JERUSALEM, May 05, 2023 (GLOBE NEWSWIRE) — Entera Bio Ltd. (NASDAQ: ENTX), ("Entera" or the "Company") a leader in the development of orally delivered peptides and therapeutic proteins, today reported corporate updates and financial results for the first quarter ended March 31, 2023.

"Our primary objectives for 2023 are to finalize our discussion with the FDA regarding our registrational phase 3 study for EB613 in post–menopausal women with low bone mineral density (BMD) and osteoporosis, and to update on our PK study which will assess the potential for a novel oral PTH(1–34) candidate for the treatment of hypoparathyroidism," said Miranda Toledano, the Company's Chief Executive Officer. "We also remain focused on our earlier stage R&D initiatives with peptides that best align to our technology, such as GLP–2."

Corporate Updates for First Quarter 2023:

• Concluded Type D Meeting with the FDA Related to EB613. Entera previously reported that it will continue discussions with the agency until final guidance is received on the proposed statistical evaluation of its primary endpoint. This is likely to occur pursuant to the FDA's evaluation and qualification of the Foundation for the National Institutes of Health Bone Quality Project (FNIH BQP)¹. Entera plans to provide an update on its discussions with the FDA as the year progresses. Meanwhile, the Company continues to strengthen its ecosystem of endocrinology and women's health advisory board for EB613 with the addition of Dr. Steve Goldstein, a global leader in menopause health and former President of the North American and International Menopause Society.
• Institutional Review Board (IRB) Accepted and the Company Plans to Initiate Next Generation Platform PK Study in H1'2023. Topline results expected in H2'2023 including the potential for a novel candidate to treat hypoparathyroidism with once or twice a day oral PTH(1–34) tablets. This initiative builds on prior PK and Phase 2 results of an earlier generation of EB612 in hypoparathyroidism patients.
• Entera Oral GLP–2 Pre–Clinical Manuscript Accepted for Publication by the International Journal of Peptide Research and Therapeutics. Based on this work, Entera believes GLP–2 represents a strong candidate for its oral delivery platform and warrants further development as an injection free alternative to patients suffering from short bowel syndrome and other disorders requiring parenteral nutrition.
• Amgen Research Collaboration. After over four years of collaborative pre–clinical work evaluating the use of Entera's delivery technology with one molecule selected by Amgen, both collaborators have agreed to discontinue the Research Collaboration and License Agreement entered into in 2018 out of mutual convenience.

_______________
¹ FNIH BQP is also knows as the ASBMR FNIH–SABRE, American Society for Bone and Mineral Research–Foundation for the National Institutes of Health (FNIH) Strategy to Advance BMD as a Regulatory Endpoint (SABRE)

Financial Results for the Three Months Ended March 31, 2023

As of March 31, 2023, Entera had cash and cash equivalents of $10.7 million. Entera expects that its existing cash resources are sufficient to meet its projected operating requirements into the third quarter of 2024, which includes the capital required to fund our ongoing operations, including R&D and the completion of the Phase 1 PK study related to the new formulation of EB612.

Research and development expenses for the three months ended March 31, 2023 were $0.9 million, as compared to $1.7 million for the three months ended March 31, 2022. The decrease of $0.8 million was primarily due to a decrease of $0.6 million in materials and production costs and a decrease of $0.2 million in employee compensation, including share–based compensation.

General and administrative expenses for the three months ended March 31, 2023 were $1.3 million, as compared to $2.2 million for the three months ended March 31, 2022. The decrease of $0.9 million was mainly attributable to a decrease of $0.6 million in employee compensation, including share–based compensation, a decrease of $0.2 million in professional fees and a decrease of $0.1 million in D&O insurance costs.

Operating expenses for the quarter ended March 31, 2023 were $2.2 million, as compared to $3.8 million for the quarter ended March 31, 2022. Entera's operating loss was $2.2 million for quarter ended March 31, 2023, as compared to $3.8 million for the quarter ended March 31, 2022.

Net loss was $2.2 million, or $0.08 per ordinary share (basic and diluted), for the quarter ended March 31, 2023, as compared to $3.8 million, or $0.13 per ordinary share (basic and diluted), for the quarter ended March 31, 2022.

