News & Events zu Entera Bio Ltd (ENTX)ENTXEntera Bio Ltd

Company Not Selling 134.8M Ordinary Shares

This filing relates to the offer and sale from time to time by the selling stockholders of up to 134.8M ordinary shares. The company is not selling any shares under this prospectus and will not receive any of the proceeds from the sale of shares by the selling stockholders.

Entera Bio Completes $275M Private Placement Financing

Entera Bio announced that it has entered into a securities purchase agreement for an oversubscribed private placement financing. The Private Placement is expected to result in aggregate gross proceeds to the company of approximately $275M, before deducting placement agent fees and other offering expenses. Pursuant to the terms of the Purchase Agreement, the company agreed to issue and sell an aggregate of 122,961,215 ordinary shares of the company and, in lieu of Ordinary Shares to certain investors, pre-funded warrants to purchase up to an aggregate of 11,842,695 Ordinary Shares. The purchase price per Ordinary Share is $2.04, and the purchase price per Pre-Funded Warrant is equal to $2.04 minus the exercise price of NIS 0.0000769 per Ordinary Share issuable thereunder. The Pre-Funded Warrants may not be exercised if the aggregate number of Ordinary Shares beneficially owned by the holder thereof, together with its affiliates, would exceed either 4.99% or 9.99, at the option of the holder, immediately after exercise thereof, subject to increases not in excess of 19.99% at the option of the holder. Each Pre-Funded Warrant has an exercise price of NIS 0.0000769 per Ordinary Share, is immediately exercisable and may be exercised at any time and has no expiration date, and is subject to customary adjustments. The Private Placement was priced at the market under the rules of the Nasdaq Stock Market. The Private Placement is expected to close on or about July 28, subject to the satisfaction of customary closing conditions. In addition, upon closing of the Private Placement, the company has agreed to grant BVF the right to designate two directors to the company's board of directors, subject to each BVF designee's satisfaction of all applicable requirements regarding service as a director under applicable law and Nasdaq rules and such other criteria and qualifications applicable to all directors of the company. Leerink Partners is acting as lead placement agent for the Private Placement. Evercore ISI, Guggenheim Securities, Cantor, LifeSci Capital, and Canaccord Genuity are acting as co-placement agents for the Private Placement.

Entera Bio Receives FDA Feedback on EB613

Entera Bio announced that it has received feedback from the FDA on its Phase 3 registrational protocol for EB613, the first oral anabolic tablet in development for the treatment of osteoporosis. The FDA feedback is in response to a Clinical Amendment submitted by Entera to its investigational new drug, or IND, application, as announced in March. The FDA accepted Entera's plan to conduct a single, randomized, double-blind, placebo-controlled, Phase 3 trial in approximately 750 postmenopausal women with osteoporosis, with a primary endpoint of percent change from baseline in total hip BMD at Month 12 to support a potential new drug application submission for EB613 for the treatment of women with post-menopausal osteoporosis. The proposed NDA package will also include Entera's scientific bridge analysis with Forteo under the 505 pathway, and a transiliac crest bone biopsy sub-study in a subset of patients. The FDA also agreed with Entera's proposal to continue following the randomized patients out to 24 months in an open-label extension study under a separate protocol. Entera will plan to submit data through up to 18 months as part of the 120-day safety update to its NDA. Additionally, Entera will submit the complete 2-year data upon completion of the open-label extension study to characterize further the durability of the treatment effect, safety, and sequence data for EB613 followed by a standard anti-resorptive therapy for 12 months. The registrational study is powered to demonstrate EB613's clinical effectiveness with projected increases in total hip BMD that are comparable to reported outcomes for Forteo at 12 months, changes associated with a 60% to 80% relative reduction in vertebral fracture risk. The company plans to initiate the registrational Phase 3 study in late 2026, with topline results anticipated in the second half of 2028.