hypoparathyroidism, including without limitation any changes to the design of the Phase 3 clinical trial of EB613;
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• |
the Food and Drug Administration (FDA) and other regulatory agencies’ acceptance of the proposed design for the Phase 3 clinical trial of EB613 and the outcome of future studies for EB612;
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• |
the accuracy of our estimates regarding expenses, capital requirements, the sufficiency of our cash resources and the need for additional financing;
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• |
our ability to raise additional funds on commercially reasonable terms, including via our Amended ATM Program (as defined in Part I, Item 2 “Management’s Discussion and Analysis of Financial Condition and Results of Operation—Liquidity and Capital Resources” of this Quarterly Report);
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• |
our reliance on third parties to conduct our clinical trials and on third-party suppliers to supply or produce our product candidates;
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• |
our interpretation of U.S. Food and Drug Administration (the “FDA”) feedback and guidance and how such guidance may impact our clinical development plans, specifically our ability to utilize the 505(b)(2) pathway for the development and potential approval of EB613 and any other product candidates we may develop;
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• |
our expectations regarding licensing, business transactions and strategic collaborations, including our ongoing collaboration with Amgen;
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our ability to use and expand our drug delivery technology to additional product candidates;
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• |
our operation as a development stage company with limited operating history and a history of operating losses and our ability to fund our operations going forward;
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• |
our ability to continue as a going concern absent access to sources of liquidity;
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• |
our ability to obtain and maintain regulatory approval for any of our product candidates;
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• |
our competitive position with respect to other products on the market or in development for the treatment of osteoporosis and hypoparathyroidism;
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our ability to establish and maintain development and commercialization collaborations;
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• |
any potential commercial launch of current or future product candidates, and the timing, cost or other aspects of such commercialization;
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our ability to manufacture and supply, in conjunction with our third-party supply chain partners, sufficient amounts of material to support our clinical trials and any potential future commercial requirements;
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the safety and efficacy of therapeutics marketed by competitors that are targeted toward indications for which we are developing product candidates;
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the size of any market we may target and the adoption of our product candidates, if approved, by physicians and patients;
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our ability to obtain, maintain and protect our intellectual property and operate our business without infringing misappropriating or otherwise violating any intellectual property rights of others;
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our ability to retain key personnel and recruit additional qualified personnel;
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the possibility that competing products or technologies may make any product candidates we may develop and commercialize or our oral delivery technology obsolete;
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the pricing and reimbursement of our product candidates, if approved;
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our ability to develop a sales, marketing and distribution infrastructure, if any;
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our ability to manage growth; and
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the duration and severity of the coronavirus (COVID-19) pandemic, the actions that may be required to contain the coronavirus or treat its impact, and its impact on our operations and workforce, including our research and development and clinical trials.
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Page | |
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS: | |
4 | |
5 | |
6 | |
7 | |
8 |
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June 30,
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December 31,
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||||||
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2022
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2021
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||||||
A s s e t s
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||||||||
CURRENT ASSETS:
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||||||||
Cash and cash equivalents
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||||||
Accounts receivable
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||||||
Other current assets
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TOTAL CURRENT ASSETS
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NON-CURRENT ASSETS:
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Property and equipment, net
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||||||
Operating lease right-of-use assets
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||||||
Deferred income taxes
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Funds in respect of employee rights upon retirement
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||||||
TOTAL NON-CURRENT ASSETS
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||||||
TOTAL ASSETS
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||||||
L i a b i l i t i e s and shareholders' equity
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||||||||
CURRENT LIABILITIES:
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||||||||
Accounts payable
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||||||