About Entera Bio

Entera is a leader in the development of orally delivered macromolecules, including peptides and other therapeutic proteins. The Company focuses on significant unmet medical needs where a daily mini tablet form of a peptide treatment or replacement therapy holds the potential to transform the standard of care. The Company's most advanced product candidates, EB613 for the treatment of high risk, post–menopausal osteoporosis and EB612 for the treatment of hypoparathyroidism, are in clinical development. EB613 is the first oral, once daily mini tablet presentation of synthetic hPTH (1–34), (teriparatide), consisting of the exact same 34 amino acid sequence as daily subcutaneous teriparatide injection, Forteo , which requires daily SC injections. A placebo controlled, dose ranging Phase 2 study of EB613 tablets (n= 161) met primary (PD/biomarker) and secondary endpoints (BMD) in a dose dependent manner and was presented at the ASBMR 2021 Annual Conference. A phase 1 PK study of novel PTH formulations is planned for H1 2023 to ascertain feasibility of a new hypo candidate (a prior formulation had positive Phase 2a data announced in 2015 and published in JBMR 2019) and for another potential indication. For more information on Entera Bio, visit www.enterabio.com.

Cautionary Statement Regarding Forward Looking Statements

Various statements in this press release are "forward–looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. All statements (other than statements of historical facts) in this press release regarding our prospects, plans, financial position, business strategy and expected financial and operational results may constitute forward–looking statements. 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: changes in the interpretation of clinical data; results of our clinical trials; the FDA's interpretation and review of our results from and analysis of our clinical trials; 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; the potential disruption and delay of manufacturing supply chains; loss of available workforce resources, either by Entera or its collaboration and laboratory partners; impacts to research and development or clinical activities that Entera is contractually obligated to provide, such as those pursuant to Entera's agreement with Amgen; overall regulatory timelines; the size and growth of the potential markets for our product candidates; 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 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 "Cautionary Statements Regarding Forward–Looking Statements," "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Entera's most recent Annual Report on Form 10–K filed with the SEC, as well as the company's subsequently filed Quarterly Reports on Form 10–Q and Current Reports on Form 8–K. 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 or implied in such forward–looking statements and estimates will be achieved. Entera cautions investors not to rely on the forward–looking statements Entera makes in this press release. The information in this press release is provided only as of the date of this press release, and Entera undertakes no obligation to update or revise publicly any forward–looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law.

ENTERA BIO LTD.
CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. dollars in thousands, except share and per share data)

GLOBENEWSWIRE (Distribution ID 8833207)

JERUSALEM, March 31, 2023 (GLOBE NEWSWIRE) — Entera Bio Ltd. (NASDAQ: ENTX), ("Entera" or the "Company") a leader in the development of orally delivered peptides and therapeutic proteins, today announced a summary of 2022 corporate achievements and financial results for the year ended December 31, 2022.

"The year 2022 and 2023 year to date, has been a critical time for Entera, during which focus, optimization and execution across our organization has been paramount to adequately prepare our EB613 program to become phase 3 ready, from a clinical, regulatory, and manufacturing standpoint. EB613 (oral PTH(1–34), teriparatide) is positioned as the first potential daily tablet anabolic therapy for the treatment of post–menopausal women with low Bone Mineral Density (BMD) and osteoporosis. In addition, we have continued to harness our scientific capabilities and intellectual property to expand our proprietary platform with novel drug candidates, including a new generation for EB612, potentially the first PTH (1–34) peptide replacement therapy in tablet form for the treatment of hypoparathyroidism," stated Miranda Toledano, Chief Executive Officer of Entera.

A brief review of key EB613 related milestones:

