Entera Bio Ltd. – Business Times Oman http://www.businesstimesoman.com Fri, 08 Mar 2024 21:05:00 +0000 en-US hourly 1 https://wordpress.org/?v=5.3.2 Entera Bio Announces Full Year 2023 Financial Results and Provides Business Updates http://www.businesstimesoman.com/?p=310487/ http://www.businesstimesoman.com/?p=310487/#respond Fri, 08 Mar 2024 21:05:00 +0000 http://www.businesstimesoman.com/?p=310487 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 through Phase 3, into the clinic by the end of 2025. Each of these programs has been carefully selected to align with our platform and our mission to develop treatments that stand to become the number one choice for patients requiring peptide therapies, in a simple and convenient tablet format. Each of these programs is expected to have important catalysts during 2024. Following our December 2023 financing, we expect to have sufficient cash to fund operations through the first half of 2025,” said Miranda Toledano, CEO of Entera.

EB613: First Oral PTH(1–34) Daily Osteoanabolic Tablets for Osteoporosis

  • In March 2023, a Type D meeting between Entera and the U.S. Food and Drug Administration (FDA) re–affirmed that a placebo–controlled phase 3 study design with Bone Mineral Density (BMD) and not fracture as primary endpoint could support a New Drug Application for EB613
  • In November 2023, Entera echoed the American Society for Bone and Mineral Research (ASBMR) announcement that the Strategy to Advance BMD as a Regulatory Endpoint (SABRE) team had submitted its final qualification plan to the FDA
  • At the Annual ASBMR Meeting in October 2023, Entera presented the differentiated pharmacokinetic profile of EB613, versus Forteo® PTH(1–34) 20 µg which requires a daily subcutaneous injection. EB613 consistently shows an increased Cmax and shorter duration of systemic exposure versus Forteo®. Furthermore, EB613’s brief “pulsatile” action appears to simultaneously stimulate both a dual bone formation and a mild anti–resorptive effect, as compared to Forteo®
  • During the fourth quarter of 2023, Entera submitted its Phase 2 manuscript for potential publication in a major medical journal related to its phase 2, 6–month, 161–patient, placebo–controlled study in post–menopausal women with low bone mass and osteoporosis which met primary and secondary endpoints

“We expect an update on the qualification process of SABRE and BMD as the surrogate endpoint for fracture in 2024. We view this as the final de–risking event from a regulatory standpoint to move EB613 to Phase 3. We believe EB613 stands as the first program to potentially avail itself of the landmark SABRE initiative which is also the first biomarker to potentially be approved as part of the 2016 21st Century Cures Act. As the first potential oral tablet osteoanabolic treatment, EB613 holds the potential to address the treatment chasm in this severe, potentially lethal disease which remains significantly undertreated despite efficacious injectable treatments. Fracture rates continue to rise globally, and we have not seen any new drugs approved for osteoporosis since 2019 due to the ethical concerns and the costs of fracture endpoint studies. Our discussions with key clinicians and patient advocacy groups and other key stakeholders in this ecosystem indicate that an oral anabolic treatment is absolutely warranted and a potential ‘game changer’ for the estimated 200 million women with osteoporosis globally. We continue to hold strategic discussions related to EB613 and look forward to initiating our pivotal phase 3 study once the final qualification of the SABRE endpoint is announced by FDA,” said Miranda Toledano, CEO of Entera.

EB612: First Oral PTH(1–34) Peptide Replacement Therapy Tablets for Hypoparathyroidism
EB612, is being developed as the first oral PTH(1–34) peptide replacement treatment for hypoparathyroidism. Entera is currently evaluating its hypoparathyroidism program with an improved formulation of EB612 using the naked PTH(1–34) peptide and new intellectual property, tailored to optimize its PK profile and the potential for reduced daily dosing. Entera is also combining its N–Tab™ platform with an alternative PTH receptor agonist in a third party collaboration. Entera expects to submit data from the Phase 1 of its next generation EB612 program using the naked PTH(1–34) peptide in the first half of 2024.

First GLP–2 Peptide Tablets for Short Bowel Syndrome
Under a collaboration agreement with OPKO Health (“OPKO”), Entera is combining its N–Tab™ technology with a proprietary long–acting GLP–2 peptide for the development of the first potential daily oral GLP–2 for the treatment of short bowel syndrome and other GI disorders such as Crohn’s and Celiac disease for which GLP–2 has relevance. Entera published pre–clinical data in May 2023 demonstrating that its oral peptide delivery platform enables gastric absorption of teduglutide (Gattex®), the only approved GLP–2 treatment, as a convenient potential tablet alternative to daily injections. Pre–IND in vivo PK data for oral GLP–2 using OPKO’s long–acting analogue is expected in the first half of 2024.

First GLP–1/Glucagon Agonist (Oxyntomodulin) Peptide Tablets for Obesity
Under a collaboration agreement with OPKO, Entera is combining its N–Tab™ technology with a proprietary long–acting Oxyntomodulin (OXM) peptide for the development of the first potential daily OXM treatment for obesity and other metabolic diseases. Previously, an injectable pegylated version of this OXM peptide demonstrated significant reductions in weight loss and decreased plasma triglyceride levels with cardioprotective benefits in over 420 patients in phase 2/2B studies. Pre–IND in vivo PK data for oral OXM using OPKO’s long acting, modified analogue is expected in mid–2024.

EB613: First Oral PTH(1–34) Osteoanabolic Tablets to Treat Intense Sport and Military Stress Injuries
Entera is collaborating with leading researchers in orthopedics and sports medicine to contribute its proprietary oral PTH(1–34) tablets for an investigator sponsored Phase 2 Study seeking to treat young women and men athletes that experience stress fractures as a result of intense sports training. More details on this study are expected in the second half of 2024.

Financial Results for the year Ended December 31, 2023

As of December 31, 2023, Entera had cash and cash equivalents of $11.0 million. The Company believes that its existing cash resources will be sufficient to meet its projected operating requirements through the second quarter of 2025, which includes the capital required to fund our ongoing operations, including R&D, the completion of the Phase 1 PK study related to our new generation platform and the GLP–2/OXM collaborative research we are conducting with OPKO.

Research and development expenses for the year ended December 31, 2023 were $4.5 million, as compared to $5.8 million for the year ended December 31, 2022. The decrease of $1.3 million was primarily due to a decrease of $1.5 million in pre–clinical activity and materials costs and a decrease of $0.6 million in employee compensation, including a one–time payment made to a former employee pursuant to the terms of his separation agreement. The decrease was partially offset by an increase of $0.8 million in clinical expenses for our Phase 1 PK study related to our new generation platform and new formulations for EB612.

