Entera Bio (ENTX) Q4 2025 earnings summary

Executive summary

• Achieved major milestones in 2025, including FDA alignment on primary endpoints for EB613 and streamlined Phase 3 protocol submission, accelerating potential approval timeline.

• Advanced all pipeline programs, including EB612 for hypoparathyroidism and EB618 for metabolic syndromes, with strong preclinical and clinical data.

• Expanded collaboration with OPKO, fully funding key programs through Phase 1.

Financial highlights

• Cash and cash equivalents totaled $14.9 million at year-end 2025, with $7.8 million in restricted cash for OPKO collaboration.

• Net loss was $11.4 million ($0.25 per share) for 2025, compared to $9.5 million ($0.25 per share) in 2024.

• Research and development expenses rose to $6.0 million from $4.5 million year-over-year, reflecting increased regulatory and Phase 3 preparation activities.

• General and administrative expenses increased to $5.5 million from $5.1 million year-over-year.

• Net cash used in operating activities was $7.4 million for 2025.

Outlook and guidance

• Cash on hand (excluding restricted cash) expected to support operations through mid-Q3 2026.

• Phase 3 trial for EB613 planned to initiate in late 2026, with topline results anticipated in H2 2028, about one year earlier than previously expected.

• IND filing for EB612 targeted for late 2026; Phase 1 for EB618 to follow OPKO injectable data by year-end 2026.