ENTX

Company Achievements: Entera Bio Ltd. reported significant advancements in 2024, including the development of oral peptide therapies for osteoporosis and obesity, with plans to initiate a Phase 3 study for their lead candidate EB613, an oral PTH(1-34) treatment for women with osteoporosis.

Financial Overview: The company ended 2024 with $8.7 million in cash, which increased to $21 million by March 2025, allowing them to fund ongoing operations and clinical studies, despite reporting a net loss of $9.5 million for the year.

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Collaboration Announcement: OPKO Health and Entera Bio have entered a collaboration to develop the first oral dual agonist GLP-1/glucagon peptide for treating obesity and metabolic disorders, with plans to file an Investigational New Drug application with the FDA later this year.

Ownership and Funding Structure: Under the agreement, OPKO will hold a 60% ownership interest and Entera 40%, with OPKO purchasing shares from Entera to fund its share of development costs; Entera can opt-out after Phase 1, retaining a smaller ownership stake.

Company Participation in Conferences: Entera Bio Ltd. will participate in several upcoming conferences, including the Leerink Partners Global Healthcare Conference, the World Congress on Osteoporosis, and the BIO International Convention, showcasing their advancements in oral peptide and protein replacement therapies.

Product Development and Clinical Trials: Entera is focused on developing innovative oral treatments for conditions such as osteoporosis and hypoparathyroidism, with their lead candidate EB613 showing promising results in Phase 2 trials and plans for a Phase 3 study pending FDA qualification.

Entera Bio's Quarterly Performance: Entera Bio Ltd. reported a quarterly loss of $0.08 per share, missing the Zacks Consensus Estimate of a loss of $0.05, while revenues reached $0.04 million, surpassing expectations and showing growth from zero revenues a year ago.

Market Outlook and Comparisons: Despite the earnings miss, Entera Bio shares have risen 191.7% this year, outperforming the S&P 500; however, the stock holds a Zacks Rank #3 (Hold), indicating expected performance in line with the market, as investors await further revisions on earnings estimates.

Financial Results and Business Updates: Entera Bio Ltd. reported a net loss of $3 million for Q3 2024, with cash reserves of $6.9 million expected to last until Q3 2025. The company is advancing its oral peptide therapies, particularly EB613 for osteoporosis, and anticipates a significant FDA ruling in January 2025.

Clinical Developments: Entera is developing several innovative oral treatments, including the first oral PTH(1-34) tablet for osteoporosis, an oral GLP-1/glucagon dual agonist for obesity, and a GLP-2 tablet for short bowel syndrome, aiming to address significant unmet medical needs in women's health and metabolic disorders.

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Positive Research Results: Entera Bio Ltd. and OPKO Health, Inc. announced successful pharmacokinetic/pharmacodynamic results for their oral dual agonist GLP-1/glucagon peptide aimed at treating obesity and metabolic disorders, with significant weight loss effects observed in studies.

Market Impact: Following the announcement, shares of ENTX and OPK experienced slight declines, but both companies have seen substantial stock gains over the past six months, contrasting with a general industry decline.

Positive Study Results: Entera Bio Ltd. and Opko Health Inc. reported promising pharmacokinetic and pharmacodynamic results from their study of oral Oxyntomodulin (OXM), which may serve as a treatment for obesity and metabolic disorders, showing significant effects in rodent and pig models.

Market Reaction: Despite the positive findings, Entera's stock fell by 3.06% to $1.90 on the Nasdaq following the announcement.

Collaboration Announcement: Entera Bio and OPKO Health have reported positive pharmacokinetic/pharmacodynamic results from their collaboration on an oral dual agonist GLP-1/glucagon peptide, aimed at treating obesity and metabolic disorders.

Clinical Development Plans: The companies plan to present their findings at a clinical conference and are progressing towards IND-enabling efforts for the oral oxyntomodulin program, which could transform treatment options in this area.

Financial Performance and Updates: Entera Bio Ltd. reported a net loss of $2.1 million for the quarter ending June 30, 2024, with cash reserves of $9.1 million expected to last into Q3 2025. The company is advancing its oral peptide programs, particularly EB613 for osteoporosis, and preparing for a pivotal study pending FDA approval.

Product Development Highlights: Entera is progressing with multiple oral peptide therapies, including EB612 for hypoparathyroidism and GLP-2/GLP-1 analogues for short bowel syndrome and obesity, with significant clinical milestones anticipated in the coming months.

Entera Bio's New Treatment Announcement: Entera Bio Ltd. announced that its investigational oral agent EB613 for treating post-menopausal osteoporosis will be presented at the ASBMR 2024 Annual Meeting, highlighting its potential as a once-daily tablet therapy compared to injectable treatments.

Clinical Development and FDA Interaction: The company is preparing for a Phase 3 study of EB613, aiming to meet FDA guidelines regarding bone mineral density as a regulatory endpoint, with results from prior studies showing promising outcomes for patients at high risk of fractures.

Entera Bio's New Treatment: Entera Bio Ltd. announced that its investigational oral agent EB613, aimed at treating post-menopausal women with high-risk osteoporosis, will be presented at the ASBMR 2024 Annual Meeting. This treatment is designed as a once-daily tablet to address the limitations of current injectable therapies.

FDA and Clinical Trials Update: The company is preparing for a Phase 3 study of EB613, pending FDA qualification of bone mineral density as a surrogate endpoint for fractures, which is expected by January 2025.

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Entera Bio (ENTX):

• Entera Bio, a biotech company, focuses on orally delivered therapeutic proteins and has surged 150% in the last year.
• With promising pipeline candidates targeting osteoporosis and hypoparathyroidism, ENTX stock may see substantial growth.
• The company's clinical trials' success could lead to a significant rally in the next few years.

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Entera Bio (ENTX):

• Entera Bio (NASDAQ:ENTX) is a clinical-stage biotech company focusing on orally delivered peptide and protein therapeutics.
• Their most advanced product candidate, EB613, targets post-menopausal osteoporosis, with potential blockbuster status as it enters phase three trials.
• Entera Bio has a cash runway through the first half of 2025, minimizing immediate equity dilution concerns, and multiple programs are expected to enter the clinical stage in 2025, providing a positive outlook for ENTX stock.