Executive Summary

Entera reported FY 2024 results (Q4 period release) with revenues of $0.18M, operating expenses of $9.59M, and net loss of $9.54M ($0.25 per share); year-end cash and equivalents were $8.66M, rising to $21M by March 28, 2025, extending runway into Q3 2026 .
Pipeline progressed: EB613 Phase 2 data were published in JBMR and highlighted at ASBMR; management anticipates FDA/SABRE surrogate endpoint qualification enabling Phase 3 initiation “promptly thereafter” .
Sequential trend ahead of Q4: Q3 2024 net loss was $3.0M ($0.08 per share) on operating expenses of $3.02M; Q2 2024 net loss was $2.15M ($0.06 per share) on operating expenses of $2.17M .
Key catalysts: FDA decision on SABRE endpoint (expected around January 2025 per prior update) and EB613 Phase 3 start; OPKO collaboration on oral oxyntomodulin (OXM) with joint ownership and an IND planned later in 2025 .

What Went Well and What Went Wrong

What Went Well

EB613 advanced with peer-reviewed Phase 2 publication and favorable ASBMR exposure; management reiterated readiness to initiate Phase 3 once FDA validates BMD as surrogate endpoint .
Balance sheet strengthened post-year-end to $21M cash, extending runway into Q3 2026 and supporting EB613 Phase 3 preparations and GLP-1/glucagon Phase 1 share of costs with OPKO .
Strategic collaboration deepened with OPKO: signed OXM license/collaboration (60/40 program ownership and cost-share), targeting IND filing later in 2025 .

What Went Wrong

Minimal FY revenue ($0.18M) reflects pre-commercial status; gross profit of $9K underscores limited near-term P&L leverage .
Operating expenses rose to $9.59M in FY 2024 (vs. $8.89M in FY 2023), driven by IP expansion and program preparation; net loss widened to $9.54M .
Year-end cash decreased YoY ($8.66M vs. $11.02M), increasing financing sensitivity before the March 2025 capital inflows; sequential OpEx increased from Q2 to Q3 as EB613 Phase 3 prep ramped .

Financial Results

Note: Entera furnished FY 2024 results and did not disclose standalone Q4 metrics; sequential trends are shown using Q2–Q3 2024. Estimates were unavailable via S&P Global for ENTX.

Annual Comparison

Metric	FY 2023	FY 2024
Revenue ($USD Millions)	$0.000	$0.181
Gross Profit ($USD Millions)	$0.000	$0.009
Total Operating Expenses ($USD Millions)	$8.891	$9.594
Operating Loss ($USD Millions)	$8.891	$9.585
Net Loss ($USD Millions)	$8.889	$9.541
Diluted EPS ($USD)	$0.31	$0.25
Cash and Equivalents ($USD Millions, year-end)	$11.019	$8.660

Sequential Quarterly Trend (Prior Two Quarters)

Metric	Q2 2024	Q3 2024
Revenue ($USD Millions)	$0.057	$0.042
Gross Profit ($USD Millions)	$0.009	$0.000
Total Operating Expenses ($USD Millions)	$2.174	$3.021
Net Loss ($USD Millions)	$2.145	$3.021
Diluted EPS ($USD)	$0.06	$0.08
Cash and Equivalents ($USD Millions, quarter-end)	$9.056	$6.915

Balance Sheet Snapshot (Year-End)

Metric	Dec 31, 2023	Dec 31, 2024
Cash and Equivalents ($USD Millions)	$11.019	$8.660
Total Assets ($USD Millions)	$11.765	$9.390
Total Liabilities ($USD Millions)	$1.379	$1.310
Shareholders’ Equity ($USD Millions)	$10.386	$8.080

Segment breakdown: Not applicable; the company does not report revenue segments .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Cash Runway	Corporate	Sufficient into Q3 2025	Sufficient into Q3 2026	Raised
EB613 Phase 3 Start	Program	Preparing to initiate after FDA BMD surrogate endpoint qualification; endpoint expected by Jan 2025	“Look forward to potential updates from FDA and SABRE” and to “potentially initiating our pivotal Phase 3 study… promptly thereafter”	Maintained/Clarified
Oral OXM (GLP-1/glucagon)	Program	PK data expected early H2 2024	Collaboration signed; IND planned later in 2025	Advanced to IND plan

No revenue, margin, OpEx, OI&E, tax rate, or dividend guidance was provided numerically in these materials .

