ENTX Entera Bio Ltd.

1.65
-0.04  -2%
Previous Close 1.69
Open 1.65
52 Week Low 1.59
52 Week High 3.4
Market Cap $30,086,415
Shares 18,234,191
Float 6,309,570
Enterprise Value $28,939,303
Volume 101,535
Av. Daily Volume 830,633
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Upcoming Catalysts

Drug Stage Catalyst Date
EB613
Osteoporosis
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
EB612
Hypoparathyroidism
Phase 2b
Phase 2b
Phase 2b results presented September 22, 2019.

Latest News

  1. BOSTON and JERUSALEM, Aug. 10, 2020 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ:ENTX), a leader in the development of orally delivered large molecule therapeutics, announced today that its Board of Directors has appointed Roger Garceau as Interim Chief Executive Officer, effective immediately.  Dr. Garceau will succeed Chief Executive Officer and Board Member Adam Gridley, who has resigned from the company to pursue a new opportunity.  Dr. Garceau will continue to serve as a Director of Entera Bio. 

    "I look forward to working with the talented team at Entera as interim CEO to ensure that the EB613 development program remains on track and that we continue to advance our pipeline, including the selection of a formulation of EB612 that we intend…

    BOSTON and JERUSALEM, Aug. 10, 2020 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ:ENTX), a leader in the development of orally delivered large molecule therapeutics, announced today that its Board of Directors has appointed Roger Garceau as Interim Chief Executive Officer, effective immediately.  Dr. Garceau will succeed Chief Executive Officer and Board Member Adam Gridley, who has resigned from the company to pursue a new opportunity.  Dr. Garceau will continue to serve as a Director of Entera Bio. 

    "I look forward to working with the talented team at Entera as interim CEO to ensure that the EB613 development program remains on track and that we continue to advance our pipeline, including the selection of a formulation of EB612 that we intend to move into a Phase 2b or Phase 3 pivotal clinical trial.  With several important data readouts for the Company over the coming months, including the final Phase 2 data from the EB613 Phase 2 trial in the first half of 2021, as well as numerous potential business development opportunities for our platform technology, I am excited to join the management team," said Dr. Garceau.

    Dr. Garceau is a seasoned pharmaceutical executive with more than 30 years of industry experience and has served as a Director of the Company since March 2016 and as Chief Development Advisor since December 2016.  Prior to joining Entera, Dr. Garceau served as Chief Medical Officer and Executive Vice President of NPS Pharmaceuticals, Inc. (NPS), since December 2008 and January 2013 respectively, until February 2015, when NPS was acquired by Shire plc. Prior to his time at NPS, Dr. Garceau served in several managerial positions Sanofi-aventis and Pharmacia Corporation.  Dr Garceau has been a non-executive director of Enterome SA since December 2016. He is a board-certified pediatrician and is a Fellow of the American Academy of Pediatrics.  Dr. Garceau holds B.S. in Biology from Fairfield University in Fairfield, Connecticut and an M.D. from the University of Massachusetts Medical School.

    "On behalf of the Board, I would like to thank Adam for his contributions and am excited that Roger is assuming the role of CEO.  Roger's background, including his experience with oral parathyroid hormone (PTH 1-34), makes him uniquely qualified to lead the Company at this exciting time.  With EB613 Phase 2 data on the horizon and the results of our recently completed market research which demonstrated the clear unmet need for oral therapies that may offer osteoporosis patients a more convenient, needle free alternative to the current injectable products currently available, this is a very exciting time for the Company," stated Gerald Lieberman, Entera's Chairman of the Board. 

    About Entera Bio

    Entera is a leader in the development of orally delivered macromolecule 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 proprietary, oral drug delivery technology is designed to address the technical challenges of poor absorption, high variability, and the inability to deliver large molecules to the targeted location in the body through the use of a synthetic absorption enhancer to facilitate the absorption of large molecules, and protease inhibitors to prevent enzymatic degradation and support delivery to targeted tissues. The Company's most advanced product candidates, EB613 for the treatment of osteoporosis and EB612 for the treatment of hypoparathyroidism are in Phase 2 clinical development. Entera also licenses its technology to biopharmaceutical companies for use with their proprietary compounds and, to date, has established a collaboration with Amgen Inc. For more information on Entera Bio, visit www.enterabio.com.

