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 ...

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].

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 ...

JERUSALEM, Jan. 30, 2024 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ:ENTX), ("Entera" or the "Company") a leader in the development of orally delivered peptides and therapeutic proteins, announced that it will participate and be available for investor meetings at the Oppenheimer 34th Annual Healthcare Life Sciences Conference being held February 13 – 14, 2024 in a virtual format. The presentation at 8am Wednesday, February 14th will feature a business overview and update by Miranda Toledano, the Company's C ...

WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to UNITED STATES SECURITIES AND EXCHANGE COMMISSION Commission file number: 001-38556 ENTERA BIO LTD. (Exact name of Registrant as specified in its charter) | Israel | Not applicable | | --- | --- | | (State or oth ...

Financial Performance - As of June 30, 2023, Entera Bio Ltd. reported total assets of $10.445 million, a decrease from $13.127 million as of December 31, 2022, representing a decline of approximately 20.6%[22] - The company incurred a net loss of $4.515 million for the six months ended June 30, 2023, compared to a net loss of $6.969 million for the same period in 2022, reflecting a reduction of approximately 35.5%[25] - The loss per share for the six months ended June 30, 2023, was $0.16, compared to $0.24 for the same period in 2022, reflecting an improvement of approximately 33.3%[25] - For the three months ended June 30, 2023, the company reported an operating loss of $2.33 million, a decrease of 28% compared to an operating loss of $3.25 million for the same period in 2022[93] - The net loss for the six months ended June 30, 2023 was $4.5 million, a reduction of 35% from a net loss of $7.0 million in the same period of 2022[100] Cash and Assets - Cash and cash equivalents decreased to $9.135 million as of June 30, 2023, from $12.309 million at the end of 2022, a decline of about 25.5%[22] - As of June 30, 2023, the company had cash and cash equivalents of $9.1 million, down from $12.3 million at the end of the previous period[109] - The company recorded prepaid expenses of $296,000 and other current assets of $354,000 as of June 30, 2023, compared to $86,000 and $208,000 respectively as of December 31, 2022[48] Liabilities and Deficits - Total current liabilities increased to $1.865 million as of June 30, 2023, from $1.341 million at the end of 2022, marking an increase of approximately 39.0%[22] - The company's accumulated deficit reached $100.012 million as of June 30, 2023, up from $95.497 million at the end of 2022, indicating an increase of approximately 4.0%[22] - The accumulated deficit as of June 30, 2023 was $100.0 million, indicating significant ongoing financial challenges[107] Research and Development - Research and development expenses for the six months ended June 30, 2023, were $2.140 million, down from $3.084 million in the same period of 2022, indicating a decrease of about 30.6%[25] - The company expects to increase research and development expenses significantly as it advances EB613 and EB612 into later stages of clinical development[85] - Research and development expenses for the three months ended June 30, 2023, were $1.21 million, a 13% decrease from $1.39 million in the same period of 2022[93] Funding and Capital - Entera Bio Ltd. plans to fund ongoing operations, including R&D and the completion of the Phase 1 study for EB612, with available funds expected to last into Q3 2024[37] - The company has raised a total of $84.7 million since inception from various sources, including public and private equity offerings[76] - The company anticipates needing to raise additional capital to fund further operations, which may include private or public equity offerings and strategic collaborations[81] - The company has substantial doubt about its ability to continue as a going concern without additional capital[108] Clinical Development - Entera Bio has two product candidates, EB613 and EB612, currently in clinical development, with EB613 being positioned as a potential first oral anabolic treatment for post-menopausal osteoporosis[56] - The company has completed two Phase 1 clinical trials and a Phase 2, 161-patient study for EB613, showing positive results in increasing bone mineral density[62] - On April 3, 2023, the FDA indicated it would not oppose Entera initiating the Phase 3 study for EB613 under the proposed FNIH BQP pathway[66] Legal and Compliance - No material legal proceedings are currently ongoing against the company[131] - There have been no material changes in risk factors since the 2022 Annual Report[132] - No unregistered sales of equity securities occurred during the reporting period[133] - The company has not experienced any defaults upon senior securities[134] - No mine safety disclosures are applicable to the company[135] - During the quarter ended June 30, 2023, no contracts or trading plans were adopted or terminated by officers or directors[136] - The report includes various certifications under the Sarbanes-Oxley Act of 2002[137]

