Entera Bio Ltd. Q2 FY2020 earnings call

• Phase 2 clinical trial of EB613 in postmenopausal women with osteoporosis: Interim six-month data shows EB613 has a positive impact on lumbar spine BMD in a dose-dependent manner. Amended protocol to add 2.5 mg dose group based on interim data. - Enrollment in Phase 2 trial: Anticipates total enrollment of ~160 subjects, with 68 of first 80 subjects completing six-month visit despite COVID-19. - Safety: No serious drug-related adverse events. - Collaboration with Amgen: Continues to support Amgen's program advancement. - Progress on EB612: Conducting formulation work for hypoparathyroidism treatment, evaluating dosing to improve PK/PD profile. - Technology platform: Attracts interest from potential collaborators for its patent-protected drug delivery of macromolecules.

For the six months ended June 30, 2020, revenue was $94,000 compared to $74,000 in the first half of 2019, attributable to R&D services provided to Amgen. Cost of revenues for the six months ended June 30, 2020 was $73,000, versus $62,000 in 2019. Total operating expenses for the six months ended June 30, 2020 were $6.4 million, with $3.6 million in research and development expense and $2.8 million in general and administrative expenses. Net comprehensive loss was $6.1 million or $0.34 per ordinary share basic and diluted. Cash and cash equivalents at June 30, 2020 were $9.8 million, and expected 2020 operating loss is approximately $11 million, with cash expected to fund operations into Q2 2021.

• Current cash position sufficient to support operations into Q2 2021. - Expected 2020 operating loss approximately $11 million, subject to product development timing and COVID-19 impact. - Targeting to begin Phase 3 pivotal study for EB613 in late 2021 or 2022.

• Phase 2 trial interim data may not be indicative of final trial results. - Uncertainty in impact of COVID-19 on operations. - Regulatory approvals uncertainties for EB613.

Q: Questions on Amgen partnership and BD initiatives, specifically color on Amgen collaboration and other BD efforts, and qualitative color on BMD data showing spine improvement but not femur.

A: Jon Lieber mentioned supporting Amgen's program advancement, Amgen in control of project plan but potential for milestones. Phillip Schwartz discussed BD initiatives in two buckets: new APIs and existing products. Roger Garceau and Arthur Santora explained BMD pattern similar to injectable PTH, with spine being trabecular bone responsive to PTH and femur being cortical bone with neutral effect.