Entera Bio Ltd.
Entera Bio Ltd. Q3 FY2020 earnings call
November 19, 2020 · fiscal period ended 2020-09
EPS · actual vs est
Revenue · actual vs est
Summary
Generated 2020-11-19
Management highlights
- Completion of enrollment of Phase 2 Clinical Trial of EB613 amidst COVID-19 challenges, a major milestone towards Phase 3 trial. The trial is a dose-ranging, placebo-controlled study in postmenopausal females with osteoporosis. - Phase 2 protocol amended in Q3 to discontinue lower doses of EB613 and add 2.5 mg dose based on interim data. - Six-month interim biomarker and BMD data showed EB613 had dose-dependent positive impact on lumbar spine BMD. - Updates on EB612 for hypoparathyroidism with ongoing formulation work and potential Phase 2b/3 trial in 2021/2022. - Continued collaboration with Amgen and business development dialogues with companies interested in oral delivery technology.
Segment performance
For the nine months ended September 30, 2020, revenues were $144,000 compared to $134,000 in the first nine months of 2019, attributable to R&D services provided to Amgen. Cost of revenues were $104,000 for 2020 vs $102,000 in 2019. Total operating expenses for the nine months ended September 30, 2020 were $8.9 million, with $5.2 million in research and development expenses and $3.7 million in general and administrative expenses.
Guidance
- Cash on hand sufficient to support operations into second quarter of 2021. - Expect biomarker data including 2.5 mg dose of EB613 in Q1 2021 and final BMD data including 2.5 mg dose in Q2 2021. - Targeting to begin Phase 3 trial for EB613 in 2022 if Phase 2 data is positive.
Risks
- Uncertainty in the impact of COVID-19 pandemic on future operations. - Uncertainties in timing of collaborations and ability to raise additional capital.
Q&A highlights
Q: Do you have any plans in place to extend your cash runway?
A: Thanks for the question. We have enough cash to get to the second quarter of next year. We are evaluating various opportunities to raise additional capital, including business development activities. We are evaluating different strategies to put more capital on the balance sheet and will provide updates as we have more information.
Key numbers
Reported versus consensus
Earnings calendar feed
| Metric | Reported | Consensus | Delta | Prior year |
|---|---|---|---|---|
| EPS | $-0.09 | $-0.20 | +55.0% | — |
| Revenue | $50,000 | $69,750 | -28.3% | — |
Transcript
November 19, 2020Full transcript unavailable for redistribution
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