Entera Bio Ltd.
For the period ended Jun 30, 2026. Filed Aug 7, 2026.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2026 · Filed Aug 7, 2026
ENTX$3.14+5.0%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-03-31; filed 2026-05-08.
0001178913-26-002458
Item 2. Management's Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-06-30; filed 2026-08-07.
0001178913-26-003947
Item 2. Management's Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 124 previous paragraphs and 154 current paragraphs.
76 unchanged; 33 reworded; 44 added; 15 removed; 0 previous and 1 current paragraphs rearranged.
Tables are not compared: 21 previous and 18 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (44)
Current report
Osteoporosis is a chronic, progressive disorder in which bone resorption exceeds formation, resulting in decreased bone strength and increased susceptibility to fracture. The mechanism for low bone mineral density (“BMD”) in postmenopausal women is primary estrogen deficiency, which leads to accelerated bone loss, especially in the first five to ten years after menopause. Postmenopausal women are at higher risk of developing osteoporosis-related fractures, particularly in the hip, spine, and wrist.
Current report
Osteoporosis is a major and growing public health issue, responsible for over two million fractures annually in the United States. After age 50, one in three women and one in five men will suffer an osteoporosis-related fracture in their remaining lifetime. Osteoporotic fractures lead to chronic pain, decreased quality of life, increased disability, and contribute to premature death. Studies show that up to 20-24% of hip fracture patients die within one year of the fracture. The total medical cost of osteoporotic fractures is projected to increase from $57 billion in 2018 to $95 billion by 2040, largely due to the aging population.
Current report
The three approved anabolic drugs, including Forteo®, are indicated for the treatment of very high-risk osteoporosis patients as first line therapy and as second line treatment in osteoporosis patients who cannot tolerate or progress on other osteoporosis drugs. Despite the superior efficacy of anabolic drugs, existing treatments require daily or monthly subcutaneous injections and are estimated to be used in a minority of very high-risk patients.
Current report
EB613 is being developed under a 505(b)(2) application to the listed drug, Forteo® (teriparatide SC injection, Eli Lilly), which was first approved by the FDA in 2002 for the treatment of postmenopausal women with osteoporosis at high risk of fracture and later indicated for men with osteoporosis and osteoporosis associated with sustained systemic glucocorticoid therapy. Forteo® has been in clinical use for over 20 years with a well-established benefit-risk profile.
Current report
We have completed a comprehensive nonclinical and clinical package for the EB613 program, including three Phase 1 comparative studies with Forteo® and three Phase 2 clinical studies. EB613 has been safely administered to a total of 270 study participants, including postmenopausal women with low BMD or osteoporosis (n=118 on EB613, n=43 on placebo), healthy volunteers, and male and female patients with hypoparathyroidism.
Current report
In a Phase 2, 6-month, 161-patient, placebo-controlled study in postmenopausal women with osteoporosis or low BMD, EB613 produced rapid dose-proportional increases in biochemical markers of bone formation, reductions in markers of bone resorption, and increased lumbar spine, total hip, and femoral neck BMD. At 6 months of treatment, EB613 2.5mg produced comparable total hip BMD increases as those that have been reported for Forteo® at 6 months.
Current report
In September and April 2025, the effects of EB613 on trabecular and cortical bone indices based on a 3D-Shaper DXA post-hoc analysis of Phase 2 results were presented at the American Society for Bone and Mineral Research (“ASBMR”) 2025 Annual Meeting and at the 2025 World Congress on Osteoporosis (WCO-IOF-ESCEO), respectively. The data using 3D-DXA modelling showed evidence of an early effect on both trabecular and cortical bone of the proximal femur. Mechanistically, the findings suggest that bone strengthening and fracture resistance may occur rapidly with EB613.
Current report
In October 2025, we reported clinical data from a post-hoc analysis of our Phase 2 trial of EB613 at the 2025 North American Menopause Society (NAMS) Annual Meeting in a poster presentation titled “EB613 (Oral PTH[1-34] Tablets) Increases BMD Over Six Months in Early Postmenopausal Women with Low Bone Mass or Osteoporosis: A Phase 2 Randomized Trial (P-66)”. In this analysis of the Phase 2 data, EB613 produced significant and consistent gains in BMD at the spine, femoral neck and hip in women within 10 years of menopause and in women more than 10 years post-menopause.
Current report
Since 2023, we have advanced a simplified single-tablet formulation of EB613 that builds on clinical experience with the multi-tablet formulation which was used in Phase 1 and Phase 2 clinical studies and a new generation of our N-Tab® platform. At the ASBMR Annual Meeting in September 2025, preclinical data for EB613 single tablet formulation from a cross-over pharmacokinetic mini-pig study was presented.
