UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 6-K

REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16

OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934

For the month of August 2019

Commission file number: 001-38556

ENTERA BIO LTD.

(Exact Name of Registrant as Specified in Its Charter)

Kiryat Hadassah
Minrav Building – Fifth Floor

Jerusalem, Israel
(Address of principal executive office)

_____________________

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

Form 20-F ☒           Form 40-F ☐

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

Date: August 20, 2019

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Exhibit 99.1

	Page
CONDENSED CONSOLIDTED FINANCIAL STATEMENTS (Unaudited) – U.S DOLLARS IN THOUSANDS ($):
Condensed consolidated statements of financial position	2
Condensed consolidated statements of comprehensive loss (income)	3
Condensed consolidated statements of changes in shareholders’ equity (capital deficiency)	4-5
Condensed consolidated statements of cash flows	6-7
Notes to the condensed consolidated financial statements	8-16

		June 30				December 31
		2019				2018
		U.S. dollars in thousands
A  s  s  e  t  s
CURRENT ASSETS:
Cash and cash equivalents			7,386				7,506
Short-term bank deposits			-				4,015
Accounts receivable			-				725
Other current assets			486				220
TOTAL CURRENT ASSETS			7,872				12,466
NON-CURRENT ASSETS:
Property and equipment			231				224
Right to use assets			327				-
Intangible assets			621				651
TOTAL NON-CURRENT ASSETS			1,179				875
TOTAL ASSETS			9,051				13,341
Liabilities and shareholders' equity
CURRENT LIABILITIES:
Accounts payable:
Trade			494				473
Other			939				1,090
Lease liabilities			163				-
Contract liabilities			151				225
TOTAL CURRENT LIABILITIES			1,747				1,788
NON-CURRENT LIABILITIES:
Warrants to purchase ordinary shares			578				1,372
Lease liabilities			190				-
Severance pay obligations, net			68				65
TOTAL NON-CURRENT LIABILITIES			836				1,437
TOTAL LIABILITIES			2,583				3,225
COMMITMENTS AND CONTINGENCIES
SHAREHOLDERS' EQUITY:
Ordinary Shares, NIS 0.0000769 par value:
Authorized - as of June 30, 2019 and December 31, 2018, 140,010,000 shares; issued and outstanding: as of June 30, 2019, and December 31, 2018 – 11,899,159 shares and 11,459,780 shares, respectively.			*				*
Accumulated other comprehensive income			41				41
Other reserves			13,563				13,019
Additional paid in capital			49,342				49,173
Accumulated deficit			(56,478	)			(52,117	)
TOTAL SHAREHOLDERS' EQUITY			6,468				10,116
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY			9,051				13,341

		Six months ended								Three months ended
		June 30								June 30
		2019				2018				2019				2018
		U.S. dollars in thousands
REVENUE			(74	)			-				(74	)			-
COST OF REVENUE			62				-				62				-
RESEARCH AND DEVELOPMENT EXPENSES, NET			3,448				4,658				1,413				1,765
GENERAL AND ADMINISTRATIVE EXPENSES (INCOME)			1,684				854				628				(409	)
OPERATING LOSS			5,120				5,512				2,029				1,356
FINANCIAL EXPENSES (INCOME):
Income from change in fair value of financial      liabilities at fair value			(794	)			(2,896	)			(682	)			(2,876	)
Other financial expenses (income), net			35				(23	)			19				(43	)
FINANCIAL INCOME, net			(759	)			(2,919	)			(663	)			(2,919	)
NET COMPREHENSIVE LOSS (INCOME) FOR THE PERIOD			4,361				2,593				1,366				(1,563	)

		U.S. dollars								U.S. dollars
LOSS (INCOME) PER ORDINARY SHARE:
Basic			0.38				0.58				0.12				(0.35	)
Diluted			0.38				0.70				0.12				0.11
WEIGHTED AVERAGE NUMBER OF       SHARES OUTSTANDING:
Basic			11,601,289				4,490,720				11,742,797				4,490,720
Diluted			11,601,289				4,735,510				11,742,797				9,640,930

