Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
ENTERA BIO LTD.
(Registrant)
|
|||
By:
|
/s/ Spiros Jamas, Sc.D
|
||
Name: Spiros Jamas
|
|||
Title: Chief Executive Officer and Director
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|||
Page | |
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited) - U.S DOLLARS IN THOUSANDS ($): | |
F-2 | |
F-3 | |
F-4 | |
F-6 - F-7 | |
F-8 - F-13 |
_______________
_________________________
_______________
June 30
|
December 31
|
|||||||
2021
|
2020
|
|||||||
U.S. dollars in thousands
|
||||||||
A s s e t s |
||||||||
CURRENT ASSETS:
|
||||||||
Cash and cash equivalents
|
|
|
||||||
Accounts receivable
|
|
|
||||||
Other current assets
|
|
|
||||||
TOTAL CURRENT ASSETS
|
|
|
||||||
NON-CURRENT ASSETS:
|
||||||||
Property and equipment
|
|
|
||||||
Right of use assets
|
|
|
||||||
Intangible assets
|
|
|
||||||
TOTAL NON-CURRENT ASSETS
|
|
|
||||||
TOTAL ASSETS
|
|
|
||||||
Liabilities and shareholders' equity
|
||||||||
CURRENT LIABILITIES:
|
||||||||
Accounts payable:
|
||||||||
Trade
|
|
|
||||||
Other
|
|
|
||||||
Current maturities of lease liabilities
|
|
|
||||||
Warrants to purchase ordinary shares
|
|
|
||||||
Contract liabilities
|
|
|
||||||
TOTAL CURRENT LIABILITIES
|
|
|
||||||
NON-CURRENT LIABILITIES:
|
||||||||
Lease liabilities
|
|
|
||||||
Severance pay obligations, net
|
|
|
||||||
TOTAL NON-CURRENT LIABILITIES
|
|
|
||||||
TOTAL LIABILITIES
|
|
|
||||||
COMMITMENTS AND CONTINGENCIES
|
||||||||
SHAREHOLDERS' EQUITY:
|
||||||||
Ordinary Shares, NIS
|
||||||||
Authorized - as of June 30, 2021 and December 31, 2020,
|
|
|
||||||
Accumulated other comprehensive income
|
|
|
||||||
Other reserves
|
|
|
||||||
Additional paid in capital
|
|
|
||||||
Accumulated deficit
|
(
|
)
|
(
|
)
|
||||
TOTAL SHAREHOLDERS' EQUITY
|
|
|
||||||
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY
|
|
|
F - 2
ENTERA BIO LTD.
(UNAUDITED)
Six months ended
|
Three months ended
|
|||||||||||||||
June 30
|
June 30
|
|||||||||||||||
2021
|
2020
|
2021
|
2020
|
|||||||||||||
U.S. dollars in thousands
|
||||||||||||||||
REVENUE
|
|
|
|
|
||||||||||||
COST OF REVENUE
|
|
|
|
|
||||||||||||
RESEARCH AND DEVELOPMENT EXPENSES, NET
|
|
|
|
|
||||||||||||
GENERAL AND ADMINISTRATIVE EXPENSES
|
|
|
|
|
||||||||||||
OTHER INCOME
|
(
|
) |
|
(
|
) |
|
||||||||||
OPERATING LOSS
|
|
|
|
|
||||||||||||
FINANCIAL EXPENSES (INCOME):
|
||||||||||||||||
Loss (income) from change in fair value of financial liabilities at fair value
|
|
(
|
)
|
|
(
|
)
|
||||||||||
Other financial expenses, net
|
|
|
|
|
||||||||||||
FINANCIAL EXPENSES (INCOME), NET
|
|
(
|
)
|
|
(
|
)
|
||||||||||
NET LOSS BEFORE TAXES
|
|
|
|
|
||||||||||||
TAXES ON INCOME
|
|
|
|
|
||||||||||||
NET COMPREHENSIVE LOSS FOR THE PERIOD
|
|
|
|
|
U.S. dollars
|
U.S. dollars
|
|||||||||||||||
LOSS PER ORDINARY SHARE:
|
||||||||||||||||
Basic
|
|
|
|
|
||||||||||||
Diluted
|
|
|
|
|
||||||||||||
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING:
|
||||||||||||||||
Basic
|
|
|
|
|
||||||||||||
Diluted
|
|
|
|
|
F - 3
ENTERA BIO LTD.
