Entera Announces Third Quarter 2026 Financial Results and Business Updates

The planned osteoporosis trial will measure total hip bone mineral density changes at Month 12 as its primary endpoint.

Rhea-AI Summary

Entera Bio (NASDAQ: ENTX) reported a third-quarter net loss of $15.597 million while advancing preparations for its EB613 osteoporosis trial. Loss per share was $0.11 versus $0.07 a year earlier. Research and development expenses rose to $4.925 million from $1.643 million.

Cash and equivalents were $265.883 million at September 30, 2026, following July’s approximately $275.0 million gross private placement. Entera expects funding to cover the planned EB613 Phase 3 program through results and an anticipated regulatory application, supporting operations into 2030.

Entera expects first Phase 3 site activation in late 2026 and topline results in the second half of 2028. The trial is expected to enroll approximately 900 women. A Phase 2 post-hoc analysis showed enhanced bone-marker changes in women with lower bone density. Entera plans an EB612 Phase 1 study with OPKO in 2027. Laura Hamill and Juan Camilo Arjona Ferreira join the board December 1, 2026.

8 points · 1 major

PositiveiHow this balance works

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It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.

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0 major · 5 points

Hollow bars mark forward-looking points. How the balance works

Positive

• Major pointJuly’s completed private placement raised approximately $275.0 million gross, before placement agent fees and offering expenses. 53% of market cap
• Moderate point. Forward-looking: it has not happened yet and may not happen.Entera expects cash to fund EB613 through anticipated NDA submission and operations into 2030.
• Moderate pointFDA acceptance of EB613’s proposed registrational plan allows a Phase 3 trial that may support a marketing application.
• Minor pointCash and equivalents increased to $265.883 million at September 30, 2026, from $7.108 million at December 31, 2025.
• Minor point. Forward-looking: it has not happened yet and may not happen.Entera expects first EB613 Phase 3 site activation in late 2026 and topline results in second-half 2028.

3 minor points

• Minor point. Forward-looking: it has not happened yet and may not happen.EB613 Phase 3 is expected to enroll approximately 900 women, randomized 2:1 to EB613 or placebo.
• Minor pointEB613 Phase 2 post-hoc analysis showed enhanced bone-marker changes in women with T-scores of -2.5 or lower.
• Minor point. Forward-looking: it has not happened yet and may not happen.EB612 development with OPKO has IND-enabling studies ongoing; Entera plans a Phase 1 single ascending dose study in 2027.

Negative

• Moderate pointQuarterly net loss widened to $15.597 million from $3.200 million; basic and diluted loss per share rose to $0.11 from $0.07.
• Minor pointResearch and development expenses rose to $4.925 million from $1.643 million in the prior-year quarter.
• Minor pointGeneral and administrative expenses rose to $2.340 million from $1.613 million in the prior-year quarter.
• Minor pointNet financial expenses were $8.332 million versus $56,000 net financial income in the prior-year quarter.
• Minor pointRestricted cash of $6.536 million at September 30, 2026, was primarily designated for the OPKO collaboration.

Key Figures

Cash and cash equivalents: $265.9 million Restricted cash: $6.5 million Private placement proceeds: Approximately $275.0 million gross +5 more

Cash and cash equivalents

$265.9 million

As of September 30, 2026

Restricted cash

$6.5 million

As of September 30, 2026

Private placement proceeds

Approximately $275.0 million gross

Completed in July 2026, before fees and expenses

Expected funding horizon

Into 2030

Company says resources are expected to support operations

Research and development expenses

$4.9 million vs. $1.6 million

Three months ended September 30, 2026 vs. 2025

Net loss

$15.6 million vs. $3.2 million

Three months ended September 30, 2026 vs. 2025

Planned Phase 3 enrollment

Approximately 900 women; randomized 2:1

EB613 or placebo

Phase 3 milestones

First site activation expected in late 2026; topline results anticipated in the second half of 2028