		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, 2018			4,490,720				*				41				7,361				2,853				(41,813	)			(31,558	)
CHANGES FOR SIX MONTHS ENDED JUNE 30, 2018:																							(2,593	)			(2,593	)
Net loss for the period
Share-based compensation			-				-				-				597				-				-				597
Reclassification of capital contribution from controlling shareholder			-				-				-				(51	)			51				-				-
Reclassification due to share-based compensation forfeited			-				-				-				(11	)			11				-				-
BALANCE AT JUNE 30, 2018			4,490,720				*				41				7,896				2,915				(44,406	)			(33,554	)

BALANCE AT JANUARY 1, 2019			11,459,780				*				41				13,019				49,173				(52,117	)			10,116
CHANGES FOR SIX      MONTHS ENDED JUNE      30, 2019:
Net loss for the period			-				-				-				-				-				(4,361	)			(4,361	)
Exercise of options to       ordinary shares			439,379				*				-				(143	)			169				-				26
Share-based compensation															687												687
BALANCE AT JUNE 30, 2019			11,899,159				*				41				13,563				49,342				(56,478	)			6,468

		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 MARCH 31, 2018			4,490,720				*				41				8,520				2,915				(45,969	)			(34,493	)
CHANGES FOR THREE MONTHS ENDED JUNE 30, 2018:
Net Income (loss) for the period			-				-				-				-				-				1,563				1,563
Share-based compensation			-				-				-				(624	)			-				-				(624	)
BALANCE AT JUNE 30, 2018			4,490,720				*				41				7,896				2,915				(44,406	)			(33,554	)

BALANCE AT MARCH 31, 2019			11,459,780				*				41				13,560				49,173				(55,112	)			7,662
CHANGES FOR THREE      MONTHS ENDED JUNE      30, 2019:
Net loss for the period			-				-				-				-				-				(1,366	)			(1,366	)
Exercise of options to       ordinary shares			439,379				*				-				(143	)			169				-				26
Share-based compensation			-				-				-				146				-				-				146
BALANCE AT JUNE 30, 2019			11,899,159				*				41				13,563				49,342				(56,478	)			6,468

		Six months ended June 30
		2019				2018
		(Unaudited)
		U.S dollars in thousands
CASH FLOWS USED IN OPERATING ACTIVITIES:
Net loss for the period			(4,361	)			(2,593	)
Adjustments required to reflect net cash
used in operating activities (see appendix A)			304				(2,614	)
Net cash used in operating activities			(4,057	)			(5,207	)
CASH FLOWS PROVIDED BY (USED IN) INVESTING    ACTIVITIES:
Short-term bank deposits			4,000				-
Purchase of property and equipment			(37	)			(68	)
Net cash provided by (used in) investing activities			3,963				(68	)
CASH FLOWS USED IN FINANCING ACTIVITIES:
Principle element of lease payments			(52	)			-
Proceeds from exercise of options			26				-
Net cash used in financing activities			(26	)			-
NET DECREASE IN CASH AND CASH EQUIVALENTS			(120	)			(5,275	)
CASH AND CASH EQUIVALENTS AT BEGINNING OF THE YEAR			7,506				11,746
CASH AND CASH EQUIVALENTS AT END OF THE PERIOD			7,386				6,471

		Six months ended June 30
		2019				2018
		(Unaudited)
		U.S dollars in thousands
APPENDIX A:
Adjustments required to reflect net cash used in operating activities:
Depreciation and amortization			122				27
Change in fair value of financial    liabilities at fair value			(794	)			(2,896	)
Financial expenses			58				32
Changes in severance pay obligations, net			3				(4	)
Share-based compensation			687				597
			76				(2,244	)
Changes in working capital:
Decrease in accounts receivables			725				-
Increase in other current assets			(266	)			(346	)
Decrease in contract liability			(74	)			-
Increase (decrease) in accounts payable and accruals:
Trade			21				(334	)
Other			(151	)			342
			255				(338	)
Cash used for operating activities -
Interest paid			(27	)			(32	)
			304				(2,614	)

