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
Minrav Building – Fifth Floor
Jerusalem, Israel
(Address of principal executive office)
(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): ☐
CONTENTS
This report on Form 6-K of the registrant consists of a press release issued by the registrant on August 5, 2019, attached hereto as an exhibit and incorporated by reference herein.
Exhibit
SIGNATURES
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.
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ENTERA BIO LTD.
(Registrant)
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By:
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/s/ Dr. Phillip Schwartz
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Name: Dr. Phillip Schwartz
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Title: Chief Executive Officer
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Date: August 5, 2019
Exhibit 99.1
Entera Bio Appoints Adam Gridley as Chief Executive Officer
Jerusalem, Israel – Aug. 5, 2019
– Entera Bio Ltd. (Nasdaq: ENTX), announced today the appointment of Adam Gridley as Chief Executive Officer, effective immediately. Phillip Schwartz, Ph.D., former CEO of Entera since the Company’s inception in 2010, will
continue with the Company as President of Research & Development and Executive Vice President at Entera.
“We are thrilled to have Adam, a highly accomplished pharmaceutical executive with proven business development and financial acumen, join Entera as CEO,” said Mr. Gerald Lieberman, Chairman
of Entera’s Board of Directors. “Adam has a successful track record in developing and executing plans to grow start-ups to fully integrated global commercial organizations and building multiple executive leadership teams. His capabilities in
business development and finance are highlighted by his involvement in over 15 strategic transactions and financings worth in excess of $600 million. The Board also thanks Dr. Schwartz for his many contributions and development progress since
joining the Company in 2010. We are grateful for Phillip’s continued commitment and leadership in his new role as President of R&D given his extensive development history and scientific expertise for our leading technology platform.”
Mr. Gridley stated, “I am delighted to lead Entera at this pivotal time, and believe there are substantial opportunities to create value both
by leveraging the Company’s powerful oral delivery technology platform and by advancing our underlying therapeutic pipeline, for which we retain full global rights. We intend to continue the strategy of exploring strategic collaborations and
licensing agreements with biotech and pharmaceutical partners for other large molecules and proteins, and building on the success of the strategic research collaboration signed with Amgen in 2018.”
“For Oral human parathyroid hormone (“PTH”) in osteoporosis, the Company’s most advanced internal candidate, the positive guidance recently received from the FDA has provided clarity on the
development path for this program, via the 505(b)(2) regulatory pathway,” Mr. Gridley continued. “I look forward to working with our talented team to advance this program rapidly, with the immediate priority of conducting a Phase 2a
dose-ranging study, designed to inform the design of a Phase 3 study in osteoporosis. Further, we intend to maximize the value of our Hypoparathyroidism clinical candidate, which has Orphan Disease designation in the U.S. and E.U.”
Dr. Phillip Schwartz stated “I am honored to have served as CEO of Entera for almost a decade and very proud of the team we have built. I am excited to work together with Adam and am very
confident passing the reigns to him with the broad experience in biotechnology and capital markets which he brings to the table. I look forward to myself and the team working with Adam to fully unlock the full potential of this platform with
other companies, as we have started to show with our Amgen collaboration.”
Prior to Entera, Mr. Gridley was President and CEO, and a Director of Histogenics Corporation, a public regenerative medicine company developing novel cell therapies and biologics for cartilage
defects. He led Histogenics’ $70 million IPO in December 2014, subsequently raised over $50 million of additional capital, and completed multiple strategic transactions including a $30 million collaboration with Intrexon to develop allogeneic cell
therapies, and an $87 million Japanese license agreement with MEDINET for its Phase 3 biologic product. Before joining Histogenics, Mr. Gridley served in several senior roles at Merz, a privately-held
specialty healthcare company. As Senior Vice President, Technical Operations at Merz, he led a variety of functions, including R&D, Manufacturing, Quality Operations, Finance and IT for a portfolio of aesthetics, dermatology,
neurology and OTC products that generated annual revenues of over $300 million. Previously, Mr. Gridley was Senior Vice President of Corporate Development for BioForm Medical, which was acquired by Merz in
2010. His responsibilities included all business development, investor relations, strategic planning, and R&D functions, and he was part of the executive leadership team who led the Company’s $90 million IPO and subsequent acquisition by Merz
for approximately $250 million in 2010. Mr. Gridley is currently a Director and Executive Chairman at LifeSprout, a Director of the Alliance for Regenerative Medicine (ARM), and a member of the board of advisors for Life Science Cares in Boston.
Mr. Gridley holds a B.S. and a M.B.A. from the University of Denver.
The terms of Mr. Gridley’s engagement are subject to the approval of the company's shareholders.
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.
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 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.
Contact:
Bob Yedid
LifeSci Advisors, LLC
646-597-6989
bob@lifesciadvisors.com