General and administrative expenses for the year ended December 31, 2023 were $4.4 million, compared to $7.3 million for the year ended December 31, 2022. The decrease of $2.8 million was mainly attributable to a decrease of $1.1 million in employee compensation, including a one–time payment to our former employee pursuant to the terms of his separation agreement, a decrease of $0.8 million as part of a restructuring of professional fees and other advisor expenses, a decrease in Board fees of $0.2 million due to the Board’s forfeiture of their fees for the third and fourth quarters of 2023 and a decrease of $0.7 million in D&O insurance costs.

Operating expenses for year ended December 31, 2023 were $8.9 million, as compared to $13.0 million for the year ended December 31, 2022.

Net loss was $8.9 million, or $0.31 per ordinary share (basic and diluted), for the year ended December 31, 2023, as compared to $13.1 million, or $0.45 per ordinary share (basic and diluted), for the year ended December 31, 2022.

About Entera Bio

Entera is a clinical stage company focused on developing oral peptide or protein replacement therapies for significant unmet medical needs where an oral tablet form holds the potential to transform the standard of care. The Company leverages on a disruptive and proprietary technology platform and its pipeline includes five differentiated, first–in–class oral peptide programs, expected to enter into the clinic (Phase 1 to Phase 3) by 2025. The Company’s most advanced product candidate, EB613 (oral PTH(1–34), teriparatide), is being developed as the first oral, osteoanabolic (bone building) once–daily tablet treatment for post–menopausal women with low BMD and high–risk osteoporosis, with no prior fracture. A placebo controlled, dose ranging Phase 2 study of EB613 tablets (n=161) met primary (PD/bone turnover biomarker) and secondary endpoints (BMD). Entera is preparing to initiate a Phase 3 registrational study for EB613 pursuant to the FDA’s qualification of a quantitative BMD endpoint which is expected to occur in 2024. The EB612 program is being developed as the first oral PTH(1–34) tablet peptide replacement therapy for hypoparathyroidism. Entera is also developing the first oral oxyntomodulin, a dual targeted GLP1/glucagon peptide, in tablet form for the treatment of obesity; and first oral GLP–2 peptide tablet as an injection–free alternative for patients suffering from rare malabsorption conditions such as short bowel syndrome in collaboration with OPKO Health. For more information on Entera Bio, visit www.enterabio.com or follow us on LinkedIn, Twitter, Facebook, Instagram.

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 may be contractually obligated to provide; 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 BALANCE SHEETS
(U.S. dollars in thousands)
 
       
  December 31   December 31
  2023   2022
  (Unaudited)   (Audited)
   
Cash and cash equivalents 11,019   12,309
Accounts receivable and other current assets 238   540
Property and equipment, net 100   139
Other assets, net 408   139
Total assets 11,765   13,127
     
     
Accounts payable and other current liabilities 1,091   1,341
Total non–current liabilities 288   32
Total liabilities 1,379   1,373
Total shareholders' equity 10,386   11,754
Total liabilities and shareholders' equity 11,765   13,127

ENTERA BIO LTD.
CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. dollars in thousands, except share and per share data)
 
(Unaudited)
 
  Year Ended
December 31,
  2023   2022
       
REVENUES   134
COST OF REVENUES   101
GROSS PROFIT   33
OPERATING EXPENSES:      
Research and development 4,510   5,848
General and administrative 4,430   7,253
Other income (49)   (51)
TOTAL OPERATING EXPENSES 8,891   13,050
OPERATING LOSS 8,891   13,017
FINANCIAL INCOME, NET (31)   (83)
LOSS BEFORE INCOME TAX 8,860   12,934
INCOME TAX EXPENSES 29   137
NET LOSS 8,889   13,071
       
BASIC AND DILUTED LOSS PER SHARE 0.31   0.45
WEIGHTED AVERAGE NUMBER OF SHARES      
OUTSTANDING USED IN COMPUTATION OF 29,007,794   28,808,090
BASIC AND DILUTED LOSS PER SHARE      


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Interim Results from Ongoing Clinical Study Confirm EB613 Optimized Profile for Osteoporosis Treatment and Potential for Entera’s Next Generation Oral Peptide Platform http://www.businesstimesoman.com/interim-results-from-ongoing-clinical-study-confirm-eb613-optimized-profile-for-osteoporosis-treatment-and-potential-for-enteras-next-generation-oral-peptide-platform/ http://www.businesstimesoman.com/interim-results-from-ongoing-clinical-study-confirm-eb613-optimized-profile-for-osteoporosis-treatment-and-potential-for-enteras-next-generation-oral-peptide-platform/#respond Wed, 29 Nov 2023 13:30:00 +0000 http://www.businesstimesoman.com/?p=309797 JERUSALEM, Nov. 29, 2023 (GLOBE NEWSWIRE) — Entera Bio Ltd. (NASDAQ: ENTX), ("Entera" or the "Company") a leader in the development of orally delivered peptides and therapeutic proteins, reported today interim data from an ongoing Phase 1 study designed to assess and compare the pharmacokinetic (PK) and early pharmacodynamic (PD) profile of current and several next generation compositions of its oral peptide platform (NCT05965167).

EB613 Continues to Display an Optimal Profile as First–in–Class Oral PTH(1–34) Peptide for Osteoporosis

The Phase 1 study first compared the PK profile of Entera's Phase 3 candidate, oral once–daily PTH(1–34) mini–tablets (EB613, a.k.a. EBP05 formulation) with subcutaneous (SC) PTH(1–34) 20 g (Forteo ). Consistent with previously reported PK and bioavailability data, EBP05 induced a rapid and dose–proportional increase in plasma drug concentrations of PTH(1–34) at all doses tested. The target bioavailability of PTH (1–34) with EB613 at doses of 1.5 mg and 2.5 mg, covering the dose range planned for phase 3 was met. Additionally, EB613 exhibited consistent and statistically significant (p<0.05) effects across all early PD markers such as plasma levels of endogenous PTH(1–84), serum calcium, phosphorus, and 1,25–dihydroxyvitamin D.

