Entera Bio Ltd.

ENTX

$2.95

+1.03%

N/A+$0.03

Healthcare

Biotechnology

NASDAQ

Active Trading

Entera Bio Ltd. is a biopharmaceutical firm in the clinical development phase, dedicated to creating and marketing oral medications composed of large ...

Fundamental Analysis of ENTX

Key Strengths

FDA engagement for EB613: written agreement outlining a single Phase 3 design supporting an NDA, reducing regulatory uncertainty versus a less-defined path

Promising Phase 2 signals for EB613: reported biomarker and multi-site BMD improvements with no significant safety concerns cited in the provided materials

Risk Factors

Clinical-stage execution risk: Phase 3 success is not assured; oral peptide/protein therapies can face absorption, durability, or tolerability issues not fully captured in Phase 2

Financing and dilution risk: development-stage losses and a recent going-concern/shelf warning increase the probability of additional equity/warrant issuance

Profitability

Net Margin0.00%

Operating Margin0.00%

Valuation

P/E Ratio-8.82x

Current Ratio8.98

Efficiency

ROE-147.19%

ROA-87.44%

Fundamental Analysis of ENTX

Entera Bio (ENTX) is a clinical-stage biopharmaceutical company focused on converting injectable peptide/protein replacement therapies into orally delivered tablet formulations using its proprietary N-Tab platform. The investment case is largely tied to the probability-weighted success of its lead asset EB613 (oral PTH(1-34)) in postmenopausal osteoporosis. The company reports Phase 2 results demonstrating improvements in bone turnover biomarkers and bone mineral density (BMD) measures versus placebo, and it has secured FDA alignment on a single registrational Phase 3 approach (24-month study; total hip BMD as the primary endpoint; vertebral fractures as a key secondary endpoint). Management also expects Phase 3 initiation and continued execution catalysts in late 2026, with topline results anticipated in H2 2028. A second internal program, EB612 (oral PTH(1-34)) for hypoparathyroidism, is expected to move toward IND submission late 2026, while additional preclinical-stage tablet candidates exist through collaborations with OPKO Health (oral GLP-2 and oxyntomodulin programs). Fundamentally, the business remains loss-making with minimal revenue. FY2025 revenue was approximately $42K, while net income was about -$11.4M and operating cash flow about -$7.4M, reflecting a development-stage profile typical for small-cap biotech. Profitability metrics (gross/operating/net margins) are effectively not meaningful at this stage, and current financial ratios indicate liquidity strength (current ratio reported near ~6.9–9 depending on source snapshot), but liquidity can change quickly given ongoing clinical and platform costs. Balance-sheet solvency appears supported by working capital, yet the company has recently disclosed a going-concern warning tied to the shelf/sourcing of capital, and it has executed a sizable PIPE/private placement recently—highlighting ongoing funding needs. Valuation multiples are not informative (negative P/E; margins near zero). From a risk/return standpoint, ENTX offers upside convexity if EB613 demonstrates a differentiated safety/efficacy profile in Phase 3 and achieves regulatory approval, potentially enabling a new standard of care for anabolic osteoporosis via an oral alternative. Offsetting risks include clinical trial risk (endpoint validity, durability, safety), regulatory and manufacturing scale-up execution, competitive dynamics in osteoporosis and endocrine replacement therapies, and continued reliance on external capital markets given losses and near-zero revenues. Overall, the fundamentals are best viewed as a catalyst-driven, long-duration biotech bet rather than a stable cash-flow compounder.

