Executive Summary

Q2 2024 net loss improved year over year to $2.15M (loss per share $0.06) vs. $2.33M ($0.08) in Q2 2023; sequentially, net loss widened modestly from $2.02M in Q1 2024 .
Reported revenue of $0.057M and gross profit of $0.009M, marking a small but positive contribution versus zero revenue in Q2 2023 .
Cash and cash equivalents were $9.06M; management reiterated cash runway into Q3 2025 (maintained from Q1 guidance), supporting ongoing clinical programs without near‑term financing needs .
Pipeline catalysts intensify: JBMR publication for EB613, Phase 1 PK/PD results for EB612, and ASBMR selection of EB613 vs. Forteo data; FDA SABRE surrogate endpoint decision expected within ~five months of Aug 9, 2024, a potential valuation inflection for EB613 .
S&P Global Wall Street consensus estimates for ENTX were unavailable; comparisons to estimates cannot be made at this time (S&P Global consensus unavailable).

What Went Well and What Went Wrong

What Went Well

YoY operating discipline: total operating expenses declined to $2.17M from $2.33M; R&D decreased to $1.09M from $1.21M; G&A held flat at $1.09M vs. $1.14M, driving a YoY improvement in net loss and EPS .
Initial revenue contribution and gross profit: $0.057M revenue and $0.009M gross profit in Q2 2024 vs. zero a year ago, signaling early monetization of activities .
Strategic momentum in EB613 with CEO emphasizing broader pivotal design, dual mechanism, and oral mini‑tablet advantages: “we believe EB613 is uniquely positioned to support earlier osteoanabolic intervention…”; upcoming ASBMR data and anticipated FDA SABRE ruling cited as major catalysts .

What Went Wrong

Minimal top‑line scale: revenue remains de minimis ($0.057M) and gross profit modest ($0.009M), leaving losses driven by R&D and G&A; operating loss was $2.17M .
Sequential net loss widened slightly from Q1 ($2.02M to $2.15M), reflecting increased spend vs. Q1 as programs advance; loss per share rose from $0.05 to $0.06 .
Regulatory dependency and development risk remain high; management reiterates typical biotech risk factors and reliance on FDA SABRE timing and interpretation for Phase 3 EB613 pathway .

Financial Results

Year-over-Year (Q2 2023 → Q2 2024)

Metric ($USD thousands unless noted)	Q2 2023	Q2 2024
Revenues	$0	$57
Cost of Revenues	$0	$48
Gross Profit	$0	$9
Research & Development	$1,209	$1,086
General & Administrative	$1,135	$1,088
Total Operating Expenses	$2,330	$2,174
Operating Loss	$2,330	$2,165
Financial Income, net	$(5)	$(20)
Net Loss	$2,325	$2,145
Loss per share (basic & diluted)	$0.08	$0.06
Weighted Avg Shares (basic & diluted)	28,812,375	37,090,160

Sequential Trend (Q1 2024 → Q2 2024)

Metric ($USD thousands unless noted)	Q1 2024	Q2 2024
Research & Development	$735	$1,086
General & Administrative	$1,327	$1,088
Total Operating Expenses	$2,062	$2,174
Net Loss	$2,017	$2,145
Loss per share (basic & diluted)	$0.05	$0.06
Cash & Cash Equivalents (period-end)	$9,189	$9,056

Balance Sheet Snapshot

Metric ($USD thousands)	Dec 31, 2023	Mar 31, 2024	Jun 30, 2024
Cash & Cash Equivalents	$11,019	$9,189	$9,056
Total Assets	$11,765	$10,239	$10,035
Total Liabilities	$1,379	$1,376	$1,503
Total Shareholders’ Equity	$10,386	$8,863	$8,532

Segment breakdown: Not applicable (clinical-stage; no reportable revenue segments) .

KPIs:

Cash runway guidance: into Q3 2025 (maintained from Q1) .
Weighted average shares increased YoY (28.8M → 37.1M) .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Cash Runway	Through Q3 2025	Into Q3 2025 (Q1 2024)	Into Q3 2025 (Q2 2024)	Maintained
Revenue	FY/Quarter	Not provided	Not provided	N/A
Margins	FY/Quarter	Not provided	Not provided	N/A
Operating Expenses	FY/Quarter	Not provided	Not provided	N/A
OI&E / Tax	FY/Quarter	Not provided	Not provided	N/A
Dividends	FY/Quarter	None	None	Unchanged

Earnings Call Themes & Trends

Note: No Q2 2024 earnings call transcript was found for ENTX; themes below reflect management disclosures in Q4 2023, Q1 2024, and Q2 2024 press releases.