"EB613's reproducible PK profile across all our clinical studies, irrespective of age and gender, demonstrates the superiority of our platform to consistently deliver oral peptides in a small and convenient tablet form. Although the amino acid sequence in our oral PTH(1–34) is identical to commercially available injectable teriparatide, there is a clear difference in the exposure profile. EB613 appears to produce a shorter duration of osteoblast and osteoclast activation, which is essential for osteoporosis treatment. EB613 induces the "pulsatile" exposure required to simultaneously stimulate bone formation (anabolic) with a mild anti–resorptive property, as compared to Forteo . This exciting mechanism is consistent with the primary endpoint, bone turnover data reported from our placebo–controlled Phase 2 study in post–menopausal women at high risk of osteoporosis and potentially, the reason we see more rapid BMD increases at 6 months of treatment with EB613, especially at the total hip and proximal femur sites," said Miranda Toledano, Chief Executive Officer of Entera.

Next Generation Platform Demonstrates Robust Bioavailability with Novel Oral Peptide Compositions

The Phase 1 PK study also assessed novel compositions comprising PTH(1–34) as a model peptide to test Entera's proprietary, next generation platform.

The new compositions show enhanced bioavailability (BA) versus our first–generation platform, as expected from pre–clinical data. All formulations demonstrated a consistent PK profile to EBP05 with rapid absorption and elimination; and induced fast PD responses increasing calcium, vitamin D levels along with reducing phosphate and endogenous PTH(1–84).

Entera expects to unveil additional data at an upcoming conference.

About Entera Bio

Entera focuses on significant unmet medical needs where an oral tablet form of a peptide treatment or protein replacement therapy holds the potential to transform the standard of care. The Company's oral PTH (1–34) teriparatide mini tablets have been administered to a total of 255 subjects (153 patients) across Phase 1 and Phase 2 studies, with demonstrated bioavailability and clinical benefit across two distinct diseases. The Company's most advanced product candidate, EB613 (oral PTH (1–34), teriparatide), is being developed as the first oral, osteoanabolic (bone building) once–daily tablet treatment for post–menopausal women with low BMD and high–risk osteoporosis, with no prior fracture. A placebo controlled, dose ranging Phase 2 study of EB613 tablets (n= 161) met primary (PD/bone turnover biomarker) and secondary endpoints (BMD). Entera is preparing to initiate a Phase 3 registrational study for EB613. EB612 is being developed as the first tablet peptide replacement therapy for the treatment of hypoparathyroidism. The Company is currently conducting a phase 1 PK study of novel PTH formulations using its proprietary, next generation oral delivery platform. Entera is also developing oral GLP–2 peptide as an injection–free alternative for patients suffering from short bowel syndrome and other severe intestinal and malabsorption metabolic conditions and oral Oxyntomodulin (GLP1/glucagon) peptide for obesity in collaboration with OPKO Health. 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 may be contractually obligated to provide; 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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Entera Bio Reports Q3 2023 Financial Results, Highlights Transformational Steps and Unveils Vision as Premier Oral Peptide Company with Five Potential Programs in Development http://www.businesstimesoman.com/entera-bio-reports-q3-2023-financial-results-highlights-transformational-steps-and-unveils-vision-as-premier-oral-peptide-company-with-five-potential-programs-in-development/ http://www.businesstimesoman.com/entera-bio-reports-q3-2023-financial-results-highlights-transformational-steps-and-unveils-vision-as-premier-oral-peptide-company-with-five-potential-programs-in-development/#respond Tue, 14 Nov 2023 12:30:00 +0000 http://www.businesstimesoman.com/?p=309649 JERUSALEM, Nov. 14, 2023 (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 corporate updates and financial results for the third quarter ended September 30th, 2023.

"Today, after over a year of steadfast transformation and execution, Entera stands as a premier oral peptide company. It is our goal to potentially move five high value, first–in–class programs, Phase 1 through Phase 3, into the clinic by the end of 2025."

"Our disruptive and proprietary technology simultaneously inhibits gastrointestinal enzymatic degradation and consistently produces bioavailability of peptides, via a simple tablet format (around 6mm in diameter). Each of our oral peptide programs has been carefully selected based on platform alignment and our mission to successfully develop treatments that stand to become the number one choice for patients. Importantly Entera has sufficient cash on hand to enable key read–outs from our significant pipeline expansion efforts over the coming year," said Miranda Toledano, Chief Executive Officer of Entera.

"With our Phase 3 ready EB613 (oral PTH (1–34) peptide), we aim to transform the lives of osteoporosis patients, starting with the estimated 200 million women globally at–risk of fracture. We are also exploring the potential use of EB613 to accelerate stress fracture healing due to high intensity athletic or military training. Our EB612 program aimed at the development of a once–a–day (oral PTH (1– 34) peptide) replacement therapy for patients suffering from hypoparathyroidism, a disease which also disproportionately afflicts women, is being tested using a new generation of our platform. In September 2023, we announced a transformative collaboration with OPKO Health, Inc. ("OPKO") that expands our oral delivery technology across two additional peptides: GLP–2 for the treatment of short bowel syndrome, and oxyntomodulin, a dual targeted GLP–1 / glucagon agonist, for the treatment of obesity," said Ms. Toledano

"On a separate note, we would like to thank our collaborators, partners, and shareholders around the world for reaching out during the last six weeks since the war in Israel erupted to ensure the safety of our team and loved ones. Entera houses R&D, some manufacturing and key personnel across Israel, alongside our clinical, supply chain, regulatory and other functions in the U.S., UK and the EU. While our entire team at Entera is "safe" and continues to meet goals; we are all deeply affected by the current situation. Entera stands with Israel and its right to protect its diverse population of Jewish, Muslim, Druze and Christian citizens and residents. All of us are united in the protection and preservation of our heterogeneous and democratic country," said Ms. Toledano.

Entera Q3 2023 Updates and Goals for 5 Oral Peptide Programs:

EB613: First Oral PTH (1–34) Daily Osteoanabolic Tablets for Osteoporosis
EB613 (oral PTH (1–34), teriparatide), is being developed as the first oral, osteoanabolic (bone building) once–daily tablet treatment for osteoporosis. Entera is prepared to initiate a pivotal phase 3 study in post–menopausal women with high–risk osteoporosis and no prior fracture. Entera successfully completed a phase 2, 6–month, 161–patient, placebo–controlled study. EB613 produced rapid dose–proportional increases in biochemical markers of bone formation, reductions in markers of bone resorption, and increased lumbar spine, total hip, and femoral neck BMD in postmenopausal women with low mass or osteoporosis and no prior fracture. In October 2022, following a Type C meeting and in March 2023 following a Type D meeting, Entera announced the U.S. Food and Drug Administration's (FDA) concurrence that a 2–year, placebo–controlled phase 3 (registrational) study with Total Hip Bone Mineral Density (BMD) as primary endpoint could support an NDA for EB613. On November 9th, 2023, Entera reported that the American Society for Bone and Mineral Research (ASBMR) announced that the SABRE (Strategy to Advance BMD as a Regulatory Endpoint) project team had submitted to its full qualification plan to FDA for the use of BMD as a surrogate endpoint for fractures in future trials of new anti–osteoporosis drugs. EB613 stands as the first program to potentially avail itself of the ASBMR–SABRE BMD endpoint.

