Executive Summary

Q3 2024 was steady operationally with continued advancement of EB613 toward Phase 3 and delivery of topline PK/PD for the oral GLP-1/glucagon (OXM) tablet in collaboration with OPKO; financially, operating expenses rose as the company prepared for EB613 Phase 3, widening the quarterly loss to $3.0M (–$0.08/share) .
Revenue was de minimis ($0.042M) and gross profit was nil, consistent with Entera’s development-stage profile; net loss increased QoQ on higher R&D (materials for EB613 Phase 3 prep) and higher G&A (IP, consulting, SBC) .
Liquidity remains the key watch item: cash was $6.9M at quarter-end with runway “into Q3 2025,” unchanged from prior quarters, implying a financing/partnership need ahead of Phase 3 initiation absent additional capital .
Near-term catalysts center on the FDA’s potential January 2025 decision on SABRE (qualification of BMD as a surrogate endpoint), which management believes EB613 is “first in line” to leverage; positive OXM PK/PD readout in September supports optionality outside bone health .

What Went Well and What Went Wrong

What Went Well
- EB613 momentum: management reiterated anticipation of an FDA SABRE ruling by January 2025 and positioned EB613 as first to leverage the pathway; Phase 3 preparation continued .
- OXM (oral GLP-1/glucagon) delivered: Entera and OPKO announced topline OXM PK/PD showing significant systemic exposure, favorable PK/bioavailability, and statistically significant glucose reduction vs placebo; data to be presented at an upcoming conference .
- Portfolio breadth maintained: GLP-2 program pre-IND work continued with final in vivo PK/PD expected in 2H 2024; EB612 collaboration remained productive .
What Went Wrong
- Operating expense uptick: Operating expenses rose to $3.0M (from $2.2M in Q2), driven by EB613 Phase 3 materials and higher G&A, widening net loss to $3.0M (from $2.1M in Q2) .
- Revenue remained negligible ($0.042M) with zero gross profit, underscoring continued reliance on external financing or partnerships to fund pivotal programs .
- No explicit financial guidance beyond runway; lack of an earnings call transcript limited external Q&A and guidance color for investors this quarter .

Financial Results

Operating performance (USD thousands, except per-share; periods are fiscal quarters, oldest → newest)

Metric	Q1 2024	Q2 2024	Q3 2024
Revenues ($k)	— (not disclosed in Q1 8-K)	57	42
Cost of Revenues ($k)	— (not disclosed in Q1 8-K)	48	42
Gross Profit ($k)	— (not disclosed)	9	0
Research & Development ($k)	735	1,086	1,477
General & Administrative ($k)	1,327	1,088	1,544
Total Operating Expenses ($k)	2,062	2,174	3,021
Net Loss ($k)	2,017	2,145	3,021
Loss per Share (Basic & Diluted)	$0.05 loss	$0.06 loss	$0.08 loss
Weighted Avg Shares (Basic & Diluted)	36,735,429	37,090,160	37,644,612

Liquidity (USD thousands; balance sheet dates)

Metric	Q1 2024 (Mar 31)	Q2 2024 (Jun 30)	Q3 2024 (Sep 30)
Cash & Cash Equivalents ($k)	9,189	9,056	6,915
Total Assets ($k)	10,239	10,035	7,741
Total Liabilities ($k)	1,376	1,503	1,289
Shareholders’ Equity ($k)	8,863	8,532	6,452
Runway Commentary	Runway into Q3 2025	Runway into Q3 2025	Runway into Q3 2025

Comparison highlights:

Revenue: $42k vs $57k in Q2 (–$15k QoQ), vs $0 in Q3’23 (first nominal revenue) .
Net loss: $3.0M vs $2.1M in Q2 (driven by EB613 materials and higher G&A) .
Cash: $6.9M vs $9.1M in Q2; “runway into Q3 2025” maintained .

Segment breakdown and KPIs

No reportable segments or product revenue KPIs disclosed; gross profit was $0 and the business remains pre-commercial .

Non-GAAP

No non-GAAP financial measures were presented; all figures above are GAAP .

Guidance Changes

Metric/Topic	Period	Previous Guidance	Current Guidance	Change
Cash runway	Operating runway	“Sufficient into Q3 2025” (Q1 and Q2)	“Sufficient into Q3 2025”	Maintained
EB613 Phase 3 path (BMD surrogate endpoint)	Regulatory timing	FDA/SABRE surrogate endpoint ruling expected within ~10 months from Mar 26, 2024 (i.e., by Jan 2025)	“Keenly anticipating FDA’s potential ruling… expected in January 2025; EB613 first in line to leverage”	Maintained (timing reiterated)
OXM (oral GLP-1/glucagon)	Data milestones	PK data expected early 2H 2024	Topline PK/PD announced Sep 2024; statistically significant glucose reduction vs placebo	Delivered
GLP-2 (oral GLP-2 tablet)	Data milestones	Pharmacology data expected early 2H 2024	Final in vivo PK/PD expected 2H 2024; pre-IND validation ongoing	Maintained
EB612 (oral PTH for hypopara)	Program status	Phase 1 data supports moving BID dose to Phase 2; collaboration ongoing	Collaboration continues productively	Maintained

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

Earnings Call Themes & Trends

(Company did not furnish an earnings call transcript; themes reflect management commentary across quarterly press releases/8-Ks.)

