JERUSALEM, May 10, 2024 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ:ENTX), ("Entera" or the "Company") a leader in the development of orally delivered peptides and small therapeutic proteins, today reported financial results and key business updates for the quarter ended March 31, 2024. "Entera is off to a strong start in 2024 thanks to the growth strategy we implemented in 2023, expanding our N-Tab™ therapeutic pipeline with potential first in class oral GLP-2, GLP-1/glucagon and PTH(1-34) peptide treatmen ...

Entera Bio Ltd. (ENTX) closed at $1.98 in the latest trading session, marking a -1% move from the prior day. The stock's performance was behind the S&P 500's daily gain of 1.02%. Meanwhile, the Dow gained 0.4%, and the Nasdaq, a tech-heavy index, added 2.03%.Shares of the company witnessed a gain of 19.76% over the previous month, beating the performance of the Medical sector with its loss of 5.2% and the S&P 500's loss of 3.15%.The investment community will be paying close attention to the earnings perform ...

Entera Bio Ltd. (ENTX) ended the recent trading session at $2.24, demonstrating a +0.9% swing from the preceding day's closing price. The stock's performance was ahead of the S&P 500's daily loss of 0.22%. Meanwhile, the Dow experienced a rise of 0.06%, and the technology-dominated Nasdaq saw a decrease of 0.52%.Heading into today, shares of the company had gained 46.05% over the past month, outpacing the Medical sector's loss of 6.22% and the S&P 500's loss of 1.66% in that time.The investment community wi ...

For those looking to find strong Medical stocks, it is prudent to search for companies in the group that are outperforming their peers. Has Entera Bio Ltd. (ENTX) been one of those stocks this year? A quick glance at the company's year-to-date performance in comparison to the rest of the Medical sector should help us answer this question.Entera Bio Ltd. is a member of the Medical sector. This group includes 1051 individual stocks and currently holds a Zacks Sector Rank of #4. The Zacks Sector Rank gauges th ...

Entera Bio (ENTX) makes oral peptide therapies, validating its disruptive N-Tab oral peptide proprietary technology platform.Its leading pipeline candidate is EB613, an oral, osteoanabolic (bone building) once-daily tablet for treating osteoporosis, a bone disease that develops when bone mass decreases, leading to an increase in the risk of fractures. A phase IIb study of the EB613 tablets met the primary and secondary endpoints.Entera Bio plans to begin a phase III registrational study on EB613 once the FD ...

JERUSALEM, April 08, 2024 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ:ENTX), ("Entera" or the "Company") a leader in the development of orally delivered peptides, announced today that data from the Phase 2 Trial of its lead clinical compound, EB613 (Oral PTH(1-34) Tablets) for the Treatment of Post-Menopausal Women with Low BMD or Osteoporosis compared to placebo were published in the Journal of Bone and Mineral Research (JBMR). Miranda Toledano, CEO of Entera, commented, "We are excited to share that data ...

JERUSALEM, March 20, 2024 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ:ENTX), ("Entera" or the "Company") a leader in the development of orally delivered peptides, announced today positive pharmacokinetic results from its collaborative research combining a proprietary long acting GLP-2 agonist developed by OPKO Health, Inc. (Nasdaq: "OPK", or "OPKO") with Entera's proprietary N-Tab™ technology. The program is focused on developing the first and only GLP-2 peptide tablet alternative for patients suffering fro ...

JERUSALEM, March 08, 2024 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ:ENTX), ("Entera" or the "Company") a leader in the development of orally delivered peptides, today reported financial results and key business updates for the fourth quarter and year ended December 31, 2023. "2023 was an inflection point for Entera, with consistent validation of our disruptive N-Tab™ oral peptide technology platform and the unveiling of our goal to advance five potential first-in-class oral peptide programs, Phase 1 throu ...

Exhibit 99.1 Entera Bio Announces Full Year 2023 Financial Results and Provides Business Updates JERUSALEM – March 8, 2024 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX), ("Entera" or the "Company") a leader in the development of orally delivered peptides, today reported financial results and key business updates for the fourth quarter and year ended December 31, 2023. "2023 was an inflection point for Entera, with consistent validation of our disruptive N-Tab™ oral peptide technology platform and the u ...