EB613: First Oral PTH (1–34) Osteoanabolic Tablets to Treat Intense Sport and Military Stress Injuries
Entera's ability to consistently deliver its oral PTH (1–34) peptide in a simple mini tablet format with reproduceable, dose dependent pharmacokinetics and rapid biological responses across gender, age, and health status was highlighted as part of two poster sessions at the Annual Society of Bone and Mineral Research (ASBMR) 2023 Annual Meeting held on October 13–16, 2023. This work also builds the foundation for Entera's oral PTH (1–34) tablets to potentially treat diverse patient populations including younger men and women athletes at risk of stress fractures. The Company is working towards a potential Phase 2 study for EB613 in this important indication.

EB612: First Oral PTH (1–34) Peptide Replacement Therapy Tablets for Hypoparathyroidism
EB612, is the first oral formulation of PTH (1–34), as a hormone replacement treatment for hypoparathyroidism. An open–label Phase 2a multicenter Phase 2A study, evaluating the safety, tolerability and PK of EB612 in 19 patients with hypoparathyroidism, achieved its primary and secondary endpoints, including a significant reduction in calcium supplementation (42% reduction from baseline, (p=0.001), a decline of 23% (p=0.0003) in median serum phosphate levels two hours following the first dose that was maintained for the duration of the study, improvement in quality of life score and maintenance of median calcium levels above the lower target level for hypoparathyroidism patients (>7.5 mg/dL) throughout the study. There were no treatment emergent adverse events of hypercalcemia reported and no treatment–emergent serious adverse events. Entera is currently evaluating its hypoparathyroidism program with improved formulations of EB612 based on new intellectual property, tailored to optimize its PK profile and the potential for reduced daily dosing as well as by potentially combining Entera's platform with alternative PTH analogues. Updates from the ongoing PK/PD study are expected by the end of 2023.

First GLP–2 Peptide Tablets for Short Bowel Syndrome
Under our collaboration agreement with OPKO, OPKO will supply its proprietary long–acting GLP–2 peptide to combine with Entera's oral peptide platform for the development of the first potential daily oral GLP–2 for the treatment of short bowel syndrome. Treatment with Glucagon–Like Peptide–2 (GLP–2) analogs has been shown to improve the absorption of nutrients in patients with short bowel syndrome (SBS) and reduce parenteral support requirements. Teduglutide, the only approved GLP–2 analog, requires daily subcutaneous injections. In SBS patients, oral drug delivery is particularly challenging because the site of absorption, the intestine, is short and less functional. Entera published pre–clinical data in May 2023 demonstrating that its oral peptide delivery platform enables gastric absorption of teduglutide, as a convenient potential tablet alternative to daily injections. OPKO and Entera expect to update on the program in the first half of 2024.

First GLP–1/Glucagon Agonist (Oxyntomodulin) Peptide Tablets for Obesity
Oxyntomodulin is a naturally occurring peptide hormone found in the colon, with glucagon–like–peptide 1 (GLP–1) and glucagon dual agonist activity which suppresses appetite and induces weight loss. OPKO has developed several proprietary, modified OXM analogs as potential candidates for treating obesity, including an injectable pegylated peptide which demonstrated significant reductions in weight loss and decreased plasma triglyceride levels with cardioprotective benefits in a 420 patient phase 2 study. Under the collaboration agreement, OPKO will supply certain OXM analogs to combine with Entera's oral peptide platform. OPKO and Entera expect to update on the program in the first half of 2024.

Financial Results for the Three Months Ended September 30, 2023

As of September 30, 2023, Entera had cash and cash equivalents of $7.6 million. The Company 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 the completion of the Phase 1 PK study related to our new generation platform and the GLP–2/OXM collaborative research we are conducting with OPKO.

Research and development expenses for the three months ended September 30, 2023 and 2022 were approximately $1.4 million. For the quarter ended September 30, 2023, there was an increase of $0.4 million in clinical expenses for our Phase 1 PK study related to our new generation platform and new formulations for EB612, which was offset by a decrease of $0.3 million materials and production costs and a decrease of $0.1 million in share–based compensation expense.

General and administrative expenses for the three months ended September 30, 2023 were $1.0 million, as compared to $1.5 million for the three months ended September 30, 2022. The decrease of $0.5 million was mainly attributable to a decrease of $0.3 million in professional fees and other consultants and a decrease of $0.2 million in D&O insurance costs.

Operating expenses for the three months ended September 30, 2023 were $2.4 million, as compared to $2.9 million for the three months ended September 30, 2022.

Net loss was $2.4 million, or $0.08 per ordinary share (basic and diluted), for the three months ended September 30, 2023, as compared to $3.1 million, or $0.11 per ordinary share (basic and diluted), for the three months ended September 30, 2022.

About Entera Bio

Entera focuses on significant unmet medical needs where an oral tablet form of a peptide treatment or protein replacement therapy holds the potential to transform the standard of care. The Company's oral PTH (1–34) teriparatide mini tablets have been administered to a total of 240 subjects (153 patients) across Phase 1 and Phase 2 studies, with demonstrated bioavailability and clinical benefit across two distinct diseases. The Company's most advanced product candidate, EB613 (oral PTH (1–34), teriparatide), is being developed as the first oral, osteoanabolic (bone building) once–daily tablet treatment for post–menopausal women with low BMD and high–risk osteoporosis, with no prior fracture. A placebo controlled, dose ranging Phase 2 study of EB613 tablets (n= 161) met primary (PD/bone turnover biomarker) and secondary endpoints (BMD). Entera is preparing to initiate a Phase 3 registrational study for EB613. EB612 is being developed as the first tablet peptide replacement therapy for the treatment of hypoparathyroidism. The Company is currently conducting a phase 1 PK study of novel PTH formulations using its proprietary, next generation oral delivery platform with data expected in the second half of 2023. Entera is also developing oral GLP–2 peptide as an injection–free alternative for patients suffering from short bowel syndrome and other severe intestinal and malabsorption metabolic conditions and oral Oxyntomodulin (GLP1/glucagon) peptide for obesity in collaboration with OPKO Health. 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 may be contractually obligated to provide; 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 BALANCE SHEETS
(U.S. dollars in thousands)
September 30 December 31
2023 2022
(Unaudited) (Audited)
Cash and cash equivalents 7,585 12,309
Accounts receivable and other current assets 431 540
Property and equipment, net 108 139
Other assets, net 441 139
Total assets 8,565 13,127
Accounts payable and other current liabilities 2,027 1,341
Total non–current liabilities 302 32
Total liabilities 2,329 1,373
Total shareholders' equity 6,236 11,754
Total liabilities and shareholders' equity 8,565 13,127

