Entera Bio Reports Second Quarter 2018 Financial Results and Operating Update
- Closed Initial Public Offering on
July 2, 2018 - Completed Part 1 of a Phase 2 PK/PD Study in Hypoparathyroidism Patients
- Mr.
Gerald Lieberman was Appointed as Chairman of the Board of Directors
“We are happy to have successfully completed our IPO in
“This PK/PD study is designed to confirm Entera’s ability to orally deliver a protein therapeutic, PTH 1-34, and to maintain its appropriate biological effect in patients with hypoparathyroidism. Increases in serum calcium as well as decreases in serum phosphate are usually the result of the biological activity of PTH. The ability to orally deliver biologic molecules, has been exceptionally difficult to achieve for many companies,” continued Dr. Schwartz.
Recent Highlights
The Company completed the treatment of patients in the first part of the PK/PD study in hypoparathyroidism patients with its oral parathyroid hormone (PTH) drug, EB612. In part 1 of the Phase 2 study, ten patients completed two treatment visits, including three overnight stays each during which patients received various dose regimens of EB612 with or without a 100 microgram injection of Natpara administered on a separate visit. Throughout the treatment visits, patients were continuously monitored and various tests were performed, including blood and urine sampling.
The second and final part of the study will evaluate selected dose regimens chosen based on the results of the trial’s first part. The results from this Phase 2 PK/PD trial will provide input for the design of our anticipated pivotal clinical trial.
In the fourth quarter of 2018, the Company expects to meet with the
Effective as of
Six months ended
Research and development expenses for the six months ended June 30, 2018 were
General and administrative expenses for the six months ended June 30, 2018 were $0.9 million, compared to
Financial income, net for the six months ended June 30, 2018 was
Comprehensive loss for the six months ended
Basic and diluted loss per share for the six months ended
Three months ended
Research and development expenses for the three months ended June 30, 2018 were
General and administrative income for the three months ended June 30, 2018 were $0.4 million, compared to general and administrative expenses of
Financial income net for the three months ended June 30, 2018 was
Comprehensive income for the three months ended
Basic income per share for the three months ended
As of
About
Forward Looking Statements
This press release contains "forward-looking statements." 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. 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 Registration Statement on Form F-1 and other filings with the
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION
(UNAUDITED)
June 30 | December 31 | |||||
2018 | 2017 | |||||
U.S. dollars in thousands | ||||||
A s s e t s | ||||||
CURRENT ASSETS: | ||||||
Cash and cash equivalents | 6,471 | 11,746 | ||||
Other current assets | 1,017 | 671 | ||||
TOTAL CURRENT ASSETS | 7,488 | 12,417 | ||||
NON-CURRENT ASSETS: | ||||||
Property and equipment | 248 | 207 | ||||
Intangible assets | 654 | 654 | ||||
TOTAL NON-CURRENT ASSETS | 902 | 861 | ||||
TOTAL ASSETS | 8,390 | 13,278 | ||||
Liabilities net of capital deficiency | ||||||
CURRENT LIABILITIES: | ||||||
Accounts payable: | ||||||
Trade | 262 | 596 | ||||
Other | 1,766 | 1,424 | ||||
TOTAL CURRENT LIABILITIES | 2,028 | 2,020 | ||||
NON-CURRENT LIABILITIES: | ||||||
Convertible loan | 3,925 | 3,893 | ||||
Preferred shares | 30,905 | 33,455 | ||||
Warrants to purchase preferred shares and shares | 5,020 | 5,398 | ||||
Severance pay obligations, net | 66 | 70 | ||||
TOTAL NON-CURRENT LIABILITIES | 39,916 | 42,816 | ||||
TOTAL LIABILITIES | 41,944 | 44,836 | ||||
COMMITMENTS AND CONTINGENCIES | ||||||
CAPITAL DEFICIENCY: | ||||||
Ordinary Shares, NIS 0.01 par value: | ||||||
Authorized - as of June 30, 2018 and December 31, 2017, | ||||||
1,000,000 shares; issued and outstanding | ||||||
as of June 30, 2018, and December 31, 2017-34,544 shares | * | * | ||||
Accumulated other comprehensive income | 41 | 41 | ||||
Other reserves | 7,896 | 7,361 | ||||
Additional paid in capital | 2,915 | 2,853 | ||||
Accumulated deficit | (44,406 | ) | (41,813 | ) | ||
TOTAL CAPITAL DEFICIENCY | (33,554 | ) | (31,558 | ) | ||
TOTAL LIABILITIES NET OF CAPITAL DEFICIENCY | 8,390 | 13,278 |
* Represents an amount less than one thousand.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE LOSS (INCOME)