• In June 2021, Entera reported positive results from its double–blind, placebo–controlled Phase 2 study of EB613 in 161 post–menopausal women with low BMD and osteoporosis. The study met all PD/ biomarker, BMD endpoints, and demonstrated a generally well tolerated safety profile. It was also noted that EB613 had a differentiated biomarker and BMD profile versus historical 6–month data reported with daily subcutaneous injections of Forteo in a similar population.
• In January 2022, Entera received FDA's End of Phase 2 meeting minutes which conveyed concern with the previously proposed Phase 3 study, based on a 12–month non–inferiority head–to–head design versus Forteo and whether such a trial would be successful.
• In response to the FDA's End of Phase 2 minutes, Entera re–designed the proposed phase 3 to potentially align with FDA's suggestion to explore a placebo–controlled phase 3 design with a Total Hip BMD (TH BMD) endpoint, given emerging seminal publications from the FNIH BQP–ASBMR project.
• On July 18th, 2022, Entera announced that the FDA had granted Entera's request for a Type C Meeting based on the revised phase 3 registrational protocol for EB613.
• On October 6^th 2022, Entera announced the conclusion of its Type C meeting and concurrence with the FDA that a single well designed Phase 3 placebo–controlled study with a proposed primary endpoint of TH BMD may support a New Drug Application (NDA) submission of EB613; and that a relative PK study comparing its oral tablet form of teriparatide, EB613 versus the subcutaneous injection of teriparatide, Forteo , may be utilized as a scientific bridge to support the 505(b)(2) NDA pathway.
• On February 15^th, 2023, Entera announced that a Type D meeting had been accepted by the FDA. As part of its briefing documents for the Type D process, Entera aimed to confirm that the protocol fully met FDA's expectations, including the analysis of the primary TH BMD endpoint and the population PK evaluations.

"We look forward to continuing our dialogue with the FDA and reaching consensus to de–risk our potential pivotal regulatory pathway for EB613. It is our belief that Entera stands as the first osteoporosis drug development company to potentially pursue a placebo–controlled registrational study with a BMD (rather than fracture) endpoint. We are cognizant that to be successful in pioneering a path takes time and the agency's partnership to move forward successfully. From a corporate finance perspective, Entera has sufficient cash on hand into Q3 2024 including the read–out from our planned next generation platform PK study, which may enable us to advance the EB612 program for the treatment of hypoparathyroidism into Phase 2 in 2024. From a strategic standpoint, we will continue to hold both strategic and other discussions to determine the best path forward to finance our pivotal program for EB613. This process is of course dependent on when we conclude our regulatory discussions with FDA. This has been a challenging year for the Company, and I am proud of our resilience and accomplishments," stated Miranda Toledano, Chief Executive Officer of Entera.

Financial Results for the year Ended December 31, 2022

Revenues for the year ended December 31, 2022 and 2021 were $134,000 and $571,000, respectively, mainly attributable to research and development, or R&D services provided to Amgen and other third parties under material transfer agreements. The cost of revenues for the year ended December 31, 2022 was $101,000 as compared to $373,000 for the year ended December 31, 2021 and primarily attributed to expenses in connection with R&D services provided and reimbursed by Amgen.

Research and development expenses for the year ended December 31, 2022, were $5.8 million, as compared to $6.8 million for the year ended December 31, 2021. The decrease was primarily attributed to completion of pre–clinical activities related to our Phase 3 clinical trial for EB613 which was offset by continued materials and production expenses related to clinical supply and a one–time payment to our former President. in 2021.

General and administrative expenses for the year ended December 31, 2022 were $7.3 million, compared to $5.7 million for the year ended December 31, 2021. The increase was mainly attributable to an increase in non–cash share–based compensation granted to directors and executive officers and a one–time payment to our former Chief Executive Officer.

Operating expenses for the year ended December 31, 2022 were $13 million compared to $12.4 million for the year ended December 31, 2021. Entera's operating loss was $13 million for the year ended December 31, 2022, compared to $12.2 million for the year ended December 31, 2021.

Net loss was $13.1 million or $0.45 per ordinary share (basic and diluted) for the year ended December 31, 2022, compared to $12.2 million, or $0.47 per ordinary share (basic and diluted) for the year ended December 31, 2021.

As of December 31, 2022, Entera had cash and cash equivalents of $12.3 million. Entera expects that its existing cash resources are sufficient to meet our projected operating requirements into the third quarter of 2024, which includes the capital required to fund our ongoing operations, including R&D and the completion of the Phase 1 PK study related to the new formulation EB612. This does not include the capital required to fund our proposed Phase 3 pivotal program for EB613 in osteoporosis.