Current report
In June 2026, we reported comparative, crossover Phase 1 data evaluating single-tablet and multi-tablet oral EB613 with Forteo® (teriparatide SC injection, Eli Lilly). The oral presentation “Transforming Anabolic Treatments for Osteoporosis: New Clinical Data Supports a Single EB613 Tablet [Oral PTH(1-34)] as the Final Candidate for a Phase 3 Study” was presented as a Late-Breaking Oral Presentation at ENDO 2026. The single-tablet EB613 showed a PK profile comparable to multi-tablet EB613, with similar Cmax, Tmax, and total systemic exposure (AUC). The AUC of single tablet and multi-tablet EB613 was comparable with Forteo®, exhibiting a slightly shorter duration of exposure, which is consistent with prior Phase 1 studies. Comparable calcemic effects (serum calcium) and consistent suppression of endogenous PTH(1-84) were shown for both oral EB613 treatments and Forteo®. Finally, the safety profile of EB613 was consistent with Forteo®, with no drug-related serious adverse events; all other adverse events were mild and resolved with no action taken. These data support advancing single-tablet EB613 into Entera’s planned Phase 3 study of EB613 in postmenopausal women with osteoporosis
Current report
Regulatory Background
Current report
Initial approvals of drugs for the treatment of osteoporosis have historically required a placebo-controlled trial demonstrating reduction in the risk of fractures as the primary outcome measure in women with postmenopausal osteoporosis. The regulatory requirement for using fracture as the primary efficacy endpoint is challenging due to the patient types who would need to be studied: (1) very high risk patients may be randomized to placebo in a clinical trial, which poses an ethical concern; and (2) evaluation of moderate risk patients would require a very large sample size to evaluate treatment effectiveness. The last drug approval for osteoporosis occurred in 2019.
Current report
In the United States, the Foundation for the National Institute of Health-American Society for Bone and Mineral Research-Study to Advance BMD as a Regulatory Endpoint (FNIH-ASBMR-SABRE, previously known as the FNIH-Bone Quality Project [FNIH-BQP], hereinafter “SABRE”) was launched in 2013. This initiative was established as a public-private partnership with the FDA to study whether change in BMD at the lumbar spine, total hip or femoral neck in a placebo-controlled trial of an osteoporosis drug was predictive of vertebral, nonvertebral, hip and all clinical fracture risk reduction.
Current report
Since the end of our Phase 2 Meeting in December 2021, we have engaged in FDA Type C, D, and A Meetings in 2022, 2023, 2024, and 2025 to obtain clarity and alignment on total hip BMD as a primary endpoint and an appropriate data package to support a new drug application (“NDA”) for EB613 under a 505(b)(2) application.
Current report
Following Type C and Type D meetings with the FDA in March 2023, we announced the FDA’s concurrence that a 2-year, placebo-controlled phase 3 study with total hip BMD as primary endpoint could support an NDA for EB613; however the SABRE BMD endpoint remained unqualified as a surrogate endpoint by FDA at that time. On the same day, we announced that we planned to continue our dialogue with the FDA and await the final qualification of the SABRE qualification and FDA’s guidance on the statistical evaluation of our BMD endpoint before initiating a Phase 3 study for EB613.
Current report
In March 2024, the ASBMR announced that the FDA had communicated to the SABRE project team that a ruling to qualify the treatment-related change in BMD as a surrogate endpoint for fractures in future trials of new anti-osteoporosis drugs would be provided within 10 months.
Current report
In May 2025, as part of our scientific bridging, we received a written concurrence from the FDA that dedicated oral carcinogenicity studies are not warranted for EB613 given the totality of evidence generated from the literature and nonclinical studies conducted with EB613.
Current report
In June 2025, we received a written concurrence from the FDA that comprehensive nonclinical developmental and reproductive toxicity (DART) studies are not required given the totality of evidence generated from Forteo®, published literature, and EB613 nonclinical studies.
Current report
In June 2026, we announced that The FDA accepted our plan to conduct a single, randomized, double-blind, placebo-controlled, Phase 3 trial in approximately 750 postmenopausal women with osteoporosis, with a primary endpoint of percent change from baseline in total hip BMD at Month 12 to support a potential New Drug Application (NDA) submission for EB613 for the treatment of women with post-menopausal osteoporosis. The proposed NDA package will also include Entera’s scientific bridge analysis with Forteo® (teriparatide SC injection, Eli Lilly) under the 505(b)(2) pathway, and a transiliac crest bone biopsy sub-study in a subset of patients.
Current report
The FDA also agreed with Entera’s proposal to continue following the randomized patients out to 24 months in an open-label extension study under a separate protocol. Entera will plan to submit data through up to 18 months as part of the 120-day safety update to its NDA. Additionally, Entera will plan to submit the complete 2-year data upon completion of the open-label extension study to characterize further the durability of the treatment effect, safety, and sequence data for EB613 followed by a standard anti-resorptive therapy for 12 months.
Current report
The registrational study is powered to demonstrate EB613’s clinical effectiveness with projected increases in total hip BMD that are comparable to reported outcomes for Forteo® at 12 months, changes associated with a 60% to 80% relative reduction in vertebral fracture risk. We plan to initiate the registrational program for EB613 in late 2026.
Current report
In June 2026, at ENDO 2026, we presented preclinical data for EB612 from three animal models — a thyroparathyroidectomized (TPTx) rat model, a minipig model and a non-human primate model — showing sustained increases in serum calcium consistent with clinically validated injectable PTH-replacement therapies for hypoparathyroidism, and no safety concerns identified.
Current report
We are advancing the EB612 program into IND enabling studies and plan to submit an IND application to the FDA in the first half of 2027.
Current report
In June 2026, at ENDO 2026, we presented preclinical data for EB618 from a single-dose pharmacokinetic-pharmacodynamic study in non-human primates, showing dose-proportional systemic exposure across three tablet strengths, a dose-proportional pharmacologic effect on postprandial blood glucose and no safety concerns identified at doses exceeding the anticipated clinical dose range by more than tenfold. These data support the continued development of EB618 as an oral once-daily GLP-1/glucagon receptor agonist for the treatment of obesity and metabolic disorders.