Earnings Call Themes & Trends

No Q4 2024 earnings call transcript was found in the document catalog (press releases and 8-K furnished). Themes are tracked via Q2/Q3 releases and FY update.

Topic	Previous Mentions (Q2 2024)	Previous Mentions (Q3 2024)	Current Period (FY 2024 Release)	Trend
FDA/SABRE surrogate endpoint	Anticipated SABRE update at ASBMR Sept 2024	FDA/SABRE ruling expected Jan 2025; EB613 positioned to leverage	Awaiting FDA/SABRE updates; Phase 3 initiation planned promptly thereafter	Progressing toward decision
EB613 clinical profile	JBMR Phase 2 paper; ASBMR selection notice	Comparative pharmacology vs Forteo highlighted	JBMR publication, ASBMR data; dual mechanism emphasized	Strengthening clinical narrative
OXM (GLP-1/glucagon) oral tablet	PK data expected H2 2024	Topline PK/PD announced with OPKO	60/40 collaboration; IND planned later 2025	Advancing to IND
GLP-2 oral tablet	Positive in vivo PK announced (Mar 2024)	Pre-IND validation continues; final PK/PD expected H2 2024	PoC study showed ~10x plasma levels vs teduglutide; long half-life noted	Strengthened preclinical data
Cash runway	Cash $9.06M (Q2); runway into Q3 2025	Cash $6.92M (Q3); runway into Q3 2025	$21M cash as of Mar 28, 2025; runway into Q3 2026	Improved liquidity

Management Commentary

“2024 was a truly transformational year for Entera… advanced each of our oral peptide PTH(1-34), GLP1/Glucagon and GLP2 tablet programs, significantly increased our stockholder value, and efficiently strengthened our balance sheet.” — CEO Miranda Toledano .
“We look forward to potential updates from FDA and SABRE… and to potentially initiating our pivotal Phase 3 study of EB613 promptly thereafter.” — CEO Miranda Toledano .
“We are headed into a busy year end… keenly anticipating FDA’s potential landmark ruling on the ASBMR-FNIH SABRE regulatory endpoint… expected in January 2025.” — CEO Miranda Toledano (Q3 update) .

Q&A Highlights

No Q4 2024 earnings call transcript or Q&A session materials were found among furnished documents (8-K and press releases) for ENTX during the Q4 reporting period .

Estimates Context

Wall Street consensus estimates via S&P Global for ENTX Q4 2024 EPS and revenue were unavailable due to missing CIQ mapping; retrieval attempts failed. Where estimates are unavailable, comparisons to consensus cannot be made.

Metric	Q2 2024	Q3 2024	Q4 2024
EPS Consensus Mean	N/A	N/A	N/A
Revenue Consensus Mean ($USD Millions)	N/A	N/A	N/A

Values retrieved from S&P Global were unavailable (CIQ mapping not found).

Key Takeaways for Investors

Liquidity materially improved post-year-end to $21M, extending runway into Q3 2026 and de-risking near-term financing around Phase 3 initiation for EB613 .
EB613’s clinical profile continues to strengthen (JBMR publication, ASBMR presentation), positioning it well if FDA/SABRE qualifies BMD as a surrogate endpoint; Phase 3 could start promptly after regulatory updates .
The OPKO collaboration formalizes OXM’s path with shared economics and a 2025 IND, broadening optionality beyond osteoporosis into obesity/metabolic indications .
Operating losses persist as expected for a clinical-stage company; FY 2024 OpEx increased vs FY 2023 as programs advanced, and minimal revenue limits near-term P&L leverage .
Near-term stock reaction may hinge on FDA/SABRE outcome and EB613 Phase 3 start timing; positive regulatory clarity is a clear upside catalyst, while delays could pressure sentiment .
Sequentially, OpEx rose from Q2 to Q3 with EB613 prep; investors should expect continued investment intensity into Phase 3 and early clinical work for OXM/GLP-2 .
With estimates unavailable, focus should be on execution milestones (FDA/SABRE decision, Phase 3 initiation, OXM IND) and cash discipline to manage development timelines .

Sources: FY 2024 8-K and press release dated March 28, 2025 , Q3 2024 8-K/press release dated November 8, 2024 , Q2 2024 8-K dated August 9, 2024 .

Entera Bio Ltd. (ENTX)·Q4 2024 Earnings Summary