About Entera Bio

Entera is a leader in the development of orally delivered macromolecules, including peptides and other therapeutic proteins. The Company focuses on significant unmet medical needs where a mini daily tablet form of a peptide treatment or replacement therapy holds the potential to transform the standard of care. The Company's most advanced product candidates, EB613 for the treatment of high risk, post–menopausal osteoporosis and EB612 for the treatment of hypoparathyroidism, are in clinical development. EB613 is the first oral, once daily mini tablet presentation of synthetic hPTH (1–34), (teriparatide), consisting of the exact same 34 amino acid sequence as daily subcutaneous teriparatide injection, Forteo , which requires daily SC injections. A placebo controlled, dose ranging Phase 2 study of EB613 tablets (n= 161) met primary (PD/biomarker) and secondary endpoints (BMD) in a dose dependent manner and was presented at the ASBMR 2021 Annual Conference. A phase 1 PK study of novel PTH formulations is planned for H1 2023 to ascertain feasibility of a new hypo candidate (a prior formulation had positive Phase 2a data announced in 2015 and published in JBMR 2019) and for another potential indication. For more information on Entera Bio, visit www.enterabio.com.

Cautionary Statement Regarding Forward Looking Statements

Various statements in this press release are "forward–looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. All statements (other than statements of historical facts) in this press release regarding our prospects, plans, financial position, business strategy and expected financial and operational results may constitute forward–looking statements. 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: changes in the interpretation of clinical data; results of our clinical trials; the FDA's interpretation and review of our results from and analysis of our clinical trials; 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; the potential disruption and delay of manufacturing supply chains; loss of available workforce resources, either by Entera or its collaboration and laboratory partners; impacts to research and development or clinical activities that Entera is contractually obligated to provide, such as those pursuant to Entera's agreement with Amgen; overall regulatory timelines; the size and growth of the potential markets for our product candidates; 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 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 "Cautionary Statements Regarding Forward–Looking Statements," "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Entera's most recent Annual Report on Form 10–K filed with the SEC, as well as the company's subsequently filed Quarterly Reports on Form 10–Q and Current Reports on Form 8–K. 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 or implied in such forward–looking statements and estimates will be achieved. Entera cautions investors not to rely on the forward–looking statements Entera makes in this press release. The information in this press release is provided only as of the date of this press release, and Entera undertakes no obligation to update or revise publicly any forward–looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law.

GLOBENEWSWIRE (Distribution ID 8799784)

JERUSALEM, Nov. 10, 2022 (GLOBE NEWSWIRE) — Entera Bio Ltd. (NASDAQ: ENTX), ("Entera" or the "Company") a leader in the development of orally delivered peptides and therapeutic proteins, today announced its financial results for the third quarter of 2022 and provided the following corporate updates.

Corporate Updates:

Achieved FDA Agreement for Pivotal Study of EB613, the World's First Daily Bone Forming Oral PTH Tablet

• On October 6th, 2022, Entera announced that it had successfully completed its Type C meeting and reached a record agreement with the U.S. Food and Drug Administration (FDA) that a single pivotal Phase 3 placebo–controlled study could support a New Drug Application (NDA) submission for its lead clinical candidate, EB613 under the 505(b)(2) regulatory pathway.
• Importantly, the FDA also agreed that total hip bone mineral density (BMD), not fracture, could serve as the primary endpoint for the registrational study of EB613; and that Entera could enroll the same post–menopausal osteoporosis patient population that significantly benefited from EB613 treatment during Entera's Phase 2 clinical study which was reported in 2021.
• EB613 is the first oral, daily tablet formulation of synthetic hPTH (1–34), (teriparatide), consisting of the exact same 34 amino acid sequence as daily subcutaneous teriparatide injection, Forteo which has been the leading anabolic treatment of osteoporosis since 2002 with peak sales of $1.7 billion in 2018 prior to patent expiration. EB613 tablets are simple, small (~ 6 mm wide) and administered once daily.
• Low BMD osteoporotic patients at high risk of fracture are often reluctant to initiate injectable anabolic (bone forming) therapy and represent an estimated 40% of the 3 million currently treated patients across the United States, while current bone forming injections treat less than 10% of these patients¹. As the first daily tablet PTH osteoanabolic treatment, EB613 could significantly impact the osteoporosis treatment paradigm. Patient enrollment in the pivotal phase 3 study is expected to commence in 2023.