Accrued expenses and other payables
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||||||
Current maturities of operating lease
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||||||
Contract liabilities
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||||||
TOTAL CURRENT LIABILITIES
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||||||
NON-CURRENT LIABILITIES:
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||||||||
Operating lease liabilities
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||||||
Liability for employee rights upon retirement
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||||||
TOTAL NON-CURRENT LIABILITIES
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||||||
TOTAL LIABILITIES
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||||||
COMMITMENTS AND CONTINGENCIES
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||||||||
SHAREHOLDERS' EQUITY:
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||||||||
Ordinary Shares, NIS
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||||||
Additional paid-in capital
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||||||
Accumulated other comprehensive income
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||||||
Accumulated deficit
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(
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)
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(
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)
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||||
TOTAL SHAREHOLDERS' EQUITY
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||||||
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY
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||||||
Six Months Ended
June 30,
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Three Months Ended
June 30,
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|||||||||||||||
2022
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2021 |
2022
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2021 | |||||||||||||
REVENUES
|
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||||||||||||
COST OF REVENUES
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||||||||||||
GROSS PROFIT
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||||||||||||
OPERATING EXPENSES:
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||||||||||||||||
Research and development
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||||||||||||
General and administrative
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||||||||||||
Other income
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(
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)
|
(
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)
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(
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)
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(
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)
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||||||||
TOTAL OPERATING EXPENSES
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||||||||||||
OPERATING LOSS
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||||||||||||
FINANCIAL (INCOME) LOSS ,NET
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(
|
)
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(
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)
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(
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)
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|||||||||
LOSS BEFORE INCOME TAX
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||||||||||||
INCOME TAX BENEFIT
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(
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)
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(
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)
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(
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)
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(
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)
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||||||||
NET LOSS
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||||||||||||
LOSS PER SHARE BASIC AND DILUTED
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||||||||||||
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER SHARE
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ENTERA BIO LTD
Ordinary shares |
Additional |
Accumulated
other
|
||||||||||||||||||||||
Number of
shares issued
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Amounts
|
paid-in
capital
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Comprehensive
income
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Accumulated
deficit
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Total
|
|||||||||||||||||||
BALANCE AT JANUARY 1, 2022
|
|
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(
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)
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|||||||||||||||||
Net loss
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-
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(
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(
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)
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||||||||||||||||
Exercise of options to ordinary shares
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||||||||||||||||||
Share-based compensation
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-
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||||||||||||||||||
BALANCE AT JUNE 30, 2022
|
|
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(
|
)
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|||||||||||||||||
BALANCE AT APRIL 1, 2022
|
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(
|
)
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|
|||||||||||||||||
Net loss
|
-
|
|
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(
|
)
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(
|
)
|
||||||||||||||||
Exercise of options to ordinary shares
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|
|
|
|
|
|
||||||||||||||||||
Share-based compensation
|
-
|
|
|
|
|
|
||||||||||||||||||
BALANCE AT JUNE 30, 2022
|
|
|
|
|
(
|
)
|
|
|||||||||||||||||
BALANCE AT JANUARY 1, 2021
|
|
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(
|
)
|
|
|||||||||||||||||
Net loss
|
-
|
|
|
|
(
|
)
|
(
|
)
|
||||||||||||||||