(UNAUDITED)
Six months ended |
Three months ended | |||||||||||||
June 30 |
June 30 | |||||||||||||
2018 |
2017 |
2018 |
2017 |
|||||||||||
U.S. dollars in thousands | ||||||||||||||
RESEARCH AND DEVELOPMENT EXPENSES | 4,658 | 1,280 | 1,765 | 601 | ||||||||||
GENERAL AND ADMINISTRATIVE EXPENSES (INCOME) | 854 | 2,894 | (409 | ) | 2,392 | |||||||||
OPERATING LOSS | 5,512 | 4,174 | 1,356 | 2,993 | ||||||||||
FINANCIAL EXPENSES (INCOME): | ||||||||||||||
Income from change in fair value of financial liabilities at fair value | (2,896 | ) | (479 | ) | (2,876 | ) | (742 | ) | ||||||
Other financial expenses (income), net | (23 | ) | 71 | (43 | ) | 8 | ||||||||
FINANCIAL INCOME, net | (2,919 | ) | (408 | ) | (2,919 | ) | (734 | ) | ||||||
NET COMPREHENSIVE LOSS (INCOME) FOR THE PERIOD | 2,593 | 3,766 | (1,563 | ) | 2,259 |
U.S. dollars |
U.S. dollars |
||||||||||
LOSS(INCOME) PER ORDINARY SHARE - | |||||||||||
Basic | 75.06 | 109.02 | (45.25 | ) | 65.39 | ||||||
Diluted | 91.14 | 123.86 | 13.97 | 77.87 | |||||||
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING - | |||||||||||
Basic | 34,544 | 34,544 | 34,544 | 34,544 | |||||||
Diluted | 36,427 | 47,320 | 74,161 | 44,766 |
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CHANGES IN CAPITAL DEFICIENCY
(UNAUDITED)
Number of Ordinary Shares |
Ordinary Shares- Amount |
Accumulated other comprehensive income |
Other reserve |
Additional paid in capital |
Accumulated deficit |
Total | ||||||||||
U.Sdollars in thousands |
||||||||||||||||
BALANCE AT JANUARY 1, 2017 | 34,544 | * | 41 | 2,844 | 2,485 | (30,616 | ) | (25,246 | ) | |||||||
CHANGES FOR SIX MONTHS ENDED JUNE 30, 2017: | ||||||||||||||||
Net loss for the period | - | - | - | - | - | (3,766 | ) | (3,766 | ) | |||||||
Share-based compensation | - | - | - | 2,247 | - | - | 2,247 | |||||||||
BALANCE AT JUNE 30, 2017 | 34,544 | * | 41 | 5,091 | 2,485 | (34,382 | ) | (26,765 | ) | |||||||
BALANCE AT JANUARY 1, 2018 | 34,544 | * | 41 | 7,361 | 2,853 | (41,813 | ) | (31,558 | ) | |||||||
CHANGES FOR SIX MONTHS ENDED JUNE 30, 2018: | ||||||||||||||||
Net loss for the period | (2,593 | ) | (2,593 | ) | ||||||||||||
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 | 34,544 | * | 41 | 7,896 | 2,915 | (44,406 | ) | (33,554 | ) | |||||||
CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS
(UNAUDITED)
Six months ended June 30 | |||||
2018 |
2017 |
||||
(Unaudited) | |||||
U.S dollars in thousands | |||||
CASH FLOWS USED IN OPERATING ACTIVITIES: | |||||
Net loss for the period | (2,593 | ) | (3,766 | ) | |
Adjustments required to reflect net cash | |||||
used in operating activities (see appendix A) | (2,614 | ) | 1,916 | ||
Net cash used in operating activities | (5,207 | ) | (1,850 | ) | |
CASH FLOWS PROVIDED BY (USED IN) INVESTING ACTIVITIES: | |||||
Decrease in restricted deposits | - | 1,054 | |||
Purchase of property and equipment | (68 | ) | (47 | ) | |
Net cash provided by (used in) investing activities | (68 | ) | 1,007 | ||
CASH FLOWS USED IN FINANCING ACTIVITIES: | |||||
Payment for maturity of Convertible loans | - | (980 | ) | ||
Net cash used in financing activities | - | (980 | ) | ||
NET DECREASE IN CASH AND CASH EQUIVALENTS | (5,275 | ) | (1,823 | ) | |
CASH AND CASH EQUIVALENTS AT BEGINNING OF THE YEAR | 11,746 | 4,163 | |||
CASH AND CASH EQUIVALENTS AT END OF THE PERIOD | 6,471 | 2,340 |
CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS
(UNAUDITED)
Six months ended June 30 |
|||||
2018 |
2017 |
||||
(Unaudited) | |||||
U.S dollars in thousands | |||||
APPENDIX A: | |||||
Adjustments required to reflect net cash used in operating activities: | |||||
Depreciation | 27 | 19 | |||
Gain from change in fair value of financial liabilities at fair value | (2,896 | ) | (479 | ) | |
Financial expenses | 32 | 47 | |||
Net changes in severance pay | (4 | ) | 5 | ||
Share-based compensation | 597 | 2,247 | |||
(2,244 | ) | 1,839 | |||
Changes in working capital: | |||||
Increase in other current assets | (346 | ) | (219 | ) | |
Increase (decrease) in accounts payable and accruals: | |||||
Trade | (334 | ) | 202 | ||
Other | 342 | 168 | |||
(338 | ) | 151 | |||
Cash used for operating activities - | |||||
Interest paid | (32 | ) | (74 | ) | |
(2,614 | ) | 1,916 | |||
Entera Bio Ltd. Phillip Schwartz, CEO Tel: +972-2- 532-7151 phillip@enterabio.com |
INTERNATIONAL INVESTOR RELATIONS Bob Yedid LifeSci Advisors, LLC 646-597-6989 bob@lifesciadvisors.com |
Source: Entera Bio