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Entera Bio Ltd.

Entera Bio Ltd. Q1 FY2022 earnings call

May 18, 2022 · fiscal period ended 2022-03

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Summary

Generated 2022-05-18

Management highlights

• Lead program EB613 moving to Phase III clinical development, with compelling Phase II efficacy and safety data. EB613 has unique oral route, safety profile, and validated mechanism. • Completed market and analytics study on EB613, highlighting large untreated osteoporosis market in US, clinicians receptive to EB613's efficacy and oral route, payers favorable to its value proposition. • Filed multiple US patent applications to expand patent protection and support optimization of oral delivery platform. • Evaluating material transfer agreements with potential strategic partners for proprietary molecules.

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Guidance

• Focus on finalizing registrational study plans and dialogue with FDA for EB613. • Actively pursuing global partnerships for EB613, expecting to finish deals by end of the year. • Optimizing oral delivery platform with new IP, aiming for higher bioavailability, lower variability, and ability to address more molecules.

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Risks

• Developments related to COVID-19 pandemic continue to evolve, impact on future operations depends on duration and magnitude of impact, which are difficult to predict. Risks described in SEC filings.

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Q&A highlights

Q: Did you collect data on what percentage or portion of prescribers would utilize EB613 before bisphosphonates in patients with no prior history of fractures?

A: Spiros Jamas mentioned payers and prescribers see an oral anabolic like EB613 moving up the chain and not requiring step edit for use in the population, with large untreated population that could benefit and payers willing to cover. Miranda Toledano added data collected in micro way and plan to disseminate portions to analysts.

Q: Could EB613 be used in other demographics down the line?

A: Spiros Jamas mentioned similar demographics as FORTEO or anabolics for males, like men with osteoporosis (idiopathic, glucocorticoid-induced) could be subsequent target populations after initial indication in postmenopausal women at high risk of osteoporosis.

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Key numbers

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Transcript

May 18, 2022

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