Executive Summary

Q2 2025 delivered a net loss of $2.66M ($0.06 loss per share) on $0 revenue, as Entera completed the first stage of a 2024 research services agreement and did not recognize revenue in the quarter; operating expenses rose 23% year over year to $2.67M .
Material regulatory de-risking: FDA concurred with EB613 Phase 3 design using total hip BMD as the primary endpoint, with vertebral fracture incidence as key secondary, and waived dedicated oral carcinogenicity and comprehensive DART studies—streamlining the registrational path for the first oral anabolic osteoporosis tablet .
Pipeline momentum with OPKO: mini‑pig PK for oral dual GLP‑1/glucagon OPK‑88006 showed plasma levels consistent with the highest subcutaneous Wegovy dose, supporting a once‑daily tablet regimen; Phase 1 planning underway with IND targeted in H1 2026 .
Balance sheet: $10.86M cash and $8.02M restricted cash (OPKO escrow) at quarter‑end; management guides runway through mid‑Q3 2026, excluding funding needed to initiate EB613 Phase 3 .
EPS beat vs S&P Global consensus: actual loss per share of $0.06 vs consensus $0.11 loss, a $0.05 beat; revenue consensus was unavailable for Q2 2025 (data from S&P Global). *

What Went Well and What Went Wrong

What Went Well

FDA alignment on EB613 Phase 3 design (BMD primary endpoint; fractures key secondary) materially de‑risks registration; management: “pivotal milestone…opens the door to addressing a massive unmet need” .
Regulatory burden reduced: FDA agreed dedicated oral carcinogenicity and comprehensive DART studies are not warranted based on EB613 and Forteo literature—accelerating timelines and lowering cost .
OPKO obesity program progressed: oral OPK‑88006 PK in mini‑pig matched plasma levels associated with high‑dose Wegovy, supporting a once‑daily tablet; IND planned for H1 2026 .

What Went Wrong

No quarterly revenue; Q2 gross profit was $0 as research services revenue recognized in 2024 did not recur in Q2 2025 .
R&D spending increased by $0.43M YoY on Phase 3 preparations and regulatory activities, elevating operating loss YoY and sequentially .
Going‑concern risk persists; runway guided through mid‑Q3 2026, but additional capital is required to commence EB613 Phase 3 (not covered by current resources) .

Financial Results

Metric	Q2 2024	Q1 2025	Q2 2025
Revenue ($USD Thousands)	57	42	0
Net Loss ($USD Thousands)	2,145	2,567	2,656
Diluted EPS ($USD)	0.06 (loss)	0.06 (loss)	0.06 (loss)
Total Operating Expenses ($USD Thousands)	2,174	2,563	2,668

Notes:

Q1 2025 revenue equals six‑month revenue ($42K) less Q2 ($0), per disclosures; Q1 operating expenses equal six‑month OpEx ($5,231K) less Q2 ($2,668K) .
Q1 2025 EPS equals six‑month loss per share ($0.12) less Q2 loss per share ($0.06) .

Cash and Liquidity

Metric	Dec 31 2024	Jun 30 2025
Cash and cash equivalents ($USD Thousands)	8,660	10,858
Restricted cash ($USD Thousands)	0	8,015
Total cash & restricted cash ($USD Thousands)	8,660	18,954

KPIs

KPI	Q2 2024	Q2 2025
R&D Expense ($USD Thousands)	1,086	1,520
G&A Expense ($USD Thousands)	1,088	1,148
Weighted Avg Shares (Millions)	37.09	46.84

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Cash runway	Operating runway	Not disclosed prior in these documents	Through mid‑Q3 2026	New disclosure
EB613 Phase 3 design	Registration path	Prior FDA concurrence in 2023 on BMD‑based Phase 3, pending SABRE qualification	FDA Type A concurrence confirming single 24‑month Phase 3; total hip BMD primary, vertebral fractures key secondary	Clarified/strengthened
Next‑gen EB613 Phase 1	Program start	Not previously dated in these docs	Phase 1 Safety/PK start expected Nov 2025	New timing
OPK‑88006 (oral dual GLP‑1/glucagon)	IND timing	Program progressing; preclinical PK/PD announced Sept 2024	IND expected H1 2026	New timing/affirmed
EB612 hypoparathyroidism	Near‑term data	Phase 1 data presented Jun 2024	First preclinical PK/PD data for once‑daily tablet format expected by year‑end	Updated milestone

Earnings Call Themes & Trends

No Q2 2025 earnings call transcript was available in the document catalog.