		January 1, 2019				June 30, 2019
Facility			151				314
Vehicles			15				13
Total right-of-use asset			166				327

		Six months ended				Three months ended
		June 30, 2019
Depreciation expense:
Facility			55				29
Vehicles			6				4
Financial expense			27				15
Cash paid for amounts included in     the measurement of lease liabilities			79				44
Right of use assets obtained in     exchange for new operating lease     liabilities			223				-

		Six months ended								Three months ended
		June 30								June 30
		2019				2018				2019				2018
		U.S. dollars (except for share numbers)
Loss (Income) attributable to equity holders of the Company			4,361,000				2,593,000				1,366,000				(1,563,000	)
Less: Income from change in fair value of financial liabilities at fair value			-				(727,000	)			-				(2,599,000	)
Loss used for the computation of diluted loss per  share			4,361,000				3,320,000				1,366,000				1,036,000
Weighted average number of Ordinary Shares used in the computation of basic loss (income) per share			11,601,289				4,490,720				11,742,797				4,490,720
Add:
Weighted average number of additional shares issuable upon the assumed conversion/ exercise of:
Preferred shares			-				-				-				4,905,420
Warrants to issue preferred shares and shares			-				244,790				-				244,790
			-				244,790				-				5,150,210
Weighted average number of shares used in the computation of diluted loss per share			11,601,289				4,735,510				11,742,797				9,640,930
Basic loss (income) per Share			0.38				0.58				0.12				(0.35	)
Diluted loss per Share			0.38				0.70				0.12				0.11

MANAGEMENT’S DISCUSSION AND ANALYSIS

OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The following discussion of our financial condition and results of operations should be read in conjunction with our condensed consolidated financial statements and the related notes to the financial statements, which are included in this Report of Foreign Private Issuer on form 6-K. You should also read the following discussion in conjunction with the information contained in our annual report on Form 20-F for the year ended December 31, 2018 filed with the Securities and Exchange Commission on March 28, 2019 We have prepared our financial statements in accordance with IFRS as issued by IASB.

This Report of Foreign Private Issuer on Form 6-K of Entera Bio Ltd. includes forward looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements include all statements that are not historical facts and can be identified by words such as, but not limited to, “believe,” “expect,” “anticipate,” “estimate,” “intend,” “plan,” “targets,” “likely,” “will,” “would,” “could,” and similar expressions or phrases. We have based these forward-looking statements largely on our management’s current expectations and future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs.

Forward-looking statements include, but are not limited to, statements about:

All forward-looking statements in this Report of Foreign Private Issuer on Form 6-K involve risks, assumptions and uncertainties and made as of the date of this Report of Foreign Private Issuer on Form 6-K. You should not rely upon forward-looking statements as predictors of future events. The occurrence of the events described, and the achievement of expected results, depend on many events, some or all of which are not predictable or within our control. Actual results may differ materially from expected results. See the sections below “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Form 20-F for the year ended December 31, 2018 for a more complete discussion of these risks, assumptions and uncertainties and for other risks and uncertainties. These risks, assumptions and uncertainties are not necessarily all of the important factors that could cause actual results to differ materially from those expressed in any of our forward-looking statements. Other unknown or unpredictable factors also could harm our results. All of the forward-looking statements we have included in this Report of Foreign Private Issuer on Form 6-K are based on information available to us on the date of this Report of Foreign Private Issuer on Form 6-K. We undertake no obligation, and specifically decline any obligation, to update publicly or revise any forward-looking statements, whether as a result of new information, future events or otherwise. In light of these risks, uncertainties and assumptions, the forward-looking events discussed in this Report of Foreign Private Issuer on Form 6-K or in our Prospectus might not occur.