Issuance of shares due to the ATM program, net of issuance costs
|
|
|
|
|
|
|
||||||||||||||||||
Exercise of options to ordinary shares
|
|
|
|
|
|
|
||||||||||||||||||
Exercise of warrants to ordinary shares
|
|
|
|
|
|
|
||||||||||||||||||
Share-based compensation
|
-
|
|
|
|
|
|
||||||||||||||||||
Vested restricted share units
|
|
|
|
|
|
|
||||||||||||||||||
BALANCE AT JUNE 30, 2021
|
|
|
|
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(
|
)
|
|
|||||||||||||||||
BALANCE AT APRIL 1, 2021
|
|
|
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|
(
|
)
|
|
|||||||||||||||||
Net loss
|
-
|
|
|
|
(
|
)
|
(
|
)
|
||||||||||||||||
Issuance of shares due to the ATM program, net of issuance costs
|
|
|
|
|
|
|
||||||||||||||||||
Exercise of options to ordinary shares
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|
|
|
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|
|
||||||||||||||||||
Exercise of warrants to ordinary shares
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|
|
|
|
|
|
||||||||||||||||||
Share-based compensation
|
-
|
|
|
|
|
|
||||||||||||||||||
BALANCE AT JUNE 30, 2021
|
|
|
|
|
(
|
)
|
|
Six months
ended June 30, |
||||||||
|
2022
|
2021
|
||||||
CASH FLOWS FROM OPERATING ACTIVITIES:
|
||||||||
Net loss
|
(
|
)
|
(
|
)
|
||||
Adjustments required to reconcile net loss to net cash used in operating activities:
|
||||||||
Depreciation
|
|
|
||||||
Deferred income taxes
|
(
|
)
|
(
|
)
|
||||
Share-based compensation
|
|
|
||||||
Finance income, net
|
(
|
)
|
(
|
)
|
||||
Changes in operating asset and liabilities:
|
||||||||
Decrease (increase) in accounts receivable
|
(
|
)
|
|
|||||
Increase in other current assets
|
(
|
)
|
(
|
)
|
||||
Increase (decrease) in accounts payable
|
(
|
)
|
|
|||||
Increase (decrease) in accrued expenses and other payables
|
(
|
)
|
|
|||||
Decrease in contract liabilities
|
(
|
)
|
(
|
)
|
||||
Net cash used in operating activities
|
(
|
)
|
(
|
)
|
||||
CASH FLOWS FROM INVESTING ACTIVITIES:
|
||||||||
Purchase of property and equipment
|
(
|
)
|
|
|||||
Net cash used in investing activities
|
(
|
)
|
|
|||||
CASH FLOWS FROM FINANCING ACTIVITIES:
|
||||||||
Proceeds from issuance of shares through ATM programs, net of issuance costs
|
|
|
||||||
Exercise of options and warrants into shares
|
|
|
||||||
Net cash provided by financing activities
|
|
|
||||||
INCREASE (DECREASE) IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH
|
(
|
)
|
|
|||||
CASH, CASH EQUIVALENTS AND RESTRICTED DEPOSITS AT BEGINNING OF THE PERIOD
|
|
|
||||||
CASH, CASH EQUIVALENTS AND RESTRICTED DEPOSITS AT END OF THE PERIOD
|
|
|
||||||
Reconciliation in amounts on consolidated balance sheets:
|
||||||||
Cash and cash equivalents
|
|
|
||||||
Restricted deposits included in other current assets
|
|
|
||||||
Total cash and cash equivalents and restricted cash
|
|
|
||||||
SUPPLEMENTARY INFORMATION ON INVESTING AND FINANCING ACTIVITIES NOT INVOLVING CASH FLOWS:
|
||||||||
Operating lease right of use assets obtained in exchange for new operating lease liabilities
|
|
|
(U.S. dollars in thousands, except share and per share data)
a.
|
Entera Bio Ltd. (collectively with its subsidiary, the "Company") was incorporated on September 30, 2009 under the laws of the State of Israel and commenced operation on June 1, 2010. On January 8, 2018 the Company incorporated Entera Bio Inc., a wholly owned subsidiary incorporated in Delaware, United States.The Company is a leader in the development of orally delivered macromolecule therapeutics, including peptides and other therapeutic proteins. The Company applies its platform 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 most advanced product candidates, EB613 for the treatment of osteoporosis and EB612 for the treatment of hypoparathyroidism, are based on its proprietary technology platform and are both in clinical development. Additionally, the Company intends to license its oral delivery technology to biopharmaceutical companies for use with their proprietary compounds. Entera established such a collaboration with Amgen Inc. (“Amgen”) in December 2018, for the use of the Company’s oral delivery platform in the field of inflammatory diseases.
|
|
b.
|
The Company's ordinary shares, NIS
|
|
c.
|
On December 10, 2018, the Company entered into a research collaboration and license agreement (the “Amgen Agreement”) with Amgen for the use of the Company’s oral delivery platform in the field of inflammatory disease and other serious illnesses. Pursuant to the Amgen Agreement, the Company and Amgen have agreed to use the Company’s proprietary drug delivery platform to develop oral formulations for one preclinical large molecule program that Amgen has selected. Amgen also has options to select up to two additional programs to include in the Amgen Agreement. Amgen is responsible for the clinical development, regulatory approval, manufacturing and worldwide commercialization of the programs.
The Company granted Amgen an exclusive, worldwide, sublicensable license under certain of its intellectual property relating to its drug delivery technology to develop, manufacture and commercialize the applicable products. The Company has retained all intellectual property rights to its drug delivery technology, and Amgen has retained all rights to its large molecules and any subsequent improvements, and ownership of certain intellectual property developed through the performance of the agreement is to be determined by U.S. patent law.
|
|
d.
|
Because the Company is engaged in research and development activities, it has not derived significant income from its activities and has incurred accumulated losses in the amount of $
|
8
ENTERA BIO LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
e.
|
Covid-19
In March 2020, the World Health Organization declared the outbreak of COVID-19 to be a pandemic. The COVID-19 pandemic is having widespread, rapidly evolving, and unpredictable impacts on global society, economies, financial markets, and business practices. During 2021, there was a broad distribution of several vaccinations and medicines to overcome the pandemic. The Company has adjusted its operations to co-exist with the pandemic and has encouraged its employees to get vaccinated against COVID-19. Though the Company sees great progress to overcome the COVID-19 pandemic, the COVID-19 pandemic may continue to impact the Company’s business operations, with outbursts of new variants of the COVID-19 from time to time, and there is uncertainty in the nature and degree of its continued effects over time.