Topic	Previous Mentions (Q1 & Q2 2024)	Current Period (Q3 2024)	Trend
EB613 regulatory pathway (SABRE/FDA)	FDA expected to rule on BMD surrogate within ~10 months from Mar 26, 2024; Phase 3 prep underway	“Potential landmark ruling… expected in Jan 2025”; EB613 “first in line” to leverage; Phase 3 prep continued	On track; conviction reiterated
EB613 clinical differentiation	JBMR Phase 2 publication; ASBMR 2024 abstract selection	ASBMR 2024 presentation preview; continued positioning as first oral anabolic tablet	Increasing visibility
OXM (oral GLP-1/glucagon)	PK readout expected early 2H 2024	Topline PK/PD delivered; significant systemic exposure and glucose reduction vs placebo	Milestone achieved
GLP-2 (SBS)	Positive in vivo PK; pharmacology data expected early 2H 2024	Final in vivo PK/PD expected 2H 2024; pre-IND validation ongoing	On track
EB612 (hypopara)	Phase 1 data supportive; collaboration ongoing	Collaboration continues	Stable
Cash runway	Runway into Q3 2025	Runway into Q3 2025	Maintained

Management Commentary

“We are headed into a busy year end across all programs and keenly anticipating FDA’s potential landmark ruling on the ASBMR-FNIH SABRE regulatory endpoint for osteoporosis drugs, expected in January 2025… We believe that our pivotal program for EB613 is first in line to leverage this pathway.” — Miranda Toledano, CEO .
On OXM: “Oral OXM exhibited significant systemic exposure across two in vivo models… high plasma concentrations with prolonged systemic exposure… Oral OXM showed a statistically significant reduction in plasma glucose levels compared with placebo.” .
Expense drivers: R&D increased due to “materials… related to the preparation of the EB613 phase 3 study”; G&A up on IP, consulting, and SBC .

Q&A Highlights

No earnings call transcript was available in the company’s filings/press releases set this quarter; as such, there were no publicly documented Q&A exchanges. Notable clarifications came in the release: higher R&D tied to EB613 Phase 3 materials and G&A increases from IP/consulting/SBC .

Estimates Context

Wall Street consensus (S&P Global) for Q3 2024 EPS and revenue was unavailable for ENTX in our toolset (missing mapping); consequently, we cannot quantify beats/misses versus consensus this quarter. We attempted to retrieve S&P Global consensus via GetEstimates for Q3 2024 and received a mapping error indicating no CIQ link for ENTX in the database [functions.GetEstimates error].
Given minimal revenue and development-stage status, we would expect estimate dispersion and limited analyst coverage; if needed, we can revisit once S&P Global coverage mapping becomes available.

Key Takeaways for Investors

The story remains binary around the FDA’s anticipated January 2025 SABRE decision; a positive ruling that qualifies BMD as a surrogate could materially de-risk EB613’s Phase 3 design and timeline .
OXM’s positive PK/PD results with OPKO broaden optionality beyond bone health, potentially enhancing partnership appeal and diversified value creation pathways .
Operating expenses are ramping with EB613 Phase 3 preparation; expect elevated burn and a financing/partnering need before Phase 3 unless additional capital is secured (runway “into Q3 2025”) .
Revenue remains negligible, and gross profit is effectively zero; investment case hinges on clinical/regulatory milestones rather than near-term P&L .
Watch for: (1) FDA SABRE ruling (Jan 2025), (2) EB613 Phase 3 initiation steps, (3) GLP-2 final in vivo PK/PD disclosure, (4) OXM data presentations, and (5) financing or business development updates .
In the short term, shares may trade on regulatory headline risk and partnering signals; medium term, EB613 Phase 3 initiation and broader N-Tab pipeline execution will shape the valuation narrative .

References

Q3 2024 press release: Entera Bio Reports Q3 2024 Financial Results and Provides Business Updates (financials, program updates, balance sheet) .
Q3 2024 8-K (Item 2.02) and Exhibit 99.1 (press release; financial statements) .
Q2 2024 8-K and press release (trend analysis) ; .
Q1 2024 8-K and press release (trend analysis) .
Additional Q3-relevant context on EB613/ASBMR and investor activities .

Entera Bio Ltd. (ENTX)·Q3 2024 Earnings Summary