Current report
On July 26, 2026, we entered into a securities purchase agreement (the “July 2026 Purchase Agreement”) with certain institutional and accredited investors, including funds affiliated with BVF Partners L.P. (“BVF”), providing for the private placement (the “July 2026 Private Placement”) of an aggregate of 134,803,910 Ordinary Shares, or, in lieu thereof, pre-funded warrants to purchase Ordinary Shares (the “July 2026 Pre-Funded Warrants”), at a purchase price of $2.04 per Ordinary Share, for aggregate gross proceeds of approximately $275.0 million, before deducting placement agent fees and other related offering expenses. On July 28, 2026 (the “Closing Date”), we issued 122,961,215 Ordinary Shares and July 2026 Pre-Funded Warrants to purchase 11,842,695 Ordinary Shares.
Current report
The July 2026 Pre-Funded Warrants have an exercise price of NIS 0.0000769 per Ordinary Share, are immediately exercisable, do not expire and are subject to customary beneficial ownership limitations and adjustments. The Company intends to use the net proceeds from the July 2026 Private Placement to support activities related to the initiation of its Phase 3 registrational study of EB613 in postmenopausal women with osteoporosis and for general working capital and corporate purposes.
Current report
Pursuant to the July 2026 Purchase Agreement, effective upon the closing of the July 2026 Private Placement, we also granted BVF certain rights to designate two nominees to the Company’s board of directors, subject to specified ownership thresholds and other conditions as set forth in the July 2026 Purchase Agreement.
Current report
From our inception through June 30, 2026, we have financed our operations primarily through a combination of public and private equity offerings, grants from the IIA and the issuance of Ordinary Shares upon the exercise of options and warrants. Through June 30, 2026, we had raised an aggregate of approximately $121.8 million from these sources.
Current report
Since inception, we have incurred significant operating losses and negative cash flows from operations as we have devoted substantially all of our resources to the research and development of our product candidates. We expect to incur significant operating losses for the foreseeable future as we advance our clinical development programs. For the three months ended June 30, 2026 and 2025, our operating losses were $4.6 million and $2.7 million, respectively. For the six months ended June 30, 2026 and 2025, our operating losses were $8.1 million and $5.2 million, respectively.
Current report
On July 28, 2026, we consummated the July 2026 Private Placement and received aggregate gross proceeds of approximately $275.0 million, before deducting placement agent fees and other offering expenses. See “—Recent Developments— July 2026 Private Placement.” Based on our current operating plan, we believe that our existing cash resources, together with the net proceeds from the July 2026 Private Placement, will be sufficient to fund our planned operations into 2030.
Current report
Our estimate regarding the period through which our financial resources will be sufficient to support our operations is based on our current operating plan and assumptions regarding the timing and costs of our development programs and other operating activities. These assumptions are subject to change, and we may use our available capital resources sooner than currently anticipated.
Current report
General and administrative expenses for the three months ended June 30, 2026 were $1.4 million as compared to $1.1 million for the three months ended June 30, 2025. The increase of $0.3 million was mainly attributable to an increase in investor relations consulting fees, portion of offering costs related to the April 2026 Pre-Funded Warrants that were recorded as part of general and administrative expenses and an increase in compensation expenses, primarily reflecting unfavorable foreign exchange rate fluctuation.
Current report
Financial expenses, net for the three months ended June 30, 2026 was $2.7 million as compared to financial income, net of ($12) thousand for the three months ended June 30, 2025. The change was primarily driven by the fair value remeasurement of the April 2026 Pre-Funded Warrants classified as a financial liability and exchange rate differences of certain currencies against our functional currency, which is the U.S. Dollar. These were partially offset by interest income generated from bank deposits.
Current report
Comparison of Six Months Ended June 30, 2026 and 2025
Current report
Research and development expenses for the six months ended June 30, 2026 were $5.5 million, as compared to $2.6 million for the six months ended June 30, 2025. The increase in expenses of $2.9 million was mainly attributable to an increase of $1.1 million in materials expenses and other preparation of the EB613 Phase 3 program, an increase of $0.3 million related to our Phase 1 safety and PK bridging study for the Next Generation of EB613, an increase of $1.1 million in connection with our collaboration programs with OPKO for EB612 and EB618 and an increase of $0.4 million in compensation expenses, primarily reflecting unfavorable foreign exchange rate fluctuation and non-cash compensation.
Current report
General and administrative expenses for the six months ended June 30, 2026 were $2.7 million, as compared to $2.6 million for the six months ended June 30, 2025. The increase of $0.1 million was mainly attributable to the portion of offering costs related to the April 2026 Pre-Funded Warrants that were recorded as part of general and administrative expenses.
Current report
Financial expenses, net for the six months ended June 30, 2026 was $2.7 million as compared to financial income, net ($8) thousand for the six months ended June 30, 2025. The change was primarily driven by the fair value remeasurement of the April 2026 Pre-Funded Warrants classified as a financial liability and exchange rate differences of certain currencies against our functional currency, which is the U.S. Dollar. These were partially offset by interest income generated from bank deposits.
Current report
Liquidity, Capital Resources and Cash Requirements
Current report
Since inception, we have incurred significant operating losses and negative cash flows from operations as we have devoted substantially all of our resources to the research and development of our product candidates. We expect to incur significant operating losses for the foreseeable future as we advance our clinical development programs.
Current report
As disclosed above, on July 28, 2026, we consummated the July 2026 Private Placement which significantly strengthened our financial position and liquidity, providing us with the capital to execute our current operating plan, including our Phase 3 registrational program for EB613, the advancement of EB612 and our other development activities, and supporting our expected operations into 2030.