Financial Performance - As of March 31, 2023, Entera Bio Ltd. reported total assets of $11.606 million, a decrease of 11.6% from $13.127 million as of December 31, 2022[18]. - The company incurred a net loss of $2.190 million for the three months ended March 31, 2023, compared to a net loss of $3.784 million for the same period in 2022, representing a 42% improvement[20]. - The total shareholders' equity decreased to $10.080 million as of March 31, 2023, from $11.754 million at the end of 2022, reflecting a decline of 14.2%[18]. - Cash and cash equivalents at the end of Q1 2023 were $10.691 million, down from $12.309 million at the end of 2022, indicating a decrease of 13.1%[18]. - The company reported a basic and diluted loss per share of $0.08 for Q1 2023, compared to $0.13 for Q1 2022, showing a reduction in loss per share[20]. - For the three months ended March 31, 2023, the company reported operating losses of $2.2 million, a decrease of 42% compared to $3.8 million for the same period in 2022[91]. - The net cash used in operating activities for the three months ended March 31, 2023 was $1.6 million, a decrease of $3.2 million compared to $4.8 million for the same period in 2022[107][110]. - The company has raised a total of $84.7 million since inception, with $25.3 million from at-the-market offerings and $11.2 million from its IPO in 2018[100]. Research and Development - Research and development expenses for Q1 2023 were $0.931 million, down 44.9% from $1.690 million in Q1 2022[20]. - The company anticipates significant increases in research and development expenses as it advances product candidates EB613 and EB612 into later clinical stages[81]. - The company plans to conduct a pharmacokinetic study for a new formulation of EB612 in the first half of 2023, which may support regulatory approval[63]. - Entera Bio has two product candidates in clinical development: EB613 and EB612, both of which are first-in-class daily mini tablets of human parathyroid hormone[49]. - The Phase 2 study of EB613 in osteoporosis met its primary endpoint, showing significant improvement in bone mineral density at Month 6[54]. - EB612 has received orphan drug designation from the FDA and the European Medicines Agency for the treatment of hypoparathyroidism[61]. - The company received approximately $0.5 million in grants from the Israeli Innovation Authority to partially fund research and development, with a royalty rate of 3% on revenues derived from products developed using these grants[67]. Financing and Capital Resources - The company plans to fund ongoing operations, including R&D and the completion of the Phase 1 study for the new formulation EB612, into Q3 2024[32]. - Entera Bio Ltd. is evaluating various financing alternatives to support future R&D activities and working capital needs[32]. - The company expects its existing capital resources to meet projected operating requirements into the third quarter of 2024, but additional funding will be necessary for future studies[102]. - There is substantial doubt about the company's ability to continue as a going concern without additional capital infusion[105]. - The company has not generated any revenue from product sales and does not expect to do so until regulatory approval is obtained[76]. - The company has substantial doubt about its ability to continue as a going concern due to recurring losses and negative cash flows[71]. - The company anticipates that any additional capital raised through equity or debt financing may dilute existing shareholders' interests[104]. Agreements and Collaborations - The company has entered into a collaboration with Amgen for drug delivery technology, which was terminated on May 2, 2023[33]. - Entera Bio terminated its research collaboration and license agreement with Amgen on May 2, 2023, as per the agreement's terms[66]. - The company has a patent transfer agreement with Oramed, which includes a royalty payment of 3% on net revenues generated from the assigned patent rights[64]. - Under the Amgen Agreement, the company received a total of $1.7 million from 2019 through March 31, 2023, with no revenue recognized for the three months ended March 31, 2023[77][92]. Expenses and Liabilities - General and administrative expenses decreased to $1.3 million for the three months ended March 31, 2023, from $2.2 million in the same period in 2022, reflecting a 40% reduction[91][96]. - As of March 31, 2023, accrued expenses and other payables totaled $1,296,000, an increase from $1,233,000 as of December 31, 2022[41]. - As of March 31, 2023, the company had tax loss carry-forwards of $69.2 million, which can be utilized indefinitely against future taxable income[89]. - Entera Bio Ltd. has an accumulated deficit of $97.687 million as of March 31, 2023, up from $95.497 million at the end of 2022[18].