All references to “we,” “us,” “our,” “Entera”, “the Company” and “our Company” in this Report of Foreign Private Issuer on Form 6-K are to Entera Bio Ltd. and its U.S. subsidiary Entera Bio Inc., unless the context otherwise requires.

Overview

We are also developing an additional oral PTH product candidate, EB612, which has successfully completed a Phase 2a trial for hypoparathyroidism, a rare condition in which the body fails to produce sufficient amounts of PTH. We completed a clinical trial to evaluate the PK/PD profile of various EB612 dose regimens and Natpara. Data processing and statistical analysis is currently ongoing and results will be presented at a scientific meeting later this year. Following the evaluation of our PK/PD clinical trial and subject to receipt of additional funding, we expect in the future to initiate a Phase 2b/3 clinical trial of EB612 in hypoparathyroidism which would potentially support a submission for regulatory approval of EB612. The FDA and the EMA have granted EB612 orphan drug designation for the treatment of hypoparathyroidism.

In addition, we intend to use our technology as a platform for the oral delivery of other protein and large molecule therapeutics as well as novel therapeutics. We have signed a license agreement with Amgen and may sign additional licensing or collaboration agreements in the future. We intend to utilize future funds, as available, to advance EB613 and EB612 for advanced clinical studies and ultimately for regulatory approval.

 

Financial Results 

Comparison of Six-Month Period Ended June 30, 2019 and 2018

  

Revenues. Revenues for the six months ended June 30, 2019 are comprised of revenue from services provided to Amgen under the license agreement.

Research and development, net expenses. Research and development expenses for the six months ended June 30, 2019 were $3.5 million, compared to $4.7 million for the six months ended June 30, 2018, a decrease of $1.2 million, or 26%. The decrease in research and development expenses was primarily attributed to a decrease of $0.8 million in materials, clinical manufacturing and production capabilities and a decrease of $0.5 million in share-based compensation expenses due to higher fair value of the options granted to the previous CMO in the same period last year. The decrease was partially offset by an increase of $0.1 million in salaries and related expenses mainly due to hiring full time employees in the US  during the first quarter of 2018.

General and administrative expenses. General and administrative expenses for the six months ended June 30, 2019 were $1.7 million, compared to $0.9 million for the six months ended June 30, 2018, an increase of $0.8 million, or 97%. The increase in general and administrative expenses was primarily attributed to an increase of $0.6 million in share-based compensation expenses due to a reversal of share based compensation recorded in the previous period as the result of termination of services of our previous Chairman of the board, in the same period in the prior year, increase of $0.1 million for insurance expenses and $0.1 million for investor relation expenses due to regulation and the requirements of a public company.

Financial income, net. Financial income, net for the six months ended June 30, 2019 was $0.8 million, compared to  financial income, net of $2.9 million for the six months ended June 30, 2018, a decrease of $2.2 million. Financial income, net for the six months ended June 30, 2019 resulted mainly from the change in the fair value of warrants to purchase ordinary shares that were recorded as a financial liability at fair value through profit or loss.During the same period last year, the company recognized financial income from changes in fair value of financial liabilities comprised of convertible loans, preferred shares and warrants which were converted or recorded as equity upon completion of our initial public offering (IPO). During the six months ended June 30, 2019 and 2018, we recorded a gain of $0.8 million and $2.9 million, respectively, on changes in fair value of financial liabilities.

 

Comprehensive loss. Comprehensive loss for the six months ended June 30, 2019 was approximately $4.4 million, compared with approximately $2.6 million in the same period in 2017 an increase of approximately $1.8 million, or 68%.

Comparison of Three-Month Period Ended June 30, 2019 and 2018

Revenues. Revenues for the three months ended June 30, 2019 are comprised of revenue from services provided to Amgen under the license agreement.

