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

ירושלים, 9 באוגוסט 2024 (GLOBE NEWSWIRE) –

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 ביוני 2024.

"אנו ממשיכים לספק ביצועים חזקים עם ציוני דרך מרכזיים שהושגו במהלך הרבעון השני של 2024 בכל אחת מתוכניות N-Tab™ oral peptideשלנו המוקדשות לחולים עם OBGYN/אנדוקרינולוגיה, GI ומחלות מטבוליות", אמרה מירנדה טולדנו, מנכ"לית אנטרה. "חשוב לציין, אנו נמצאים כעת במרחק של חמישה חודשים בלבד מהפסיקה הפוטנציאלית פורצת הדרך של ה- FDA לגבי נקודת הקצה הרגולטורית ASBMR-FNIH SABRE עבור תרופות לאוסטאופורוזיס, שאנו רואים בהן זרז עיקרי עבור EB613. אנו להוטים במיוחד להתחיל את המחקר המרכזי שלנו על EB613 באוכלוסייה רחבה הרבה יותר שבה תרופות אנבוליות בהזרקה אינן ממלאות תפקיד דומיננטי. בגלל מנגנון הפעולה הכפול הפוטנציאלי שלו, תחילת פעולה מהירה יותר לצורך חיזוק אנבולי ופורמט מיני-טבליות אוראלי, אנו מאמינים כי EB613 ממוקם באופן ייחודי לתמיכה בהתערבות אוסטאואנאבולית מוקדמת יותר בנשים לאחר גיל המעבר בסיכון גבוה לשברים", הוסיפה.

Entera Bio Reports Q2 2024 Financial Results and Provides Business Updates

JERUSALEM, Aug. 09, 2024 (GLOBE NEWSWIRE) –

Entera Bio Ltd. (NASDAQ: ENTX), (“Entera” or the “Company”) a leader in the development of orally delivered peptides and small therapeutic proteins, today reported financial results and key business updates for the quarter ended June 30, 2024.

“We continue to deliver strong execution with key milestones achieved during the second quarter of 2024 across each of our N-Tab™ oral peptide programs dedicated to patients with OBGYN/endocrinology, GI and metabolic diseases,” said Miranda Toledano, Entera’s CEO. “Importantly, we are now just five months away from FDA’s potential landmark ruling on the ASBMR-FNIH SABRE regulatory endpoint for osteoporosis drugs, which we view as a major catalyst for EB613. We are especially keen to start our pivotal study of EB613 in a much wider population where injectable anabolic drugs do not play a dominant role. Because of its potential dual mechanism of action, faster onset of action as an anabolic boosting agent and oral minitablet format, we believe EB613 is uniquely positioned to support earlier osteoanabolic intervention in post-menopausal women at high risk of fracture,” she added.

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

• In April 2024, theJournal of Bone and Mineral Research (JBMR) published “Oral dailyPTH(1-34) Tablets [EB613] in Postmenopausal Women with Low BMD orOsteoporosis: A Randomized, Placebo-Controlled, 6-Month, Phase 2 Study”
• In May 2024,Entera welcomed Dr. Rachel Wagman as Key Clinical Advisor to lead EB613clinical development. Wagman has successfully advanced the development offive molecules, including the osteoporosis products Forteo®, Prolia® andEvenity® through registration
• In June 2024, theJMBR published an independent editorial titled “A Novel Oral hPTH(1-34)[EB613] Unveils the Promise of Modeling-Based Anabolism with No Increasein Bone Remodeling”
• In July 2024,Entera announced that new comparative pharmacological data for itsinvestigational agent EB613 vs. Forteo® was selected forpresentation at the ASBMR September 2024 Annual Meeting in Toronto
• In July 2024,Entera announced that the SABRE (Study to Advance BMD as a RegulatoryEndpoint) is expected to provide an update at the ASBMR September 2024Annual Meeting in Toronto

EB612: First Oral PTH(1-34) Peptide Replacement Therapy Tablets for Hypoparathyroidism

• In June 2024,Entera presented Phase 1 clinical data for its hypoparathyroidism focusedinvestigational program, EB612, at the Endocrine Society ENDO 2024 AnnualMeeting. Entera showed that the data supports potentially moving the BID(twice-daily) tablet dose to Phase 2 development in patients withhypoparathyroidism
• Entera continuesto collaborate with a third party on the development of another PTHreplacement treatment for hypoparathyroidism

First GLP-2 Peptide Tablets for Short Bowel Syndrome

• In March 2024,Entera announced positive in vivo PK results from its program combiningOPKO Health, Inc.’s (Nasdaq: OPK) long acting GLP-2 analogue with N-Tab™technology. Pharmacology data is expected early in the second half of 2024

First GLP-1/Glucagon Agonist (Oxyntomodulin) Peptide Tablets for Obesity

• Collaborative workis ongoing combining N-Tab™ with OPKO’s long-acting Oxyntomodulin (OXM)analogues for potential treatment for obesity and other metabolicdiseases. PK data for the oral OXM tablet are expected early in the secondhalf of 2024

Financial Results for the Quarter Ended June 30, 2024

As of June 30,2024, Entera had cash and cash equivalents of $9.1 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 June 30, 2024 were $1.1 million, as compared to $1.2 million for the three months ended June 30, 2023. The decrease of $0.1 million was primarily due to a decrease of $0.3 million in clinical expenses for our Phase 1 PK study related to our new generation platform and new formulations for EB612, which completed its first stage in 2023.

General and administrative expenses for both the three months ended June 30, 2024 and 2023 were $1.1 million.

Operating expenses for the period ended June 30, 2024 were $2.2 million, as compared to $2.3 million for the quarter ended June 30, 2023.

Net loss was $2.1 million, or $0.06 per ordinary share (basic and diluted), for the quarter ended June 30, 2024, as compared to $2.3 million, or $0.08 per ordinary share (basic and diluted), for the quarter ended June 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 on 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, 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 by January 2025. 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.

Contact:

Entera Bio:

Ms. Miranda Toledano

Chief Executive Officer

Entera Bio

Email: [email protected]

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