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אנטרה ביו מדווחת על תוצאותיה הכספיות לרבעון השלישי של שנת 2024 ומספקת עדכונים עסקיים

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אנטרה ביו Entera Bio Ltd. (נאסד"ק: ENTX), מובילה בפיתוח פפטידים וחלבונים טיפוליים הניתנים דרך הפה, דיווחה היום על תוצאותיה הכספיות ועדכונים עסקיים מרכזיים לרבעון שהסתיים ביום 30 בספטמבר 2024.

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<html> <head> <title>אנטרה ביו מדווחת על תוצאותיה הכספיות לרבעון השלישי של שנת 2024 ומספקת עדכונים עסקיים</title> <meta name="description" content="אנטרה ביו Entera Bio Ltd. (נאסד"ק: ENTX), מובילה בפיתוח פפטידים וחלבונים טיפוליים הניתנים דרך הפה, דיווחה היום על תוצאותיה הכספיות ועדכונים עסקיים מרכזיים לרבעון שהסתיים ביום 30 בספטמבר 2024."> <meta name="keywords" content="GLOBE NEWSWIRE, noy tikshoret"> <meta name="expires" CONTENT="never"> <meta name="language" CONTENT="hebrew"> <meta name="distribution" CONTENT="Global"> <meta name="robots" content="index, follow"> <meta http-equiv="Content-Type" content="text/html; charset=windows-1255"> </title> <body dir="rtl"> <h1>אנטרה ביו מדווחת על תוצאותיה הכספיות לרבעון השלישי של שנת 2024 ומספקת עדכונים עסקיים</h1><br/> <br/><strong>נכתב על ידי: <a title="אנטרה ביו מדווחת על תוצאותיה הכספיות לרבעון השלישי של שנת 2024 ומספקת עדכונים עסקיים" href="http://www.portal-asakim.com/Authors//Author576.aspx ">חיים נוי</a></strong><br/> <br/><p align="center"><a name="_Hlk181935985"></a><a name="_Hlk164141897">אנטרה ביו מדווחת על תוצאותיה הכספיות לרבעון השלישי של שנת 2024 ומספקת עדכונים עסקיים</a></p> <p>ירושלים, 8 בנובמבר 2024, (GLOBE NEWSWIRE) – </p> <p>אנטרה ביוEntera Bio Ltd.(נאסד"ק: ENTX), מובילה בפיתוח פפטידים וחלבונים טיפוליים הניתנים דרך הפה, דיווחה היום על תוצאותיה הכספיות ועדכונים עסקיים מרכזיים לרבעון שהסתיים ביום 30 בספטמבר 2024.</p> <p align="center">Entera Bio Reports Q3 2024 Financial Results and Provides Business Updates</p> <p>JERUSALEM, Nov. 08, 2024 (GLOBE NEWSWIRE) – </p> <p>Entera Bio Ltd. (NASDAQ: ENTX), ("Entera" or the "Company") a leader in the development of oral peptides and small therapeutic proteins, today reported financial results and key business updates for the quarter ended September 30, 2024.</p> <p>"The third quarter of 2024 drew consistent attention to our pivotal-staged clinical asset, EB613, the first oral PTH(1-34) tablet treatment dedicated to post-menopausal women with high risk osteoporosis. Entera’s proprietary N-Tab™ platform consistently delivered across our oral GLP-2 tablet, oral GLP-1/Glucagon tablet and confidential hypoparathyroidism tablet program. Finally, we are humbled by key additions from around the world to our clinical and scientific advisory board which we view as testament to what we are aspiring to build at Entera," said Miranda Toledano, Chief Executive Officer of Entera.</p> <p>Ms. Toledano continued, "We are headed into a busy year end across all programs and keenly anticipating FDA’s potential landmark ruling on the ASBMR-FNIH SABRE regulatory endpoint for osteoporosis drugs, expected in January 2025. Current regulatory guidelines requiring fracture outcomes have curtailed innovation in the treatment of this significant disease due to ethical, time and sizing of studies required to evaluate new treatments. The SABRE work is based on a statistical meta-analysis of over 170,000 patients across 53 randomized clinical studies and 7 osteoporosis drug classes correlating total hip Bone Mineral Density (BMD) to fracture outcomes. We believe that our pivotal program for EB613 is first in line to leverage this pathway. Our recent discussions with patients, regulatory agencies, clinicians and fellow industry colleagues acknowledge the need for new treatments for osteoporosis and, especially, oral anabolic therapy. Osteoporosis is one of the foremost underserved women’s health issues globally, where fracture rates continue to rise and where, despite medical guidelines, efficacious injectable anabolics are used in a minority of patients worldwide. We are developing EB613 to help close this treatment gap."