Showing the first 40 of 44 passages. Open the source sections for the rest.
Removed paragraphs (15)
Previous report
From our inception through March 31, 2026, we have raised a total of $111.8 million from a combination of public and private equity offerings, IIA grants and the issuance of Ordinary Shares upon the exercise of options and warrants. Since inception, we have incurred significant losses. For the three months ended March 31, 2026 and 2025, our operating losses were $3.5 million and $2.6 million, respectively, and we expect to continue to incur significant expenses and losses for the foreseeable future.
Previous report
The Company is engaged in research and development activities, and it has not derived significant income from its activities and has incurred an accumulated deficit and negative cash flows from operating activities since inception. These factors raise substantial doubt as to the Company's ability to continue as a going concern. The unaudited condensed consolidated financial statements included herein have been prepared assuming that we will continue as a going concern and do not include adjustments that might result from the outcome of this uncertainty. See Part I, Item 1A-Risk Factors—Risks Related to Our Financial Position and Need for Additional Capital contained in our 2025 Annual Report.
Previous report
In order to fund further operations, we will need to raise additional capital. We may raise these funds through a variety of means, including private or public equity offerings, debt financings, strategic collaborations and licensing arrangements. Additional financing may not be available when we need it or may not be available on terms that are favorable to us.
Previous report
Research and Development Expenses
Previous report
General and Administrative Expenses
Previous report
Financial Income, Net
Previous report
Research and Development Expenses
Previous report
General and Administrative Expenses
Previous report
General and administrative expenses for the three months ended March 31, 2026 were $1.3 million, as compared to $1.4 million for the three months ended March 31, 2025. The decrease of $0.1 million was mainly attributable to a decrease in consultants and legal fees.
Previous report
Financial Income, Net
Previous report
Financial income, net for the three months ended March 31, 2026 was $34 thousand as compared to financial expenses, net of $4 thousand for the three months ended March 31, 2025. Our financial income mainly included interest income from bank deposits and exchange rate differences of certain currencies against our functional currency, which is the U.S. Dollar.
Previous report
Liquidity and Capital Resources
Previous report
Since inception, we have incurred significant losses from operations and negative cash flows from operating activities. For the three months ended March 31, 2026 and 2025, our operating losses were $3.5 million and $2.6 million, respectively. As of March 31, 2026, we had an accumulated deficit of $128.9 million. We expect to continue to incur significant expenses and losses for the next several years as we advance our products through development and provide administrative support for our operations. These factors raise substantial doubt about our ability to continue as a going concern. The unaudited condensed consolidated financial statements contained in this Quarterly Report have been prepared on a going concern basis and do not include any adjustments that may be necessary should we be unable to continue as a going concern.
Previous report
We have based these estimates on assumptions that may prove to be wrong, and we may use our available capital resources sooner than we currently expect. Because of the numerous risks and uncertainties associated with the development of our product candidates, and the extent to which we may enter into additional collaborations with third parties for development of these or other product candidates, we are unable to estimate the amounts of increased capital outlays and operating expenses associated with completing the development of our current and future product candidates. Our future capital requirements will depend on many factors, including:
Previous report
There was no net cash used in or provided by investing activities for the three months ended March 31, 2026.
Reworded paragraphs (33)
Previous wording
ITEM 2. MANAGEMENT’S DISCUSSION****AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Current wording
. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Previous wording
Entera is a clinical stage company focused on developing first-in-class oral tablet formats of peptides or protein replacement therapies. We focus on underserved, chronic medical conditions for which oral administration of a protein therapy has the potential to significantly shift a treatment paradigm. Our pipeline includes differentiated, first-in-class oral peptide programs targeting PTH(1-34), GLP-1/Glucagon and GLP-2.
Current wording
Entera is a clinical stage company focused on developing first-in-class oral peptides. We focus on underserved, chronic medical conditions for which oral administration of a protein therapy has the potential to significantly shift a treatment paradigm. Our pipeline includes differentiated, first-in-class oral peptide programs targeting PTH(1-34), GLP-1/Glucagon and GLP-2.
Previous wording
Our most advanced product candidate, EB613, oral PTH(1-34), is being developed as the first oral, osteoanabolic (bone building) once-daily tablet treatment for osteoporosis. EB613 is intended to provide an oral anabolic treatment earlier in an osteoporosis patient’s journey to increase skeletal mass, reduce the risk of fracture and limit the disease progression, and decrease disability and mortality. A placebo controlled, dose ranging Phase 2 study of EB613 tablets (n= 161) met primary (pharmacodynamic/bone turnover biomarker) and secondary endpoints (bone mineral density (“BMD”)). In April 2024, the Phase 2 data was published in the Journal of Bone and Mineral Research (JBMR).
Current wording
Our most advanced product candidate, EB613, oral PTH (1-34), is being developed as the first oral, osteoanabolic (bone building) tablet for osteoporosis. EB613 is intended to provide an oral anabolic treatment earlier in an osteoporosis patient’s journey to increase skeletal mass, reduce the risk of fracture and consequently limit the progression of the disease, and its associated disability and mortality.
Previous wording
In July 2025, we announced that in a written response to a Type A meeting request, the FDA agreed that a new drug application (“NDA”) filing for EB613 could be supported by a phase 3 study in women with postmenopausal osteoporosis, where change in total hip BMD is evaluated as the primary endpoint, and incidence of new or worsening vertebral fractures is evaluated as the key secondary endpoint at 24 months.