EB613 study

Previous Earnings Reports

1 past event · Latest: Aug 07

Same Type 1 event

1. Aug 07

   Quarterly results

   24h Move

   +5.9%

   FDA accepted EB613 Phase 3 plan; placement was expected to fund development through NDA.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

bmd, dxa, 505(b)(2), nda, +1 more

5 terms

bmd medical

"bone mineral density (BMD) accrual"

Bone mineral density (BMD) is a medical measure of how much mineral — mainly calcium — is packed into a specific volume of bone, often reported as a number from a scan. Investors care because changes in BMD are common primary endpoints for drugs and devices treating osteoporosis and bone disorders; stronger effects on BMD can signal higher chances of regulatory approval, broader market use, and bigger revenue potential. Think of it as a method for checking how solid a building’s concrete is.

dxa medical

"diagnosed by DXA with BMD T-score ≤-2.5"

DXA (dual-energy X-ray absorptiometry) is a medical imaging test that measures bone density and body composition by passing two low-dose X-ray beams through the body. Investors care because DXA machines and the tests they perform are central to diagnosing osteoporosis, monitoring treatments, and generating recurring revenue for clinics and device makers; think of it like a high-precision ruler that tracks bone health and demand for related healthcare services.

505(b)(2) regulatory

"under the 505(b)(2) regulatory pathway"

A 505(b)(2) is an FDA drug approval pathway that lets a company win approval by relying partly on existing studies or published data instead of doing all new clinical trials. Think of it like building a renovated house using the original foundation: it can be faster and less costly than a full new-drug route, reducing development risk and expense. Investors care because it can speed market entry, lower capital needs, and offer opportunities for exclusivity or competitive advantage.

nda regulatory

"may support the NDA"

An NDA, or nondisclosure agreement, is a legal contract that keeps certain information private between parties. It’s like a promise not to share sensitive details, helping protect business ideas, strategies, or data from being leaked or used without permission. For investors, NDAs help ensure that confidential information remains secure, enabling trust and open communication during business discussions.

pk medical

"separate population PK and PK substudies planned"

Pharmacokinetics (PK) describes how a drug moves through the body—how quickly it is absorbed, how it spreads to tissues, how the body breaks it down, and how it is eliminated. For investors, PK data help predict whether a medicine can reach effective levels without causing harm, how often it must be dosed, and whether drug interactions or patient differences could affect commercial success; think of it as the drug’s travel and timing profile inside the body.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Clinical Preparations Advanced for EB613 Phase 3 Osteoporosis Study, with First Site Activation Expected in Late 2026

Clinical and Commercial Leadership Expanded with Appointment of Senior Executives and Directors

EB613 Enhanced Anabolic Effect Highlighted at ASBMR Plenary Poster Presentation

IND-Enabling Activities Ongoing for EB612, in Development with OPKO for Hypoparathyroidism

Tel Aviv, Nov. 06, 2026 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX) (“Entera” or the “Company”), a leader in the development of oral peptides, today reported financial results and key business updates for the quarter ended September 30, 2026.

“The third quarter of 2026 transitioned our expanding team into late-stage clinical execution mode. The opportunity to evaluate the safety and efficacy of EB613 as the first oral anabolic treatment for osteoporosis has generated excitement among clinical investigators and patients. Our team is fully focused on ensuring a seamless trial launch, with expected first site activation in late 2026. Additionally, the post-hoc analysis that we presented at ASBMR 2026 demonstrated that our Phase 2 6-month clinical data with EB613 show rapid stimulation of bone formation and robust early bone mineral density (BMD) accrual, especially in patients who start with lower BMD and who need the largest gains. These are the women we plan to enroll in our Phase 3 study. Finally, we continue to invest in expanding our human capital at Entera with early and late-stage clinical leadership and board appointments,” said Miranda Toledano, Chief Executive Officer of Entera.