</p> <p>Q3 2024 Updates:</p> <p>EB613: First Oral PTH(1-34) Anabolic Tablet Treatment for Women with Osteoporosis</p> <ul type="disc"> <li>In September 2024,new comparative pharmacological data for EB613 was presented at theAmerican Society for Bone Mineral Research September 2024 (ASBMR 2024) AnnualMeeting in Toronto. The abstract was previewed by Dr. Serge Ferrari ofGeneva University Hospital in Switzerland in his sneak-peak highlights ofcutting-edge clinical abstracts on osteoporosis therapy at ASBMR2024.</li> </ul> <p>First GLP-1/Glucagon Agonist (Oxyntomodulin) Peptide Tablets for Obesity</p> <ul type="disc"> <li>In September 2024,Entera and OPKO Health, Inc. ("OPKO"; Nasdaq: OPK), jointly announcedtopline pharmacokinetic/ pharmacodynamic (PK/PD) results for the oraloxyntomodulin (OXM) tablet program. The program is focused on developingthe first oral dual agonist GLP-1/glucagon peptide as a potentialonce-daily treatment for patients with obesity and metabolic disordersusing Entera’s proprietary N-Tab™ platform. Oral OXM exhibited significantsystemic exposure across two <em>in vivo</em> models, a favorablePK profile and bioavailability. The high plasma concentrations withprolonged systemic exposure were consistent with the reported half-lifefor semaglutide (Rybelsus®), the only approved oral GLP-1 analog. Oral OXMshowed a statistically significant reduction in plasma glucose levelscompared with placebo. Entera plans to present this data together withOPKO at an upcoming clinical conference.</li> </ul> <p>First GLP-2 Peptide Tablets for Short Bowel Syndrome</p> <ul type="disc"> <li>Entera continuespre-IND validation of its oral GLP-2 tablet in partnership with OPKO.Final <em>in vivo</em> PK/PD data is expected in the second halfof 2024. This program is being developed as the first potential tabletGLP-2 replacement therapy for patients suffering with Short BowelSyndrome, a rare and devastating intestinal failure condition. The programmay also provide value to other critical conditions of GI inflammation,which is being explored with external parties. </li> </ul> <p>EB612: First Oral PTH(1-34) Peptide Replacement Therapy Tablets for Hypoparathyroidism</p> <ul type="disc"> <li>Entera continuesto collaborate productively with a third party on the oral tabletdevelopment of another PTH replacement treatment for hypoparathyroidism.</li> </ul> <p>Financial Results for the Quarter Ended September 30, 2024</p> <p>As of September 30,2024, Entera had cash and cash equivalents of $6.9 million. The Company expects that its existing cash resources are sufficient to meet its projected operating requirements into the third quarter of 2025.</p> <p>Research and development expenses for the three months ended September 30, 2024 were $1.5 million, as compared to $1.4 million for the three months ended September 30, 2023. The increase of $0.1 million was primarily due to an increase of $0.5 million in materials required in connection with the optimization processes related to the preparation of the EB613 phase 3 study. The increase was partially offset by a decrease of $0.4 million related to a completed Phase 1 PK, which occurred in 2023.</p> <p>General and administrative expenses for the three months ended September 30, 2024 were $1.5 million, as compared to $1.0 million for the three months ended September 30, 2023. The increase of $0.5 million was mainly attributable to increases in intellectual property expenses, consultancy fees and share-based compensation.</p> <p>Operating expenses for the period ended September 30, 2024 were $3.0 million, as compared to $2.4 million for the quarter ended September 30, 2023.