Entera Bio Ltd. announced data from the ongoing Phase 2 clinical trial of EB613 in osteoporosis patients. The study demonstrated statistically significant effects on the P1NP biomarker after one month of treatment (p(0.001) as compared to placebo, and meaningful increases at months two and three as compared to placebo with the higher EB613 dose (1.5 mg). There was also a dose response at one month, with those trends continuing at two months. The two lower doses (0.5 mg and 1.0 mg) demonstrated suboptimal increases and likely do not warrant further clinical advancement after the completion of this trial. The Company believes that the maximum efficacious dose has not yet been achieved and will continue the evaluation of the data from the existing patients including 6-month bone mineral density (BMD) results. Based on the favorable safety profile for patients on EB613 in the ongoing Phase 2 study, the Company intends to evaluate additional doses greater than 1.5mg to advance into a potential Phase 3 study, if appropriate. P1NP is an important biomarker of bone formation and in prior published studies of other osteoporosis products, was predictive of long-term improvements in bone mineral density, or BMD. Increases and maintenance of BMD are widely accepted by clinicians and regulatory agencies throughout the world as indicators of an overall improvement of the underlying disease. There were no serious product-related adverse events, and the overall safety profile of EB613 was favorable. The Phase 2 clinical trial of EB613, the Company's orally delivered parathyroid hormone 1-34, or PTH, is a dose-ranging, placebo-controlled, clinical trial in female patients with osteoporosis, or low BMD, and is being conducted at four leading medical centers in Israel. Patients were randomized to receive either a placebo or one of three doses of EB613, 0.5 mg, 1.0 mg, and 1.5 mg of PTH 1-34. The primary endpoint of the study is the change in P1NP from baseline during treatment with oral PTH doses at three months compared to the change from baseline with placebo. Secondary endpoints included change in bone mineral density (BMD), change in P1NP, serum CTX (a marker of bone resorption), and a variety of other measures at three and six months. The limited interim analysis of the changes in P1NP (and CTX) of the first 50% of the patients at three months was part of the trial design and prospectively planned in order to determine if maximal dosing had been achieved. Of the 80 patients that were enrolled, the results below are from the 72 patients that had completed their three-month treatment visits. The demographics for the EB613 Phase 2 clinical trial such as age, BMI and baseline levels of bone markers were generally consistent with demographics from studies in the literature.

The company is currently evaluating changes to its operating plan based on these data and expects an operating loss of approximately $10 million for the year ending December 31, 2020 subject to the impact of COVID-19 and the further evaluation of the Phase 2 EB613 results, and believes its current cash position will be sufficient to fund its operations into the second quarter of 2021.