Research and development, net expenses. Research and development expenses for the three months ended June 30, 2019 were $1.4 million, compared to $1.8 million for the three months ended June 30, 2018, a decrease of $0.4 million, or 20%. The decrease in research and development expenses was primarily attributed to a decrease of approximately $0.3 million in materials, clinical manufacturing and production capabilities and $0.2 million in clinical trials, which was partially offset by an increase of $0.1 million in other research and development expenses primarily for consulting with regard to regulation expenses.

General and administrative expenses (income). General and administrative expenses for the three months ended June 30, 2019 were $0.6 million, compared to a general and administrative income of $0.4 million for the three months ended June 30, 2018, an increase in expenses of $1.0 million. The increase in general and administrative expenses was primarily attributed to an increase of $0.9 million in share-based compensation due to a reversal of compensation recorded in the previous period as a result of termination of services of our previous Chairman of the board. In addition, insurance expenses increased by $0.1 million.

Financial income, net. Financial income, net for the three months ended June 30, 2019 was $0.7 million, compared to a financial income, net of $2.9 million for the three months ended June 30, 2018. Financial income, net for the three months ended June 30, 2019 resulted mainly from the change in the fair value of warrants to purchase shares that were recorded as a financial liability at fair value through profit or loss. During the three months ended June 30, 2019 and 2018, we recorded a gain of $0.7 million and $2.9 million, respectively, on changes in fair value of financial liabilities.

Comprehensive loss (income), net. Comprehensive loss for the three months ended June 30, 2019, was approximately $1.4 million, compared with a comprehensive income of approximately $1.6 million in the same period in 2018 an increase in expenses of approximately $2.9 million.

Basic and diluted Loss (income) per share.

Basic and diluted loss per share for the three months ended June 30, 2019 was $0.12 compared with a basic income of $0.35 and diluted loss per share of $0.11, for the three months ended June 30, 2018.

Liquidity and Capital Resources  

 

Since our inception through June 30, 2019, we have raised a total of $31.3 million through private offerings, convertible loans and grants from governmental authorities.

As of June 30, 2019, we had cash and cash equivalents of approximately $7.4 million. As of December 31, 2018, we had cash and cash equivalents of approximately $11.5 million (including $4 million in short-term bank deposits).

Net Cash Used in Operating Activities

 

 Net cash used in operating activities for the six months ended June 30, 2019 was $4.1 million, consisting primarily of our operating loss of $5.1 million arising mainly from research and development expenses and general and administrative expenses, partially offset by $0.7 million in share-based compensation and a $0.3 million decrease in working capital.

Net cash used in operating activities for the six months ended June 30, 2018 was $5.2 million, consisting primarily of our operating loss of $5.5 million arising mainly from research and development expenses and general and administrative expenses and a $0.3 million increase in working capital, which was partially offset by $0.6 million of share-based compensation.

The decrease in cash used in operating activities for the six months ended June 30, 2019 compared to the same period of 2018, was mainly due to a decrease of $0.8 million for materials, clinical manufacturing and production capabilities, payment received from Amgen of $0.7 million which was offset by other working capital due to an increase in professional services and other expenses related to regulation and the requirements of a public company.

 

Net Cash Provided by (Used in) Investing Activities

Net cash provided by investing activities for the six months ended June 30, 2019 were $4.0 million primarily attributed to the release of a short-term bank deposit.

Net cash used in investing activities for the six months ended June 30, 2018 consisted of purchase of property, plant and equipment.

Net Cash Used in Financing Activities

Net cash used in financing activities for the six months ended June 30, 2019 was primarily due to lease payments which were partially offset by cash received from exercise of options granted to employees.

No cash provided by or used in financing activities for the six months ended June 30, 2018.

5

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Exhibit 99.3

Entera Bio Reports Second Quarter 2019 Financial Results and Provides
 Operating Update

JERUSALEM, Israel & BOSTON, Mass. (August 20, 2019) – Entera Bio Ltd. (NASDAQ: ENTX) today provided a corporate update and reported financial results for second quarter ended June 30, 2019.

