Entera Bio Ltd Announces Operating and Financial Results for the Fourth Quarter and Year Ended December 31, 2020

‒ Achieved Primary Endpoint in EB613 Phase 2 Clinical Trial ‒
‒ Final Data, Including Bone Mineral Density, Expected in Q2:21 ‒
‒ FDA Approval of EB613 IND for the Treatment of Osteoporosis Enables Initial U.S. Clinical Trial ‒
‒ Amgen Collaboration Continues to Progress; Company Evaluating Additional Molecules, Including GLP-2, in Multiple Pre-clinical Studies ‒
‒ Company Strengthened Balance Sheet and Now Funded into the Second Quarter of 2022 ‒
‒ Company to Host Conference Call and Webcast Today at 8:30 a.m. ET ‒BOSTON and JERUSALEM, March 18, 2021 (GLOBE NEWSWIRE) — Entera Bio Ltd. (NASDAQ: ENTX), a leader in the development of orally delivered large molecule therapeutics, announced its financial and operating results for the quarter and year ended December 31, 2020 and provided an update on its clinical programs and pre-clinical programs.2020 and Recent HighlightsFDA Approval of EB613 IND and Completion of Enrollment in EB613 Phase 2 Clinical Trial in Israel: EB613, an orally delivered human parathyroid hormone (1-34) or PTH, drug candidate, is positioned to be the first oral bone building (osteoanabolic) treatment for osteoporosis. In December 2020, the U.S. Food and Drug Administration, or FDA, approved Entera’s Investigational New Drug, or IND, application for the initial US EB613 study in osteoporosis. Enrollment in the Phase 2 clinical trial in Israel was completed in November 2020 with 161 subjects. Assuming positive final results from this trial, Entera intends to meet with the FDA to discuss the design of a pivotal Phase 3 non-inferiority trial examining the increase in spine bone mineral density of EB613 compared to the increase observed with Forteo® (SC PTH 1-34) and confirm the potential for approval under the 505 (b)(2) regulatory pathway.
Positive Final 3-Month Biomarker Data from Phase 2 Trial of EB613 in Osteoporosis: The Phase 2 study’s efficacy endpoints include an evaluation of biomarker data after 3- and 6-months of treatment and bone mineral density data, or BMD, after 6 months of treatment. Interim 6-month BMD data reported in August 2020 indicate EB613 has a statistically significant positive impact on lumbar spine BMD in a dose dependent manner. In the recently completed 3-month biomarker data analyses, subjects in the 2.5 mg dose group had a significant increase in bone formation biomarkers P1NP (primary endpoint) and Osteocalcin, from baseline compared to placebo. Patients in the 2.5 mg dose group also had a significant reduction in CTX. Reduction in CTX, a bone resorption marker, is correlated with a reduction in the break down of bone and is an important factor for a potential increase in BMD. Taken together, these results are supportive of the osteoanabolic or bone building effects of EB613, and the potential of EB613 to produce meaningful significant increases in BMD at 6 months. Final data analyses including 6-month BMD data are expected the second quarter of 2021.Publication of Positive Data from EB612 Phase 2a Clinical Trial in Hypoparathyroidism (HypoPT): Results from a Phase 2a clinical trial were recently published in The Journal of Bone and Mineral Research in an article, titled “Safety and Efficacy of Oral Human Parathyroid Hormone (1-34) in Hypoparathyroidism: An Open-Label Study.” The Phase 2a study achieved its primary and secondary endpoints including a statistically significant decrease in supplemental calcium usage, maintenance of serum albumin-adjusted calcium and reduction of serum phosphate with the addition of EB612 to the standard of care. Entera is currently working on optimizing the formulation of EB612 and the design of a Phase 2b clinical trial which the Company expects to initiate in 2022.Initiation of Oral GLP–2 Program: Leveraging its large molecule oral delivery platform, Entera initiated a new research program for an oral glucagon-like peptide-2 (GLP-2) analog. The only GLP-2 analog currently on the market is a once-daily injection for the treatment of short bowel syndrome with reported global sales of $574 million in 2019. In preclinical models, Entera’s oral GLP-2 analog has shown a comparable pharmacokinetic profile to a subcutaneous injection. GLP-2 analogs, which improve intestinal absorption of nutrients and fluids, have the potential to emerge as a new class of drugs to treat a broad range of gastrointestinal and metabolic diseases. Entera is currently evaluating different strategies to advance the oral GLP-2 program into clinical development.Pipeline and Collaboration Developments: The Company’s collaboration with Amgen reached its third year and Amgen has completed several studies of its drug using Entera’s oral delivery technology. In addition, Entera continues to pursue new molecules, targets, and indications for preclinical development with a goal of building its pipeline and creating partnership opportunities.