New Phase 2 Data Presented at the ASBMR Annual Meeting Demonstrate Statistically Significant Correlation of EB613's Dose Proportional Oral Absorption and Clinical Benefit

• New findings on EB613 were presented in a poster titled "A Six–month Phase 2 Study of Oral PTH (EBP05) in Postmenopausal Women with Low Bone Mass "" Dose Proportional Absorption and Effect on Lumbar Spine BMD (SUN–591)" at the American Society for Bone and Mineral Research (ASBMR) 2022 Annual Meeting in September.
• New analyses of hPTH concentration in blood shortly after a dose of EB613 tablets confirmed a strong, statistically significant correlation between mean blood level and the dose of EB613 taken.
• These findings are consistent with the positive correlation between the change in lumbar spine BMD and EB613 dose after six months of treatment.

"Following a full redesign of our proposed Phase 3 study, timely submission, and successful conclusion of our Type C meeting, our third quarter culminated with the FDA's concurrence with our proposed registrational path for EB613. This was an historic moment for Entera. We believe this is the first osteoporosis program that has reached agreement on both a placebo–controlled design and a BMD endpoint, which we believe speaks to the urgent need for highly effective and more patient friendly treatments to help rebuild bone. EB613 leverages the validated and safe mechanism of action of PTH which has been at the forefront of osteoporosis therapy for the last 20 years, and addresses patients' unease with injections via our simple daily tablet form. We continue to strengthen all functional areas at Entera to remain on track for patient enrollment to commence in 2023, while continuing our strategic discussions and preparing our new formulation of EB612 PTH tablets for hypoparathyroidism to re–enter the clinic in 2023," stated Miranda Toledano, Chief Executive Officer of Entera.

Results for Third Quarter Ended September 30, 2022

Revenues for the three months ended September 30, 2022 were $8,000 compared to $140,000 for the three months ended September 30, 2021. For both the three months ended September 30, 2022 and 2021, the majority of our revenues were attributable to pre–clinical R&D services provided to Amgen as part of our ongoing license agreement. The decrease in revenue for the quarter ended September 30, 2022 as compared to the prior year period was primarily due to finalization of third year pre–clinical R&D services to Amgen. The cost of revenues for the three months ended September 30, 2022 was $6,000 compared to $65,000 for the three months ended September 30, 2021 and were primarily attributed to expenses in connection with R&D services provided to Amgen.

Research and development expenses for the three months ended September 30, 2022 were $1.4 million compared to $1.8 million for the three months ended September 30, 2021. The decrease of $0.4 million was primarily due to a decrease of $0.7 million in pre–clinical activities related to our Phase 3 clinical trial for EB613 and a decrease of $0.1 million related to the completion of our Phase 2 trial for EB613 in September 2021. This decrease was partially offset by an increase of $0.1 million in connection with a one–time employee compensation payment as part of a separation agreement and an increase of $0.3 million attributed to ongoing materials and production costs to supply our Phase 3 clinical trial for EB613.

General and administrative expenses for both the three months ended September 30, 2022 and 2021 were $1.5 million. For the quarter ended September 30, 2022, there was an increase of $0.2 million in professional fees and an increase of $0.1 million in D&O insurance costs, as compared to the 2021 period, which was offset by a decrease of $0.3 million in share–based compensation mainly due to a reversal of share–based compensation expense related to the separation agreement of our former Chief Executive Officer.

Operating expenses for the three months ended September 30, 2022 were $2.9 million compared to $3.3 million for the three months ended September 30, 2021. Entera's operating loss was $2.9 million for the three months ended September 30, 2022, compared to $3.2 million for the three months ended September 30, 2021.

The net comprehensive loss was $3.1 million or $0.11 per ordinary share (basic and diluted) for the three months ended September 30, 2022, compared to $3.2 million, or $0.11 per ordinary share (basic and diluted) for the three months ended September 31, 2021.

As of September 30, 2022, Entera had cash and cash equivalents of $14.3 million, compared to $17.3 million as of June 30, 2022. Entera expects that its existing cash resources are sufficient to fund operations through the second quarter of 2023. This assumes ongoing R&D, the Hypo PK study and continued investments in production, analytics, and clinical research operations to enable initiation of EB613 phase 3 during the second half of 2023.