Current wording
In July 2025, we announced that, in a written response to a Type A meeting request, the FDA agreed that an NDA filing for EB613 could be supported by a phase 3 study in women with postmenopausal osteoporosis, where change in total hip BMD is evaluated as the primary endpoint, and incidence of new or worsening vertebral fractures is evaluated as the key secondary endpoint at 24 months.
Previous wording
In December 2025, the FDA released the Determination for Qualification of BMD qualifying total hip BMD as a surrogate efficacy endpoint for fracture that could be used in future studies of new anti-osteoporosis therapies. The FDA’s suggested a context of use (COU): “The percentage change from baseline at 24 months in total hip bone mineral density (BMD) assessed by dual-energy X-ray absorptiometry (DXA) can be used as a validated surrogate endpoint for the assessment of investigational therapies for postmenopausal women with osteoporosis at risk for fracture.”
Current wording
In December 2025, the FDA released the Determination for Qualification of BMD qualifying total hip BMD as a surrogate efficacy endpoint for fracture that could be used in future studies of new anti-osteoporosis therapies.
Previous wording
In February 2026, we submitted to the FDA a clinical amendment that included the EB613 Phase 3 protocol, statistical analysis plan and open-label extension synopsis. Subject to regulatory feedback, we are planning to initiate the Phase 3 study in the second half of 2026.
Current wording
In February 2026, we submitted to the FDA a clinical amendment that included a streamlined EB613 Phase 3 protocol to evaluate the percentage change in total hip BMD from baseline to month 12 as the primary endpoint, statistical analysis plan and open-label extension synopsis.
Previous wording
In February 2026, we announced the expansion of our collaboration with OPKO Biologics, Inc. (“OPKO Biologics”), a subsidiary of OPKO Health, Inc. (“OPKO”), and OPKO to jointly advance this LA-PTH program. Under the expanded collaboration, Entera and OPKO each hold a 50% pro-rata ownership interest in the LA-PTH hypoparathyroidism program, and each is responsible for 50% of development costs. We intend to accelerate development and currently expect to submit an IND application to the FDA in late 2026.
Current wording
In February 2026, we announced the expansion of our collaboration with OPKO Biologics, Inc. (“OPKO Biologics”), a subsidiary of OPKO Health, Inc. (“OPKO”), and OPKO to jointly advance this LA-PTH program. Under the expanded collaboration, Entera and OPKO each hold a 50% pro-rata ownership interest in the LA-PTH hypoparathyroidism program, and each is responsible for 50% of development costs.
Previous wording
The EB618 program focuses on developing the first oral dual agonist GLP-1/Glucagon (OXM) peptide as a potential once-daily tablet treatment for patients with obesity and metabolic disorders using the N-Tab® platform. Currently, there are no approved dual GLP-1/Glucagon agonists available. Currently, there are no approved dual GLP-1/Glucagon agonists available.
Current wording
The EB618 program focuses on developing the first oral dual agonist GLP-1/Glucagon (OXM) peptide as a potential once-daily tablet for patients with obesity and metabolic disorders using the N-Tab® platform. Oxyntomodulin (OXM) is a naturally occurring dual GLP-1/glucagon receptor agonist hormone that regulates appetite and glucose metabolism and promotes weight loss, with additional cardioprotective and anti-fibrotic properties; its therapeutic potential as a native hormone is limited by a short plasma half-life. Currently, there are no approved dual GLP-1/Glucagon agonists available.
Previous wording
OPKO is planning to initiate a single ascending dose (SAD) and multiple ascending dose (MAD) Phase 1 clinical study with the subcutaneous injection formulation in 2027. We plan to file an IND for the oral OXM tablet formulation thereafter.
Current wording
OPKO is planning to initiate a single ascending dose (SAD) and multiple ascending dose (MAD) Phase 1 clinical study with the subcutaneous injection formulation in 2027. We plan to determine next steps of the clinical development plan for oral OXM based on the outcomes of that study.
Previous wording
Israel-Hamas War and Regional Conflicts
Current wording
Israel-Hamas War and Regional Conflict
Previous wording
The Company’s research personnel and management personnel are located in Israel, however other core activities including clinical, regulatory and supply chain are located outside of Israel. Currently, such activities in Israel remain largely unaffected. During the three months ended March 31, 2026 and March 31, 2025, the impact of this war on the Company’s results of operations and financial condition was immaterial. See Item 1.A. “Risk Factors—Security, political and economic instability in the Middle East may harm our business.”
Current wording
The Company’s research personnel and management personnel are located in Israel, however other core activities including clinical, regulatory and supply chain are located outside of Israel. Currently, such activities in Israel remain largely unaffected. During the three and six months ended June 30, 2026 and June 30, 2025, the impact of this war on the Company’s results of operations and financial condition was immaterial. See Item 1.A. “Risk Factors—Security, political and economic instability in the Middle East may harm our business.”
Previous wording
As of March 31, 2026, we had an accumulated deficit of $128.9 million. Our losses may fluctuate significantly from quarter to quarter and year to year, depending on the timing of our clinical trials, our expenditures on research and development activities and any third-party collaborations into which we may enter.
Current wording
As of June 30, 2026, we had an accumulated deficit of $136.2 million. Our operating results may increase significantly from period to period depending on, among other things, the timing and progress of our clinical trials, research and development activities, manufacturing activities, regulatory interactions, strategic collaborations and any third-party collaborations into which we may enter.
