Entera Bio Reports Third Quarter 2018 Financial Results and Operating Update
- Entered into research collaboration and license agreement with
Amgen , potential for up to$270 million in milestone payments, as well as royalties on commercial sales - Met with
FDA in lateNovember 2018 to discuss clinical development plan for EB613 in the treatment of osteoporosis - Reported positive results from Part 1 of a Phase 2 PK/PD study in hypoparathyroidism patients and completed the treatment phase of Part 2 of this study
- Mr.
Gerald Lieberman named as Chairman and three new independent members appointed to the board of directors - Appointed Dr.
Arthur Santora , former Merck executive and lead clinical research physician on Fosamax®, as Chief Medical Officer
“We achieved a number of important R&D and corporate milestones in 2018, including the successful execution of an important collaboration and licensing agreement with
Recent Highlights
Strategic Research Collaboration with
Dr. Schwartz continued, “We believe this important collaboration with
Oral PTH (1-34) Phase 2 Study: Entera completed 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 parathyroid hormone (PTH) drug (“Oral PTH (1-34)”) and injectable PTH (1-84), Natpara®. An initial analysis of the Part 1 data demonstrated that Oral PTH (1-34), administered 4 times daily (Q.I.D.), had a positive impact on serum calcium, phosphate, and active vitamin D levels, and was associated with a significant decrease in 24-hour urinary calcium levels. The concentration of PTH (1-34) in blood after administration of Oral PTH (1-34) in the current study was controlled and sufficient to produce the desired physiological and clinical effects, The drug also did not induce hypercalcemia. No drug related serious adverse events were reported in the study.
The second and final part of this PK/PD study evaluated a three times per day (T.I.D.) treatment regimen with a high and low dose of Oral PTH (1-34), as well as Natpara. The treatment phase of Part 2 is complete and the data will be analyzed over the coming weeks/months. The results from the complete Phase 2 PK/PD trial will provide input for the design of the Company’s anticipated registration clinical trials. Details of the complete data set of this PK/PD study, once available, are expected to be submitted for presentation at scientific meetings and for publication in 2019. Dr. Schwartz, stated, “The results from our Phase 2 PK/PD study provide valuable insight into the profile of Oral PTH (1-34) as a treatment option for hypoparathyroidism. The available data support our belief that Oral PTH (1-34) can be more effective and convenient for patients than the commercially available injectable PTH (1-84). We look forward to reporting the results from the Phase 2 study in 2019.”
FDA Meeting: In
Management and Board Appointments
Entera announced the appointment of industry veteran
Mr.
Commenting on the new developments at Entera, Dr. Schwartz stated: “In order to support the advancement of our programs and our status as a publicly listed company, we have expanded our team with several key executive and Board level appointments, including the appointment of
Additionally, the Company expanded its board of directors with the appointments of
Three Months Ended
Research and development expenses for the three months ended September 30, 2018 were
General and administrative expenses for the three months ended September 30, 2018 were
Financial expense, net for the three months ended September 30, 2018, was
Comprehensive loss for the three months ended
Basic and diluted loss per share for the three months ended
On
As of
Cash and cash equivalents at
Nine Months Ended
Research and development expenses for the nine months ended September 30, 2018 were
General and administrative expenses for the nine months ended September 30, 2018 were
Financial income, net for the nine months ended September 30, 2018 was $0.7 million, compared to a financial expense, net of $0.5 million for the nine months ended September 30, 2017. Financial income, net and financial expenses, net resulted mainly from the changes in the fair value of financial liabilities through profit and loss.