Product Development - Entera's most advanced product candidate, EB613, is being developed as the first oral, osteoanabolic tablet treatment for post-menopausal women with low bone mineral density and high-risk osteoporosis, with a Phase 2 study involving 161 patients meeting primary and secondary endpoints[31]. - The FDA has concurred that a 2-year, placebo-controlled Phase 3 study with Total Hip BMD as the primary endpoint could support a new drug application for EB613, expected to initiate in 2024[31][41]. - Entera's proprietary PTH tablets have been safely administered to a total of 102 healthy subjects in Phase 1 studies and 153 patients in Phase 2 studies, indicating a strong safety profile[33][52]. - The company is collaborating with OPKO Biologics to develop oral tablet formulations of GLP-2 and Oxyntomodulin, with in vivo PK/PD data expected in 2024[37][39]. - EB613 is positioned to potentially be the first oral anabolic treatment for osteoporosis, addressing the treatment gap where less than 10% of patients agree to injectable therapies[50][49]. - The Phase 2a trial for EB612 demonstrated a statistically significant reduction in calcium supplementation and maintenance of calcium levels above the target for hypoparathyroidism patients[41]. - The Phase 2 clinical trial of EB613 involved 161 postmenopausal women with osteoporosis, evaluating doses from 0.5 mg to 2.5 mg daily tablets[55]. - Statistically significant increases in the bone formation marker P1NP were observed at Month 1 (p<0.001), Month 2 (p<0.005), and Month 3 (p<0.05) for the 2.5 mg EB613 dose group[58]. - The 2.5 mg EB613 group showed a 2.07% increase in total hip BMD and a 2.92% increase in femoral neck BMD after six months, surpassing the increases reported with Forteo®[61]. - The Phase 2 PK/PD trial showed an average increase in serum calcium of approximately 0.3 mg/dL and a decrease in serum phosphate by 0.5 mg/dL, maintained over 24 hours[81]. - The company has developed an improved formulation of EB612 utilizing N-Tab™ Technology, optimizing its pharmacokinetic profile and potentially reducing daily dosing[83]. - The company is exploring the use of PTH(1-34) tablets for treating stress fractures in athletes, with further details expected in the second half of 2024[34]. Market Need and Financial Impact - The prevalence of osteoporosis affects approximately 10 million Americans, with an estimated 2 million osteoporosis-related fractures occurring annually, leading to significant healthcare costs[46]. - The annual cost of osteoporotic fractures in the U.S. is estimated to reach $25.3 billion by 2025, highlighting the urgent need for effective treatments[46]. - The company expects to continue incurring substantial losses for the next several years, particularly as it develops product candidates EB613 and EB612[188]. - Existing cash and cash equivalents are projected to fund operations through the second quarter of 2025, excluding capital needed for a proposed Phase 3 pivotal study for EB613[188]. - The company may need to conduct expensive pharmacoeconomic studies to demonstrate the medical necessity and cost-effectiveness of its product candidates[169]. - Legislative changes, including increased rebates and mandatory discounts under the Affordable Care Act, may reduce the profitability of drug products[174]. - The U.S. government and third-party payers are increasingly scrutinizing drug pricing, which could limit coverage and reimbursement for the company's products[170]. Regulatory and Compliance - The FDA is expected to provide an update on the qualification of BMD as a surrogate endpoint in 2024[72]. - The SABRE project team submitted a full qualification plan to the FDA to use treatment-related changes in BMD as a surrogate endpoint for fractures in future trials[71]. - The FDA confirmed that 400 patients exposed to EB613 would be sufficient for safety and efficacy assessments for the NDA[68]. - The FDA has a 60-day initial review period for NDA submissions, followed by a ten-month standard review or six-month priority review[120]. - The company must comply with extensive Good Manufacturing Practice (cGMP) requirements before the FDA approves any NDA or BLA[116]. - The FDA may issue a complete response letter if an NDA or BLA is not approved, outlining conditions for securing final approval[122]. - The FDA may require post-approval studies, including Phase 4 clinical trials, to assess product safety after approval[125]. - The centralized procedure for marketing authorization in the EU is mandatory for certain products, including those derived from biotechnology[146]. - The EMA's Committee for Human Medicinal Products has 210 active days to adopt an opinion on marketing authorization, which can be reduced to 150 days for accelerated assessments[147]. - Drug manufacturers must comply with cGMP regulations and are subject to periodic inspections by the FDA[127]. - The approval process for