Number of Ordinary
Shares
|
Ordinary
Shares-
Amount
|
Accumulated other comprehensive income
|
Other
reserve
|
Additional
paid in
capital
|
Accumulated deficit
|
Total
|
||||||||||||||||||||||
U.S dollars in thousands
|
||||||||||||||||||||||||||||
BALANCE AT JANUARY 1, 2020
|
|
|
|
|
|
|||||||||||||||||||||||
CHANGES DURING THE SIX MONTHS ENDED JUNE 30, 2020:
|
|
|
|
|
|
( |
) |
|
||||||||||||||||||||
Net loss for the period
|
-
|
|
|
|
|
(
|
) |
(
|
) | |||||||||||||||||||
Exercise of options to ordinary shares
|
|
|
|
(
|
) |
|
|
|
||||||||||||||||||||
Issuance of shares and warrant due to |
||||||||||||||||||||||||||||
a private placement, net of issuance costs |
|
|||||||||||||||||||||||||||
Expiration of options and warrants |
- | ( |
) | |||||||||||||||||||||||||
Share-based compensation
|
-
|
|
|
|
|
|
|
|||||||||||||||||||||
BALANCE AT JUNE 30, 2020
|
|
|
|
|
|
(
|
) |
|
||||||||||||||||||||
BALANCE AT JANUARY 1, 2021 |
||||||||||||||||||||||||||||
CHANGES DURING THE SIX MONTHS ENDED JUNE 30, 2021: |
|
|
|
|
|
(
|
) |
|
||||||||||||||||||||
Net loss for the period
|
|
|
|
|
|
(
|
) |
(
|
) | |||||||||||||||||||
Exercise of warrants to ordinary shares |
||||||||||||||||||||||||||||
Exercise of options to ordinary shares
|
|
|
|
(
|
)
|
|
|
|
||||||||||||||||||||
Issuance of shares under the ATM program, net of issuance costs |
||||||||||||||||||||||||||||
Vested restricted share units |
( |
) | ||||||||||||||||||||||||||
Share-based compensation
|
-
|
|
|
|
|
|
|
|||||||||||||||||||||
BALANCE AT JUNE 30, 2021
|
|
|
|
|
|
(
|
) |
|
|
The accompanying notes are an integral part of the condensed consolidated financial statements.
F - 4
Number of Ordinary
Shares
|
Ordinary Shares- Amount |
Accumulated
other comprehensive income
|
Other
reserve
|
Additional
paid in
capital
|
Accumulated
deficit
|
Total
|
||||||||||||||||||||||
U.S dollars in thousands
|
||||||||||||||||||||||||||||
BALANCE AT APRIL 1, 2020
|
||||||||||||||||||||||||||||
CHANGES DURING THE THREE MONTHS ENDED JUNE 30,
2020:
|
|
|
|
|
|
( |
) |
|
||||||||||||||||||||
Net loss for the period
|
-
|
|
|
|
|
(
|
) |
(
|
) | |||||||||||||||||||
Exercise of options to ordinary |
||||||||||||||||||||||||||||
Expiration of warrants |
- | ( |
) | |||||||||||||||||||||||||
Share-based compensation
|
-
|
|
|
|
|
|
|
|||||||||||||||||||||
BALANCE AT JUNE 30, 2020
|
|
|
|
|
|
(
|
) |
|
||||||||||||||||||||
BALANCE AT APRIL 1, 2021 |
||||||||||||||||||||||||||||
CHANGES DURING THE THREE MONTHS ENDED JUNE 30, 2021: |
|
|
|
|
|
(
|
)
|
|
||||||||||||||||||||
Net loss for the period
|
-
|
|
|
|
|
(
|
) |
(
|
) | |||||||||||||||||||
Exercise of warrants to ordinary shares |
||||||||||||||||||||||||||||
Exercise of options to ordinary shares |
( |
) | ||||||||||||||||||||||||||
Issuance of shares under the ATM program, net of issuance costs |
||||||||||||||||||||||||||||
Share-based compensation
|
-
|
|
|
|
|
|
|
|||||||||||||||||||||
BALANCE AT JUNE 30, 2021
|
|
|
|
|
|
(
|
) |
|
F - 5
Six months ended
June 30
|
||||||||
2021
|
2020
|
|||||||