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

(Unaudited)

Three Months Ended
September 30,
2023 2022
REVENUES 8
COST OF REVENUES 6
GROSS PROFIT 2
OPERATING EXPENSES:
Research and development 1,370 1,413
General and administrative 1,028 1,460
Other income (12) (6)
TOTAL OPERATING EXPENSES 2,386 2,867
OPERATING LOSS 2,386 2,865
FINANCIAL EXPENSES (INCOME), NET (36) 8
LOSS BEFORE INCOME TAX 2,350 2,873
INCOME TAX 29 194
NET LOSS 2,379 3,067
BASIC AND DILUTED LOSS PER SHARE 0.08 0.11
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER SHARE 28,813,952 28,809,922


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http://www.businesstimesoman.com/entera-bio-reports-q3-2023-financial-results-highlights-transformational-steps-and-unveils-vision-as-premier-oral-peptide-company-with-five-potential-programs-in-development/feed/ 0
Entera Bio Reports Key Milestone Relating to Oral PTH (1-34) Peptide (EB613) Phase 3 Program: ASBMR-SABRE Has Submitted to FDA the Full Qualification Plan to Approve BMD as a Surrogate Endpoint for Osteoporosis http://www.businesstimesoman.com/entera-bio-reports-key-milestone-relating-to-oral-pth-1-34-peptide-eb613-phase-3-program-asbmr-sabre-has-submitted-to-fda-the-full-qualification-plan-to-approve-bmd-as-a-surrogate-endpoint-for-os/ http://www.businesstimesoman.com/entera-bio-reports-key-milestone-relating-to-oral-pth-1-34-peptide-eb613-phase-3-program-asbmr-sabre-has-submitted-to-fda-the-full-qualification-plan-to-approve-bmd-as-a-surrogate-endpoint-for-os/#respond Thu, 09 Nov 2023 19:30:00 +0000 http://www.businesstimesoman.com/?p=309612 JERUSALEM, Nov. 09, 2023 (GLOBE NEWSWIRE) — Entera Bio Ltd. (NASDAQ: ENTX), ("Entera" or the "Company") a leader in the development of orally delivered peptides and therapeutic proteins, reports today that the American Society for Bone and Mineral Research (ASBMR) has announced that the SABRE (Strategy to Advance BMD as a Regulatory Endpoint) project team has submitted to the U.S. Food and Drug Administration (FDA) its full qualification plan to use the treatment–related change in bone mineral density (BMD) as a surrogate endpoint for fractures in future trials of new anti–osteoporosis drugs.

BMD is the first surrogate endpoint undergoing qualification by the FDA under the 21st Century Cures Act which was signed into law on December 13, 2016, to help accelerate medical product development and bring new innovations and advances to patients who need them faster and more efficiently.

"This submission is critical to the future of osteoporosis drug innovation which has been hampered by ethical and cost constraints associated with fracture outcome studies. We would like to sincerely acknowledge and thank the ASBMR–FNIH–SABRE team for its significant contributions and for furthering this key initiative with the FDA," said Miranda Toledano, Chief Executive Officer of Entera. "The last 15 months have been intense for Entera from a regulatory standpoint, and we believe EB613 stands as the first program to potentially avail itself of the ASBMR–SABRE BMD endpoint. We have powered our proposed phase 3 study using the published SABRE quantitative thresholds which statistically correlate to reductions in vertebral, non–vertebral and all site fracture risk. Much like biomarkers and validated surrogates that are routinely used across oncology, cardiovascular and metabolic disorders, we look forward to FDA's potential qualification of BMD for osteoporosis and to promptly advancing EB613 forward using this more ethical approach," said Ms. Toledano.

EB613 (oral PTH (1–34), teriparatide), is being developed as the first oral, osteoanabolic (bone building) once–daily tablet treatment for osteoporosis. In a phase 2, 6–month, 161–patient, placebo–controlled study EB613 produced rapid dose–proportional increases in biochemical markers of bone formation, reductions in markers of bone resorption, and increased lumbar spine, total hip, and femoral neck BMD in postmenopausal women with low mass or osteoporosis and no prior fracture. In October 2022, following a Type C meeting, Entera announced FDA's concurrence that a 2–year, placebo–controlled phase 3 (registrational) study with Total Hip BMD as primary endpoint could support an NDA for EB613.

About ASBMR–FNIH SABREi

Initiated in 2013, the Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium Bone Quality Project assembled data from more than 150,000 participants across more than 50 clinical trials of anti–osteoporosis drugs. The project team re–evaluated these existing data to understand which measurements could predict the ability of the treatment to reduce fractures. The study findings identified an increase in bone mineral density, as measured by a low–dose X–ray imaging technique, as a strong predictor of the extent to which treatments reduce fracture risk. A change in bone mineral density could therefore be used in future clinical trials to determine the effectiveness of osteoporosis drugs. Through a partnership with ASBMR, the FNIH extended and continues to support the original study, renamed SABRE, to seek FDA approval for the surrogate biomarker.

About the Cures Act

The 21st Century Cures Act (Cures Act), signed into law on December 13, 2016, is designed to help accelerate medical product development and bring new innovations and advances to patients who need them faster and more efficiently.

The law builds on FDA's ongoing work to incorporate the perspectives of patients into the development of drugs, biological products, and devices in FDA's decision–making process. Cures enhances our ability to modernize clinical trial designs, including the use of real–world evidence, and clinical outcome assessments, which will speed the development and review of novel medical products, including medical countermeasures.

It also provides new authority to help FDA improve our ability to recruit and retain scientific, technical, and professional experts and it establishes new expedited product development programs.