“Entera’s evolution into one of the leading oral delivery companies for human parathyroid hormone (“PTH”) and other biologics or large molecule drugs continues at a rapid pace.  For our internal proprietary Phase 2 therapeutic pipeline, we continue to execute on our two lead PTH programs with a number of near-term milestones over the coming year,” stated Adam Gridley, CEO of Entera.  “We are pleased to advance our lead program in osteoporosis with the recent initiation of a Phase 2 dose ranging study for EB613, our oral PTH candidate.   Given the potential commercial potential for an orally delivered drug for osteoporosis, and the recent FDA guidance on endpoints via the 505(b)2 regulatory pathway, we’ve accelerated our clinical efforts for this program.   This study is designed to build upon the strong safety and efficacy data generated to date, and inform the appropriate dose to evaluate for our global registrational Phase 3 study to support potential FDA review.  We have also completed Part 2 of our Phase 2 PK/PD study of Oral PTH in hypoparathyroidism, and we plan to present them at a scientific meeting in the third quarter of 2019.”

“In addition to executing on our lead development programs, our strategic priorities over the next 12 months will encompass a concerted investor relations outreach strategy and executing on a holistic business development initiative to drive shareholder value.  To that end, we are excited by the opportunity to expand on the work we are doing in our partnership with Amgen, and with other leading biotechnology and pharmaceutical companies to apply our novel technology platform to other efficacious injectable products that may benefit from oral delivery,” continued Mr. Gridley. “We currently see three main areas for potential partnerships: (1) companies with leading injectable franchises that are now facing a growing threat from biosimilars, (2) biologics and proteins that may prove to be complementary to our oral delivery platform, as demonstrated by the strategic research collaboration we signed with Amgen in 2018, and (3) opportunities to license EB613 or EB612 globally, or in certain regions of Asia with the goal of rapidly developing and commercializing these products globally.”

Clinical and Corporate Highlights

 

Phase 2 Study for Oral PTH in osteoporosis: The overall design and registration requirements for the planned pivotal Phase 3 study have been largely defined following the input from the U.S. Food and Drug Administration (FDA) in our pre-IND meeting held in 2018.  Coupled with the vast clinical experience with the marketed PTH injection (Forteo^® by Lilly^®), the Company initiated a dose-ranging, placebo-controlled, Phase 2 study in June 2019.  This study will enroll 160 postmenopausal women with osteoporosis or low bone mineral density at four internationally recognized clinical sites in Israel.  The primary endpoint of this study is bone formation biomarkers (serum P1NP, a biochemical marker that is correlated with bone formation rate) at 3 months with an additional evaluation at 6 months, of bone mineral density (BMD).

The first patients were recently enrolled, with recruiting and screening efforts underway at all sites.  The Company expects enrollment to be completed in the first quarter of 2020, with results from this Phase 2 expected starting in 2020, the first being the interim 3-month biomarker data, followed by the full 3-month and 6-month biomarker data, per the approved study design. These biomarker data, along with the bone mineral density data expected at 6 months, will inform the design of our  registrational Phase 3 study. This registrational study is expected to be substantially smaller and less costly than studies used for previously studied PTH products, where the FDA required a fracture endpoint, which historically require thousands of patients over a number of years.

Osteoporosis is a disease in which the density and quality of bone are reduced. As the loss of bone silently progresses, bones become more porous and fragile, greatly increasing the risk of fracture. Worldwide, osteoporosis causes more than 8.9 million fractures annually, resulting in an osteoporotic fracture every 3 seconds.  Worldwide incidence of osteoporosis is estimated to exceed 200 million people¹, with only a small percentage of that population undergoing treatment.

Phase 2b Study for Oral PTH in hypoparathyroidism:  Oral PTH for hypoparathyroidism is Entera’s second major proprietary pipeline program. Entera completed in 2018 a two-part Phase 2 trial in patients with hypoparathyroidism that was designed to evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) profiles of its oral PTH drug and injectable PTH (Natpara^®).

