Entera Bio Ltd. (ENTX)·Q1 2025 Earnings Summary

Executive Summary

• Q1 2025 was an execution-heavy quarter marked by extended cash runway, advancing EB613 toward a pivotal program, and formalizing the OPKO collaboration on oral OPK-88006; loss narrowed sequentially vs Q3’24 on lower OpEx, though YoY OpEx rose modestly as R&D stepped up for EB613 and collaboration prep .
• Reported minimal revenue ($0.04M) with cost of revenues equal to revenue (gross profit $0), consistent with a pre-commercial profile; net loss was $2.57M, or $0.06 per share, versus $2.02M ($0.05) a year ago as the company invested in regulatory and development activities .
• Cash and restricted cash totaled $20.6M, sufficient through mid-Q3 2026; $8M is designated for the OPKO collaboration, providing funding clarity for near-term milestones .
• Catalysts to watch: potential 2025 FDA decision on SABRE’s BMD surrogate endpoint (key to EB613 Phase 3 design/start), initiation of Phase 1 for Next Gen EB613 in H2 2025, and IND filing for oral OPK-88006 later 2025 or early 2026; each could re-rate expectations and drive stock reaction on regulatory/milestone timing .

What Went Well and What Went Wrong

What Went Well

• Cash runway extended into mid-Q3 2026 following direct investments, including from OPKO; $20.6M total cash and restricted cash as of 3/31/25, with $8M earmarked to OPKO development activities .
• EB613 momentum: post-hoc Phase 2 analyses showed early effects on trabecular and cortical bone using 3D-DXA; abstracts accepted/presented at WCO-IOF-ESCEO; quote: “Mechanistically, the findings suggest that bone strengthening, and fracture resistance may occur rapidly with EB613” (CEO) .
• Platform/portfolio breadth: OPKO collaboration advanced oral OPK-88006 (dual GLP‑1/glucagon) toward IND with 60/40 cost and economics split; GLP‑2 oral tablet program progressing with plans for 2025 abstracts .

What Went Wrong

• No earnings call transcript available this quarter, limiting color on timing risks and spend cadence; the company furnished an 8‑K and press release but no call transcript was located [List: earnings-call-transcript returned none].
• SABRE BMD surrogate timeline has effectively slipped from “expected by January 2025” (prior communications) to “expected in 2025,” introducing timing uncertainty for EB613’s pivotal start .
• S&P Global consensus was unavailable for ENTX this quarter, preventing a standard “vs. estimates” performance read; investors must anchor on reported figures and milestones until coverage deepens (consensus data unavailable).

Financial Results

Quarterly trend (oldest → newest)

Notes: Q4 2024 quarterly detail was not separately disclosed; the company reported full-year 2024 on March 28, 2025 .

Year-over-year comparison

KPIs/Other:

• Cash and cash equivalents + restricted cash: $20.6M; $8M designated to OPKO collaboration; runway through mid‑Q3 2026 .
• Headcount/leadership strengthening: appointments of EVP, Head of Clinical Ops and CBO to support execution .

Segment breakdown: Not applicable (pre-commercial clinical-stage company).

Guidance Changes

Earnings Call Themes & Trends

Note: No Q1 2025 earnings call transcript was available; themes reflect press releases and 8‑K.

Management Commentary

• “During Q1 2025, Entera continued to generate intrinsic value… while significantly extending our cash runway into late 2026 via direct investment from… OPKO… Pre‑IND activities for our Next Gen EB613… plan to initiate a Phase 1 study in H2 2025… fully funded to co‑develop Oral OPK‑88006… retaining a 40% stake” — Miranda Toledano, CEO .
• “We continue to optimize and prepare to initiate our proposed pivotal program for EB613… We strongly endorse the proposed BMD ruling… and view it as crucial…” — Miranda Toledano, CEO .
• “After 6 months of treatment… increases with EB613 compared with placebo… suggest that bone strengthening, and fracture resistance may occur rapidly” — Dr. Rachel B. Wagman (WCO‑IOF‑ESCEO oral presentation) .

Q&A Highlights

• No Q1 2025 earnings call transcript was found; therefore, no Q&A highlights or on-the-fly guidance clarifications were available this quarter [List: earnings-call-transcript returned none].

Estimates Context

• S&P Global/Capital IQ consensus for ENTX Q1 2025 was unavailable; as a result, we cannot provide “vs. estimates” comparisons or estimate dispersion. Investors should focus on cash runway, regulatory timing, and pipeline milestones as primary valuation drivers until broader sell-side coverage develops (S&P Global consensus unavailable).

Key Takeaways for Investors

• Runway clarity: $20.6M in cash and restricted cash supports operations through mid‑Q3’26; $8M carved out for OPKO collaboration costs reduces funding uncertainty for near-term pipeline steps .
• EB613 narrative strengthening: new 3D‑DXA post‑hoc analysis supports early effects on cortical and trabecular compartments; continued medical conference visibility aids credibility ahead of pivotal planning .
• Regulatory hinge: SABRE/FDA BMD surrogate decision is the gating event; a positive 2025 ruling would simplify EB613 Phase 3 and could be a major stock catalyst; delays would defer that timeline .
• Portfolio breadth as upside optionality: OPK‑88006 (GLP‑1/glucagon) targeting IND late 2025/early 2026, plus GLP‑2 oral tablet progress, offers multi-asset optionality on the N‑Tab platform .
• Spend discipline with focused step-up: YoY OpEx increased to support EB613 optimization and collaboration work; sequentially lower OpEx vs Q3’24 shows control; expect R&D to flex with trial starts .
• Trading setup: Near-term stock moves likely driven by regulatory headlines (SABRE/FDA), clinical-start milestones (Next Gen EB613 Phase 1 in H2’25), and OPK‑88006 IND timing; absence of consensus estimates shifts focus to milestone execution and balance sheet .

Supporting documents and data:

• Q1 2025 press release and 8‑K (Item 2.02) .
• Q3 2024 financial results press release .
• FY 2024 results press release and 8‑K .
• Additional Q1 2025 period press releases (WCO‑IOF‑ESCEO/3D‑DXA; upcoming events) .