Executive Summary

Q3 2025 net loss was $3.2M ($0.07 per share) versus $3.0M ($0.08) in Q3 2024; revenue was $0 with operating expenses of $3.3M as Phase 3 preparation for EB613 drove modest OpEx growth .
The company highlighted a key regulatory milestone: FDA agreement on total hip BMD as the primary endpoint for EB613’s single Phase 3 study, supporting an NDA path; Next-Gen EB613 remains on track for Phase 1 initiation in late 2025 .
Cash and restricted cash totaled $16.7M at quarter-end (cash $8.6M, restricted $8.1M), with runway through mid-Q3 2026 maintained; dedicated restricted cash supports OPKO collaboration programs .
Versus S&P Global consensus, EPS of -$0.07 beat the -$0.09 estimate (+$0.02), and revenue matched $0; estimate breadth remains thin (1 covering estimate)*.

What Went Well and What Went Wrong

What Went Well

FDA agreement on Phase 3 design for EB613 (BMD primary endpoint; vertebral fractures secondary) provides pivotal regulatory clarity and a streamlined path to NDA submission .
EB613 Phase 2 post-hoc 3D-DXA analyses showed early anabolic effects with significant trabecular and cortical gains at 6 months, comparable to injectable teriparatide/abaloparatide, reinforcing clinical differentiation .
Management emphasized leadership in oral peptides and ongoing milestones across GLP‑2 (SBS) and oral OXM (obesity) with OPKO; CEO: “Our FDA agreement…is unprecedented and underscores the strength of our data and the promise for EB613…” .

What Went Wrong

No revenue in Q3 2025 (clinical-stage profile), with operating loss of $3.3M; net loss increased sequentially vs Q2 2025 ($3.2M vs $2.7M) on higher R&D and G&A .
R&D rose to $1.6M (from $1.5M YoY; $1.5M Q2) and G&A to $1.6M (from $1.5M YoY; $1.1M Q2), reflecting Phase 3 preparation and corporate spend; total OpEx up to $3.3M .
Limited estimate coverage (single analyst) reduces external benchmarking and may dampen near-term institutional engagement for the stock*.

Financial Results

Core P&L (YoY and Sequential)

Metric	Q3 2024	Q2 2025	Q3 2025
Revenue ($USD Thousands)	$42	$0	$0
R&D ($USD Thousands)	$1,477	$1,520	$1,643
G&A ($USD Thousands)	$1,544	$1,148	$1,613
Total Operating Expenses ($USD Thousands)	$3,021	$2,668	$3,256
Operating Loss ($USD Thousands)	$(3,021)	$(2,668)	$(3,256)
Financial Income, Net ($USD Thousands)	$0	$(12)	$(56)
Net Loss ($USD Thousands)	$(3,021)	$(2,656)	$(3,200)
Loss per Share (Basic & Diluted, $USD)	$0.08	$0.06	$0.07
Weighted Avg Shares	37,644,612	46,836,700	47,085,722

Actuals vs Consensus (Q3 2025)

Metric	Q3 2025 Actual	Q3 2025 Consensus	Surprise
Revenue ($USD)	$0	$0.0*	$0.0
EPS ($USD)	-$0.07	-$0.09*	+$0.02 (beat)

Values with asterisks retrieved from S&P Global.*

Margins

Metric	Q3 2024	Q2 2025	Q3 2025
Net Income Margin %	N/A (immaterial revenue)	N/A (0 revenue)	N/A (0 revenue)
EBIT Margin %	N/A	N/A	N/A

Balance Sheet and Liquidity

Metric	Q2 2025	Q3 2025
Cash and Equivalents ($USD Thousands)	$10,858	$8,574
Restricted Cash/Deposit ($USD Thousands)	$8,015	$8,114
Total Assets ($USD Thousands)	$19,667	$17,407
Total Liabilities ($USD Thousands)	$2,411	$2,173
Shareholders’ Equity ($USD Thousands)	$17,256	$15,234
Cash Runway (Mgmt)	Through mid‑Q3 2026	Through mid‑Q3 2026

KPIs (Operating Spend Mix)

KPI	Q3 2024	Q2 2025	Q3 2025
R&D ($USD Thousands)	$1,477	$1,520	$1,643
G&A ($USD Thousands)	$1,544	$1,148	$1,613
Total OpEx ($USD Thousands)	$3,021	$2,668	$3,256