Topic	Previous Mentions (Q4 2023)	Previous Mentions (Q1 2024)	Current Period (Q2 2024)	Trend
Regulatory/SABRE (FDA BMD surrogate)	Expect SABRE qualification update; EB613 poised to leverage SABRE	FDA expects ruling qualifying BMD as surrogate within 10 months (Mar 2024)	“Five months away” from potential ruling; major catalyst for EB613	Momentum building; timeline narrowing
EB613 (oral PTH(1‑34) osteoanabolic)	Phase 2 manuscript submitted; differentiated PK vs Forteo presented Oct 2023	JBMR publication; pivotal study design aligned to SABRE	ASBMR selection for comparative data vs Forteo; SABRE update session at ASBMR	Strong scientific visibility; pivotal readiness
EB612 (hypoparathyroidism)	Advancing next‑gen formulation; Phase 1 data expected H1 2024	Submitted Phase 1 PK/early PD to ENDO 2024	Phase 1 PK/PD and safety presented at ENDO; BID dosing supported for Phase 2	Progressing to Phase 2 pathway
GLP‑2 (short bowel)	OPKO long‑acting GLP‑2 oral program; pre‑IND PK H1 2024	Positive in vivo PK; pharmacology expected early H2 2024	Pharmacology data expected early H2 2024	Execution moving from PK to pharmacology
OXM GLP‑1/glucagon (obesity)	Oral OXM PK mid‑2024 (OPKO)	Oral OXM PK mid‑2024; plan pharmacology thereafter	Oral OXM PK expected early H2 2024	Slight schedule slide to early H2 2024
Macro/supply chain/tariffs	Not discussed	Not discussed	Not discussed	No change

Management Commentary

“We continue to deliver strong execution… we are now just five months away from FDA’s potential landmark ruling on the ASBMR‑FNIH SABRE regulatory endpoint… a major catalyst for EB613… EB613 is uniquely positioned to support earlier osteoanabolic intervention in post‑menopausal women at high risk of fracture.” — Miranda Toledano, CEO .
On EB613 clinical positioning: selection for ASBMR comparative data vs. Forteo with SABRE update session scheduled, highlighting differentiation and regulatory pathway visibility .
On EB612: Phase 1 study showed significant systemic exposure with sustained PD effects (calcium, phosphate, vitamin D), reduced endogenous PTH, and no hypercalcemia; BID dosing supported for Phase 2 .

Q&A Highlights

No Q2 2024 earnings call transcript or Q&A was available in the company document set; therefore, no analyst Q&A themes or clarifications can be reported for this quarter. If a call occurred without a published transcript, key points were not accessible via primary filings [Search returned none].

Estimates Context

S&P Global Wall Street consensus estimates for ENTX (EPS, revenue) for Q2 2024 were unavailable; as a result, we cannot assess beats/misses versus consensus this quarter (S&P Global consensus unavailable).
Given the absence of estimates, near‑term adjustments will be driven more by regulatory/milestone timing and cash runway than by financial model revisions .

Key Takeaways for Investors

Cash runway into Q3 2025 provides a stable funding horizon to reach pivotal EB613 milestones and additional Phase 1/2 readouts across the peptide portfolio .
FDA SABRE qualification is the dominant near‑term catalyst; a positive ruling could unlock EB613 Phase 3 initiation and de‑risk the regulatory path, potentially reframing valuation .
EB613 scientific momentum is strong (JBMR publication, ASBMR comparative selection), supporting differentiation vs. injectable teriparatide and addressing adherence/treatment gaps in osteoporosis .
EB612 Phase 1 results (PK/PD/safety) and prospective BID dosing support movement into Phase 2, expanding Entera’s endocrine franchise .
GLP‑2 and OXM programs with OPKO advance from PK to pharmacology in H2 2024, broadening optionality in GI/metabolic indications and potential partnering pathways .
Financials remain loss‑making with minimal revenue; equity issuance risk is mitigated near‑term by runway, but milestones and regulatory outcomes will dictate future capital needs .
Trading implications: stock likely sensitive to news flow from ASBMR (late Sep 2024) and any FDA SABRE communications; position sizing should reflect binary regulatory risk and microcap volatility .

Entera Bio Ltd. (ENTX)·Q2 2024 Earnings Summary