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Entera Bio
Entera Bio is a Jerusalem-based clinical biotech developing oral alternatives to injectable osteoporosis drugs, led by CEO Miranda Toledano.
Entera Bio
Entera Bio was founded in Jerusalem in 2010 to commercialize an oral drug-delivery platform that lets large-molecule biologics survive the digestive tract. The firm listed on Nasdaq in 2018 under the ticker ENTX, raising capital from a mix of Israeli life-science funds and US healthcare specialists. CEO Miranda Toledano, a former Roche and Bristol Myers Squibb executive, joined the same year and refocused the pipeline exclusively on metabolic bone diseases. The lead asset, EB613, is an oral formulation of teriparatide — the active ingredient in Forteo, a blockbuster injectable from Eli Lilly that lost patent protection in 2019. Entera completed a Phase 2 dose-ranging study in post-menopausal osteoporosis patients in 2022, reporting statistically significant bone-formation biomarker data (per the firm, 2022). A Phase 3 registrational study is the next gating event. A second oral parathyroid-hormone candidate, EB612 for hypoparathyroidism, sits at the preclinical stage. The platform has also been validated by a licensing deal with Amgen for an undisclosed metabolic target, signed early in the company's history. As a clinical-stage micro-cap, Entera runs lean. Total headcount is not publicly tracked, though the firm operates from a single office in Jerusalem's Hadassah medical hub. In December 2024, Entera raised $5.1 million in a registered direct offering to extend its cash runway into mid-2025 (per the firm, December 2024). The company has no philanthropic vehicles or separate operating businesses disclosed. Entera's structural differentiation lies in its single-device, single-chemistry platform approach. Unlike most oral-peptide delivery firms that customize formulation for each drug, Entera applies a standard excipient-plus-absorption-enhancer technology, which shortens toxicology work and appeals to pharma partners seeking repeatable CMC packages for multiple molecules.
General information
Firm type
Asset Manager
Year founded
2010
AUM
Undisclosed
Location
Region
Middle East
Country
Israel
City
Jerusalem
Corporate office
Kiryat Hadassah, Minrav Building, Fifth Floor, Jerusalem, Israel
Principals
Miranda Toledano
Chief Executive Officer
Hillel Galitzer
Chief Operating Officer
Sector focus
Frequently asked questions
What is Entera Bio's lead drug candidate and what problem does it solve?
The lead candidate is EB613, an oral tablet formulation of teriparatide — the same active ingredient in Eli Lilly's injectable osteoporosis drug Forteo. Entera aims to replace a daily subcutaneous injection with a pill, targeting the roughly 80% of severe osteoporosis patients who refuse or discontinue injectable therapy. A Phase 2 study completed in 2022 showed statistically significant increases in bone-formation markers P1NP and osteocalcin (per the firm, 2022).
How does Entera's oral delivery technology work?
Entera's platform combines the active biologic drug with an absorption enhancer and standard pharmaceutical excipients in a single tablet. The formulation protects the peptide from stomach acid and temporarily opens tight junctions in the intestinal lining, allowing large molecules to pass into the bloodstream intact. The technology is designed to be molecule-agnostic, meaning the same excipient-enhancer combination can be applied to multiple peptide drugs without reformulating from scratch.
Has Entera Bio partnered with any large pharmaceutical companies?
Yes. Early in its corporate history, Entera signed a licensing deal with Amgen around an undisclosed metabolic target, validating the platform's attractiveness to large pharma. However, the company has not disclosed subsequent milestones or royalties from that agreement. Its current osteoporosis program, EB613, is being developed independently without a partner.
What is the regulatory path for EB613 and when might a Phase 3 trial start?
EB613 benefits from the FDA's 505(b)(2) pathway, which allows Entera to reference existing safety and efficacy data from Forteo, the injectable originator drug. The pivotal Phase 3 study is expected to be a fracture-outcomes trial, and the company has been in dialogue with the FDA on trial design. As of early 2025, Entera has not announced a Phase 3 start date, and funding remains the primary gating factor.
How does Entera Bio fund its operations as a clinical-stage company?
Entera accesses capital through registered direct offerings, at-the-market equity programs, and earlier venture funding from Israeli life-science investors. The firm raised $5.1 million in a December 2024 offering (per the firm, December 2024). It carries no disclosed debt facility, and its burn rate is closely tied to clinical-trial pacing.
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