Key Strengths of ENTX

FDA engagement for EB613: written agreement outlining a single Phase 3 design supporting an NDA, reducing regulatory uncertainty versus a less-defined path
Promising Phase 2 signals for EB613: reported biomarker and multi-site BMD improvements with no significant safety concerns cited in the provided materials
Platform differentiation potential: N-Tab is intended to solve the technical challenge of oral delivery of macromolecule therapeutics (peptides/proteins)
Portfolio expansion beyond osteoporosis: EB612 (hypoparathyroidism) plus OPKO-collaborated oral GLP-2 and oxyntomodulin programs diversify the pipeline
Liquidity indicators are relatively strong in the near term (high reported current ratio/working capital), supporting the runway to planned major milestones
Upcoming high-impact catalysts: planned late-2026 IND/Phase 3 initiation events can re-rate sentiment if execution remains on track

Risk Factors of ENTX

Clinical-stage execution risk: Phase 3 success is not assured; oral peptide/protein therapies can face absorption, durability, or tolerability issues not fully captured in Phase 2
Financing and dilution risk: development-stage losses and a recent going-concern/shelf warning increase the probability of additional equity/warrant issuance
Low current fundamentals: revenue is negligible and margins are effectively zero/negative, making valuation sentiment-driven rather than cash-flow supported
Regulatory and endpoint risk: reliance on BMD endpoints and fracture incidence as secondary outcomes creates the possibility of regulatory non-acceptance or weaker-than-expected results
Manufacturing and CMC risk: scaling formulation and ensuring consistent oral tablet performance can be difficult for macromolecule delivery
Market and competitive pressure: osteoporosis and endocrine markets have established therapies and ongoing R&D; an oral entrant must demonstrate meaningful differentiation
Timeline risk: the Phase 3 roadmap spans multiple years; delays in dosing/monitoring/capital availability can impact probability-weighted value

Market Cap vs Revenue & Earnings

Earnings

n/a

Revenue

n/a

Market cap

$145.41M

-8.8x

P/E Ratio

0.0x

P/S Ratio

Earnings & Revenue

Last Reportedn/a

Earnings per share (EPS)n/a

Gross Margin0.00%

Net Profit Margin0.00%

Debt/Equity Ratio0.06

Profitability Bridge (Current vs YoY)

How gross, operating and net margins shifted versus last year.

Revenue / Net Income / FCF History (USD B)

Growth Signals of ENTX

Metric	Current	Previous	YoYYear-over-Year change: current quarter versus the same quarter last year.	QoQQuarter-over-Quarter change: current quarter versus the immediately previous quarter.	Signal
Revenue	—	—	—	—	Flat
Diluted EPS	—	—	—	—	Flat
Free Cash Flow	—	—	—	—	Flat

Profitability of ENTX

Metric	Current	Previous	YoYYear-over-Year change: current quarter versus the same quarter last year.	QoQQuarter-over-Quarter change: current quarter versus the immediately previous quarter.	Signal
Net Margin	—	0.00%	—	—	Flat
Operating Margin	—	0.00%	—	—	Flat
ROE	—	—	—	—	Flat

Financial Health of ENTX

Metric	Current	Previous	YoYYear-over-Year change: current quarter versus the same quarter last year.	QoQQuarter-over-Quarter change: current quarter versus the immediately previous quarter.	Signal
Current Ratio	—	8.981	—	—	Flat
Quick Ratio	—	8.981	—	—	Flat
Debt / Equity	—	0.058	—	—	Flat

Valuation of ENTX

Metric	Current	Previous	YoYYear-over-Year change: current quarter versus the same quarter last year.	QoQQuarter-over-Quarter change: current quarter versus the immediately previous quarter.	Signal
P/E	—	-3.16x	—	—	Flat
P/B	—	12.29x	—	—	Flat

Supply Chain of ENTX

RELATIONS

Upstream

UK-Based Contract Manufacturing Organization (CMO)OPKO Health, Inc.NASDAQ:OPKPeptide API Raw Material Suppliers (via CMO / OPKO)American Stock Transfer & Trust CompanyKesselman & Kesselman (PwC Israel)

Downstream

OPKO Health, Inc.NASDAQ:OPK Amgen Inc.NASDAQ:AMGNFuture Commercial Partners (Not Yet Established)

Proxies

Oramed Pharmaceuticals Inc.NASDAQ:ORMP Novo Nordisk A/SNYSE:NVORadius Health, Inc.OTCPK:RDUS

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Plutux is not an investment adviser. Market data and AI-generated analysis are for information and education only, not investment advice. Disclaimer