    Forward Looking Statements

    Various statements in this release are "forward-looking statements" under the securities laws. Words such as, but not limited to, "anticipate," "believe," "can," "could," "expect," "estimate," "design," "goal," "intend," "may," "might," "objective," "plan," "predict," "project," "target," "likely," "should," "will," and "would," or the negative of these terms and similar expressions or words, identify forward-looking statements. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. 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.

    Important factors that could cause actual results to differ materially from those reflected in Entera's forward-looking statements include, among others:  unexpected changes in our ongoing and planned preclinical development and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates; a possible suspension of the Phase 2 clinical trial of EB613 for clinical or data-related reasons; the impact of COVID-19 on Entera's business operations including enrollment in the Phase 2 clinical trial for EB613 in patients with osteoporosis and the ability to collect the necessary data from the Phase 2 trial of EB613; the potential disruption and delay of manufacturing supply chains, loss of available workforce resources, either by Entera or its collaboration and laboratory partners, due to travel restrictions, lay-offs or forced closures or repurposing of hospital facilities; impacts to research and development or clinical activities that Entera is contractually obligated to provide, such as pursuant to Entera's agreement with Amgen; overall regulatory timelines, if the FDA or other authorities are closed for prolonged periods, choose to allocate resources to review of COVID-19 related drugs or believe that the amount of Phase 2 clinical data collected so far are insufficient to initiate a Phase 3 trial, or a meaningful deterioration of the current political, legal and regulatory situation in Israel or the United States; the availability, quality and timing of the data from the Phase 2 clinical trial of EB613 in osteoporosis patients; the ability to find a dose that demonstrates the comparability of EB613 to FORTEO in the ongoing Phase 2 clinical trial of EB613; the size and growth of the potential market for EB613 and Entera's other product candidates including any possible expansion of the market if an orally delivered option is available in addition to an injectable formulation; Entera's interpretation of the results of the market research studies conducted to date; the scope, progress and costs of developing Entera's product candidates; Entera's reliance on third parties to conduct its clinical trials; Entera's expectations regarding licensing, business transactions and strategic collaborations; Entera's operation as a development stage company with limited operating history; Entera's ability to continue as a going concern absent access to sources of liquidity; Entera's expectations regarding its expenses, revenue, cash resources; Entera's ability to raise additional capital; Entera's interpretation of FDA feedback and guidance and how such guidance may impact its clinical development plans; Entera's ability to obtain and maintain regulatory approval for any of its product candidates; Entera's ability to comply with Nasdaq's minimum listing standards and other matters related to compliance with the requirements of being a public company in the United States; Entera's intellectual property position and its ability to protect its intellectual property; and other factors that are described in the "Special Note Regarding Forward-Looking Statements," "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Entera's annual and current filings which are on file with the SEC and available free of charge on the SEC's website at http://www.sec.gov. In addition to the risks described above and in Entera's annual report on Form 20-F and current reports on Form 6-K and other filings with the SEC, other unknown or unpredictable factors also could affect Entera's results. There can be no assurance that the actual results or developments anticipated by Entera will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Entera. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved.

    All written and verbal forward-looking statements attributable to Entera or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Entera cautions investors not to rely too heavily on the forward-looking statements Entera makes or that are made on its behalf.  The information in this release is provided only as of the date of this release, and Entera undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

    Contact:
    
    Jonathan Lieber, CFO
    Tel: +972-2-532-7151
    

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  2. BOSTON and JERUSALEM, Aug. 05, 2020 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ:ENTX), a leader in the development of orally delivered large molecule therapeutics, announced that members of its management team will participate virtually in the BTIG Biotechnology Conference on Monday, August 10, 2020 at 12:30 p.m. EDT. 

    To access a live webcast of the fireside chat on the "Investor Relations" page of Entera's website, please click here. A replay of the webcast will be archived on Entera's website for approximately 45 days following the presentation.

    About Entera Bio

    Entera is a leader in the development of orally delivered macromolecule therapeutics for use in areas with significant unmet medical need where adoption of injectable therapies…

    BOSTON and JERUSALEM, Aug. 05, 2020 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ:ENTX), a leader in the development of orally delivered large molecule therapeutics, announced that members of its management team will participate virtually in the BTIG Biotechnology Conference on Monday, August 10, 2020 at 12:30 p.m. EDT. 

    To access a live webcast of the fireside chat on the "Investor Relations" page of Entera's website, please click here. A replay of the webcast will be archived on Entera's website for approximately 45 days following the presentation.