Previous wording
As of March 31, 2026, we had cash and cash equivalents and restricted cash of $11.9 million, of which $7.8 million has been designated to fund the collaboration activity with OPKO under the A&R Collaboration Agreement. In April 2026, we consummated the April 2026 Private Placement and received gross proceeds of approximately $10.0 million. Based on our current cash position and operating plan, we believe that our existing cash resources will be sufficient to fund our projected operating requirements through the first quarter of 2027, including activities related to the preparation for our planned Phase 3 registrational study of EB613. However, the Company’s ability to commence and complete the Phase 3 clinical study of EB613 in osteoporosis is dependent on its ability to obtain additional funding, which may not be available on acceptable terms, or at all. Any delay or our inability to secure such funding will delay or prevent the commencement of these studies. These factors raise substantial doubt as to our ability to continue as a going concern.
Current wording
As of June 30, 2026, we had cash, cash equivalents and restricted cash of $18.4 million, of which $7.1 million has been designated to fund collaboration activities with OPKO under the A&R Collaboration Agreement.
Previous wording
Our research and development expenses may vary substantially from period to period based on the timing of our research and development activities, including due to the timing of initiation of clinical trials and the enrolment of patients in clinical trials. For the three months ended March 31, 2026 and 2025, our research and development expenses were $2.3 million and $1.1 million, respectively. Research and development expenses for the three months ended March 31, 2026 were primarily for the development of EB613 and the next-generation of EB613 and our collaboration with OPKO related to the EB618 (OXM) and EB612 (LA-PTH) programs. The successful development of our product candidates is highly uncertain. At this time, we cannot reasonably estimate the nature, timing and estimated costs of the efforts that will be necessary to complete the development of, or the period, if any, in which material net cash inflows may commence from any of our product candidates. This is due to numerous risks and uncertainties associated with developing drugs, including:
Current wording
Our research and development expenses may vary substantially from period to period based on the timing of our research and development activities, including due to the timing of initiation of clinical trials and the enrolment of patients in clinical trials. For the three months ended June 30, 2026 and 2025, our research and development expenses were $3.2 million and $1.5 million, respectively. For the six months ended June 30, 2026 and 2025, our research and development expenses were $5.5 million and $2.6 million, respectively. Research and development expenses for the three and six months ended June 30, 2026 were primarily for the development of the EB613 program and our collaboration with OPKO related to the EB612 (LA-PTH) and EB618 (OXM) programs. The successful development of our product candidates is highly uncertain. At this time, we cannot reasonably estimate the nature, timing and estimated costs of the efforts that will be necessary to complete the development of, or the period, if any, in which material net cash inflows may commence from any of our product candidates. This is due to numerous risks and uncertainties associated with developing drugs, including:
Previous wording
Our research and development expenses for the three months ended March 31, 2026 and March 31, 2025 are summarized as follows:
Current wording
Our research and development expenses for the three and six months ended June 30, 2026 and June 30, 2025 are summarized as follows:
Previous wording
Financial income, net is composed primarily of interest income from bank deposits and exchange rate differences of certain currencies against our functional currency, which is the U.S. Dollar.
Current wording
Financial expenses (income), net is composed primarily of changes in fair value of the April 2026 Pre-Funded Warrants classified as a financial liability, interest income from bank deposits and exchange rate differences of certain currencies against our functional currency, which is the U.S. Dollar.
Previous wording
We have not generated taxable income since our inception, and, as of March 31, 2026, we had carryforward tax losses of $93.9 million.
Current wording
We have not generated taxable income since our inception, and, as of June 30, 2026, we had carryforward tax losses of $96.4 million.
Previous wording
Research and development expenses for the three months ended March 31, 2026 were $2.3 million, as compared to $1.1 million for the three months ended March 31, 2025. The increase in expenses of $1.2 million was mainly attributable to an increase of $0.5 million related to our Phase 1 safety and PK bridging study for the Next Generation of EB613, an increase of $0.5 million in connection with our collaboration programs with OPKO for EB618 and EB612 and an increase of $0.2 million in compensation mainly due to unfavorable foreign exchange rate changes.
Current wording
Research and development expenses for the three months ended June 30, 2026 were $3.2 million, as compared to $1.5 million for the three months ended June 30, 2025. The increase in expenses of $1.7 million was mainly attributable to an increase of $0.8 million in materials and production costs and other costs related to the preparation of the EB613 Phase 3 program, an increase of $0.6 million in connection with our collaboration programs with OPKO, mainly for EB612, an increase of $0.1 million related to our Phase 1 safety and PK bridging study for the Next Generation of EB613, and an increase of $0.2 million in compensation expenses, primarily reflecting unfavorable foreign exchange rate fluctuation and non-cash compensation costs.
Previous wording
Revenues for the three months ended March 31, 2025 were $42 thousand, which were attributable to research services we provided pursuant to a research services agreement with an external party. The Company completed its obligations under the research services agreement in the first quarter of 2025. We did not recognize any revenue for the three months ended March 31, 2026.
Current wording
Revenues for the six months ended June 30, 2025 were $42 thousand, which were attributable to research services we provided pursuant to a research services agreement with an external party. The Company completed its obligations under the research services agreement in the first quarter of 2025. We did not recognize any revenue for the six months ended June 30, 2026.