</p> <p>Net loss was $3.0 million, or $0.08 per ordinary share (basic and diluted), for the quarter ended September 30, 2024, as compared to $2.4 million, or $0.08 per ordinary share (basic and diluted), for the quarter ended September 30, 2023.</p> <p>About Entera Bio</p> <p>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 a disruptive and proprietary technology platform (N-Tab™) and its pipeline includes five differentiated, first-in-class oral peptide programs, expected to enter the clinic (Phase 1 to Phase 3) by 2025. The Company’s most advanced product candidate, EB613 (oral PTH (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. A placebo controlled, dose ranging Phase 2 study of EB613 tablets (n=161) met primary (PD/bone turnover biomarker) and secondary (BMD) endpoints. 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 by January 2025. The EB612 program is being developed as the first oral PTH (1-34) tablet peptide replacement therapy for hypoparathyroidism. In collaboration with OPKO Health, Entera is also developing the first oral oxyntomodulin, a dual targeted GLP-1/glucagon peptide, in tablet form for the treatment of obesity; and the first oral GLP-2 peptide tablet as an injection-free alternative for patients suffering from rare malabsorption conditions such as short bowel syndrome. For more information, visit <a href="https://www.globenewswire.com/Tracker?data=korz1oCnMx5Uz1XlqmLtIaar_njqDIupnYfS8oAqBcHmKZkB0KZG1JRcp7WrN4s509Tx5xDCu49GIdoIX5mYteygSubA7paPUndSEKvTjI8gTn8nBSCFiYixzDUcui4tE8DOaaW509JwfRTd_TgG74FDodfUbZYbflojgKPeIsA_v_i1IYXdkuUwKHynfE_UwccX4cIUj7fLnLTEwjWSR_GnX8gJQBpvzs3pIEClY2RGxrpQMGssX-jhl8UWucKsVDdyfc_5VNnOLU771LmS0w==" target="_blank">www.enterabio.com</a> or follow us on <a href="https://www.globenewswire.com/Tracker?data=U049gfWwNQmBM5yRZGxTFdgWmQNdiidzGJXUPaZXzPa6bYJAvt3LI_zj6845o_jP8hK3J9ehL7xnm1AFH8cKUcbnfX9Tb5oVDrG-rXXYG0YnZk3xravkhWDrrY41go_TFC1A-9phvLAlhCvycoOSjQxu181diZfpf4qnL87Wz8gniyTDi3vwpTz8XTjVBUr3D6esKBsSWdezA1p2t-HgytO1FJirUP8gdK8eHnoh9SLqvgg1zKXaI3kLWP0IKM6U" target="_blank">LinkedIn</a>, X (formerly <a 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align="center">(U.S. dollars in thousands)</p> </td> </tr> <tr> <td colspan="4" width="100%"> </td> </tr> <tr> <td width="67%"> </td> <td width="15%"> </td> <td width="0%"> </td> <td width="15%"> </td> </tr> <tr> <td width="67%"> </td> <td width="15%"> <p>September30,</p> </td> <td width="0%"> </td> <td width="15%"> <p>December31,</p> </td> </tr> <tr> <td width="67%"> </td> <td width="15%"> <p>2024</p> </td> <td width="0%" valign="bottom"> </td> <td width="15%"> <p>2023</p> </td> </tr> <tr> <td width="67%"> </td> <td width="15%"> <p>(Unaudited)</p> </td> <td width="0%" valign="bottom"> </td> <td width="15%"> <p>(Audited)</p> </td> </tr> <tr> <td width="67%"> </td> <td colspan="3" width="32%"> </td> </tr> <tr> <td width="67%" valign="bottom"> <p>Cashand cash equivalents</p> </td> <td width="15%" valign="bottom"> <p>6,915</p> </td> <td width="0%" valign="bottom"> </td> <td width="15%" valign="bottom"> <p>11,019</p> </td> </tr> <tr> <td width="67%" valign="bottom"> <p>Accountsreceivable and other current assets</p> </td> <td width="15%" valign="bottom"> <p>425</p> </td> <td width="0%" valign="bottom"> </td> <td width="15%" valign="bottom"> <p>238</p> </td> </tr> <tr> <td width="67%" valign="bottom"> <p>Propertyand equipment, net</p> </td> <td width="15%" valign="bottom"> <p>65</p> </td> <td width="0%" valign="bottom"> </td> <td width="15%" valign="bottom"> <p>100</p> </td> </tr> <tr> <td width="67%" valign="bottom"> <p>Otherassets, net</p> </td> <td width="15%" valign="bottom"> <p>336</p> </td> <td width="0%" valign="bottom"> </td> <td width="15%" valign="bottom"> <p>408</p> </td> </tr> <tr> <td width="67%" valign="bottom"> <p>Totalassets</p> </td> <td width="15%" valign="bottom"> <p>7,741</p> </td> <td