(Unaudited)
|
||||||||
U.S dollars in thousands
|
||||||||
CASH FLOWS USED IN OPERATING ACTIVITIES:
|
||||||||
Net loss for the period
|
(
|
)
|
(
|
)
|
||||
Adjustments required to reflect net cash used in operating activities (see appendix A)
|
10,249 | (74 | ) | |||||
Net cash used in operating activities
|
(
|
)
|
(
|
)
|
||||
CASH FLOWS USED IN INVESTING ACTIVITIES:
|
||||||||
Purchase of property and equipment
|
|
(
|
)
|
|||||
Net cash used in investing activities
|
|
(
|
)
|
|||||
CASH FLOWS PROVIDED BY FINANCING ACTIVITIES:
|
||||||||
Proceeds from issuance of ordinary shares and warrants, net of issuance costs
|
|
|
||||||
Issuance of shares due to the ATM program, net of issuance costs
|
|
|
||||||
Proceeds from exercise of options and warrants
|
|
|
||||||
Principle element of lease payments
|
(
|
)
|
(
|
)
|
||||
Net cash provided by financing activities
|
|
|
||||||
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
|
|
(
|
)
|
|||||
CASH AND CASH EQUIVALENTS AT BEGINNING OF THE PERIOD
|
|
|
||||||
CASH AND CASH EQUIVALENTS AT END OF THE PERIOD
|
|
|
F - 6
(UNAUDITED)
Six months ended June 30
|
||||||||
2021
|
2020
|
|||||||
(Unaudited)
|
||||||||
U.S dollars in thousands
|
||||||||
APPENDIX A:
|
||||||||
Adjustments required to reflect net cash used in operating activities:
|
||||||||
Depreciation
|
|
|
||||||
Change in fair value of financial liabilities at fair value through profit or loss
|
|
(
|
)
|
|||||
Financial expenses
|
|
|
||||||
Net changes in severance pay obligation
|
|
|
||||||
Share-based compensation
|
|
|
||||||
|
|
|||||||
Changes in working capital:
|
||||||||
Decrease in accounts receivables
|
|
|
||||||
Increase in other current assets
|
(
|
)
|
(
|
)
|
||||
Increase (decrease) in accounts payable and accruals:
|
||||||||
Trade
|
|
(
|
)
|
|||||
Other
|
|
(
|
)
|
|||||
Decrease in contract liabilities
|
(
|
)
|
(
|
)
|
||||
(
|
)
|
(
|
)
|
|||||
Cash used for operating activities -
|
||||||||
Interest paid
|
(
|
)
|
(
|
)
|
||||
|
(
|
)
|
||||||
APPENDIX B:
|
||||||||
Supplementary information on investing and financing activities not involving cash flows:
|
||||||||
Right of use assets obtained in exchange for new operating lease liabilities
|
|
|
||||||
Exercise of warrants
|
|
|
||||||
Cashless exercise of warrants
|
|
|
||||||
Vested restricted shares units
|
|
|
F - 7
a.
|
General:
|
1)
|
Entera Bio Ltd. (collectively with its subsidiary, the "Company") was incorporated on September 30, 2009 and commenced operation on June 1, 2010. On January 8, 2018 the Company incorporated Entera Bio Inc., a fully owned subsidiary incorporated in Delaware USA. The Company is a leader in the development and commercialization of orally delivered large molecule 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 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 Phase 2 clinical development. The Company also licenses its technology to biopharmaceutical companies for use with their proprietary compounds and, to date, has completed one such collaboration with Amgen Inc.