“We continue to leverage Entera’s oral protein delivery platform, with a goal of developing a robust pipeline of orally-delivered large molecules across several therapeutic areas. We believe that the ability to replace a daily injection with an orally delivered alternative, will improve convenience, compliance and outcomes while lowering the total cost of care,” stated Entera CEO Spiros Jamas. “We are highly encouraged by the data we have released to date from our EB613 Phase 2 trial in osteoporosis and we are working toward several additional milestones in 2021 including the announcement of the BMD results from this trial in the second quarter of 2021.”Financial Results for the Year Ended December 31, 2020Revenues for the year ended December 31, 2020 were $365,000 as compared to $236,000 for the year ended December 31, 2019, with revenues in both years attributable to R&D services provided to Amgen. The cost of revenues for year ended December 31, 2020 and 2019 were $209,000 and $210,000 respectively and were comprised of salaries and related expenses in connection with the R&D services provided to Amgen. Operating expenses were $11.3 million for the year ended December 31, 2020, compared to $11.5 million for the year ended December 31, 2019. Entera’s operating loss was $(11.1) million for the year ended December 31, 2020, compared to $(11.5) million for the year ended December 31, of 2019.Research and development expenses were $6.4 million for the year ended December 31, 2020, compared to $7.2 million for the year ended December 31, 2019. An increase in clinical trial expense in 2020 primarily due to the conduct of the Phase 2 clinical trial of EB613 was offset by decreases in compensation and consulting expenses and manufacturing costs.General and administrative expenses were $4.9 million for the year ended December 31, 2020, compared to $4.3 million for the year ended December 31, 2019. The increase was primarily due to increases in compensation related expenses, professional and legal fees and insurance costs.Net comprehensive loss was $(10.0) million or $(0.55) per ordinary share (diluted) for the year ended December 31, 2020 compared to $(10.8) million, or $(0.89) per ordinary share (basic and diluted) for the year ended December 31, 2019. The change in net loss is primarily due to decrease in the operating loss and an increase in financial income related to the change in fair value of outstanding warrants.At December 31, 2020, Entera had cash and cash equivalents of $8.6 million, compared to $15.2 million at December 31, 2019 and in the 20F the Company intends to file today, it will report $15.4 million in cash and cash equivalents at March 16, 2021. This amount includes total net proceeds of $13.3 million from the sale of ordinary shares under Company’s previously filed Equity Distribution Agreement, which has now been fully utilized. Entera currently has approximately 23.7 million primary ordinary shares outstanding.Entera expects an operating loss of between $11 and $12 million for the year ending December 31, 2021, and believes its current cash position will be sufficient to fund its operations into the second quarter of 2022.Conference Call and Webcast InformationEntera’s management will host a conference call on Thursday, March 18, 2021 at 8:30 a.m. EDT. A question-and-answer session will follow Entera’s remarks. To participate on the live call, please dial (855) 547-3865 (US) or (409) 217-8787 (international) and provide the conference ID “5557946” five to ten minutes before the start of the call.To access a live audio webcast of the presentation on the “Investor Relations” page of Entera’s website, please click here. A replay of the webcast will be archived on Entera’s website for approximately 45 days following the presentation.