width="0%" valign="bottom"> </td> <td width="15%" valign="bottom"> <p>11,765</p> </td> </tr> <tr> <td width="67%"> </td> <td width="15%"> </td> <td colspan="2" width="16%"> </td> </tr> <tr> <td width="67%"> </td> <td width="15%"> </td> <td colspan="2" width="16%"> </td> </tr> <tr> <td width="67%" valign="bottom"> <p>Accountspayable and other current liabilities</p> </td> <td width="15%" valign="bottom"> <p>1,111</p> </td> <td width="0%" valign="bottom"> </td> <td width="15%" valign="bottom"> <p>1,091</p> </td> </tr> <tr> <td width="67%" valign="bottom"> <p>Totalnon-current liabilities</p> </td> <td width="15%" valign="bottom"> <p>178</p> </td> <td width="0%" valign="bottom"> </td> <td width="15%" valign="bottom"> <p>288</p> </td> </tr> <tr> <td width="67%" valign="bottom"> <p>Totalliabilities</p> </td> <td width="15%" valign="bottom"> <p>1,289</p> </td> <td width="0%" valign="bottom"> </td> <td width="15%" valign="bottom"> <p>1,379</p> </td> </tr> <tr> <td width="67%" valign="bottom"> <p>Totalshareholders' equity</p> </td> <td width="15%" valign="bottom"> <p>6,452</p> </td> <td width="0%" valign="bottom"> </td> <td width="15%" valign="bottom"> <p>10,386</p> </td> </tr> <tr> <td width="67%" valign="bottom"> </td> <td width="15%" valign="bottom"> </td> <td width="0%" valign="bottom"> </td> <td width="15%" valign="bottom"> </td> </tr> <tr> <td width="67%" valign="bottom"> <p>Totalliabilities and shareholders' equity</p> </td> <td width="15%" valign="bottom"> <p>7,741</p> </td> <td width="0%" valign="bottom"> </td> <td width="15%" valign="bottom"> <p>11,765</p> </td> </tr> </tbody> </table> <table border="0" cellspacing="0" cellpadding="0"> <tbody> <tr> <td colspan="4" width="100%" valign="bottom"> </td> </tr> <tr> <td colspan="4" width="100%" valign="bottom"> <p align="center">ENTERA BIO LTD.<br /> CONSOLIDATED STATEMENTS OF OPERATIONS<br /> (U.S. dollars in thousands, except share and per share data)<br /> <br /> (Unaudited)</p> </td> </tr> <tr> <td colspan="4" width="100%" valign="bottom"> </td> </tr> <tr> <td width="67%" valign="bottom"> </td> <td colspan="3" width="32%" valign="bottom"> <p>ThreeMonths Ended<br /> September 30,</p> </td> </tr> <tr> <td width="67%" valign="bottom"> </td> <td width="15%" valign="bottom"> <p>2024</p> </td> <td width="0%" valign="bottom"> </td> <td width="15%" valign="bottom"> <p>2023</p> </td> </tr> <tr> <td width="67%" valign="bottom"> <p>REVENUES</p> </td> <td width="15%" valign="bottom"> <p>42</p> </td> <td width="0%" valign="bottom"> </td> <td width="15%" valign="bottom"> <p>-</p> </td> </tr> <tr> <td width="67%" valign="bottom"> <p>COSTOF REVENUES</p> </td> <td width="15%" valign="bottom"> <p>42</p> </td> <td width="0%" valign="bottom"> </td> <td width="15%" valign="bottom"> <p>-</p> </td> </tr> <tr> <td width="67%" valign="bottom"> <p>GROSSPROFIT</p> </td> <td width="15%" valign="bottom"> <p>-</p> </td> <td width="0%" valign="bottom"> </td> <td width="15%" valign="bottom"> <p>-</p> </td> </tr> <tr> <td width="67%" valign="bottom"> <p>OPERATINGEXPENSES:</p> </td> <td width="15%" valign="bottom"> </td> <td width="0%" valign="bottom"> </td> <td width="15%" valign="bottom"> </td> </tr> <tr> <td width="67%" valign="bottom"> <p>Researchand development</p> </td> <td width="15%" valign="bottom"> <p>1,477</p> </td> <td width="0%" valign="bottom"> </td> <td width="15%" valign="bottom"> <p>1,370</p> </td> </tr> <tr> <td width="67%" valign="bottom"> <p>Generaland administrative</p> </td> <td width="15%" valign="bottom"> <p>1,544</p> </td> <td width="0%" valign="bottom"> </td> <td width="15%" valign="bottom"> <p>1,028</p> </td> </tr> <tr> <td width="67%" valign="bottom"> <p>Otherincome</p> </td> <td width="15%" valign="bottom"> <p>-</p> </td> <td width="0%" valign="bottom"> </td> <td width="15%" valign="bottom"> <p>(12)</p> </td> </tr> <tr> <td width="67%" valign="bottom"> <p>TOTALOPERATING