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Cash runway	Operations	“Through mid‑Q3 2026” (Q2 release)	“Through the middle of Q3 2026” (Q3 release)	Maintained
EB613 Phase 3 design	Program	FDA agreed BMD primary endpoint (July)	Reiterated FDA agreement; Phase 3 registrational study design unchanged	Maintained
Next‑Gen EB613 Phase 1	Timing	Phase 1 expected Nov 2025	Phase 1 initiation “late 2025” on track	Maintained (timing window)
Oral OXM (OPK‑88006) IND	Timing	IND planned H1 2026	IND planned H1 2026	Maintained
Oral GLP‑2 (SBS)	Program status	ESPEN poster selection; advancing	PK half‑life ~15 hours; daily tablet potential	Enhanced detail (positive PK)

Earnings Call Themes & Trends

Topic	Previous Mentions (Q-2)	Current Period (Q-3)	Trend
Regulatory/EB613 Phase 3	FDA concurrence on BMD primary endpoint; reduced nonclinical burden	Reaffirmed agreement; emphasis on endpoint strategy and Phase 3 readiness	Stable/Positive
R&D execution	EB613 3D-DXA data gaining recognition; Next-Gen EB613 preclinical progress	Early anabolic effects highlighted; Next-Gen EB613 Phase 1 timing reiterated	Continued progress
OPKO collaboration (OXM, GLP‑2)	OXM PK consistent with Wegovy exposure in mini‑pig; GLP‑2 poster at ESPEN	GLP‑2 ~15h half‑life; OXM IND H1 2026 reiterated	Advancing
Liquidity/runway	Cash + restricted cash; runway through mid‑Q3 2026	Cash + restricted cash; runway maintained	Maintained
Commercial readiness	Not applicable (pre‑registrational)	Not applicable	N/A

Note: No earnings call transcript was available in the document set for Q3 2025; themes sourced from the 8‑K press release .

Management Commentary

CEO perspective: “Our FDA agreement for EB613 this July is unprecedented and underscores the strength of our data and the promise for EB613 to close the treatment chasm in osteoporosis…” .
Platform confidence: “Our N‑Tab™ platform consistently delivered across pipeline programs, including our oral GLP‑2… and oral OXM… in partnership with OPKO Health.” .
Clinical differentiation: Phase 2 analyses show significant increases in trabecular and cortical bone indices after six months of EB613, comparable to injectables; supports rapid strengthening and fracture resistance .

Q&A Highlights

No formal Q&A transcript found for Q3 2025 within available filings; key clarifications include drivers of OpEx (EB613 Phase 3 preparation) and program timelines: Next‑Gen EB613 Phase 1 late 2025 and OXM IND H1 2026 .

Estimates Context

EPS beat: Actual -$0.07 vs consensus -$0.09, a $0.02 outperformance; revenue matched $0, consistent with clinical-stage status.*
Estimate breadth remains limited (1 EPS and 1 revenue estimate), which can reduce the statistical significance of the “beat” and implies potential volatility in consensus updates as milestones approach.*
Given maintained runway and reinforced regulatory clarity, models may modestly increase R&D and G&A trajectories into Phase 3 start while leaving revenue near zero until milestone or approval events .

Values retrieved from S&P Global.*

Key Takeaways for Investors

Regulatory clarity on EB613’s Phase 3 BMD primary endpoint is a material de‑risking event for the registrational path; narrative catalyst remains Phase 3 initiation and early enrollment progress .
Liquidity appears sufficient through mid‑Q3 2026, supported by $16.7M combined cash and restricted cash; focus near‑term is disciplined OpEx as Phase 3 preparation continues .
Pipeline breadth provides optionality: GLP‑2 program shows compelling PK (~15h half‑life), and oral OXM IND timing (H1 2026) creates future milestone cadence with OPKO .
EPS modestly beat a thin consensus; limited coverage means price reaction may be more sensitive to regulatory and clinical headlines than quarterly P&L variance.*
Watch for Next‑Gen EB613 Phase 1 start (late 2025) and operational updates on Phase 3 logistics (sites, geographies, enrollment) as catalysts .
Risk factors include clinical timing/execution, regulatory interpretation, financing optionality pre‑approval, and compliance with listing standards per cautionary statements .
Medium-term thesis hinges on successful Phase 3 readout with BMD endpoint and subsequent NDA, with platform validation potentially expanding to metabolic and SBS indications .

Entera Bio Ltd. (ENTXW)·Q3 2025 Earnings Summary