|
a.
|
Basis of presentation of the financial statements
These unaudited interim condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America ("U.S. GAAP") for interim financial statements. Accordingly, they do not include all of the information and notes required by U.S. GAAP for annual financial statements. In the opinion of management, these unaudited condensed consolidated financial statements reflect all adjustments, which include normal recurring adjustments, necessary for a fair statement of the Company’s consolidated financial position as of June 30, 2022, the consolidated results of operations, statements of changes in shareholders' equity for the three and six-month periods ended June 30, 2022 and 2021 and cash flows for the six-month periods ended June 30, 2022 and 2021.
The consolidated results for the three and six-month periods ended June 30, 2022 are not necessarily indicative of the results to be expected for the year ending December 31, 2022.
These unaudited interim condensed consolidated financial statements should be read in conjunction with the audited financial statements of the Company for the year ended December 31, 2021 as filed with the Company’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission on March 8, 2022. The comparative balance sheet at December 31, 2021 has been derived from the audited financial statements at that date but does not include all disclosures required by U.S. GAAP for annual financial statements.
|
9
ENTERA BIO LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
b.
|
Loss per share
|
Diluted loss per share is based upon the weighted average number of ordinary shares and of ordinary shares equivalents outstanding when dilutive. Ordinary share equivalents include outstanding stock options and warrants, which are included under the treasury stock method when dilutive. The calculation of diluted loss per share does not include options and warrants, exercisable into
c.
|
Newly issued and recently adopted accounting pronouncements:
|
1)
|
In November 2021, the FASB issued ASU 2021-10 “Government Assistance (Topic 832)”, which requires annual disclosures that increase the transparency of transactions involving government grants, including (1) the types of transactions, (2) the accounting for those transactions, and (3) the effect of those transactions on an entity’s financial statements. The amendments in this update are effective for financial statements issued for annual periods beginning after December 15, 2021. The adoption of this guidance did not have material impact on the Company’s consolidated financial statements.
|
2)
|
In August 2020, the FASB issued ASU 2020-06 “Debt – Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic 815 – 40).” This guidance simplifies the accounting for certain financial instruments with characteristics of liabilities and equity, including convertible instruments and contracts on an entity’s own equity. The amendments to this guidance are effective for fiscal years beginning after December 15, 2021, and interim periods within those fiscal years. The adoption of this guidance did not have material impact on the Company’s consolidated financial statements.
|
|
a. |
On August 23, 2021, the Company’s Board of Directors approved the following option grants which were approved by the shareholders of the Company on October 4, 2021:
|
i.
|
Grants of options to purchase ordinary shares with a total fair value 0f $
|
ii.
|
Grants of options to purchase ordinary shares with a total fair value 0f $
|
10
ENTERA BIO LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
b.
|
On March 31, 2022, the Company’s Board of Directors approved option grants to purchase
|
|
c.
|
On April 28, 2022, the Company’s Board of Directors approved options grants to purchase
|
|
d.
|
On May 11, 2022, the Company’s Board of Directors approved a grant of options to purchase
The fair value of each option granted is estimated at the date of grant using the Black-Scholes option-pricing model, with the following weighted average assumptions:
|
Six months | ||||
ended June 30, | ||||
2022
|
||||
Exercise price
|
$
|
|||
Dividend yield
|
|
|||
Expected volatility
|
|
|||
Risk-free interest rate
|
|
|||
Expected life - in years
|
|
e.
|
On June 15, 2022 the Company signed on a separation agreement with Dr. Phillip Schwartz, the Company’s former President of R&D, under which he agreed to continue to provide services to the Company until July 21, 2022 (the “Separation Date”). Pursuant to the terms of the separation agreement and subject to approval of the Company’s shareholders, Dr. Schwartz is entitled to receive a full acceleration of the options to purchase
In addition, the separation agreement provides for the following payments to Dr. Schwartz, all of which would have otherwise been payable in accordance with either Israeli law or pursuant to his existing employment agreement: a one-time cash separation payment in an amount equal to NIS
|
11
ENTERA BIO LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
June 30,
|
December 31,
|
|||||||
Accrued expenses and other payables:
|
2022
|
2021
|
||||||
Employees and employees related
|
|
|
||||||
Income tax
|
|
|
||||||
Provision for vacation
|
|
|
||||||
Accrued expenses
|
|
|
||||||
|
|
a.