    About Entera Bio

    Entera is a leader in the development of orally delivered macromolecule 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 proprietary, oral drug delivery technology is designed to address the technical challenges of poor absorption, high variability, and the inability to deliver large molecules to the targeted location in the body through the use of a synthetic absorption enhancer to facilitate the absorption of large molecules, and protease inhibitors to prevent enzymatic degradation and support delivery to targeted tissues. The Company's most advanced product candidates, EB613 for the treatment of osteoporosis and EB612 for the treatment of hypoparathyroidism are in Phase 2 clinical development. Entera also licenses its technology to biopharmaceutical companies for use with their proprietary compounds and, to date, has established a collaboration with Amgen Inc. For more information on Entera Bio, visit www.enterabio.com.

    Contact:
    
    Jonathan Lieber, CFO
    Tel: +972-2-532-7151
    

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  3. Approximately 85% of Clinicians Surveyed Likely to Prescribe Oral Parathyroid Hormone (PTH) to Treat Moderate to Severe Osteoporosis

    Oral PTH Described by Clinicians as Potential Game-Changer that Addresses Substantial Unmet Need with Possibility of Improving Patient Compliance and Comfort

    Potential to Significantly Expand the Multi-Billion Dollar Global Market; More than Half of Clinicians Likely to Increase Usage of PTH to Treat Osteoporosis if an Effective Orally Delivered Product is Available

    BOSTON and JERUSALEM, July 22, 2020 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ:ENTX), a leader in the development of orally delivered large molecule therapeutics, announced today the results from two primary market research studies…

    Approximately 85% of Clinicians Surveyed Likely to Prescribe Oral Parathyroid Hormone (PTH) to Treat Moderate to Severe Osteoporosis

    Oral PTH Described by Clinicians as Potential Game-Changer that Addresses Substantial Unmet Need with Possibility of Improving Patient Compliance and Comfort

    Potential to Significantly Expand the Multi-Billion Dollar Global Market; More than Half of Clinicians Likely to Increase Usage of PTH to Treat Osteoporosis if an Effective Orally Delivered Product is Available

    BOSTON and JERUSALEM, July 22, 2020 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ:ENTX), a leader in the development of orally delivered large molecule therapeutics, announced today the results from two primary market research studies of clinicians who treat osteoporosis patients. The studies were conducted by a third-party firm with a goal of gaining a better understanding of the perceived value and potential market penetration of an orally-delivered parathyroid hormone product in the treatment of osteoporosis. The survey populations were comprised of clinicians who frequently prescribe osteoporosis products including endocrinologists, gynecologists, orthopedists, and general practitioners, with over 70% of their osteoporosis patients having moderate to severe osteoporosis. One study surveyed clinicians in the U.S., Canada, and Europe, and the second surveyed clinicians in Japan. In the two studies, physicians were presented with a description of an oral PTH product that provides similar efficacy and safety of injectable PTH without the need for daily subcutaneous injections. The responses to the prospect of prescribing an oral PTH were overwhelmingly positive, driven by expected improvements in patient compliance, ease of administration, and without injection site discomfort. Physicians also considered reduced costs to patients and payers to be important features. Entera's EB613 oral PTH is currently in Phase 2 clinical development for the treatment of osteoporosis, a multi-billion dollar global market.

    "We are very pleased with the data from this important global market survey which very clearly validates the value proposition of our lead drug candidate, EB613. Due to the high cost, inconvenience, and pain associated with injectable osteoanabolic products, which are currently the standard of care for treating moderate to severe osteoporosis, it is estimated that only 5% of patients with severe osteoporosis actually receive treatment for their disease," stated Entera CEO Adam Gridley. "The results of this market analysis confirm Entera's view that an oral PTH tablet meets an unmet physician and patient need and can potentially grow the number of patients receiving treatment. Remarkably, approximately 45% of the participating physicians indicated the oral PTH would be their first line treatment choice for their patients with severe osteoporosis."

    The study conducted in the U.S./Canada/Europe included 100 clinicians with roughly 80% of the respondents from North America and 20% from Europe. Two-thirds of the clinicians were rheumatologists or endocrinologists with the balance equally split between orthopedists and general practitioners. The study conducted in Japan included 75 clinicians, approximately three-fourths of which were orthopedists. In both studies, patients treated by the physicians were predominantly female, and by progression of disease, the distribution of the patients was approximately 21% with early/mild osteoporosis, approximately 48% with moderate osteoporosis, and approximately 31% with severe osteoporosis. Clinicians in both studies were in general agreement that a safe and effective oral PTH may greatly reduce the use of PTH injectables for the treatment of osteoporosis, drastically changing the market by increasing patient comfort and compliance. 