|
2)
|
The Company's securities have been listed for trading on the Nasdaq Capital Market since the Company’s initial public offering in July 2018, where a total of
|
b.
|
Since 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 $
|
F - 8
c.
|
Approval of financial statements
|
F - 9
F - 10
Financial liabilities at fair value through profit or loss
|
Financial liabilities at amortized cost |
Total
|
||||||||||
U.S. dollars in thousands
|
||||||||||||
As of June 30, 2021:
|
||||||||||||
Trade and other payable
|
|
|
|
|||||||||
Warrants to purchase ordinary shares (level 1) (1)
|
|
|
|
|||||||||
Lease liabilities
|
|
|
|
|||||||||
|
|
|
||||||||||
As of December 31, 2020:
|
||||||||||||
Trade and other payable
|
|
|
|
|||||||||
Warrants to purchase ordinary shares (level 1) (1)
|
|
|
|
|||||||||
Warrants to purchase ordinary shares (level 3) (2)
|
|
|
|
|||||||||
Lease liabilities
|
|
|
||||||||||
|
|
|
(1)
|
|
(2)
|
|
1.
|
Equity:
|
a.
|
In February and March 2021, the Company issued additional
|
b.
|
In March 2021,
|
c.
|
During the six months ended June 30, 2021, several employees and service providers exercised
|
F - 11
NOTE 6 - SHARE CAPITAL (Continued):
d.
|
On April 21, 2021, upon satisfaction of the sale price condition pursuant to the subscription agreement signed in December 2019, the Company’s Board of Directors decided to accelerate the termination date of the Investors and Broker warrants issued in December 2019 and February 2020. In accordance with the terms of the agreement, as of the notice date and until June 23, 2021 (the “Early Termination Exercise Period”), the holders may exercise their warrants and following such Early Termination Exercise Period, these warrants shall be deemed terminated.
During the six months ended June 30, 2021, the warrants holders, including our Chairman of the board and D.N.A Biomedical Solutions Ltd. (“DNA”) exercised |
e.
|
On May 7, 2021, the Company entered into new At-the-market equity program (the "Second ATM Program") that allows the Company to issue up to additional 5 million ordinary shares, at the Company's discretion. Distributions of the ordinary shares through the Second ATM Program were made pursuant to the terms of an equity distribution agreement dated May 7, 2021 among the Company and B. Riley Securities, Inc (the "Agent").
|
2.
|
Options Grants
|
a.
|
On January 4, 2021 options to purchase
|
b.
|
On April 7, 2021, the Company’s Board of Directors approved the following option grants:
|
i.
|
Options grant to purchase
|
ii.
|
Options grants to purchase
|
F - 12
NOTE 6 - SHARE CAPITAL (Continued):
iii.
|
Options grant to purchase
|
c.
|
On April 21, 2021, options to purchase
|
a.
|
In July and August 2021, the Company issued
|
b.
|
In July 2021, a former employee exercised
|
F -13
(unaudited) Six Months Ended June 30, |
Increase (Decrease) |
|||||||||||||||
2021 |
2020 |
$ |
% |
|||||||||||||
(In thousands, except for percentage information) |
||||||||||||||||
Revenues |
$ |
266 |
$ |
94 |
$ |
172 |
183 |
|||||||||
Cost of revenues |
121 |
73 |
48 |
66 |
||||||||||||
Operating expenses: |
||||||||||||||||
Research and development expenses, net |
2,417 |
3,616 |
(1,199 |
) |
(33 |
) |
||||||||||
General and administrative expenses |
2,759 |
2,827 |
(68 |
) |
(2.4 |
) |
||||||||||
Other income |
22 |
- |
22 |
- |
||||||||||||
Operating loss |
5,009 |
6,422 |
(1,413 |
) |
(22 |
) |
||||||||||
Financial expenses (income), net |
9,555 |
(314 |
) |
9,870 |
3,142 |
|||||||||||
Taxes on income |
78 |
- |
78 |
- |
||||||||||||
Net loss |
$ |
14,642 |
$ |
6,108 |
$ |
8,534 |
140 |
(unaudited) six months ended June 30, |
||||||||
2021 |
2020 |
|||||||
(in thousands) |
||||||||
Cash used in operating activities |
$ |
(4,348 |
) |
$ |
(6,182 |
) |
||
Cash used in investing activities |
- |
(29 |
) |
|||||
Cash provided by financing activities |
22,681 |
793 |
||||||
Net increase (decrease) in cash and cash equivalents |
$ |
18,333 |
$ |
(5,418 |
) |
(unaudited) Three Months Ended June 30, |
Increase (Decrease) |
|||||||||||||||
2021 |
2020 |
$ |
% |
|||||||||||||
