Entera Bio Ltd. Ordinary Shares - ENTX STOCK NEWS

Entera Bio Ltd. (NASDAQ: ENTX) announced its financial results for Q3 2021, revealing revenues of $406,000, significantly up from $144,000 in Q3 2020. The Phase 2 clinical trial for EB613 showed promising results in increasing bone mineral density in osteoporosis patients, leading to plans for a Phase 3 trial in 2022. The company has a strong cash position of $27.4 million, which supports its operations through Q4 2022. Additionally, operating expenses decreased, but the net comprehensive loss widened to $17.1 million, up from $7.7 million in the same period last year.

Entera Bio Ltd. (NASDAQ: ENTX) announced promising results from preclinical in vivo studies showcasing its proprietary oral delivery technology, which demonstrates enhanced absorption for large biologic drugs. This technology underpins Entera's lead product, EB613, currently in Phase 3 clinical development for osteoporosis, with a pivotal study set for 2022. Researchers reported a significant increase in blood PTH levels using a dual mechanism combining protease inhibitors and permeation enhancers, making oral dosing a viable alternative to injections, which may improve patient compliance and treatment outcomes.

Entera Bio Ltd. (NASDAQ: ENTX) announced positive results from its completed Phase 2 trial of EB613, an oral formulation of human parathyroid hormone (PTH) aimed at treating osteoporosis. Key findings showed a significant placebo-adjusted increase of 3.78% in lumbar spine bone mineral density (BMD) after six months of treatment with the 2.5 mg dosage. Additionally, increases in BMD at the femoral neck and total hip were noted. The pivotal Phase 3 registration study is expected to commence in 2022. The safety profile was consistent with injectable PTH, with no serious adverse events reported.

Entera Bio Ltd. (NASDAQ: ENTX) announced its selection for a late-breaking oral presentation at the ASBMR Annual Meeting, showcasing results from its Phase 2 study on EB613 for treating osteoporosis in postmenopausal women. The presentation will highlight the 6-month bone mineral density (BMD) results, confirming dose-related efficacy. Scheduled for October 4, 2021, this position aims to attract interest from potential clinical investigators and prescribers. Entera is gearing up for a pivotal Phase 3 study, as CEO Spiros Jamas noted positive peer reviews enhancing the presentation's significance.

On August 23, 2021, Entera Bio Ltd. (NASDAQ: ENTX) announced its upcoming annual shareholders meeting scheduled for October 4, 2021. Entera is focused on developing orally delivered large molecule therapeutics to address unmet medical needs in areas where injectable therapies face adoption challenges. Its leading candidates, EB613 for osteoporosis and EB612 for hypoparathyroidism, are currently in clinical development. The company also collaborates with Amgen Inc. to leverage its proprietary oral delivery technology.

Entera Bio Ltd. (NASDAQ: ENTX) announced that CEO Spiros Jamas will present at the H.C. Wainwright 23rd Annual Global Investment Conference on September 13, 2021, at 3:30 pm ET. The conference runs from September 13-15, 2021, in New York. Entera focuses on innovative oral delivery systems for large molecule therapeutics, addressing significant unmet medical needs. Their lead candidates include EB613 for osteoporosis and EB612 for hypoparathyroidism, currently in clinical development. The company also collaborates with biopharma firms, including Amgen.

Entera Bio Ltd. (NASDAQ: ENTX) announced positive results from its Phase 2 clinical trial of EB613, an oral therapy for osteoporosis, achieving primary and key secondary endpoints. The trial demonstrated a 3.78% increase in lumbar spine bone mineral density after six months. The company is preparing for an End of Phase 2 meeting with the FDA to advance to a pivotal Phase 3 study, expected to start in Q2 2022. Financially, Entera reported $266,000 in revenue for the first half of 2021, with a net comprehensive loss of $14.6 million, or $0.63 per share.

Entera Bio Ltd. (NASDAQ: ENTX) will report its business and financial results for Q2 2021 on August 16, 2021, at 6:30 AM ET. A conference call led by management will follow at 8:30 AM EDT, allowing stakeholders to engage in a Q&A session. Entera is focused on developing orally delivered large molecule therapeutics, particularly EB613 for osteoporosis and EB612 for hypoparathyroidism, which are currently in clinical development. The company has completed a phase 2 study for EB613 and collaborates with Amgen for technology licensing.

Entera Bio Ltd. (NASDAQ: ENTX) announced that its Phase 2 clinical trial for oral EB613, aimed at treating osteoporosis, met its primary endpoint by significantly increasing P1NP, a bone formation marker, at three months. This positions EB613 as a potential first oral anabolic agent for osteoporosis, addressing the unmet need for injectable alternatives like Forteo®. Full three-month data will be presented at the ASBMR Annual Meeting in October. Entera plans to initiate a pivotal Phase 3 trial against Forteo in 2022, highlighting the promising outlook for EB613.