marketing outside the U.S. varies by country and may involve additional testing and administrative reviews[136]. - The FDA strictly regulates marketing and promotion of products, prohibiting off-label promotion[130]. - Conditional marketing authorization can be granted for products if the risk-benefit balance is positive and it fulfills unmet medical needs[148]. - A marketing authorization is valid for five years and can be renewed based on a re-evaluation of the risk-benefit balance[149]. - Orphan drug designation provides 10 years of market exclusivity, which can be reduced to six years if criteria are no longer met[151]. - New chemical entities benefit from eight years of data exclusivity and an additional two years of market exclusivity upon receiving marketing authorization[153]. - Compliance with EU pharmacovigilance rules is mandatory, with potential financial penalties for non-compliance[156]. - Manufacturing must adhere to EMA's cGMP requirements, with inspections to ensure compliance[157]. - Marketing and promotion of drugs are strictly regulated to ensure truthful and balanced information[158]. Financial Position and Risks - The company incurred a net loss of $8.9 million in 2023 and $13.1 million in 2022, with an accumulated deficit of $104.4 million as of December 31, 2023[188]. - The company faces substantial doubt about its ability to continue as a going concern due to ongoing financial losses and the need for additional capital[188]. - The company anticipates needing substantial additional funding to complete research and development, clinical trials, and regulatory filings, which may not be available on acceptable terms[191]. - The company expects to raise additional funds to support a potential Phase 3 trial of EB613 and further development of its N-Tab™ technology platform[192]. - The company has not yet demonstrated the ability to successfully complete large-scale clinical trials or obtain marketing approval for any product candidates[204]. - The Phase 2 clinical trial for EB613 was the largest trial conducted to date, highlighting the company's limited experience in large-scale clinical studies[205]. - The company may need to delay, reduce, or cease product development activities if adequate funding is not secured[191]. - Any additional equity or debt financing could be extremely dilutive to current shareholders, raising concerns about the company's ability to finance operations[189]. - The company has a limited operating history and has not generated any revenues from product sales, which may affect investor confidence[196]. - The company is in preliminary stages of developing product candidates and completing clinical trials, which are essential for generating significant revenues and achieving profitability[207]. - The company faces numerous risks and uncertainties in pharmaceutical product development, making it difficult to predict the timing or amount of increased expenses or profitability[208]. Organizational and Operational Challenges - The company has 19 employees, with 15 in Research and Development and 2 in General and Administrative roles[181]. - The company is dependent on a small number of key employees and advisors, and their loss could adversely affect business growth and product development[218]. - The company plans to expand its organization to enhance management and operational capabilities, which may pose challenges in managing growth[219]. - Patient enrollment in clinical trials is critical; delays in enrollment could materially affect research and development efforts[210]. - The company aims to leverage its N-Tab™ drug delivery technology across various product candidates, which is crucial for minimizing risk and development timelines[211]. - The success of oral PTH product candidates is vital for the company's business; failure to validate the N-Tab™ technology could limit future opportunities[212]. Cybersecurity Risks - Cybersecurity risks are increasing, and any breaches could disrupt operations and compromise sensitive data, potentially leading to significant liabilities[222]. - The company has engaged consultants to assess its internal cybersecurity programs and compliance[225]. - Significant capital and resources may be required to protect against and recover from cybersecurity incidents[225]. - Cybersecurity incidents are evolving, necessitating additional resources for protective measures and vulnerability remediation[225]. - There is a risk of public announcements regarding cybersecurity incidents that could negatively impact the company's Ordinary Shares price[225]. - The company's remediation efforts may not be successful, leading to potential service interruptions and breaches[225]. - Loss of critical or sensitive information could result in financial, legal, business, or reputational harm[225]. - The company may face challenges in maintaining relationships with third parties due to cybersecurity issues[225].