EXPENSES</p> </td> <td width="15%" valign="bottom"> <p>3,021</p> </td> <td width="0%" valign="bottom"> </td> <td width="15%" valign="bottom"> <p>2,386</p> </td> </tr> <tr> <td width="67%" valign="bottom"> <p>OPERATINGLOSS</p> </td> <td width="15%" valign="bottom"> <p>3,021</p> </td> <td width="0%" valign="bottom"> </td> <td width="15%" valign="bottom"> <p>2,386</p> </td> </tr> <tr> <td width="67%" valign="bottom"> <p>FINANCIALINCOME, NET</p> </td> <td width="15%" valign="bottom"> <p>-</p> </td> <td width="0%" valign="bottom"> </td> <td width="15%" valign="bottom"> <p>(36)</p> </td> </tr> <tr> <td width="67%" valign="bottom"> <p>INCOMETAX</p> </td> <td width="15%" valign="bottom"> <p>-</p> </td> <td width="0%" valign="bottom"> </td> <td width="15%" valign="bottom"> <p>29</p> </td> </tr> <tr> <td width="67%" valign="bottom"> <p>NETLOSS</p> </td> <td width="15%" valign="bottom"> <p>3,021</p> </td> <td width="0%" valign="bottom"> </td> <td width="15%" valign="bottom"> <p>2,379</p> </td> </tr> <tr> <td width="67%" valign="bottom"> </td> <td width="15%" valign="bottom"> </td> <td width="0%" valign="bottom"> </td> <td width="15%" valign="bottom"> </td> </tr> <tr> <td width="67%" valign="bottom"> <p>LOSSPER SHARE BASIC AND DILUTED</p> </td> <td width="15%" valign="bottom"> <p>0.08</p> </td> <td width="0%" valign="bottom"> </td> <td width="15%" valign="bottom"> <p>0.08</p> </td> </tr> <tr> <td width="67%" valign="bottom"> </td> <td width="15%" valign="bottom"> </td> <td width="0%" valign="bottom"> </td> <td width="15%" valign="bottom"> </td> </tr> <tr> <td width="67%" valign="bottom"> <p>WEIGHTEDAVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTEDLOSS PER SHARE</p> </td> <td width="15%" valign="bottom"> <p>37,644,612</p> </td> <td width="0%" valign="bottom"> </td> <td width="15%" valign="bottom"> <p>28,813,952</p> </td> </tr> <tr> <td width="67%" valign="bottom"> </td> <td width="15%" valign="bottom"> </td> <td width="0%" valign="bottom"> </td> <td width="15%" valign="bottom"> </td> </tr> </tbody> </table> <p>Contact:</p> <p>Entera Bio:</p> <p>Ms. Miranda Toledano</p> <p>Chief Executive Officer</p> <p>Entera Bio</p> <p>miranda@enterabio.com</p> <p>*** הידיעה מופצת בעולם על ידי חברת התקשורת הבינלאומית GlobeNewswire </p> <br/><br/> <strong><u>פרטים אודות כותב המאמר</u></strong> <br/> <p><strong>חיים נוי, עיתונאי, עורך ראשי של סוכנות החדשות הבינ"ל IPA, לשעבר עורך ראשי של סוכנות הידיעות עתים, חבר תא מבקרי התיאטרון באגודת העיתונאים</strong></p> <br/><a href="http://www.portal-asakim.com"> מקור המאמר: אתר מאמרים עסקיים ומקצועיים</a>

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אנטרה ביו מדווחת על תוצאותיה הכספיות לרבעון השלישי של שנת 2024 ומספקת עדכונים עסקיים אנטרה ביו מדווחת על תוצאותיה הכספיות לרבעון השלישי של שנת 2024 ומספקת עדכונים עסקיים ירושלים, 8 בנובמבר 2024, (GLOBE NEWSWIRE) – אנטרה ביוEntera Bio Ltd.(נאסד"ק: ENTX), מובילה בפיתוח פפטידים וחלבונים טיפוליים הניתנים דרך הפה, דיווחה היום על תוצאותיה הכספיות ועדכונים עסקיים מרכזיים לרבעון שהסתיים ביום 30 בספטמבר 2024. Entera Bio Reports Q3 2024 Financial Results and Provides Business Updates JERUSALEM, Nov. 08, 2024 (GLOBE NEWSWIRE) – Entera Bio Ltd. (NASDAQ: ENTX), ("Entera" or the "Company") a leader in the development of oral peptides and small therapeutic proteins, today reported financial results and key business updates for the quarter ended September 30, 2024. "The third quarter of 2024 drew consistent attention to our pivotal-staged clinical asset, EB613, the first oral PTH(1-34) tablet treatment dedicated to post-menopausal women with high risk osteoporosis. Entera’s proprietary N-Tab™ platform consistently delivered across our oral GLP-2 tablet, oral GLP-1/Glucagon tablet and confidential hypoparathyroidism tablet program. Finally, we are humbled by key additions from around the world to our clinical and scientific advisory board which we view as