    Key findings from the physician surveys included*:

     United States and

    Europe (n=100)
    Japan

    (n=75)
    Oral PTH as preferred method of treatment for severe osteoporosis patients relative to other options58%57%
    Likely to prescribe oral PTH treatment for osteoporosis84%89%
    Likely to increase prescribing levels for Osteoporosis patients if an effective oral PTH treatment is available56%78%
    Oral PTH is compelling79%81%
    * %s are those clinicians with a positive response to using an oral PTH product that could provide similar efficacy and safety of injectable PTH 

    Dr. Arthur Santora, Entera's Chief Medical Officer, added, "A majority of clinicians stated the availability of an oral PTH with the attributes presented to them would grow their practice and some of the clinicians surveyed summed things up succinctly when they stated an oral PTH would be a game changer. The data show the potential of an oral PTH to have a transformative impact on the treatment of osteoporosis by serving as a possible first line therapy, enabling doctors to treat patients with moderate to severe osteoporosis who are currently untreated by offering a much needed alternative to needle-phobic and cost-constrained patients. We believe the promising feedback from physicians currently involved in the care of high fracture risk patients with current osteoporosis medications may result in a rapid market adoption of the first oral PTH product. Our goal is for Entera Bio's EB613 oral PTH to be that product. We expect to complete patient enrollment in our Phase 2 study of EB613 in the third quarter of 2020 with a goal of moving into Phase 3 by late 2021 or 2022."

    About Entera Bio Ltd.

    Entera is a leader in the development of orally delivered macromolecule 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 proprietary, oral drug delivery technology is designed to address the technical challenges of poor absorption, high variability, and the inability to deliver large molecules to the targeted location in the body through the use of a synthetic absorption enhancer to facilitate the absorption of large molecules, and protease inhibitors to prevent enzymatic degradation and support delivery to targeted tissues. The Company's most advanced product candidates, EB613 for the treatment of osteoporosis and EB612 for the treatment of hypoparathyroidism are in Phase 2 clinical development. Entera also licenses its technology to biopharmaceutical companies for use with their proprietary compounds and, to date, has established a collaboration with Amgen Inc. For more information on Entera Bio, visit www.enterabio.com.

    Forward Looking Statements

    Various statements in this release are "forward-looking statements" under the securities laws. Words such as, but not limited to, "anticipate," "believe," "can," "could," "expect," "estimate," "design," "goal," "intend," "may," "might," "objective," "plan," "predict," "project," "target," "likely," "should," "will," and "would," or the negative of these terms and similar expressions or words, identify forward-looking statements. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. 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.

    Important factors that could cause actual results to differ materially from those reflected in Entera's forward-looking statements include, among others:  unexpected changes in our ongoing and planned preclinical development and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates; a possible suspension of the Phase 2 clinical trial of EB613 for clinical or data-related reasons; the impact of COVID-19 on Entera's business operations including enrollment in the Phase 2 clinical trial for EB613 in patients with osteoporosis and the ability to collect the necessary data from the Phase 2 trial of EB613; the potential disruption and delay of manufacturing supply chains, loss of available workforce resources, either by Entera or its collaboration and laboratory partners, due to travel restrictions, lay-offs or forced closures or repurposing of hospital facilities; impacts to research and development or clinical activities that Entera is contractually obligated to provide, such as pursuant to Entera's agreement with Amgen; overall regulatory timelines, if the FDA or other authorities are closed for prolonged periods, choose to allocate resources to review of COVID-19 related drugs or believe that the amount of Phase 2 clinical data collected so far are insufficient to initiate a Phase 3 trial, or a meaningful deterioration of the current political, legal and regulatory situation in Israel or the United States; the availability, quality and timing of the data from the Phase 2 clinical trial of EB613 in osteoporosis patients; the ability to find a dose that demonstrates the comparability of EB613 to FORTEO in the ongoing Phase 2 clinical trial of EB613; the size and growth of the potential market for EB613 and Entera's other product candidates including any possible expansion of the market if an orally delivered option is available in addition to an injectable formulation; Entera's interpretation of the results of the market research studies conducted to date; the scope, progress and costs of developing Entera's product candidates; Entera's reliance on third parties to conduct its clinical trials; Entera's expectations regarding licensing, business transactions and strategic collaborations; Entera's operation as a development stage company with limited operating history; Entera's ability to continue as a going concern absent access to sources of liquidity; Entera's expectations regarding its expenses, revenue, cash resources; Entera's ability to raise additional capital; Entera's interpretation of FDA feedback and guidance and how such guidance may impact its clinical development plans; Entera's ability to obtain and maintain regulatory approval for any of its product candidates; Entera's ability to comply with Nasdaq's minimum listing standards and other matters related to compliance with the requirements of being a public company in the United States; Entera's intellectual property position and its ability to protect its intellectual property; and other factors that are described in the "Special Note Regarding Forward-Looking Statements," "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Entera's annual and current filings which are on file with the SEC and available free of charge on the SEC's website at http://www.sec.gov. In addition to the risks described above and in Entera's annual report on Form 20-F and current reports on Form 6-K and other filings with the SEC, other unknown or unpredictable factors also could affect Entera's results. There can be no assurance that the actual results or developments anticipated by Entera will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Entera. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved.

