Entera Bio Ltd. Q1 FY2020 earnings call

• Phase 2 clinical trial of EB613: Interim data showed meaningful and statistically significant increases in P1NP with the highest EB613 1.5 mg dose at one month, with dose response observed. Upcoming six-month BMD data expected in Q3 2020. Enrollment at 102 patients as of today, with COVID-19 causing delays but on track to adjust plans. Strong unmet need in osteoporosis for an oral therapy. - EB612: Working on formulation enhancements to treat hypoparathyroidism, evaluating twice or three times daily dosing to mimic endogenous PTH activity. - Collaboration with Amgen: Progress made on oral anti-inflammatory agent development, supporting Amgen's studies with different formulations. - Financials: 2020 operating loss expected to be approximately $10 million or less, cash position to fund operations into Q2 2021.

For the quarter ended March 31, 2020, revenue was $42,000, solely from research and development services provided to Amgen. Total operating expenses were $2.9 million, with $1.6 million in research and development expenses (including headcount, clinical trial conduct, and IND application preparation) and $1.3 million in general and administrative expenses. Net comprehensive loss was $2.9 million or $0.16 per ordinary share basic and diluted. Cash and cash equivalents at March 31, 2020 were $13.3 million, and as of May 12, 2020, were approximately $11.5 million.

• Expect 2020 operating loss to be approximately $10 million or less, subject to product development timing and COVID-19 impact. - Current cash position expected to fund operations into the second quarter of 2021.

• Uncertainties in clinical trial outcomes, as analysis of EB613 interim data is ongoing and conclusions may change. - Impact of COVID-19 on operations, including delays in enrollment and data collection. - Risks associated with forward-looking statements, as future results depend on numerous uncertain factors.

Q: Unidentified Analyst: As you guys make progress with regard to EB613 and EB612, I just wanted to see if you guys planned on boarding any clinical trial sites in the U.S. or EU?

A: Adam Gridley: Indeed we do. For EB613 Phase 3 trial, envision global registration trial, preparing for IND with FDA, and would be global. For EB612, similar global consideration.

Q: Unidentified Analyst: On EB613, so I just want to make sure and with regard to – if I heard this correctly, we can expect a BMD data readout in 3Q 2020 and then you guys expect to initiate the Phase 3 trial in either late 2021 or early 2022. Is that correct?

A: Adam Gridley: That's correct. Anticipate collecting sixth bone density data in Q3 2020 from first 50% of patients. Enrollment of remaining ~60 patients, and data would support initiation of Phase 3 trial as early as late 2021 or early 2022.

Q: Unidentified Analyst: Great, thanks. And I know we could just switch gears here briefly to EB612. Could you just set some color on what parameters are currently being looked into and that would be needed to support your continued progress into Phase 2b or Phase 3? Thanks.

A: Adam Gridley: Reported Phase 2 PK and PD data in fall 2019 vs Natpara. Currently determining formulation enhancements to lengthen the tail (how long drug lasts in bloodstream) for better calcemic effects and to treat downstream effects. Phillip Schwartz: Looking at reformulation to lengthen tail, potentially reducing dosing frequency for different patient severities, as hypoparathyroidism is heterogeneous.