testament to what we are aspiring to build at Entera," said Miranda Toledano, Chief Executive Officer of Entera. Ms. Toledano continued, "We are headed into a busy year end across all programs and keenly anticipating FDA’s potential landmark ruling on the ASBMR-FNIH SABRE regulatory endpoint for osteoporosis drugs, expected in January 2025. Current regulatory guidelines requiring fracture outcomes have curtailed innovation in the treatment of this significant disease due to ethical, time and sizing of studies required to evaluate new treatments. The SABRE work is based on a statistical meta-analysis of over 170,000 patients across 53 randomized clinical studies and 7 osteoporosis drug classes correlating total hip Bone Mineral Density (BMD) to fracture outcomes. We believe that our pivotal program for EB613 is first in line to leverage this pathway. Our recent discussions with patients, regulatory agencies, clinicians and fellow industry colleagues acknowledge the need for new treatments for osteoporosis and, especially, oral anabolic therapy. Osteoporosis is one of the foremost underserved women’s health issues globally, where fracture rates continue to rise and where, despite medical guidelines, efficacious injectable anabolics are used in a minority of patients worldwide. We are developing EB613 to help close this treatment gap." Q3 2024 Updates: EB613: First Oral PTH(1-34) Anabolic Tablet Treatment for Women with Osteoporosis In September 2024,new comparative pharmacological data for EB613 was presented at theAmerican Society for Bone Mineral Research September 2024 (ASBMR 2024) AnnualMeeting in Toronto. The abstract was previewed by Dr. Serge Ferrari ofGeneva University Hospital in Switzerland in his sneak-peak highlights ofcutting-edge clinical abstracts on osteoporosis therapy at ASBMR2024. First GLP-1/Glucagon Agonist (Oxyntomodulin) Peptide Tablets for Obesity In September 2024,Entera and OPKO Health, Inc. ("OPKO"; Nasdaq: OPK), jointly announcedtopline pharmacokinetic/ pharmacodynamic (PK/PD) results for the oraloxyntomodulin (OXM) tablet program. The program is focused on developingthe first oral dual agonist GLP-1/glucagon peptide as a potentialonce-daily treatment for patients with obesity and metabolic disordersusing Entera’s proprietary N-Tab™ platform. Oral OXM exhibited significantsystemic exposure across two in vivo models, a favorablePK profile and bioavailability. The high plasma concentrations withprolonged systemic exposure were consistent with the reported half-lifefor semaglutide (Rybelsus®), the only approved oral GLP-1 analog. Oral OXMshowed a statistically significant reduction in plasma glucose levelscompared with placebo. Entera plans to present this data together withOPKO at an upcoming clinical conference. First GLP-2 Peptide Tablets for Short Bowel Syndrome Entera continuespre-IND validation of its oral GLP-2 tablet in partnership with OPKO.Final in vivo PK/PD data is expected in the second halfof 2024. This program is being developed as the first potential tabletGLP-2 replacement therapy for patients suffering with Short BowelSyndrome, a rare and devastating intestinal failure condition. The programmay also provide value to other critical conditions of GI inflammation,which is being explored with external parties. EB612: First Oral PTH(1-34) Peptide Replacement Therapy Tablets for Hypoparathyroidism Entera continuesto collaborate productively with a third party on the oral tabletdevelopment of another PTH replacement treatment for hypoparathyroidism. Financial Results for the Quarter Ended September 30, 2024 As of September 30,2024, Entera had cash and cash equivalents of $6.9 million. The Company expects that its existing cash resources are sufficient to meet its projected operating requirements into the third quarter of 2025. Research and development expenses for the three months