    All written and verbal forward-looking statements attributable to Entera or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Entera cautions investors not to rely too heavily on the forward-looking statements Entera makes or that are made on its behalf.  The information in this release is provided only as of the date of this release, and Entera undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

    Contact:
    
    Jonathan Lieber, CFO
    Tel: +972-2-532-7151
    

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  4. ‒ Institutional Review Boards (IRBs) Approve Amended Phase 2 Protocol with Newly Enrolled Patients Receiving a 2.5 mg Dose, 1.5 mg Dose, or Placebo ‒

    ‒ Company Continues to Expect Completion of Enrollment in Q3:20 and Intends to Follow All Patients for Bone Mineral Density and Biomarker (BMD) Data After Six Months of Treatment ‒

    ‒ Biomarker Data from the Higher Dose Groups Expected in Early Q1:21 with Full Six-month BMD Data Expected in Early Q2:21 ‒

    BOSTON and JERUSALEM, July 07, 2020 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ:ENTX), a leader in the development of orally delivered large molecule therapeutics, announced receipt of approval from the IRBs at the clinical sites for the amendment to its Phase 2 protocol to include the testing…

    ‒ Institutional Review Boards (IRBs) Approve Amended Phase 2 Protocol with Newly Enrolled Patients Receiving a 2.5 mg Dose, 1.5 mg Dose, or Placebo ‒

    ‒ Company Continues to Expect Completion of Enrollment in Q3:20 and Intends to Follow All Patients for Bone Mineral Density and Biomarker (BMD) Data After Six Months of Treatment ‒

    ‒ Biomarker Data from the Higher Dose Groups Expected in Early Q1:21 with Full Six-month BMD Data Expected in Early Q2:21 ‒

    BOSTON and JERUSALEM, July 07, 2020 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ:ENTX), a leader in the development of orally delivered large molecule therapeutics, announced receipt of approval from the IRBs at the clinical sites for the amendment to its Phase 2 protocol to include the testing of higher doses of EB613. 

    The amendment was submitted after the analysis of the interim Phase 2 biomarker and safety data supported the evaluation of a higher dose of EB613 in the trial. The interim readout demonstrated statistically significant effects on the P1NP biomarker after one month of treatment (p<0.001) compared to the placebo, and meaningful increases at months two and three compared to the placebo with the highest EB613 dose (1.5 mg).  There was also a dose response at one month, with those trends continuing at two months.  The two lower doses (0.5 mg and 1.0 mg) demonstrated suboptimal increases and therefore, have been discontinued in the amended protocol.  Sites have restarted new patient enrollment to include the 2.5mg dose, 1.5mg dose and placebo.  There are currently 106 patients enrolled out of the targeted 160 patients in the trial, including the new high-dose group.  The Company expects to complete enrollment for the trial in Q3:20.

    "Based on our analysis of the interim three-month biomarker data from the lowest doses in the first 50% of the patients enrolled in the trial, we believe the observed early positive trends and favorable safety profile of EB613 warranted the continued testing of the 1.5 mg dose and the addition of a 2.5 mg dose," stated Adam Gridley, CEO of Entera.  "We expect to report incremental biomarker and six-month BMD data from the first 50 percent of patients at the lower doses in Q3:20.  Given the small sample size of this limited interim BMD data readout, we may see some interesting trends but believe the more relevant data will come from the final analysis of all the patients, including those at the higher doses. After the limited interim analysis of bio markers indicated that our oral PTH had some effect on bone remodeling, we look forward to seeing the full data set, including BMD data, as BMD is the ultimate measure of efficacy for an osteoporosis drug."  

