Entera Bio Ltd. Q1 FY2021 earnings call

• Spiros Jamas joined Entera in Jan 2021, highlighted key milestones, strong balance sheet, and progress with EB613 and EB612. Mentioned material transfer agreements with 3 companies and collaboration with Amgen.
• Arthur Santora discussed details of the EB613 Phase II osteoporosis trial, biomarker data, dosing changes, and safety profile of EB613.
• Phillip Schwartz provided updates on EB612, collaboration with Amgen, new research programs for oral GLP-2 and human growth hormone, and preclinical data for these molecules.

Revenues for the three months ended March 31, 2021, were $157,000 compared to $42,000 for the same period in 2020, both from R&D services provided to Amgen. Cost of revenues for Q1 2021 was $58,000 vs. $42,000 in 2020. Total operating expenses for Q1 2021 were $2.5 million, with research and development expenses at $1.2 million and general and administrative expenses at $1.3 million. Net comprehensive loss for Q1 2021 was $9.5 million or $0.43 per ordinary share diluted, compared to a net loss of $2.9 million or $0.16 per ordinary share diluted in Q1 2020. As of March 31, 2021, Entera had cash and cash equivalents of $16.4 million, and it is expected that the cash position will fund operations into the second quarter of 2022.

• Current cash resources will fund the company into the second quarter of 2022.
• Expect 2021 operating losses to be approximately $13 million, subject to product development timing and continuing impact of COVID-19 on operations.

• Developments related to the COVID-19 pandemic continue to evolve and the impact is uncertain, with risks described more fully in SEC filings.

Q: Discuss the oral hGH opportunity A: Spiros Jamas and Phillip Schwartz noted the hGH market has compliance issues with injectable forms, and an oral version could address this, especially for non-compliant patient segments.

Q: About material transfer agreements A: Spiros Jamas explained MTAs allow generating data on proprietary molecules quickly, similar to the Amgen model, potentially leading to collaborations.

Q: Safety data for EB613 regarding gastrointestinal issues A: Arthur Santora and Phillip Schwartz stated gastrointestinal adverse events were observed but no specific signal for irritation, with events being mild/moderate and resolving quickly.

Q: Time limits on material transfer agreements A: Spiros Jamas said MTAs generate data quickly, expect announcements by end of year, and upfront payments are possible in partnerships.

Q: Amgen collaboration timeline A: Spiros Jamas mentioned Entera can suspend agreements if partners aren't progressing appropriately, but progress with Amgen is ongoing, though timeline details can't be specified