About EB613 (a.k.a. EBP05)

EB613 is the first oral, daily tablet formulation of synthetic hPTH (1–34), (teriparatide), consisting of the exact same 34 amino acid sequence as daily subcutaneous teriparatide injection, Forteo which has been the leading anabolic treatment of osteoporosis since 2002 with peak sales of $1.7 billion in 2018 prior to patent expiration. Entera's Oral PTH formulations have been administered collectively to a total of 225 subjects in two Phase 1 studies and 3 phase 2 studies (including 35 in 2 phase 2 hypoparathyroidism studies). The most recent study was a dose ranging Phase 2 study in postmenopausal women with low bone mass. This study met primary and key secondary endpoints and was presented in a late–breaker oral presentation at the ASBMR 2021 conference. For the primary efficacy endpoint: a statistically significant increase in P1NP (a bone formation marker) at 3 months was achieved. A significant dose response was observed for 0.5, 1.0, 1.5 and 2.5 mg oral PTH doses on P1NP, Osteocalcin and bone mineral density (BMD). Subjects receiving the 2.5 mg dose of EB613 showed significant increases in dose–related BMD at the Lumbar Spine, Total Hip, and Femoral Neck at 6 months. Subjects receiving the 2.5 mg dose of EB613 daily for 6 months had a significant placebo adjusted increase of 3.78% in Lumbar Spine BMD (p<0.008) which is similar to the 3.9% increase in Lumbar Spine BMD seen with Forteo in clinical studies reported in the literature. Increases in Total Hip and Femoral Neck BMD were greater than those previously reported with Forteo at 6 months. EB613 exhibited an excellent safety profile, with no drug related serious adverse events. The most common adverse events included mild nausea, moderate back pain, moderate headache, and moderate upper abdominal pain.

About Entera Bio

Entera is a leader in the development of orally delivered macromolecules therapeutics including peptides and other therapeutic proteins, 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 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:

Entera Bio:
Ms. Miranda Toledano
Chief Executive Officer
Entera Bio
Email: miranda@enterabio.com

Cautionary Statement Regarding Forward Looking Statements

Various statements in this press release are "forward–looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. All statements (other than statements of historical facts) in this press release regarding our prospects, plans, financial position, business strategy and expected financial and operational results may constitute forward–looking statements. 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: changes in the interpretation of clinical data; results of our clinical trials; the FDA's interpretation and review of our results from and analysis of our clinical trials; 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; the potential disruption and delay of manufacturing supply chains; loss of available workforce resources, either by Entera or its collaboration and laboratory partners; impacts to research and development or clinical activities that Entera is contractually obligated to provide, such as those pursuant to Entera's agreement with Amgen; overall regulatory timelines; the size and growth of the potential markets for our product candidates; 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 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 "Cautionary Statements Regarding Forward–Looking Statements," "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Entera's most recent Annual Report on Form 10–K filed with the SEC, as well as the company's subsequently filed Quarterly Reports on Form 10–Q and Current Reports on Form 8–K. 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 or implied in such forward–looking statements and estimates will be achieved. Entera cautions investors not to rely on the forward–looking statements Entera makes in this press release. The information in this press release is provided only as of the date of this press release, and Entera undertakes no obligation to update or revise publicly any forward–looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law.

ENTERA BIO LTD.
CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. dollars in thousands, except share and per share data)

^{___________________________
1} Triangle Insights Group June 2022 Analysis, EB613 Osteoporosis Opportunity

GLOBENEWSWIRE (Distribution ID 8694353)

JERUSALEM, Aug. 11, 2022 (GLOBE NEWSWIRE) — Entera Bio Ltd. (NASDAQ: ENTX), ("Entera" or the "Company") a leader in the development of orally delivered peptides and therapeutic proteins, today announced its financial and operating results for the quarter ended June 30, 2022.