About Entera Bio

Entera focuses on significant unmet medical needs where an oral tablet form of a peptide treatment or protein replacement therapy holds the potential to transform the standard of care. The Company's oral PTH (1–34) teriparatide mini tablets have been administered to a total of 240 subjects (153 patients) across Phase 1 and Phase 2 studies, with demonstrated bioavailability and clinical benefit across two distinct diseases. The Company's most advanced product candidate, EB613 (oral PTH (1–34), teriparatide), is being developed as the first oral, osteoanabolic (bone building) once–daily tablet treatment for post–menopausal women with low BMD and high–risk osteoporosis, with no prior fracture. A placebo controlled, dose ranging Phase 2 study of EB613 tablets (n= 161) met primary (PD/bone turnover biomarker) and secondary endpoints (BMD). Entera is preparing to initiate a Phase 3 registrational study for EB613. EB612 is being developed as the first tablet peptide replacement therapy for the treatment of hypoparathyroidism. The Company is currently conducting a phase 1 PK study of novel PTH formulations using its proprietary, next generation oral delivery platform with data expected in the second half of 2023. Entera is also developing oral GLP–2 peptide as an injection–free alternative for patients suffering from short bowel syndrome and other severe intestinal and malabsorption metabolic conditions and oral Oxyntomodulin (GLP1/glucagon) peptide for obesity in collaboration with OPKO Health. 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 may be contractually obligated to provide; 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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http://www.businesstimesoman.com/entera-bio-reports-key-milestone-relating-to-oral-pth-1-34-peptide-eb613-phase-3-program-asbmr-sabre-has-submitted-to-fda-the-full-qualification-plan-to-approve-bmd-as-a-surrogate-endpoint-for-os/feed/ 0
Entera Bio Reports Rapid Pharmacodynamic (PD) Response and Consistent Pharmacokinetic (PK) Data for its First-in-Class Oral PTH(1-34) Mini Tablets at the ASBMR 2023 Annual Meeting http://www.businesstimesoman.com/entera-bio-reports-rapid-pharmacodynamic-pd-response-and-consistent-pharmacokinetic-pk-data-for-its-first-in-class-oral-pth1-34-mini-tablets-at-the-asbmr-2023-annual-meeting/ http://www.businesstimesoman.com/entera-bio-reports-rapid-pharmacodynamic-pd-response-and-consistent-pharmacokinetic-pk-data-for-its-first-in-class-oral-pth1-34-mini-tablets-at-the-asbmr-2023-annual-meeting/#respond Mon, 16 Oct 2023 12:00:00 +0000 http://www.businesstimesoman.com/?p=309361 JERUSALEM, Oct. 16, 2023 (GLOBE NEWSWIRE) — Entera Bio Ltd. (NASDAQ: ENTX), ("Entera" or the "Company") a leader in the development of orally delivered peptides and therapeutic proteins, presented 2 posters at the Annual Society of Bone and Mineral Research (ASBMR) 2023 Annual Meeting held on October 13–16, 2023 in Vancouver, BC, Canada. Both posters will be available on the Company's website, www.enterabio.com.

"Entera's ability to consistently deliver our oral PTH(1–34) peptide in a simple mini tablet format with reproduceable, dose dependent pharmacokinetics and rapid biological responses irrespective of gender, age, and health status is testament to the robustness of our oral peptide platform. This work also builds the foundation for our oral PTH(1–34) tablets to potentially treat diverse patient populations including younger men and women athletes at risk of stress fractures," said Miranda Toledano, Chief Executive Officer of Entera.

The lead drug candidate of Entera's EBP05 formulation, EB613 is currently being developed as the first once–daily oral anabolic therapy for the treatment of osteoporosis. In a 6–month, 161–patient, placebo–controlled Phase 2 study, EB613 produced rapid dose–proportional changes in biochemical markers and increased Bone Mineral Density (BMD) in postmenopausal women with low BMD osteoporosis.

Abstract Title: First Oral PTH(1–34) Tablet Treatment for Osteoporosis Demonstrates Rapid Pharmacodynamic Effect on Plasma Levels of Endogenous PTH(1–84)

A Phase 1 study comparing oral EB613, subcutaneous (SC) hPTH(1–34) 20 g (Forteo ) and a new generation of Entera's oral peptide delivery platform is ongoing. One of the first objectives of this study is to rapidly evaluate the pharmacodynamic (PD) effects of Entera's oral PTH(1–34) tablets. This analysis relates to Entera's lead formulation. Additional data on new formulations will be released later in 2023.

An increase in plasma ionized calcium should result in decreased secretion and plasma concentrations of endogenous PTH(1–84). Thus, a reduction in plasma PTH(1–84) should provide an early indication of the systemic exposure and pharmacologic activity of Entera's oral PTH(1–34) tablets. In the study, the mean percentage of endogenous plasma PTH (1–84) 120 minutes after dosing was 59.2%, 54.3%, and 52.3% for EB613 1.5 mg, 2.5 mg and Forteo , respectively; and showed consistent effects across other early PD markers such as serum calcium, phosphorus, and 1,25–dihydroxyvitamin D.

"EB613 oral tablets (1.5 mg and 2.5 mg doses) rapidly decreased plasma concentrations of PTH(1–84) in all subjects, in a dose proportional manner. The results provide early proof of the systemic exposure and pharmacological activity to Entera's orally administered PTH(1–34) tablets. The ability to rapidly evaluate PD effects as early markers of therapeutic response is crucial to assessing a drug's activity in osteoporosis patients and potentially optimize their management. In contrast, response with conventional PD markers of bone metabolism may take several months. Thus, we plan to continue to measure PTH(1–84) responses in further clinical development of EB613," said Art Santora, MD, Entera's Chief Medical Officer.

Abstract Title: Pharmacokinetic (PK) Profile of EBP05/EB613 Oral Teriparatide Tablets in Women of Post Menopausal Age Versus Young Adult Men.

This retrospective analysis compares the pharmacokinetic profile of EBP05 in healthy young males versus female patients of menopausal age with hypoparathyroidism.

A single administration of the same dose, 2.25 mg oral PTH (1–34), in healthy young men (22 years, range 21–26) and women of postmenopausal age (62 years, range 49 –63) resulted in a median Cmax of 425 pg/ml vs 521 pg/ml, and a median AUC of 157 pg*hour/ml vs 158 pg*hour/ml respectively.

"The data showed a consistent PK profile following administration of oral EBP05 tablets in both young men and women of menopausal age. These similar profiles indicate that similar doses of our oral PTH tablets may be used across these different populations," said Gregory Burshtein PhD, Entera's Head of Research and Development.