Topic	Previous Mentions (Q‑2 and Q‑1)	Current Period (Q2 2025)	Trend
Regulatory endpoint (BMD)	FDA indicated BMD‑based Phase 3 could support NDA; SABRE qualification pending (2023–2024)	FDA Type A concurrence: single 24‑month Phase 3; total hip BMD primary; fractures key secondary	Improving regulatory clarity
Preclinical safety burden	Not specified	FDA waived dedicated oral carcinogenicity and comprehensive DART studies	Lower complexity/cost
Obesity (oral dual GLP‑1/glucagon)	Sept 2024 topline PK/PD for oral OXM; strong exposure and glucose reduction	Mini‑pig PK plasma levels consistent with highest Wegovy dose; IND H1 2026	Advancing to IND
EB612 hypoparathyroidism	Phase 1 data presented Jun 2024	First preclinical PK/PD on long‑acting PTH tablet expected by year‑end	Continuing progress
Liquidity/financing	ATM refresh Jan 2025; OPKO share issuance with escrow and lockup	Runway through mid‑Q3 2026; Phase 3 funding needed	Stable near‑term; funding gap for Phase 3
Geopolitical exposure	Israel conflicts disclosed; immaterial impact to date	Operations remain largely unaffected; risk disclosures reiterated	Monitored risk

Management Commentary

CEO: “Last week's FDA agreement on using BMD as the primary endpoint for EB613's Phase 3 program represents a pivotal milestone…The concurrence opens the door to addressing a massive unmet need…” .
On pipeline breadth: “We continued building momentum…presenting promising pharmacokinetic data for our oral GLP‑1/glucagon dual agonist…With our strengthened cash position of $18.9 million…we are well‑positioned to execute on multiple value‑creating milestones” .
On regulatory streamlining: Phase 3 single study design, BMD primary endpoint; waiver of dedicated oral carcinogenicity and comprehensive DART studies .

Q&A Highlights

No Q2 2025 earnings call transcript was available; therefore Q&A themes and clarifications are not available in the documents reviewed.

Estimates Context

Metric	Consensus (S&P Global)	Actual	Surprise
EPS (Q2 2025)	-$0.11*	-$0.06	+$0.05 beat
Revenue (Q2 2025)	N/A*	$0	N/A

*Values retrieved from S&P Global.

Consensus depth: One EPS estimate for Q2 2025 and one for Q3 2025 were available; revenue consensus for Q2 2025 was unavailable; Q3 2025 revenue consensus shows $0 with one estimate (S&P Global).*

Key Takeaways for Investors

FDA concurrence on EB613 Phase 3 design and waived preclinical requirements reduces regulatory risk and cost—an important catalyst for partnership or financing discussions ahead of Phase 3 initiation .
The oral dual GLP‑1/glucagon program’s PK profile aligning with Wegovy’s highest dose supports differentiation in a tablet format; IND targeted H1 2026, offering a medium‑term pipeline value driver .
Near‑term financials remain R&D‑driven with no revenue; Q2 OpEx rose 23% YoY, and net loss increased YoY—consistent with advancing programs toward registrational work .
Liquidity is adequate through mid‑Q3 2026 (including OPKO‑escrowed funds), but EB613 Phase 3 will require incremental capital; expect equity/partnering over the next 6–12 months .
EPS beat vs consensus reflects disciplined cost control amid increased regulatory activities; however, without revenue contribution, estimate revisions will hinge on Phase 3 timing and financing visibility (S&P Global; actual EPS) *.
Geopolitical risk disclosures remain heightened but operations were largely unaffected; monitor potential impacts to timelines and financing conditions .
Trading implication: Regulatory clarity on EB613 and IND timing for OPK‑88006 are likely narrative drivers; headline updates on Phase 3 start and funding could be stock‑moving events .

Additional Sources and Cross‑References

8‑K 2.02 press release with Q2 2025 financials and business updates .
Q2 2025 10‑Q for detailed financial statements, MD&A, liquidity, and risk disclosures .

Press releases and Q2 2025 earnings call transcript were not available beyond the 8‑K Exhibit 99.1 press release in the document catalog searched.

Entera Bio Ltd. (ENTXW)·Q2 2025 Earnings Summary