Entera Bio Ltd. Ordinary Shares - ENTX STOCK NEWS

Entera Bio (NASDAQ: ENTX) and OPKO Health, Inc. (NASDAQ: OPK) have announced positive results from their collaborative research on an oral oxyntomodulin (OXM) peptide tablet for obesity and metabolic disorders. The study, combining OPKO's proprietary long-acting OXM analog with Entera's N-Tab™ technology, aims to develop the first oral dual agonist GLP-1/glucagon peptide for once-daily treatment.

Key findings from the in vivo proof-of-concept PK/PD studies in rodent and pig models include:

• Significant systemic exposure following a single dose
• Favorable PK profile and bioavailability
• High plasma concentrations with prolonged systemic exposure in pigs
• Statistically significant reduction in plasma glucose levels in rats

The companies plan to present these data at an upcoming clinical conference and move towards IND-enabling efforts for the program.

Entera Bio (NASDAQ: ENTX), a leader in developing orally delivered peptides and small therapeutic proteins, has announced its participation in three upcoming conferences:

1. H.C. Wainwright 26th Annual Global Investment Conference: Virtual presentation on September 9, 2024, at 7am ET.

2. American Society for Bone and Mineral Research 2024 Annual Meeting: In-person poster presentation on September 28, 2024, from 2:15 – 3:45PM in Toronto, Canada.

3. 7th Annual Evercore ISI HealthCONx Conference: In-person fireside chat on December 4, 2024, from 3:25-3:45PM in Coral Gables, Florida.

These conferences provide Entera Bio with opportunities to showcase its developments and engage with investors and scientific communities.

Entera Bio (NASDAQ: ENTX) reported Q2 2024 financial results and provided business updates. Key highlights include:

1. Advancing EB613, the first oral PTH(1-34) daily osteoanabolic tablets for osteoporosis, with new comparative data vs. Forteo® to be presented at ASBMR 2024.

2. Progress on EB612, the first oral PTH(1-34) peptide replacement therapy for hypoparathyroidism, with Phase 1 data supporting potential Phase 2 development.

3. Positive in vivo PK results for GLP-2 peptide tablets for short bowel syndrome, with pharmacology data expected in H2 2024.

4. Ongoing development of GLP-1/Glucagon agonist tablets for obesity, with PK data expected in H2 2024.

5. Financial results: $9.1M cash on hand, sufficient until Q3 2025. Q2 2024 net loss of $2.1M ($0.06 per share) compared to $2.3M ($0.08 per share) in Q2 2023.

Entera Bio (NASDAQ: ENTX) announced that new comparative pharmacological data for its investigational agent EB613 vs. Forteo® will be presented at the American Society for Bone and Mineral Research (ASBMR) 2024 Annual Meeting. EB613 is being developed as the first once-daily oral anabolic PTH(1-34) mini tablet therapy for post-menopausal women with high-risk osteoporosis.

The company aims to address the treatment gap in current osteoporosis care, targeting the estimated 200 million women globally affected by post-menopausal osteoporosis. Entera also anticipates a key update from the SABRE (Study to Advance BMD as a Regulatory Endpoint) project at the meeting, following the FDA's communication about qualifying bone mineral density (BMD) as a surrogate endpoint for fractures in future osteoporosis drug trials.

Entera Bio announced promising Phase 1 clinical data for its oral PTH(1-34) peptide candidate, EB612, aimed at treating hypoparathyroidism. Presented at the ENDO 2024 Annual Meeting, the study showcased significant systemic exposure and sustained pharmacodynamic effects, including improved serum levels of calcium, phosphate, and Vitamin D. The treatment showed a favorable safety profile, with no serious adverse events reported and only minor side effects such as mild headaches in two subjects. The findings suggest that EB612, administered twice daily, could be a viable alternative to current injectable therapies.

Entera Bio (NASDAQ: ENTX) has announced the appointment of Dr. Rachel B Wagman as Key Clinical Advisor and Member of its Scientific Advisory Board. Dr. Wagman brings over 20 years of experience in metabolic bone disease and women's health research, including the successful development of five molecules such as teriparatide (Forteo®), denosumab (Prolia®), and romosozumab (Evenity®). Her appointment is expected to enhance Entera's oral peptide pipeline focused on chronic metabolic disorders. CEO Miranda Toledano highlighted Dr. Wagman's patient-focused approach and therapeutic specializations. Dr. Wagman expressed her commitment to innovative treatments, particularly in osteoporosis. Her past roles include senior positions at Eli Lilly, Amgen, and Myovant Sciences.

Entera Bio (NASDAQ: ENTX) will present Phase 1 data on their investigational program EB612 at the ENDO 2024 Annual Meeting. EB612 aims to provide an oral PTH(1-34) tablet peptide replacement therapy for hypoparathyroidism. The study focuses on reducing daily administration frequency by using Entera's N-Tab™ technology platform.

Entera Bio reported its Q1 2024 financial results, highlighting a strong start due to its growth strategy in 2023. The company expanded its N-Tab™ therapeutic pipeline with potential first-in-class oral peptide treatments for various disorders. Entera is focused on becoming a premier oral peptide therapeutic company. Key updates include EB613 for osteoporosis, EB612 for hypoparathyroidism, and first GLP-2, GLP-1/glucagon tablets for Short Bowel Syndrome and obesity.

EB613 is the first oral PTH(1-34) daily osteoanabolic tablet for osteoporosis. EB612 is the first oral PTH(1-34) replacement therapy tablet for hypoparathyroidism. Positive in vivo PK results were announced for the oral GLP-2 tablet for Short Bowel Syndrome. Collaborative work for GLP-1/glucagon agonist tablets for obesity is ongoing. Entera also plans to use oral PTH(1-34) tablets to treat intense sport and military stress injuries.

Financially, Entera had $9.2 million in cash and cash equivalents as of March 31, 2024, with projected cash resources expected to meet operating requirements into the third quarter of 2025. Research and development expenses decreased slightly, while general and administrative expenses remained stable. The company reported a net loss of $2.0 million for the quarter.