|
On July 15, 2022, the Company’s Board of Directors appointed Ms. Miranda Toledano as the Company’s new CEO and approved a grant of additional (see also note 3d) options to purchase
In addition, upon the occurrence of a Triggering Event (as defined below), the Board of Directors will grant Ms. Toledano options to purchase
"Triggering Event" shall mean the earlier of the following events: (i) the execution by the Company of a binding strategic or partnership agreement with a strategic partner to fund the Company's Phase III FDA Trial; or (b) raising sufficient funding to complete the Company's Phase III FDA Trial, in each case as such event was approved by the Board of Directors.
The foregoing option grants are subject to the Company’s shareholders' approval.
|
|
b.
|
On July 15, 2022, the Company entered into a mutual separation agreement with Dr. Spiros Jamas, the Company’s former CEO. Pursuant to the separation agreement, Dr. Jamas received the following benefits: (i) a one-time lump sum payment of his annual base salary for a period of 13 months, for a total gross amount equal to $
|
• | The subsequent sale or usage occurs; and |
• | The performance obligation to which some or all of the sales-based or usage-based royalty has been allocated has been satisfied (or partially satisfied). |
• | employee-related expenses, including salaries, bonuses and share-based compensation expenses for employees and service providers in the research and development function; |
• | expenses incurred in operating our laboratories including our small-scale manufacturing facility; |
• | expenses incurred under agreements with CROs, and investigative sites that conduct our clinical trials; |
• | expenses related to outsourced and contracted services, such as external laboratories, consulting and advisory services; |
• | supply, development and manufacturing costs relating to clinical trial materials; and |
• | other costs associated with pre-clinical and clinical activities. |
• | the uncertainty of the scope, rate of progress, results and cost of our clinical trials, nonclinical testing and other related activities; |
• | the cost of manufacturing clinical supplies and establishing commercial supplies of our product candidates and any products that we may develop; |
• | the number and characteristics of product candidates that we pursue; |
• | the cost, timing and outcomes of regulatory approvals; |
• | the cost and timing of establishing any sales, marketing, and distribution capabilities; and |
• | the terms and timing of any collaborative, licensing and other arrangements that we may establish, including any milestone and royalty payments thereunder. |
| Three Months Ended June 30, | Increase (Decrease) | ||||||||||||||
| 2022 | 2021 | $ | % | ||||||||||||
| (In thousands, except for percentage information) | |||||||||||||||
Revenues | $ | 44 | $ | 109 | $ | (65 | ) | (60 | )% | |||||||
Cost of revenues | $ | 33 | $ | 99 | $ | (66 | ) | (67 | )% | |||||||
Operating expenses: | ||||||||||||||||
Research and development expenses | $ | 1,394 | $ | 1,227 | $ | 167 | 14 | % | ||||||||
General and administrative expenses | $ | 1,880 | $ | 1,364 | $ | 516 | 38 | % | ||||||||
Other income | $ | (14 | ) | $ | (11 | ) | $ | (3 | ) | 27 | % | |||||
Operating loss | $ | 3,249 | $ | 2,570 | $ | 679 | 26 | % | ||||||||
Financial (income) loss, net | $ | (60 | ) | $ | 24 | $ | (84 | ) | (350 | )% | ||||||
Income tax benefit | $ | (4 | ) | $ | (17 | ) | $ | 13 | (76 | )% | ||||||
Net loss | $ | 3,185 | $ | 2,577 | $ | 608 | 24 | % |
| Six Months Ended June 30, | Increase (Decrease) | ||||||||||||||
| 2022 | 2021 | $ | % | ||||||||||||
| (In thousands, except for percentage information) | |||||||||||||||
Revenues | $ | 112 | $ | 266 | $ | (154 | ) | (58 | )% | |||||||
Cost of revenues | $ | 87 | $ | 172 | $ | (85 | ) | (49 | )% | |||||||
Operating expenses: | ||||||||||||||||
Research and development expenses | $ | 3,084 | $ | 2,351 | $ | 733 | 31 | % | ||||||||
General and administrative expenses | $ | 4,052 | $ | 2,674 | $ | 1,378 | 52 | % | ||||||||
Other income | $ | (27 | ) | $ | (22 | ) | $ | (5 | ) | 23 | % | |||||
Operating loss | $ | 7,084 | $ | 4,909 | $ | 2,175 | 44 | % | ||||||||
Financial income, net | $ | (104 | ) | $ | (5 | ) | $ | (99 | ) | 1,980 | % | |||||
Income tax benefit | $ | (11 | ) | $ | (31 | ) | $ | 20 | (65 | )% | ||||||
Net loss | $ | 6,969 | $ | 4,873 | $ | 2,096 | 43 | % |
• | the costs, timing and outcome of clinical trials for, and regulatory review of, EB613, EB612 and any other product candidates we may develop; |
• | the costs of development activities for any other product candidates we may pursue; |
• | the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims; |
• | the impact of COVID-19 on our clinical trials, regulatory timelines, business operations and financial stability; and |
• | our ability to establish collaborations on favorable terms, if at all. |