Key Recent Highlights

• Core Team Expansion: Entera has expanded its clinical and early development teams, including the following senior appointments:
  • Riccardo Paolo Camisasca, M.D., Chief Medical Officer, is a physician with more than 30 years of experience in late-stage clinical development and regulatory approvals, with previous leadership roles at Takeda, Novartis and Sumitomo Pharma Switzerland.
  • Michele McDermott, M.D., Senior Vice President, Medical Affairs, formerly Amgen US Bone Health Medical Director, is an endocrinologist with extensive clinical, research and biopharmaceutical experience focused on mid-life and older women. Dr. McDermott directed a Menopause and Osteoporosis center of excellence in Austin, Texas and was an investigator for over 40 women’s health trials evaluating new treatments for menopause and osteoporosis.
  • Ofer Spiegelstein, Ph.D., Vice President and Head of Early Clinical Development, is an experienced clinical pharmacologist with over 20 years of experience advancing novel drug candidates from early preclinical research through clinical execution and regulatory milestones, including 16 years at Teva Pharmaceuticals, where he most recently served as Head of Clinical Pharmacology & Pharmacometrics.
  • Graziella Soulban, Ph.D., Vice President, Clinical Development and Study Lead, is an accomplished clinical development leader with over 30 years of experience leading clinical research, operations and medical affairs with a particular focus on women’s health research, most recently having served at Sumitomo Pharma America and Myovant Sciences. 
• Board of Directors Appointments: Entera announced the appointments of Laura Hamill and Juan Camilo Arjona Ferreira, M.D., to its Board of Directors, each effective December 1, 2026. Ms. Hamill brings more than 35 years of global commercial, market access and business leadership experience and most recently served as Executive Vice President, Worldwide Commercial Operations at Gilead Sciences, Inc., following nearly two decades in leadership roles at Amgen Inc. Dr. Arjona Ferreira currently serves as Head of Research & Development and Chief Medical Officer at Organon & Co., and brings more than 20 years of global clinical development experience, including roles at Myovant Sciences, Shionogi and Merck & Co.

EB613: First Oral PTH(1-34) Anabolic Tablet for Osteoporosis

• New Phase 2 Analysis Presented as Plenary Poster at ASBMR 2026: On October 9, 2026, Entera presented new Phase 2 post-hoc analysis of EB613 in postmenopausal women with osteoporosis at high risk of fracture in a plenary poster presentation at the American Society for Bone and Mineral Research (ASBMR) 2026 Annual Meeting. Changes in bone turnover markers (increase in bone formation and suppression of bone resorption) were enhanced in women with T-scores of -2.5 or lower. This post-hoc analysis supports the potential benefit of EB613 within the population that is intended to be enrolled in Entera’s Phase 3 study.
• Phase 3 Study Design Presented at ASBMR 2026: In October 2026, Entera presented the design of its planned Phase 3 study of EB613 at the ASBMR 2026 Annual Meeting. The study is expected to enroll approximately 900 postmenopausal women with osteoporosis, randomized 2:1 to EB613 (N ~ 600) or placebo (N ~ 300). Eligible participants will include postmenopausal women 50-90 years of age and ≥5 years from the last menstrual period with osteoporosis diagnosed by DXA with BMD T-score ≤-2.5 at either lumbar spine, total hip, or femoral neck. Participants completing 12 months of treatment in the registrational study will be eligible to enroll in the planned extension study through Month 24.
• Phase 3 Initiation Planned for Late 2026: In June 2026, Entera announced that the FDA accepted its proposed registrational development plan for EB613 and that a randomized, double-blind, placebo-controlled Phase 3 trial with a primary endpoint of percent change from baseline in total hip BMD at Month 12 may support the NDA. In addition, under the 505(b)(2) regulatory pathway, the NDA package will include a scientific bridging analysis with Forteo® (teriparatide SC injection, Eli Lilly) with separate population PK and PK substudies planned. Entera also intends to conduct a transiliac crest bone biopsy substudy in a small subset of patients as part of the registrational plan. Entera is preparing to activate the first clinical site for the Phase 3 study in late 2026, with topline results anticipated in the second half of 2028.