Comprehensive loss for the nine months ended
Basic and diluted losses per share for the nine months ended
Entera is a Foreign Private Issuer (FPI) and is not required to report quarterly financials. This third quarter financial report was reviewed by Entera’s audit committee, approved by the board and is being issued to provide additional financial transparency to Entera’s investor community. The Israeli Companies Law requires that the financial statements be reviewed by an audit committee comprised of three independent directors. The minimum three member size of the audit committee (which is not required under NASDAQ rules applicable to Entera) was met with the appointment of
For further details on the Company’s financials for the three and nine month periods ending
About
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
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
Contact:
LifeSci Advisors, LLC
646-597-6989
bob@lifesciadvisors.com
ENTERA BIO LTD. | |||||
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION | |||||
(UNAUDITED) | |||||
September 30 | December 31 | ||||
2018 | 2017 | ||||
U.S. dollars in thousands | |||||
Assets | |||||
CURRENT ASSETS: | |||||
Cash and cash equivalents | 13,858 | 11,746 | |||
Other current assets | 398 | 671 | |||
TOTAL CURRENT ASSETS | 14,256 | 12,417 | |||
NON-CURRENT ASSETS: | |||||
Property and equipment | 238 | 207 | |||
Intangible assets | 654 | 654 | |||
TOTAL NON-CURRENT ASSETS | 892 | 861 | |||
TOTAL ASSETS | 15,148 | 13,278 | |||
Liabilities and shareholders' equity (net of capital deficiency) | |||||
CURRENT LIABILITIES: | |||||
Accounts payable: | |||||
Trade | 403 | 596 | |||
Other | 1,041 | 1,424 | |||
TOTAL CURRENT LIABILITIES | 1,444 | 2,020 | |||
NON-CURRENT LIABILITIES: | |||||
Convertible loan | - | 3,893 | |||
Preferred shares | - | 33,455 | |||
Warrants to purchase preferred shares and shares | 1,176 | 5,398 | |||
Severance pay obligations, net | 67 | 70 | |||
TOTAL NON-CURRENT LIABILITIES | 1,243 | 42,816 | |||
TOTAL LIABILITIES | 2,687 | 44,836 | |||
COMMITMENTS AND CONTINGENCIES | |||||
SHAREHOLDERS' EQUITY (CAPITAL DEFICIENCY): | |||||
Ordinary Shares, NIS 0.0000769 par value: | |||||
Authorized - as of September 30, 2018 and December 31, 2017, 140,010,000 shares; issued outstanding: | |||||
as of September 30, 2018, and December 31, 2017 - 11,428,320 | |||||
and 4,490,720 shares, respectively | * | * | |||
Accumulated other comprehensive income | 41 | 41 | |||
Other reserves | 13,128 | 7,361 | |||
Additional paid in capital | 48,764 | 2,853 | |||
Accumulated deficit | (49,472) | (41,813) | |||
TOTAL SHAREHOLDERS' EQUITY (CAPITAL DEFICIENCY) | 12,461 | (31,558) | |||
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY (NET OF CAPITAL DEFICIENCY) | 15,148 | 13,278 |
* Represents an amount less than
ENTERA BIO LTD. | |||||||
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE LOSS | |||||||
(UNAUDITED) | |||||||
Nine months ended |
Three months ended | ||||||
September 30 |
September 30 | ||||||
2018 | 2017 | 2018 | 2017 | ||||
U.S. dollars in thousands | |||||||
RESEARCH AND DEVELOPMENT EXPENSES | 6,464 | 1,686 | 1,806 | 406 | |||
GENERAL AND ADMINISTRATIVE EXPENSES | 1,914 | 5,267 | 1,060 | 2,373 | |||
OPERATING LOSS | 8,378 | 6,953 | 2,866 | 2,779 | |||
FINANCIAL EXPENSES (INCOME): | |||||||
Expenses (Income) from change in fair value of financial liabilities at fair value | (719) | 403 | 2,177 | 882 | |||
Other financial expenses (income) , net | - | 66 | 23 | (5) | |||
FINANCIAL EXPENSES (INCOME), net | (719) | 469 | 2,200 | 877 | |||
NET COMPREHENSIVE LOSS FOR THE PERIOD | 7,659 | 7,422 | 5,066 | 3,656 | |||
U.S. dollars |
U.S. dollars | ||||||
LOSS PER ORDINARY SHARE* - | |||||||
Basic | 1.13 | 1.65 | 0.45 | 0.81 | |||
Diluted | 1.14 | 1.69 | 0.45 | 0.85 | |||
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING* - | |||||||
Basic | 6,777,841 | 4,490,720 | 11,277,503 | 4,490,720 | |||
Diluted | 6,825,532 | 4,822,740 | 11,277,503 | 5,444,980 |
Entera Bio Ltd. | INTERNATIONAL INVESTOR RELATIONS |
Phillip Schwartz, CEO | Bob Yedid |
Tel: +972-2- 532-7151 | LifeSci Advisors |
phillip@enterabio.com | 646-597-6989 |
bob@lifesciadvisors.com |
Source: Entera Bio