| Six Months Ended June 30, (unaudited) | |||||||
| 2022 | 2021 | ||||||
| (in thousands) | |||||||
Net Cash used in operating activities | $ | (7,619 | ) | $ | (4,442 | ) | ||
Net Cash used in investing activities | $ | (42 | ) | - | ||||
Net Cash provided by financing activities | $ | 13 | 22,775 | |||||
Net (decrease) increase in cash and cash equivalents | $ | (7,648 | ) | $ | 18,333 |
Exhibit No. | Description of Exhibits | |
101.INS | XBRL Instance Document. | |
101.SCH | XBRL Taxonomy Extension Schema Document. | |
101.DEF | XBRL Taxonomy Extension Definition Linkbase Document. | |
101.CAL | XBRL Taxonomy Extension Calculation Linkbase Document. | |
101.LAB | XBRL Taxonomy Extension Label Linkbase Document. | |
101.PRE | XBRL Taxonomy Extension Presentation Linkbase Document. | |
104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
ENTERA BIO LTD. | ||
Date: August 11, 2022 | /s/ Miranda J. Toledano | |
Miranda J. Toledano Chief Executive Officer | ||
(Principal Executive Officer) | ||
Date: August 11, 2022 | /s/ Dana Yaacov-Garbeli | |
Dana Yaacov-Garbeli Chief Financial Officer | ||
(Principal Financial and Accounting Officer) |
1. |
I have reviewed this Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2022 of Entera Bio Ltd.;
|
2. |
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in
light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3. |
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial
condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4. |
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules
13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
a. |
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material
information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
b. |
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide
reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
c. |
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the
disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
d. |
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the
registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5. |
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s
auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
a. |
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely
affect the registrant’s ability to record, process, summarize and report financial information; and
|
b. |
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial
reporting.
|
Date: August 11, 2022
|
/s/ Miranda J. Toledano
Miranda J. Toledano
Chief Executive Officer
(Principal Executive Officer)
|
1. |
I have reviewed this Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2022 of Entera Bio Ltd.;
|
2. |
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in
light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3. |
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial
condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4. |
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules
13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
a. |
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material
information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
b. |
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide
reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
c. |
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the
disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
d. |
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the
registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5. |
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s
auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
a. |
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely
affect the registrant’s ability to record, process, summarize and report financial information; and
|
b. |
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial
reporting.
|
Date: August 11, 2022
|
/s/ Dana Yaacov Garbeli
Dana Yaacov-Garbeli
Chief Financial Officer
(Principal Financial and Accounting Officer)
|
1. |
the Quarterly Report on Form 10-Q of the Company for the fiscal quarter ended June 30, 2022 (the “Report”) fully complies with the requirements of Section 13(a) or
15(d) of the Securities Exchange Act of 1934 (15 U.S.C. 78m or 78o(d)); and
|
2. |
the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
Date: August 11, 2022
|
/s/ Miranda J. Toledano
Miranda J. Toledano
Chief Executive Officer
(Principal Executive Officer)
|
1. |
the Quarterly Report on Form 10-Q of the Company for the fiscal quarter ended June 30, 2022 (the “Report”) fully complies with the requirements of Section 13(a) or
15(d) of the Securities Exchange Act of 1934 (15 U.S.C. 78m or 78o(d)); and
|
2. |
the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
Date: August 11, 2022
|
/s/ Dana Yaacov-Garbeli
Dana Yaacov-Garbeli
Chief Financial Officer
(Principal Financial and Accounting Officer)
|