Part 2 of this PK/PD study evaluated a three times per day (TID) treatment regimen with a high and low dose of Oral PTH, as well as additional Natpara^® treatments.   Results from this study are expected to be reported in September 2019 at an upcoming scientific conference and are subsequently expected to be submitted for peer review publication in 2020.  These data will provide input for the design of the Company’s anticipated Phase 3 registration clinical trials.

Personnel Appointments & Anticipated Growth of Operations:

 

Entera announced a number of personnel appointments, with the appointment of Sean Ellis, a Managing Partner of Centillion Fund, to the Board of Directors in June 2019.  In August 2019, Adam Gridley joined the Company as CEO, and Phillip Schwartz, Ph.D., former CEO since the Company’s inception in 2010, was appointed as the Company’s President of Research & Development and Executive Vice President.

Entera expects to further build out the Company’s management teams in the United States and Israel, with several planned executive level hires in the financial and business development functions to support the Company’s planned strategic plans.  The Company is in the process of establishing a corporate office in the Boston, Massachusetts area.

Investor Relations & Research Coverage:

Frost & Sullivan published an equity research report entitled From Injections to Pills - Entera Bio (ENTX): Initiation of Coverage on July 1, 2019.  The Company expects to present at a number of investor conferences over the coming quarters, as well as expanding its investor presence with institutional and retail investors through upcoming non-deal roadshows, and a planned educational event with leading osteoporosis experts, all of which will be webcast and hosted on the Company’s investor relations portion of the website.  

Financial Results for the Six Months Ended June 30, 2019

 

Revenues. Revenue for the six months ended June 30, 2019 was $74 thousand from services provided to Amgen.

1 https://www.iofbonehealth.org/facts-statistics

Research and development expenses. Research and development expenses for the six months ended June 30, 2019 were $3.5 million, compared to $4.7 million for the six months ended June 30, 2018, a decrease of $1.2 million, or 25%. The decrease in research and development expenses was primarily attributed to a decrease of $0.8 million in materials, clinical manufacturing and production capabilities and a decrease of $0.5 million in share-based compensation expenses. The decrease was partially offset by an increase of $0.1 million in salaries and related expenses mainly due to hiring of full time employees in the US during the first quarter of 2018.

 

General and administrative expenses. General and administrative expenses for the six months ended June 30, 2019 were $1.7 million, compared to $0.9 million for the six months ended June 30, 2018, an increase of $0.8 million, or 97%. The increase in general and administrative expenses was primarily attributed to an increase of $0.6 million in share-based compensation expenses due to a reversal of compensation recorded in the previous period as a result of the termination of services of our previous Chairman of the board in the same period in the prior year, an increase of $0.1 million for insurance expenses and $0.1 million of investor relation expenses due to regulation and the requirements of public company.

 

Financial income. Financial income, net for the six months ended June 30, 2019 was $0.8 million, compared to a financial income, net of $2.9 million for the six months ended June 30, 2018, a decrease of $2.1 million. Financial expenses (income), net for the six months ended June 30, 2019 and for the same period last year, resulted mainly from the change in the fair value of financial liabilities measured at fair value through profit or loss. During the six months ended June 30, 2019 and 2018, we recorded a gain of $0.8 million and $2.9 million, respectively.

 

Comprehensive loss. Comprehensive loss for the six months ended June 30, 2019 was approximately $4.4 million, compared with approximately $2.6 million in the same period in 2017, an increase of approximately $1.8 million, or 68%.

 

Basic and Diluted Loss (income) per share.  Basic and diluted loss per share for the six months ended June 30, 2019 was $0.38, compared with $0.58 and $0.7 for the six months ended June 30, 2018.

 

Financial Results for the Three Months Ended on June 30, 2019

 

Revenues. Revenues for the three months ended June 30, 2019 was $74 thousand from services provided to Amgen.

