Entera Bio Ltd. filed SEC Form 8-K: Entry into a Material Definitive Agreement, Leadership Update, Regulation FD Disclosure, Financial Statements and Exhibits

Item 1.01 Entry into a Material Definitive Agreement

Amended and Restated Collaboration and License Agreement

As previously reported, on March 16, 2025, Entera Bio Ltd., a company organized under the laws of the State of Israel (the “Company”), entered into a collaboration and license agreement (the “Original Collaboration Agreement”) with OPKO Health, Inc., a Delaware corporation (“OPKO Health”), and OPKO Biologics Ltd., a company organized under the laws of the State of Israel (“OPKO Biologics” and, together with OPKO Health, “OPKO”).

On February 3, 2026, the Company and OPKO entered into an amended and restated collaboration and license agreement (the “A&R Collaboration Agreement”), which amends and restates the Original Collaboration Agreement to expand the scope of the agreement to include the collaboration with respect to the preclinical and clinical development of a daily long acting PTH tablet (“LA-PTH”) for the treatment of hypoparathyroidism and other indications in addition to the original oral dual agonist GLP-1/glucagon peptide program. Development costs incurred by the parties with respect to the development of the LA-PTH program will be shared equally between the Company and OPKO. Except as described herein, the material terms of the Original Collaboration Agreement remain unchanged and in full force and effect.

 

The foregoing description of the A&R Collaboration Agreement is only a summary and is qualified in its entirety by reference to the full text of the A&R Collaboration Agreement, a copy of which is filed as Exhibit 10.1 to this Current Report on Form 8-K and incorporated by reference herein.

 

Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers

Director Resignation

On January 29, 2026, Gerald Ostrov notified the Board of Directors of the Company (the “Board”) of his resignation as a Director, effective February 1, 2026. Mr. Ostrov’s resignation was not the result of any disagreement with the Company on any matter relating to the Company’s operations, policies, or practices.

Appointment of Steven D. Rubin as Director

Mr. Rubin, 65, has served as OPKO Health’s Executive Vice President – Administration since May 2007 and as a director since February 2007. He has extensive experience as a practicing lawyer, and as general counsel and board member to multiple public companies. Mr. Rubin currently serves on the board of directors of the following companies: Niagen Bioscience, Inc. (Nasdaq: NAGE), a bioscience company developing NAD+ products to support cellular health; Cocrystal Pharma, Inc. (NASDAQ:COCP), a biotechnology company developing new treatments for viral diseases; Eloxx Pharmaceuticals (NASDAQ: ELOX), a biotechnology company engaged in ribosomal RNA targeted genetic therapies for rare diseases; and Red Violet, Inc., (NASDAQ: RDVT) a leading analytics and information solutions provider. Mr. Rubin previously served as the Senior Vice President, General Counsel and Secretary of IVAX from August 2001 until September 2006. Mr. Rubin previously served as a director of the following companies: Neovasc, Inc. (NASDAQ:NVCN), a company developing and marketing medical specialty vascular devices; Non-Invasive Monitoring Systems, Inc. (OTCBB:NIMU), a medical device company; Castle Brands, Inc. (NYSE:ROX), a developer and marketer of premium brand spirits; Kidville, Inc. (OTCBB:KVIL), an operator of large, upscale facilities, catering to newborns through five-year-old children and their families and offers a wide range of developmental classes for newborns to five-year-olds; VBI Vaccines Inc. (NASDAQ CM: VBIV), a commercial-stage biopharmaceutical company developing a next generation of vaccines; Dreams, Inc. (NYSE MKT: DRJ), a vertically integrated sports licensing and products company; Safestitch Medical, Inc. prior to its merger with TransEnterix, Inc.; and, PROLOR Biotech, Inc.; and Cognit, Inc. (NASDAQ:COGT), a data and analytics company providing cloud-based mission-critical information and performance marketing solutions. Mr. Rubin holds a B.A. degree from Tulane University and a Juris Doctor from University of Florida.

There are no arrangements or understandings between Mr. Rubin and any other person pursuant to which Mr. Rubin was appointed as a director of the Company. The Board has determined that Mr. Rubin is independent under the applicable rules of the Securities and Exchange Commission and the Nasdaq Stock Market. In addition, the Board determined that Mr. Rubin qualifies as an “audit committee financial expert” (as defined in Item 407 of Regulation S-K).

 

Since the beginning of Company’s last fiscal year, the Company has not engaged in any transaction, or any currently proposed transaction, in which Mr. Rubin had or will have a direct or indirect material interest that would require disclosure pursuant to Item 404(a) of Regulation S-K.

 

Mr. Rubin will participate in the Company’s standard non-employee director compensation arrangements, which were approved by the Company’s shareholders in July 2025, including the right to annual cash payments with respect to Board and applicable committee service and an annual equity grants under the Company’s 2018 Equity Incentive Plan.

 

Item 7.01 Regulation FD Disclosure.

On February 4, 2026, the Company issued a press release announcing the A&R Collaboration Agreement and the appointment of Mr. Rubin to the Board. A copy of the press release is furnished as Exhibit 99.1 hereto and incorporated by reference herein.

The information disclosed under this Item 7.01, including in Exhibit 99.1 attached hereto, is “furnished” and not “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section. Such information shall not be incorporated by reference in another filing under the Exchange Act or the Securities Act of 1933, as amended, except to the extent such other filing specifically incorporates such information by reference.

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits.

* Pursuant to Item 601(a)(5) of Regulation S-K, schedules and similar attachments to this exhibit have been omitted because they do not contain information material to an investment or voting decision and such information is not otherwise disclosed in such exhibit. The Company will supplementally provide a copy of any omitted schedule or similar attachment to the U.S. Securities and Exchange Commission or its staff upon request.

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

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