ended September 30, 2024 were $1.5 million, as compared to $1.4 million for the three months ended September 30, 2023. The increase of $0.1 million was primarily due to an increase of $0.5 million in materials required in connection with the optimization processes related to the preparation of the EB613 phase 3 study. The increase was partially offset by a decrease of $0.4 million related to a completed Phase 1 PK, which occurred in 2023. General and administrative expenses for the three months ended September 30, 2024 were $1.5 million, as compared to $1.0 million for the three months ended September 30, 2023. The increase of $0.5 million was mainly attributable to increases in intellectual property expenses, consultancy fees and share-based compensation. Operating expenses for the period ended September 30, 2024 were $3.0 million, as compared to $2.4 million for the quarter ended September 30, 2023. Net loss was $3.0 million, or $0.08 per ordinary share (basic and diluted), for the quarter ended September 30, 2024, as compared to $2.4 million, or $0.08 per ordinary share (basic and diluted), for the quarter ended September 30, 2023. 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 a disruptive and proprietary technology platform (N-Tab™) and its pipeline includes five differentiated, first-in-class oral peptide programs, expected to enter the clinic (Phase 1 to Phase 3) by 2025. The Company’s most advanced product candidate, EB613 (oral PTH (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. A placebo controlled, dose ranging Phase 2 study of EB613 tablets (n=161) met primary (PD/bone turnover biomarker) and secondary (BMD) endpoints. 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 by January 2025. The EB612 program is being developed as the first oral PTH (1-34) tablet peptide replacement therapy for hypoparathyroidism. In collaboration with OPKO Health, Entera is also developing the first oral oxyntomodulin, a dual targeted GLP-1/glucagon peptide, in tablet form for the treatment of obesity; and the first oral GLP-2 peptide tablet as an injection-free alternative for patients suffering from rare malabsorption conditions such as short bowel syndrome. For more information, visit www.enterabio.com or follow us on LinkedIn, X (formerly Twitter), Facebook and Instagram. ENTERA BIO LTD. CONSOLIDATED BALANCE SHEETS (U.S. dollars in thousands) September30, December31, 2024 2023 (Unaudited) (Audited) Cashand cash equivalents 6,915 11,019 Accountsreceivable and other current assets 425 238 Propertyand equipment, net 65 100 Otherassets, net 336 408 Totalassets 7,741 11,765 Accountspayable and other current liabilities 1,111 1,091 Totalnon-current liabilities 178 288 Totalliabilities 1,289 1,379 Totalshareholders' equity 6,452 10,386 Totalliabilities and shareholders' equity 7,741 11,765 ENTERA BIO LTD. CONSOLIDATED STATEMENTS OF OPERATIONS (U.S. dollars in thousands, except share and per share data) (Unaudited) ThreeMonths Ended September 30, 2024 2023 REVENUES 42 - COSTOF REVENUES 42 - GROSSPROFIT - - OPERATINGEXPENSES: Researchand development 1,477 1,370 Generaland administrative 1,544 1,028 Otherincome - (12) TOTALOPERATING EXPENSES 3,021 2,386 OPERATINGLOSS 3,021 2,386 FINANCIALINCOME, NET - (36) INCOMETAX - 29 NETLOSS 3,021 2,379 LOSSPER SHARE BASIC AND DILUTED 0.08 0.08 WEIGHTEDAVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTEDLOSS PER SHARE 37,644,612 28,813,952 Contact: Entera Bio: Ms. Miranda Toledano Chief Executive Officer Entera Bio miranda@enterabio.com *** הידיעה מופצת בעולם על ידי חברת התקשורת הבינלאומית GlobeNewswire נכתב על ידי חיים נוי, עיתונאי, עורך ראשי של סוכנות החדשות הבינ"ל IPA, לשעבר עורך ראשי של סוכנות הידיעות עתים, חבר תא מבקרי התיאטרון באגודת העיתונאים מקור המאמר:אתר מאמרים עסקיים ומקצועיים http://www.portal-asakim.com
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