    EB613 Phase 2 Clinical Trial

    The Phase 2 clinical trial of EB613, the Company's orally delivered PTH 1-34, is a dose-ranging, placebo-controlled, 160-patient clinical trial in postmenopausal female patients with osteoporosis, or low BMD, being conducted at four leading medical centers in Israel.  Patients who were previously randomized received one of three doses of EB613, 1.5 mg, 1.0 mg, or 0.5 mg, or a placebo.  Under the new amendment, patients are randomized to receive either a 2.5 mg dose or 1.5 mg dose of EB613, or a placebo.  The primary endpoint of the study is the change in P1NP from baseline during treatment with oral PTH doses at three months compared to the change from baseline with placebo.  Secondary endpoints include change in BMD, change in P1NP, serum CTX (a marker of bone resorption), and a variety of other measures at three and six months.  Upon completion of the study, if successful, the Company intends to meet with the United States Food and Drug Administration, or FDA, to discuss the results and the design of a potential single Phase 3 clinical trial to support the regulatory approval of EB613.

    About Entera Bio Ltd.

    Entera is a leader in the development of orally delivered macromolecule 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 proprietary, oral drug delivery technology is designed to address the technical challenges of poor absorption, high variability, and the inability to deliver large molecules to the targeted location in the body through the use of a synthetic absorption enhancer to facilitate the absorption of large molecules, and protease inhibitors to prevent enzymatic degradation and support delivery to targeted tissues. The Company's most advanced product candidates, EB613 for the treatment of osteoporosis and EB612 for the treatment of hypoparathyroidism are in Phase 2 clinical development. Entera also licenses its technology to biopharmaceutical companies for use with their proprietary compounds and, to date, has established a collaboration with Amgen Inc. For more information on Entera Bio, visit www.enterabio.com.

    Forward Looking Statements

    Various statements in this release are "forward-looking statements" under the securities laws. Words such as, but not limited to, "anticipate," "believe," "can," "could," "expect," "estimate," "design," "goal," "intend," "may," "might," "objective," "plan," "predict," "project," "target," "likely," "should," "will," and "would," or the negative of these terms and similar expressions or words, identify forward-looking statements. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. 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.

    Important factors that could cause actual results to differ materially from those reflected in Entera's forward-looking statements include, among others:  unexpected changes in our ongoing and planned preclinical development and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates; a possible suspension of the Phase 2 clinical trial of EB613 for clinical or data-related reasons; the impact of COVID-19 on Entera's business operations including enrollment in the Phase 2 clinical trial for EB613 in patients with osteoporosis and the ability to collect the necessary data from the Phase 2 trial of EB613; the potential disruption and delay of manufacturing supply chains, loss of available workforce resources, either by Entera or its collaboration and laboratory partners, due to travel restrictions, lay-offs or forced closures or repurposing of hospital facilities; impacts to research and development or clinical activities that Entera is contractually obligated to provide, such as pursuant to Entera's agreement with Amgen; overall regulatory timelines, if the FDA or other authorities are closed for prolonged periods, choose to allocate resources to review of COVID-19 related drugs or believe that the amount of Phase 2 clinical data collected so far are insufficient to initiate a Phase 3 trial, or a meaningful deterioration of the current political, legal and regulatory situation in Israel or the United States; the availability, quality and timing of the data from the Phase 2 clinical trial of EB613 in osteoporosis patients; the ability to find a dose that demonstrates the comparability of EB613 to FORTEO in the ongoing Phase 2 clinical trial of EB613; the size and growth of the potential market for EB613 and Entera's other product candidates including any possible expansion of the market if an orally delivered option is available in addition to an injectable formulation; the scope, progress and costs of developing Entera's product candidates; Entera's reliance on third parties to conduct its clinical trials; Entera's expectations regarding licensing, business transactions and strategic collaborations; Entera's operation as a development stage company with limited operating history; Entera's ability to continue as a going concern absent access to sources of liquidity; Entera's expectations regarding its expenses, revenue, cash resources; Entera's ability to raise additional capital; Entera's interpretation of FDA feedback and guidance and how such guidance may impact its clinical development plans; Entera's ability to obtain and maintain regulatory approval for any of its product candidates; Entera's ability to comply with Nasdaq's minimum listing standards and other matters related to compliance with the requirements of being a public company in the United States; Entera's intellectual property position and its ability to protect its intellectual property; and other factors that are described in the "Special Note Regarding Forward-Looking Statements," "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Entera's annual and current filings which are on file with the SEC and available free of charge on the SEC's website at http://www.sec.gov. In addition to the risks described above and in Entera's annual report on Form 20-F and current reports on Form 6-K and other filings with the SEC, other unknown or unpredictable factors also could affect Entera's results. There can be no assurance that the actual results or developments anticipated by Entera will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Entera. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved.