Research and development, net expenses. Research and development expenses for the three months ended June 30, 2019 were $1.4 million, compared to $1.8 million for the three months ended June 30, 2018, a decrease of $0.4 million, or 20%. The decrease in research and development expenses was primarily attributed to a decrease of approximately $0.3 million in materials, clinical manufacturing and production capabilities and $0.2 million in clinical trials, which was partially offset by an increase of $0.1 million in other research and development expenses primarily for consulting with regard to regulation expenses.

General and administrative expenses (income). General and administrative expenses for the three months ended June 30, 2019 were $0.6 million, compared to general and administrative income of $0.4 million for the three months ended June 30, 2018, an increase in expenses of $1.0 million. The increase in general and administrative expenses was primarily attributed to an increase of $0.9 million in share-based compensation due to a reversal of compensation recorded in the previous period as a result of the termination of services of our previous Chairman of the board. In addition, insurance expenses increased by $0.1 million.

Financial income, net. Financial income, net for the three months ended June 30, 2019 was $0.7 million, compared to a financial income, net of $2.9 million for the three months ended June 30, 2018. Financial income, net for the three months ended June 30, 2019 and for the same period last year, resulted mainly from the change in the fair value of financial liabilities measured at fair value through profit or loss. During the three months ended June 30, 2019 and 2018, we recorded a gain of $0.7 million and $2.9 million, respectively.

Comprehensive loss (income), net. Comprehensive loss for the three months ended June 30, 2019, was approximately $1.4 million, compared with a comprehensive income of approximately $1.6 million in the same period in 2018, an increase in expenses of approximately $2.9 million.

Basic and Diluted Loss (income) per share.  Basic and diluted loss per share for the three months ended June 30, 2019 was $0.12 compared with a basic income of $0.35 and diluted loss per share of $0.11, for the three months ended June 30, 2018.

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About Entera Bio Ltd.

Entera Bio is a clinical-stage biopharmaceutical company focused on the development and commercialization of orally delivered large molecule therapeutics for use in orphan indications and other areas with significant unmet medical needs. The Company is initially applying its technology to develop an oral formulation of a human parathyroid hormone analog, Oral PTH (1-34), for treatment of hypoparathyroidism and osteoporosis.

Entera has developed a proprietary platform technology that enables oral delivery of biologicals and large molecule drugs, which are typically delivered via injections and or other non-oral pathways. However, oral drug delivery is the easiest method for self-administering medications, offers patients greater dosing flexibility, and has the highest patient acceptance and compliance rates as compared to all other routes of drug administration. The Company employs this technology for its own pipeline products and may enter into licensing agreements with biopharma companies for application of the technology to their proprietary compounds, such as the Amgen strategic research collaboration.  For more information on Entera Bio, visit www.enterabio.com.

Forward Looking Statements

This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995.  Words such as "may," "should," "could," "would," "predicts," "potential," "continue," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates," and similar expressions, as well as statements in future tense, often signify forward-looking statements. Forward-looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved. Forward-looking statements are based on information that the Company has when those statements are made or management's good faith belief as of that time with respect to future events, and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements. Those risks and uncertainties, include, but are not limited to, the timing and conduct of our clinical trials, the clinical utility of our product candidates, the timing and likelihood of regulatory filings and approvals, our intellectual property position, and our financial position. For a discussion of these and other risks that could cause such differences and that may affect the realization of forward-looking statements, please refer to the "Special Note Regarding Forward-Looking Statements" and "Risk Factors" in the Company's Annual Report on Form 20-F and other filings with the Securities and Exchange Commission (SEC).  Investors and security holders are urged to read these documents free of charge on the SEC's web site at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

ENTERA BIO LTD.

CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION

(UNAUDITED)

* Represents an amount less than one thousand.

ENTERA BIO LTD.

CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE LOSS

(UNAUDITED)