"We have reset our thesis and executed on several critical milestones in the first half of 2022. On July 18th, we announced the submission of our proposed registrational protocol for EB613 to the U.S. Food and Drug Administration (FDA). We are simultaneously finalizing the validation of an optimized formulation of EB612, while expanding our pre–clinical pipeline with additional anti–inflammatory and metabolic protein candidates. Lastly, we finished the quarter with $17.3 million in cash which, given our revised Phase 3 schedule, is projected to fund our current operations through the first half of 2023," commented Ms. Miranda Toledano, Chief Executive Officer of the Company. "I am incredibly energized by the opportunities ahead. By continuing to carry forward our internal clinical programs and strategic dialogues, we are poised to deliver tremendous value to patients and our shareholders as we reshape the future of Entera. We look forward to providing a comprehensive update to the investment community later this year."

Business Highlights:

Entera expects to hold a Type C Meeting with the FDA to discuss the potential registrational study for its lead clinical asset, EB613 in the second half of 2022. The Phase 3 is designed as an 18 month double blind placebo–controlled study using FNIH–BQP¹ total hip Bone Mineral Density (BMD) thresholds as the primary endpoint to evaluate fracture risk, followed by a 6–month open label transition to alendronate. EB613 is the first oral formulation of PTH (1–34), teriparatide, and the first proposed oral anabolic (bone forming) drug candidate to treat post–menopausal women with osteoporosis. EB613 has the same amino acid sequence as Forteo which requires daily subcutaneous injections and reported peak sales surpassing $1.7 billion in 2017, prior to patent expiry. According to early commercial assessments and clinician surveys, it is estimated that less than 10% of osteoporosis patients use current anabolic drugs (including PTH receptor activators currently available such as Forteo and Tymlos ). Despite the validated mechanism of action of these treatments, patients are deterred by their high cost and injectable mode of administration. As the first oral PTH receptor activator EB613 is expected to address this significant unmet clinical need.

Additionally, Entera is finalizing the development of an optimized formulation for EB612 which may enable twice a day administration (versus the previous 4 times a day) to patients with hypoparathyroidism. The Company anticipates conducting a first–in–human PK study of the new formulation in the first half of 2023. Entera previously conducted a pilot 4–month Phase 2 study, results of which were presented (ASBMR 2015) and published in a peer–reviewed journal (JBMR 2021), as well as a Phase 2 PK–PD study versus Natpara, whose findings have also been publicly presented (ASBMR 2019). These studies demonstrated that EB612 induced a rapid decline in median serum phosphate levels and maintenance of target calcium levels throughout the study, even as patients were able to meaningfully reduce their calcium and active vitamin D supplementation which is key to reducing common comorbidities of this disease.

Finally, Entera announced the formation of its Clinical and Scientific Advisory Board (CSAB), comprising world class experts in bone diseases, endocrinology, and metabolic disorders and will be presenting incremental data from its 6–month Oral PTH (EB613) Phase 2 Study in postmenopausal women with low bone mass, at the 2022 Annual Meeting of the American Society for Bone and Mineral Research (ASBMR), which will take place in Austin, Texas from September 9–12, 2022.

Financial Results for the Six–Month Period Ended June 30, 2022

Revenues for the six months ended June 30, 2022 were $112,000 compared to $226,000 for the six months ended June 30, 2021. In this period, the majority of our revenues were attributable to research and development, or R&D services provided to Amgen under our 2018 collaboration agreement. The cost of revenues for the six months ended June 30, 2022 were $87,000 compared to $172,000 for the six months ended June 30, 2021 and were primarily attributed to salaries and related expenses in connection with the R&D services provided to Amgen.

Operating expenses for the six months ended June 30, 2022 were $7.1 million compared to $5.0 million for the six months ended June 30, 2021. Entera's operating loss was $7.1 million for the six months ended June 30, 2022, compared to $4.9 million for the six months ended June 30, 2021.

Research and development expenses for the six months ended June 30, 2022 were $3.1 million, compared to $2.4 million for the six months ended June 30, 2021, an increase of $0.7 million. The increase was primarily due to an increase of $0.7 in materials and production costs and pre–clinical activity as part of the preparation for our Phase 3 clinical trial for EB613 and an increase of $0.4 million in employee's compensation. The increase was partially offset by a decrease of $0.4 million in other clinical trial expenses related to our Phase 2 trial for EB613 that was completed in June 2021.