(In thousands, except for percentage information) |
||||||||||||||||
Revenues |
$ |
(109 |
) |
$ |
(52 |
) |
$ |
(57 |
) |
110 |
% |
|||||
Cost of revenues |
63 |
31 |
32 |
103 |
||||||||||||
Operating expenses: |
||||||||||||||||
Research and development expenses, net |
1,258 |
2,011 |
(753 |
) |
(37 |
) |
||||||||||
General and administrative expenses |
1,450 |
1,537 |
(87 |
) |
(6 |
) |
||||||||||
Other income |
(12 |
) |
* |
(12 |
) |
- |
||||||||||
Operating loss |
2,650 |
3,527 |
(877 |
) |
(25 |
) |
||||||||||
Financial expenses (income), net |
2,464 |
(337 |
) |
2,801 |
831 |
|||||||||||
Taxes on income |
40 |
- |
40 |
- |
||||||||||||
Net loss |
$ |
5,154 |
$ |
3,190 |
$ |
1,964 |
62 |
% |
• |
the costs, timing and outcome of clinical trials for, and data 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, once known, on our clinical trials, regulatory timelines, business operations and financial stability; and |
• |
our ability to establish collaborations on favorable terms, if at all. |
• |
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 ongoing Phase 2 clinical trial of EB613 or the need for additional clinical trials or development work based on further analysis of the interim data from the ongoing EB613 Phase 2 clinical trial; |
• |
the accuracy of our estimates regarding expenses, capital requirements, the sufficiency of our cash resources and the need for additional financing; |
• |
our ability to raise additional funds on commercially reasonable terms, including via our At The Market, or ATM, Program; |
• |
our ability to develop, advance product candidates into, and successfully complete, clinical studies such as our ongoing Phase 2 clinical trial of EB613 in osteoporosis; |
• |
our reliance on third parties to conduct our clinical trials and on third-party suppliers to supply or produce our product candidates; |
• |
our interpretation of 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; |
• |
our expectations regarding licensing, business transactions and strategic collaborations, including our ongoing collaboration with Amgen; |
• |
our ability to use and expand our drug delivery technology to additional product candidates; |
• |
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; |
• |
our ability to continue as a going concern absent access to sources of liquidity; |
• |
our ability to obtain and maintain regulatory approval for any of our product candidates; |
• |
our competitive position, especially with respect to Forteo® and other products on the market or in development for the treatment of osteoporosis; |
• |
our ability to establish and maintain development and commercialization collaborations; |
• |
any potential commercial launch of current or future product candidates, and the timing, cost or other aspects of such commercialization; |
• |
our ability to manufacture and supply sufficient amounts of material to support our clinical trials and any potential future commercial requirements; |
• |
the safety and efficacy of therapeutics marketed by competitors that are targeted toward indications for which we are developing product candidates; |
• |
the size of any market we may target and the adoption of our product candidates, if approved, by physicians and patients; |
• |
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; |
• |
our ability to retain key personnel and recruit additional qualified personnel; |
• |
the possibility that competing products or technologies may make any product candidates we may develop and commercialize or our oral delivery technology obsolete; |
• |
the pricing and reimbursement of our product candidates, if approved; |
• |
our ability to develop a sales, marketing and distribution infrastructure, if any; |
• |
our ability to manage growth; |
• |
the duration and severity of the recent coronavirus (COVID-19) outbreak, 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, preclinical studies and clinical trials; and |
• |
other risk factors discussed under “Risk Factors" in our Annual report on Form 20-F for the year ended December 31, 2020. |