Previous wording
Cost of revenues for the three months ended March 31, 2025 were $42 thousand, which was attributable to research services we provided pursuant to a research services agreement with an external party. For the three months ended March 31, 2026, we did not recognize any cost of revenues.
Current wording
Cost of revenues for the six months ended June 30, 2025 were $42 thousand, which was attributable to research services we provided pursuant to a research services agreement with an external party. For the six months ended June 30, 2026, we did not recognize any cost of revenues.
Previous wording
Since our inception and through March 31, 2026, we have raised a total of $111.8 million from a combination of public and private equity offerings, IIA grants, the issuance of Ordinary Shares upon the exercise of options and warrants, and the issuance of $36.4 million of Ordinary Shares through at-the-market-offering (“ATM”) programs.
Current wording
Since our inception and through June 30, 2026, we have financed our operations primarily through a combination of public and private equity offerings, IIA grants and the issuance of Ordinary Shares upon the exercise of options and warrants. Through June 30, 2026, we had raised an aggregate of approximately $121.8 million from these sources, including the issuance of $36.4 million of Ordinary Shares through at-the-market-offering (“ATM”) programs.
Previous wording
As of March 31, 2026, we had cash and cash equivalents and restricted cash of $11.9 million, of which $7.8 million has been designated to fund our obligations under the A&R Collaboration Agreement. In April 2026, we consummated the April 2026 Private Placement and received gross proceeds of approximately $10.0 million. Our primary uses of cash have been to fund research and development, general and administrative and working capital requirements, including activities related to the preparation for and initiation of its Phase 3 registrational study of EB613 and our collaboration programs with OPKO (EB612 and EB618) and we expect these will continue to be our primary uses of cash.
Current wording
As of June 30, 2026, we had cash and cash equivalents and restricted cash of $18.4 million, of which $7.1 million has been designated to fund our obligations under the A&R Collaboration Agreement. On July 28, 2026, we consummated the July 2026 Private Placement and received aggregate gross proceeds of approximately $275.0 million, before deducting placement agent fees and other offering expenses. See “—Recent Developments—July 2026 Private Placement.”
Previous wording
On September 2, 2022, we entered into a Sales Agreement with Leerink Partners LLC (f/k/a SVB Securities LLC), as sales agent, to implement an ATM program (the “Leerink ATM Program”) under which we were originally able to sell up to 5,000,000 Ordinary Shares in an at-the-market offering registered under the Securities Act. The sales agent is entitled to a fixed commission of 3% of the aggregate gross proceeds as well as and reimbursement of expenses. As of March 31, 2026, we had sold 4,940,156 Ordinary Shares under the Leerink ATM Program for aggregate proceeds of $9.8 million, net of issuance costs. We currently have the ability, but not the obligation, to sell up to an additional 30,000,000 Ordinary Shares under the Leerink ATM Program under our currently effective Registration Statement on Form S-3.
Current wording
On September 2, 2022, we entered into a Sales Agreement with Leerink Partners LLC (f/k/a SVB Securities LLC), as sales agent, to implement an ATM program (the “Leerink ATM Program”) under which we were originally able to sell up to 5,000,000 Ordinary Shares in an at-the-market offering registered under the Securities Act. The sales agent is entitled to a fixed commission of 3% of the aggregate gross proceeds as well as reimbursement of expenses. As of June 30, 2026, we had sold 4,940,156 Ordinary Shares under the Leerink ATM Program for aggregate proceeds of $9.8 million, net of issuance costs. We currently have the ability, but not the obligation, to sell up to an additional 30,000,000 Ordinary Shares under the Leerink ATM Program under our currently effective Registration Statement on Form S-3.
Previous wording
On April 1, 2026, we entered into a securities purchase agreement with certain funds affiliated with BVF Partners LP (collectively, the “Purchaser”), providing for the private placement (the “April 2026 Private Placement”) to the Purchaser of an aggregate of 7,916,879 units (the “2026 Units”), each 2026 Unit consisting of (i) one Ordinary Share (or, in lieu thereof, one pre-funded warrant to purchase one Ordinary Share (the “2026 Pre-Funded Warrants”)) and (ii) one warrant to purchase one and one-half Ordinary Shares (the “2026 Ordinary Share Warrants”), for aggregate proceeds of approximately $10.0 million (or $1.2775 per 2026 Unit). On April 2, 2026 (the “Closing Date”), the Company issued 2,425,000 Ordinary Shares, 5,402,789 2026 Pre-Funded Warrants, and 11,741,683 2026 Ordinary Share Warrants in connection with the April 2026 Private Placement.
Current wording
On April 1, 2026, we entered into a securities purchase agreement with certain funds affiliated with BVF Partners L.P. (collectively, the “Purchaser”), providing for the private placement (the “April 2026 Private Placement”) to the Purchaser of an aggregate of 7,916,879 units (the “2026 Units”), each 2026 Unit consisting of (i) one Ordinary Share (or, in lieu thereof, one pre-funded warrant to purchase one Ordinary Share (the “2026 Pre-Funded Warrants”)) and (ii) one warrant to purchase one and one-half Ordinary Shares (the “2026 Ordinary Share Warrants”), for aggregate proceeds of approximately $10.0 million (or $1.2775 per 2026 Unit). On April 2, 2026 (the “Closing Date”), the Company issued 2,425,000 Ordinary Shares, 5,402,789 2026 Pre-Funded Warrants, and 11,741,683 2026 Ordinary Share Warrants in connection with the April 2026 Private Placement.