General and administrative expenses for the six months ended June 30, 2022 were $4.1 million, compared to $2.7 million for the six months ended June 30, 2021, an increase of $1.4 million. The increase of $1.4 million was mainly attributable to an increase of $0.8 million in share–based compensation granted to non–executive directors and employees, an increase of $0.4 million in legal, accounting fees and others consultants and an increase of $0.2 million in D&O insurance costs.

The net comprehensive loss was $7.0 million or $0.24 per ordinary share (basic and diluted) for the six months ended June 30, 2022, compared to $4.9 million, or $0.21 per ordinary share (basic and diluted) for the six months ended June 31, 2021.

As of June 30, 2022, Entera had cash and cash equivalents of $17.3 million, compared to $20.1 million as of March 31, 2021.

Entera expects that the current cash is sufficient to fund the operations through the second quarter of 2023.

About EB613 (a.k.a. EBP05)

Parathyroid hormone (PTH) is an 84–amino acid hormone and the primary regulator of calcium and phosphate metabolism in bone and kidney. EB613 is an oral formulation of synthetic hPTH (1–34), (teriparatide), a peptide consisting of the first 34 amino acids of PTH which represent the functional region. Subcutaneous Forteo (teriparatide injection) has been the leading anabolic treatment of osteoporosis since 2002. EB613 utilizes Entera's oral drug delivery platform which promotes enteric absorption and stabilizes teriparatide in the gastrointestinal tract. Entera's Oral PTH formulations have been administered collectively to a total of 225 subjects in two Phase 1 studies and 3 phase 2 studies (including 35 in 2 phase 2 hypoparathyroidism studies). The most recent study was a dose ranging Phase 2 study in postmenopausal women with low bone mass. This study met primary and key secondary endpoints and was presented in a late–breaker oral presentation at the ASBMR 2021 conference. For the primary efficacy endpoint: a statistically significant increase in P1NP (a bone formation marker) at 3 months was achieved. A significant dose response was observed for 0.5, 1.0, 1.5 and 2.5 mg oral PTH doses on P1NP, Osteocalcin and bone mineral density (BMD). Subjects receiving the 2.5 mg dose of EB613 showed significant increases in dose–related BMD at the lumbar spine, total hip, and femoral neck at 6 months. Subjects receiving the 2.5 mg dose of EB613 daily for 6 months had a significant placebo adjusted increase of 3.78% in lumbar spine BMD (p<0.008) which is similar to the 3.9% increase in lumbar spine BMD seen with Forteo in clinical studies reported in the literature. Increases in total hip and femoral neck BMD were greater than those previously reported with Forteo . EB613 exhibited an excellent safety profile, with no drug related serious adverse events. The most common adverse events included mild nausea, moderate back pain, moderate headache, and moderate upper abdominal pain.

About Entera Bio

Entera is a leader in the development of orally delivered macromolecules therapeutics including peptides and other therapeutic proteins, 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 clinical development. The Company recently completed the phase 2 study for EB613 and has a Type C meeting scheduled with FDA with respect to its Phase 3 program in H2 2022. 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.

Cautionary Statement Regarding Forward Looking Statements

Various statements in this press release are "forward–looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. All statements (other than statements of historical facts) in this press release regarding our prospects, plans, financial position, business strategy and expected financial and operational results may constitute forward–looking statements. 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: changes in the interpretation of clinical data; results of our clinical trials; the FDA's interpretation and review of our results from and analysis of our clinical trials; 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; the potential disruption and delay of manufacturing supply chains; loss of available workforce resources, either by Entera or its collaboration and laboratory partners; impacts to research and development or clinical activities that Entera is contractually obligated to provide, such as those pursuant to Entera's agreement with Amgen; overall regulatory timelines; the size and growth of the potential markets for our product candidates; 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 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 "Cautionary Statements Regarding Forward–Looking Statements," "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Entera's most recent Annual Report on Form 10–K filed with the SEC, as well as the company's subsequently filed Quarterly Reports on Form 10–Q and Current Reports on Form 8–K. 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 or implied in such forward–looking statements and estimates will be achieved. Entera cautions investors not to rely on the forward–looking statements Entera makes in this press release. The information in this press release is provided only as of the date of this press release, and Entera undertakes no obligation to update or revise publicly any forward–looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law.

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¹ Foundation for the National Institutes of Health Bone Quality Program (FNIH BQP)