EB612: First-in-Class Oral Acylated PTH(1-34) Replacement Tablet for Hypoparathyroidism

• Phase 1 Initiation Planned for 2027: Entera is conducting IND-enabling studies for EB612 in collaboration with OPKO Health (“OPKO”) and plans to initiate a Phase 1 single ascending dose (SAD) study in 2027.

Financial Results for the Three Months Ended September 30, 2026

Cash and cash equivalents were $265.9 million as of September 30, 2026, and restricted cash was $6.5 million, primarily designated to fund the OPKO collaboration. In July 2026, Entera announced that it had completed an oversubscribed private placement with gross proceeds of approximately $275.0 million before deducting placement agent fees and offering expenses. The Private Placement was led by existing investor BVF Partners L.P. (“BVF”), with participation from new investors, including Longitude Capital, Vivo Capital, TCGX, Spruce Street Capital, Venrock Healthcare Capital Partners, RA Capital Management, Perceptive Advisors, Driehaus Capital Management, Logos Capital, and Catalio Capital Management, among others. The Company’s cash resources are expected to be sufficient to fully fund the planned Phase 3 registrational program of EB613 through topline results and the anticipated submission of an NDA to the FDA and to support the Company’s operations into 2030.

Research and development expenses for the three months ended September 30, 2026 were $4.9 million, as compared to $1.6 million for the three months ended September 30, 2025. The increase of $3.3 million was primarily attributable to start-up activities for the EB613 Phase 3 program and to activities under the OPKO collaboration.

General and administrative expenses for the three months ended September 30, 2026 were $2.3 million, as compared to $1.6 million for the three months ended September 30, 2025.

Net loss was $15.6 million, or $0.11 per ordinary share (basic and diluted), for the three months ended September 30, 2026, as compared to $3.2 million, or $0.07 per ordinary share (basic and diluted), for the three months ended September 30, 2025. The increase was primarily driven by a $7.5 million non-cash fair value remeasurement of the pre-funded warrants issued in our April 2026 and July 2026 private placements, which were reclassified to equity in August 2026.

About Entera
Entera is a clinical stage company focused on developing oral peptide and protein replacement therapies for significant unmet medical needs where an oral tablet form holds the potential to transform the standard of care. The Company leverages a disruptive and proprietary technology platform (N-Tab®) and its pipeline of first-in-class oral peptide programs. The Company’s most advanced product candidate, EB613 (oral PTH(1-34)), is being developed as the first oral, osteoanabolic (bone building) once-daily tablet for osteoporosis. A placebo-controlled, dose-ranging Phase 2 study of EB613 tablets (n = 161) met primary (PD/bone turnover biomarker) and secondary endpoints (BMD). Entera is also developing the first oral acylated PTH(1-34) tablet as a replacement therapy for patients with hypoparathyroidism (EB612), the first oral oxyntomodulin, a dual targeted GLP1/glucagon peptide tablet for the treatment of obesity and metabolic syndromes; and the first oral GLP-2 tablet as an injection-free alternative for patients suffering from rare malabsorption conditions such as short bowel syndrome in collaboration with OPKO Health, Inc. For more information on Entera, visit www.enterabio.com or follow us on LinkedIn, X (Twitter), and Facebook.