About Entera Bio

Entera focuses on significant unmet medical needs where an oral form of a peptide treatment or protein replacement therapy holds the potential to transform the standard of care. The Company's oral PTH*(1–34) teriparatide mini tablets have been administered to a total of 240 subjects (153 patients) across Phase 1 and Phase 2 studies, with demonstrated bioavailability and clinical benefit across two distinct diseases. The Company's most advanced product candidate, EB613 (oral synthetic hPTH (1–34)), is being developed as the first oral, osteoanabolic (bone building) once–daily tablet treatment for post–menopausal women with low BMD and high–risk osteoporosis, with no prior fracture. A placebo controlled, dose ranging Phase 2 study of EB613 tablets (n= 161) met primary (PD/bone turnover biomarker) and secondary endpoints (BMD). Entera is preparing to initiate a Phase 3 registrational study for EB613. EB612 is being developed as the first tablet peptide replacement therapy for the treatment of hypoparathyroidism. The Company is currently conducting a phase 1 PK study of novel PTH formulations using its proprietary, next generation oral delivery platform with data expected in the second half of 2023. Entera is also developing oral GLP–2 program as an injection–free alternative for patients suffering from short bowel syndrome and other severe intestinal and malabsorption metabolic conditions and oral Oxyntomodulin (GLP1/glucacon) for obesity in collaboration with OPKO Health. 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 may be contractually obligated to provide; 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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Entera Bio Adds Sanofi Commercial Leader, Haya Taitel to its Board of Directors http://www.businesstimesoman.com/entera-bio-adds-sanofi-commercial-leader-haya-taitel-to-its-board-of-directors/ http://www.businesstimesoman.com/entera-bio-adds-sanofi-commercial-leader-haya-taitel-to-its-board-of-directors/#respond Wed, 07 Jun 2023 11:30:00 +0000 http://www.businesstimesoman.com/?p=308355 JERUSALEM, June 07, 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 that it has appointed Haya Taitel, Head of Sanofi's Global Transplant Franchise as an independent director to the Company's Board of Directors.

“We are thrilled that Haya has joined our Board,” said Miranda Toledano, Chief Executive Officer of Entera. “With more than 30 years of experience building industry–leading commercial organizations across big pharma and biotech, Haya brings a veteran and unique perspective to Entera's Board of Directors. We believe that Haya's track record shepherding late–stage products through regulatory approval to commercial readiness, implementing payor and channel strategies for blockbusters, including products in women's health, will be invaluable as we continue to prepare our global strategy related to EB613's phase 3 program and our future pipeline. We are humbled that Haya, in addition to our existing clinical and regulatory advisory board, recognizes the potential for EB613 and its unique positioning to potentially alter the paradigm for post–menopausal women with osteoporosis. These champions are paramount to adequately preparing the success of our programs."

“Entera is looking to make a real difference with its platform technology and core products across major disease areas with significant unmet need, especially with EB613 for women at high risk of fracture, there are over 100 million women globally who could become candidates for this important therapy," said Haya Taitel. "I have been following Entera's regulatory development and the progress of this program closely and am looking forward to working with the Board and management team as Entera enters this pivotal stage for EB613. I am also excited for the pipeline candidates selected where Entera's platform appears to provide a breakthrough simple mini tablet format for patients to better actively manage their health, such as GLP–2 and PTH for hypoparathyroidism."

Ms. Taitel has over 30 years of global C–level biopharma commercial and strategic executive experience. Ms. Taitel currently serves as the Head of Sanofi's Global Transplant Franchise where she is responsible for increasing franchise growth and profitability. Prior to her role at Sanofi, Ms. Taitel served as the Chief Commercial Officer of Kadmon Pharmaceuticals, LLC, where she contributed to the launch of Rezurock , from 2013 until the company was acquired by Sanofi for $1.9 billion in November 2021. Ms. Taitel also led Kadmon Board's Executive Commercial Committee. Beginning in 1997, Ms. Taitel had held various commercial leadership positions of increasing seniority at Johnson and Johnson in multiple therapeutic areas, including oncology, immunology, neurology and women's healthcare. Ms. Taitel holds a Master of Science, Pharmacology, (PharmD equivalence) from Temple University and a Bachelor of Science, Pharmacy and Biology from the Hebrew University School of Pharmacy in Jerusalem, Israel.

About Entera

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 may be contractually obligated to provide; 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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Entera Bio Announces Q1 2023 Financial Results and Corporate Updates http://www.businesstimesoman.com/entera-bio-announces-q1-2023-financial-results-and-corporate-updates/ http://www.businesstimesoman.com/entera-bio-announces-q1-2023-financial-results-and-corporate-updates/#respond Fri, 05 May 2023 20:05:00 +0000 http://www.businesstimesoman.com/?p=308110 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 BALANCE SHEETS
(U.S. dollars in thousands, except share data)
(Unaudited)
March 31 December 31
2023 2022
Cash and cash equivalents 10,691 12,309
Accounts receivable and other current assets 682 540
Property and equipment, net 136 139
Other assets, net 97 139
Total assets 11,606 13,127
Accounts payable and other current liabilities 1,494 1,341
Total non–current liabilities 32 32
Total liabilities 1,526 1,373
Total shareholders' equity 10,080 11,754
Total liabilities and shareholders' equity 11,606 13,127

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

Three Months Ended
March 31,
2023 2022
REVENUES 68
COST OF REVENUES 54
GROSS PROFIT 14
OPERATING EXPENSES:
Research and development 931 1,690
General and administrative 1,294 2,171
Other income (13 ) (12 )
TOTAL OPERATING EXPENSES 2,212 3,849
OPERATING LOSS 2,212 3,835
FINANCIAL INCOME, NET (22 ) (44 )
LOSS BEFORE INCOME TAX 2,190 3,791
INCOME TAX BENEFIT (7 )
NET LOSS 2,190 3,784
LOSS PER SHARE BASIC AND DILUTED 0.08 0.13
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER SHARE 28,809,922 28,804,411


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Entera Bio Provides Guidance from FDA Type D Meeting Related to EB613 Pivotal Program http://www.businesstimesoman.com/entera-bio-provides-guidance-from-fda-type-d-meeting-related-to-eb613-pivotal-program/ http://www.businesstimesoman.com/entera-bio-provides-guidance-from-fda-type-d-meeting-related-to-eb613-pivotal-program/#respond Mon, 03 Apr 2023 11:00:00 +0000 http://www.businesstimesoman.com/?p=307839 JERUSALEM, April 03, 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 feedback from its Type D Meeting with the U.S. Food and Drug Administration (FDA) related to EB613's [daily oral hPTH(1–34), teriparatide, tablets] proposed registrational program for the treatment of postmenopausal women with osteoporosis. Entera submitted a draft phase 3 study protocol and requested the FDA's written responses to two questions.

