Entera Bio Ltd. Q4 FY2021 earnings call

• Phase 2 clinical study of EB613 for osteoporosis met primary and key secondary endpoints, with data presented at ASBMR. Phase 2a data for hyperparathyroidism published in Journal of Bone Mineral Research.
• Engaged Torreya for strategic partnering of EB613. EB612 progress in hypoparathyroidism, with improved formulation and plans for 2022 studies.
• Collaboration with Amgen continues, with Amgen completing preclinical studies. Demonstrated oral delivery of GLP-2 and other large molecules in preclinical models.
• Strengthened balance sheet with $24.9 million cash at year-end 2021. Successful end of Phase 2 meeting with FDA, projecting Phase 3 start in second half of 2022.

Revenues for the year ended December 31, 2021, were $571,000, compared to $365,000 in 2020. A majority of revenues were from R&D services to Amgen and other MTA agreements. Cost of revenues in 2021 was $373,000 vs $300,000 in 2020. Total operating expenses in 2021 were $12.4 million, with R&D at $6.7M and G&A at $5.7M. Net loss in 2021 was $12.2 million or $0.47 per ordinary share. Cash and cash equivalents at year-end 2021 were $24.9 million, with $21.7 million as of March 1, 2022.

• Projected Phase 3 study of EB613 for osteoporosis to start in second half of 2022.
• Cash position expected to fund operations into Q4 2022.
• 2022 expected to be a year of execution and meaningful deals, with ongoing business development and strategic partnering discussions.

• COVID-19 pandemic impact is a key risk, as its duration and magnitude are uncertain and can affect the company's operations and financials.

Q: Can you confirm titration to 2.5 mg dose of EB613 in Phase 3 and details on Phase 3 timeline?

A: Yes, will titrate to 2.5 mg dose with accelerated titration over two weeks, and Phase 3 expected in second half of 2022 with 600-800 patients.

Q: Status of Phase 3 and revenue direction?

A: Phase 3 timelines remain on track for second half 2022; revenue from Amgen and new MTAs is increasing with more MTAs signed.

Q: Background therapies in EB613 studies and Phase 3 allowances?

A: Patients in studies had nutritional support with calcium and Vitamin D3, no immediate transitions from bisphosphonates in Phase 3, similar to Phase 2.