    All written and verbal forward-looking statements attributable to Entera or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Entera cautions investors not to rely too heavily on the forward-looking statements Entera makes or that are made on its behalf.  The information in this release is provided only as of the date of this release, and Entera undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

    Contact:
    
    Jonathan Lieber, CFO
    Tel: +972-2-532-7151
    

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  5. NEW YORK, June 17, 2020 /PRNewswire/ -- Equity research is published in the framework of Frost & Sullivan's Independent Equity Research Program. This type of equity research is trusted by investors as it is unbiased and analysts have no financial interest in the stock. You can explore all of the companies we cover HERE and contact us at no cost to learn more about them or to tell us about companies you want covered at: .

    Summary of Q1 Highlights (Our publically available full reports linked below give invaluable insight on the valuation of the Companies we cover and  their markets):

    Foresight Autonomous Holdings Ltd. (NASDAQ / TASE: FRSX)

    Foresight is a unique opportunity to invest in a game-changing start up firm with…

    NEW YORK, June 17, 2020 /PRNewswire/ -- Equity research is published in the framework of Frost & Sullivan's Independent Equity Research Program. This type of equity research is trusted by investors as it is unbiased and analysts have no financial interest in the stock. You can explore all of the companies we cover HERE and contact us at no cost to learn more about them or to tell us about companies you want covered at: .

    Summary of Q1 Highlights (Our publically available full reports linked below give invaluable insight on the valuation of the Companies we cover and  their markets):

    Foresight Autonomous Holdings Ltd. (NASDAQ / TASE: FRSX)

    Foresight is a unique opportunity to invest in a game-changing start up firm with three different investment opportunities: autonomous cars, trains, and cellular-based accident prevention solutions. Its inclusion in the Horizon 2020 Consortium along with Continental, the agreement with FLIR (NASDAQ:FLIR) , and the significant order from Rail Vision are all testimony to the fast moving and great potential of Foresight.

    Full Report HERE

    Itamar Medical: (NASDAQ / TASE: ITMR)

    Strong Q1 with revenue increase of 38% YoY. COVID-19 causes increased demand for flagship product. Continued strong expansion of partnerships and insurance coverage has led to Itamar working with 10% of sleep centers in the U.S. so far!

    Full Report HERE

    Allot Ltd. (NASDAQ, TASE: ALLT)

    Optimizing cellular networks for the largest international Telecoms so that they can become more profitable Allot finishes Q1 with a 16% YOY revenue increase. Broadcom's  (NASDAQ AVGO) new partnership with Allot along with Allot`s new enterprise solutions are testimony to the great growth potential of Allot.

    Full Report HERE

    Electreon Wireless LTD. (TASE: ELWS)

    Allowing EVs to charge as they drive, Electreon won tender over Volvo! Completed first segment in Sweden as well as MoU signed with a large German company to test the feasibility of the company's technology. 2020 is a significant year for Electreon with continued penetration into Europe. Our initian report summarizing 2019 and looking forward to 2020 gives invaluable insight on the fast growing Company and its ecosystem.  

    Full Report HERE 

    Enlight Renewable Energy (TASE: ENLT)

    Enlight is consistently and outstandingly delivering on growing its energy projects portfolio on an international scale. The Ministry of Energy's declarations of higher renewable energy targets are a powerful driver of company growth and provide great business potential; The company has a substantial 2 gigawatt portfolio and we have updated the Company's price target.                   

    Full Report HERE 

    DNA Biomedical Solutions: (TASE: DNA)

    DNA is a highly cost effective arbitrage to be exposed to Entera stock  (NASDAQ:ENTX). We see investment potential in DNA's share, focusing on Entera that is positioning itself as one of the leading oral delivery companies of large molecules and biologics.

    Full Report HERE 

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    SOURCE Frost & Sullivan

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