Cautionary Statement Regarding Forward Looking Statements
Various statements in this press release are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements (other than statements of historical facts) in this press release regarding our prospects, plans, financial position, business strategy, clinical development activities, collaboration arrangements and expected financial and operational results are forward-looking statements. Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward-looking statements. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Forward-looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved. Important factors that could cause actual results to differ materially from those reflected in Entera’s forward-looking statements include, among others: the anticipated use of proceeds from the July 2026 private placement; the timing, design, and results of the planned Phase 3 registrational study of EB613; the FDA’s ongoing review of the EB613 program, including the terms and interpretation of the FDA’s feedback on our Clinical Amendment; the timing of the anticipated Phase 1 initiation for EB612 and next steps for EB618 in collaboration with OPKO Health; the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates; changes in the interpretation of clinical data; results of our clinical trials; the FDA’s interpretation and review of our results from and analysis of our clinical trials; unexpected changes in our ongoing and planned preclinical development and clinical trials; the size and growth of the potential markets for our product candidates; the scope, progress and costs of developing Entera’s product candidates; Entera’s reliance on third parties to conduct its clinical trials; Entera’s ability to establish and maintain development and commercialization collaborations; Entera’s operation as a development stage company with limited operating history; Entera’s competitive position with respect to other products on the market or in development for the treatment of osteoporosis, hypoparathyroidism, short bowel syndrome, obesity, metabolic conditions and other disease categories it pursues; Entera’s ability to continue as a going concern absent access to sources of liquidity; Entera’s ability to obtain and maintain regulatory approval for any of its product candidates; Entera’s ability to comply with Nasdaq’s minimum listing standards and other matters related to compliance with the requirements of being a public company in the United States; Entera’s intellectual property position and its ability to protect its intellectual property; and other factors that are described in the “Cautionary Statement Regarding Forward-Looking Statements,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Entera’s most recent Annual Report on Form 10-K filed with the SEC, as well as Entera’s subsequently filed Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. There can be no assurance that the actual results or developments anticipated by Entera will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Entera. Therefore, no assurance can be given that the outcomes stated or implied in such forward-looking statements and estimates will be achieved. Entera cautions investors not to rely on the forward-looking statements Entera makes in this press release. The information in this press release is provided only as of the date of this press release, and Entera undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law.

Company Contact:
IR@enterabio.com

ENTERA BIO LTD.
CONDENSED CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands)

		September 30,		December 31,
		2026		2025
		(Unaudited)		(Audited)
Cash and cash equivalents		265,883		7,108
Restricted cash		6,536		7,775
Accounts receivable and other current assets		4,046		415
Property and equipment, net		133		134
Other assets		442		561
Total assets		277,040		15,993
Accounts payable and other current liabilities		2,153		2,203
Other non-current liabilities		605		689
Total liabilities		2,758		2,892
Total shareholders’ equity		274,282		13,101
Total liabilities and shareholders’ equity		277,040		15,993

 

ENTERA BIO LTD.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. dollars in thousands, except share and per share data)
(Unaudited)

		Three Months Ended September 30,
		2026		2025
REVENUES		—		—
COST OF REVENUES		—		—
GROSS PROFIT		—		—
OPERATING EXPENSES:
Research and development		4,925		1,643
General and administrative		2,340		1,613
TOTAL OPERATING EXPENSES		7,265		3,256
OPERATING LOSS		7,265		3,256
FINANCIAL EXPENSES (INCOME), NET		8,332		(56)
NET LOSS		15,597		3,200
LOSS PER SHARE BASIC AND DILUTED		0.11		0.07
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER SHARE		145,075,070		47,089,814

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What were Entera Bio’s third-quarter 2026 financial results?

Entera Bio reported a $15.597 million net loss, or $0.11 per ordinary share, basic and diluted, versus $3.200 million and $0.07 a year earlier. The increase was primarily driven by a $7.5 million non-cash fair value remeasurement of pre-funded warrants issued in April and July 2026; those warrants were reclassified to equity in August 2026.

When does Entera expect the EB613 Phase 3 trial to start and report results?

Entera expects first site activation in late 2026 and topline results in the second half of 2028. The planned study is expected to enroll approximately 900 postmenopausal women with osteoporosis, randomized 2:1 to EB613 or placebo.

What will Entera’s EB613 Phase 3 trial measure?

The primary endpoint is percent change from baseline in total hip bone mineral density at Month 12. The regulatory application package will also include a scientific comparison with Forteo under the 505(b)(2) pathway, with separate studies of drug exposure planned. Entera also intends to conduct a bone-biopsy substudy in a small subset of patients.

Who is eligible for Entera’s planned EB613 Phase 3 study?

Eligible participants will be postmenopausal women aged 50–90, at least five years from their last menstrual period, with a bone-density T-score of -2.5 or lower at the lumbar spine, total hip or femoral neck. Participants completing 12 months of treatment will be eligible for the planned extension through Month 24.