Previous wording
Given our current plans, we believe that our existing cash resources will be sufficient to support our operations through the first quarter of 2027, including activities related to the preparation for our planned Phase 3 registrational study of EB613. However, our ability to commence and complete the Phase 3 clinical study of EB613 in osteoporosis is dependent on our ability to obtain additional funding, which may not be available on acceptable terms, or at all. Any delay or our inability to secure such funding will delay or prevent the commencement of these studies. Our expectations are based on management’s current assumptions, clinical development plans and regulatory submission timelines, which may prove to be wrong, and we could spend our available financial resources much faster than we currently expect.
Current wording
We expect our operating expenses to increase significantly as we advance our planned Phase 3 registrational program for EB613, continue the development of EB612 and support our other research and development activities. Our current operating plan and expected cash runway into 2030 reflect these anticipated increases in operating expenditures. Our expectations are based on management’s current assumptions, clinical development plans and regulatory submission timelines, which may prove to be wrong, and we could spend our available financial resources much faster than we currently expect.
Previous wording
We continuously evaluate various financing alternatives in the public or private equity markets or through license of our N-Tab® platform to additional external parties through partnerships or research collaborations as we will need to finance future research and development activities, general and administrative expenses and working capital through fund raising. However, there is no certainty about our ability to obtain such funding.
Current wording
Although we believe that our existing cash resources are sufficient to execute our current operating plan, we may seek additional capital in the future to support strategic opportunities, expand our pipeline, accelerate the development of our product candidates or pursue other business development initiatives. We continuously evaluate various financing alternatives in the public or private equity markets or through license of our N-Tab® platform to additional external parties through partnerships or research collaborations. However, any future financing may not be available on favorable terms, or at all, and any equity financing may result in dilution to our shareholders.
Previous wording
Three Months Ended March 31, 2026 compared to Three Months Ended March 31, 2025
Current wording
Six Months Ended June 30, 2026 compared to Six Months Ended June 30, 2025
Previous wording
Net cash used in operating activities for the three months ended March 31, 2025 was $1.4 million, consisting primarily of our operating expenses of $2.6 million, which was partially offset by approximately $0.6 million of share-based compensation and depreciation expenses and a decrease of $0.6 million in our operating assets and liabilities.
Current wording
Net cash used in operating activities for the six months ended June 30, 2026 was $6.6 million, consisting primarily of our operating expenses of $8.1 million and decrease of $0.2 million in our net operating assets and liabilities, and approximately $1.3 million of share-based compensation and depreciation expenses.
Previous wording
Net cash used in operating activities for the three months ended March 31, 2026 was $3.1 million, consisting primarily of our operating expenses of $3.5 million, which was partially offset by approximately $0.7 million of share-based compensation and depreciation expenses and a decrease of approximately $0.3 million in our net operating assets and liabilities.
Current wording
Net cash used in operating activities for the six months ended June 30, 2025 was $3.0 million, consisting primarily of our operating expenses of $5.2 million, which was partially offset by approximately $1.1 million of share-based compensation and depreciation expenses and a decrease of $1.1 million in our net operating assets and liabilities.
Previous wording
The change in cash used in operating activities for three months ended March 31, 2026 compared to the same period in 2025 was mainly attributed to an increase of $0.9 million in our net loss, an increase of $0.9 million in our net operating assets and liabilities and an increase of $0.1 million of share-based compensation and depreciation expense.
Current wording
The change in cash used in operating activities for six months ended June 30, 2026 compared to the same period in 2025 was mainly attributed to an increase of $2.9 million in our operating expenses and an increase of $0.9 million in our net operating assets and liabilities, which was partially offset by an increase of $0.2 million of share-based compensation and depreciation expense.
Previous wording
Net cash used in investing activities for the three months ended March 31, 2025 consisted primarily of the purchase of property and equipment.
Current wording
Net cash used in investing activities for the six months ended June 30, 2026 and 2025 consisted primarily of the purchase of property and equipment.
Previous wording
Net cash provided by financing activities for the three months ended March 31, 2026 consisted of the net proceeds of $0.1 million from the issuance of Ordinary Shares upon the exercise of options.
Current wording
Net cash provided by financing activities for the six months ended June 30, 2026 consisted of the net proceeds of $9.8 million from the issuance of the securities in the April 2026 Private Placement and $0.3 million from the issuance of Ordinary Shares upon the exercise of outstanding options.
Previous wording
Net cash provided by financing activities for the three months ended March 31, 2025 consisted of the net proceeds of $6.0 million from the issuance of Ordinary Shares under the Leerink ATM Program, $0.2 million from the issuance of Ordinary Shares upon the exercise of warrants and $7.2 million from issuance of Ordinary Shares under the 2025 Collaboration Agreement.
Current wording
Net cash provided by financing activities for the six months ended June 30, 2025 consisted of the net proceeds of $6.0 million from the issuance of Ordinary Shares under the Leerink ATM Program, $0.2 million from the issuance of Ordinary Shares upon the exercise of outstanding warrants and $7.2 million from issuance of Ordinary Shares under the 2025 Collaboration Agreement.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
A placebo controlled, dose ranging Phase 2 study of EB613 tablets (n= 161) met primary (pharmacodynamic/bone turnover biomarker) and secondary endpoints (bone mineral density (“BMD”)). In April 2024, Phase 2 data was published in the Journal of Bone and Mineral Research (JBMR). Our planned Phase 3 registrational program for EB613 is focused on the treatment of postmenopausal women with osteoporosis at high risk of fracture.