On the first question, "Based on the FDA's feedback provided in the Type C meeting written response August 19, 2022, and subsequent teleconference held on September 27, 2022, the Sponsor has updated the Phase 3 protocol design including the use of Total Hip Bone Mineral Density (BMD) as the primary endpoint. Does the FDA concur that the revised protocol meets its expectations?" the FDA responded that it is not opposed to the use of BMD as a surrogate for fracture, including initiating a study under the proposed Foundation for the National Institutes of Health Bone Quality Project (FNIH BQP)1 pathway, which is undergoing review. The FNIH–BQP approach to BMD as a surrogate endpoint for fracture was first discussed with Entera during its End of Phase 2 Meeting with the FDA (as announced in July 2022). In the Type D meeting responses, the FDA confirmed to Entera that a 24–month placebo–controlled phase 3 trial with the primary efficacy analysis at 24 months is acceptable and provided some guidance on the statistical evaluation of the study.

On the second question, "Does FDA agree that the design of the population PK (pharmacokinetic) and exposure response evaluation incorporated in the draft Phase 3 study protocol meets FDA expectations?" FDA responded that the Company's proposed PK sampling scheme in the phase 3 study seems reasonable.

"We thank the FDA for our Type D Meeting and their ongoing support for our EB613 program. We are very pleased that the agency has re–affirmed its acceptance of BMD as an endpoint and our placebo–controlled design. We will continue our dialogue with the FDA and we will be ready to initiate our study once the FDA provides us with final guidance on their review of the FNIH–BQP. The ethical concerns associated with placebo–controlled fracture endpoint studies in osteoporotic patients at high risk of fracture is a critical barrier to new drug development for this common disorder. Entera is proud to be part of this incredibly significant process with FDA, which is also sponsored by the ASBMR. Our conviction that EB613, as the first potential oral osteoanabolic treatment, may help millions of women globally is unwavering; and we look forward to initiating our pivotal Phase 3 study under this critical initiative. Meanwhile, we are preparing to start the PK study for our next generation platform, which may enable us to advance our EB612 program for the treatment of hypoparathyroidism into Phase 2 in 2024," stated Miranda Toledano, Chief Executive Officer of Entera.

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.
https://force–dsc.my.site.com/ddt/s/ddt–project?ddtprojectid=97

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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); https://force–dsc.my.site.com/ddt/s/ddt–project?ddtprojectid=97


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Entera Bio Provides 2022 Corporate Milestones and Financial Results for the Year Ended December 31, 2022 http://www.businesstimesoman.com/entera-bio-provides-2022-corporate-milestones-and-financial-results-for-the-year-ended-december-31-2022/ http://www.businesstimesoman.com/entera-bio-provides-2022-corporate-milestones-and-financial-results-for-the-year-ended-december-31-2022/#respond Fri, 31 Mar 2023 20:00:00 +0000 http://www.businesstimesoman.com/?p=307825 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 6th 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 15th, 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.

ENTERA BIO LTD.
CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands, except share data)
(Unaudited)
December 31 December 31
2022 2021
Cash and cash equivalents 12,309 24,892
Accounts receivable and other current assets 540 437
Property and equipment, net 139 156
Other assets, net 139 502
Total assets 13,127 25,987
Accounts payable and other current liabilities 1,341 3,161
Total non–current liabilities 32 261
Total liabilities 1,373 3,422
Total shareholders' equity 11,754 22,565
Total liabilities and shareholders' equity 13,127 25,987

ENTERA BIO LTD.
CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. dollars in thousands, except share and per share data)
Year ended
December 31,
2022 2021
REVENUES 134 571
COST OF REVENUES 101 373
GROSS PROFIT 33 198
OPERATING EXPENSES:
Research and development 5,848 6,771
General and administrative 7,253 5,690
Other income (51 ) (46 )
TOTAL OPERATING EXPENSES 13,050 12,415
OPERATING LOSS 13,017 12,217
FINANCIAL EXPENSES(INCOME), net (83 ) 29
LOSS BEFORE INCOME TAX 12,934 12,246
INCOME TAX EXPENSE(BENEFIT) 137 (59 )
NET LOSS 13,071 12,187
LOSS PER SHARE BASIC AND DILUTED 0.45 0.47
WEIGHTED–AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER SHARE 28,808,090 28,133,770


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Entera Bio Regains Compliance with Nasdaq Listing Requirements http://www.businesstimesoman.com/entera-bio-regains-compliance-with-nasdaq-listing-requirements/ http://www.businesstimesoman.com/entera-bio-regains-compliance-with-nasdaq-listing-requirements/#respond Thu, 23 Mar 2023 13:27:58 +0000 http://www.businesstimesoman.com/?p=307726 JERUSALEM, March 23, 2023 (GLOBE NEWSWIRE) — Entera Bio Ltd. (NASDAQ: ENTX), ("Entera" or the "Company") a leader in the development of orally delivered peptides and therapeutic proteins, announced today that it received notice from The NASDAQ Stock Market LLC (NASDAQ) on March 23, 2023, informing Entera that it has regained compliance with the minimum bid price requirement under NASDAQ Listing Rule 5550(a)(2) for continued listing on The NASDAQ Capital Market.

On November 21, 2022, NASDAQ notified the Company that its ordinary shares had failed to maintain a minimum bid price of $1.00 over the previous 30 consecutive business days as required by the Listing Rules of The Nasdaq Stock Market. Since then, NASDAQ determined that for the last 14 consecutive business days, from March 3rd through 22nd 2023, the closing bid price of the Company's ordinary shares has been at $1.00 per share or greater. Accordingly, the Company has regained compliance with Listing Rule 5550(a)(2), and this matter is now closed.

Entera is in compliance with all applicable listing standards, and its ordinary shares continues to be listed on The NASDAQ Capital Market.

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. In October 2022, the Company announced concurrence with FDA that a single, placebo controlled, BMD endpoint pivotal study design could support an NDA for EB613 Oral PTH tablets under 505(b)2. On February 15th, 2022, Entera announced the acceptance of a Type D Meeting with FDA to confirm that its Phase 3 protocol fully meets FDA's expectations, including the analysis of the primary endpoint and the population PK evaluations. 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.


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