Entera Bio Ltd.

Previous wording

The following discussion and analysis provides information we believe is relevant to an assessment and understanding of our results of operations, financial condition, liquidity and cash flows for the periods presented below. This discussion should be read in conjunction with the interim unaudited condensed consolidated financial statements and related notes contained elsewhere in this Quarterly Report, Part II, Item 1A-Risk Factors in this Quarterly Report, and Part I, Item 1A-Risk Factors in our 2025 Annual Report. As discussed in the section above titled “Cautionary Note Regarding Forward-Looking Statements,” the following discussion contains forward-looking statements that are based upon our current expectations, including with respect to our future operations, revenues and operating results. Our actual results may differ materially from those anticipated in such forward-looking statements as a result of various factors. Factors that could cause or contribute to such differences include, but are not limited to, those identified below, and those discussed in the section titled “Risk Factors” included under Part II, Item 1A below, as well as in Part I, Item 1A-Risk Factors in our 2025 Annual Report.

Current wording

The following discussion and analysis provides information we believe is relevant to an assessment and understanding of our results of operations, financial condition, liquidity and cash flows for the periods presented below. This discussion should be read in conjunction with the interim unaudited condensed consolidated financial statements and related notes contained elsewhere in this Quarterly Report, Part II, Item 1A-Risk Factors in this Quarterly Report, and Part I, Item 1A-Risk Factors in our 2025 Annual Report. As discussed in the section above titled “Cautionary Note Regarding Forward-Looking Statements,” the following discussion contains forward-looking statements that are based upon our current expectations, including with respect to our future operations, revenues and operating results. Our actual results may differ materially from those anticipated in such forward-looking statements as a result of various factors. Factors that could cause or contribute to such differences include, but are not limited to, those identified below, and those discussed in the section titled “Risk Factors” included under Part II, Item 1A below, as well as in Part I, Item 1A-Risk Factors in our 2025 Annual Report. Unless otherwise provided, references to the “Company,” “we,” “us” and “our” refer to Entera Bio Ltd. and its consolidated subsidiary.

Previous 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.

Current wording

Entera is a clinical stage company focused on developing oral peptide and protein replacement therapies for significant unmet medical needs. 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 first-in-class oral PTH(1-34), GLP-1/Glucagon and GLP-2 agonists in tablet form, with indications across women centric endocrine conditions and metabolic and inflammatory disorders.

Previous wording

Currently, most protein therapies are administered via frequent intravenous, subcutaneous, or intramuscular injections. In chronic diseases where patients require persistent management, these cumbersome, often painful and high-priced injections can create a major treatment gap. From a technical standpoint, oral delivery of peptides and therapeutic proteins is challenging due to the enzymatic degradation within the gastrointestinal tract and poor absorption into the blood stream. We leverage our N-Tab® platform, which is designed to simultaneously stabilize large (4kD+) hydrophilic peptides in the gastrointestinal tract and promote their absorption into the bloodstream.

Current wording

From a technical standpoint, the development of orally available peptides is challenging due to the enzymatic degradation within the gastrointestinal tract and poor absorption into the blood stream. We leverage our N-Tab® platform, which is designed to simultaneously stabilize large (4kD+), linear, hydrophilic peptides in the gastrointestinal tract and promote their absorption into the bloodstream.

Previous 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.

Current wording

EB613 is intended to provide the first oral anabolic option to patients earlier in their treatment 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

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 wording

EB613 is being developed under a 505(b)(2) application to the listed drug, Forteo® (teriparatide daily 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.

Previous wording

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 wording

A placebo controlled, dose ranging Phase 2 study of EB613 oral tablets (n= 161) met primary (pharmacodynamic/bone turnover biomarker) and secondary endpoints (BMD). In April 2024, Phase 2 data was published in the Journal of Bone and Mineral Research (JBMR). 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.

Previous wording

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 wording

Osteoporosis is a major and growing public health issue worldwide. In the United States, osteoporosis results in over two million fractures annually, despite available treatment options. These fractures lead to chronic pain, decreased quality of life, increased disability and 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 in the United States is projected to increase from $57 billion in 2018 to $95 billion by 2040, largely due to the aging population.

Previous wording

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 wording

Initial approvals of new drugs for the treatment of osteoporosis have historically required a placebo-controlled trial demonstrating fracture risk reduction as the primary efficacy endpoint. The fracture endpoint is challenging due to ethical considerations and the very large sample sizes required to evaluate treatment effectiveness. The last drug approval for osteoporosis occurred in 2019.

Previous wording

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 wording

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. Total Hip BMD was qualified by FDA in December 2025 as a surrogate efficacy endpoint to fracture.

Previous wording

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 wording

Since the end of our Phase 2 Meeting in December 2021, we have engaged with the FDA in various Type C, D, A and other meetings in 2022, 2023, 2024, 2025 and 2026 to obtain clarity and alignment an appropriate data package to support a new drug application (“NDA”) for EB613 under a 505(b)(2) application.

Previous wording

Our product candidate, EB612, is being developed as the first oral PTH(1-34) tablet peptide replacement therapy for patients with hypoparathyroidism.

Current wording

Our product candidate, EB612, is being developed as the first oral acylated PTH(1-34) peptide replacement therapy in tablet form for patients with hypoparathyroidism.

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.

Current wording

This program is being developed as part of our February 2026 expanded collaboration with OPKO Biologics, Inc. (“OPKO Biologics”), a subsidiary of OPKO Health, Inc. (“OPKO”). Under the collaboration, Entera and OPKO each hold a 50% pro-rata ownership interest in the EB612 program, and each is responsible for 50% of development costs.

Previous wording

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 wording

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.

Previous 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.

Current wording

In September 2023, we entered into a collaboration agreement with OPKO Biologics (the “2023 Collaboration Agreement”) to develop the first oral dual agonist GLP-1/Glucagon (OXM) peptide as a tablet for patients with obesity and metabolic disorders. Oxyntomodulin (OXM) is a 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

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 wording

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.

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 determine next steps of the clinical development plan for oral OXM based on the outcomes of that study.

Current wording

OPKO is conducting a single ascending dose (SAD) Phase 1 clinical study with a weekly subcutaneous injection of the OXM peptide. We plan to determine next steps of the clinical development plan for EB618 based on the outcomes of that study.

Previous wording

Given the challenging compliance rates attributed to injectable GLP-2 therapy and heterogeneity of SBS patients, we believe a daily tablet format may address a significant unmet need in treating and titrating SBS patients more effectively than injectable alternatives.

Current wording

This program focuses on developing the first GLP-2 peptide tablet alternative for patients suffering from short bowel syndrome and additional disorders involving mucosal inflammation and nutrient malabsorption. Given the challenging compliance rates attributed to injectable GLP-2 therapy and heterogeneity of SBS patients, we believe a daily tablet format may address a significant unmet need in treating and titrating SBS patients more effectively than injectable alternatives.

Previous wording

In connection with the 2023 Collaboration Agreement, we and OPKO completed proof-of-concept pharmacokinetic studies in rodents and minipigs. Oral GLP-2 tablets exhibited significant systemic exposure with plasma levels about 10-fold higher than therapeutic plasma concentrations reported for subcutaneously administered teduglutide (Gattex® label). Rodent repeat-dose PK/PD studies showed clear pharmacologic activity in intestinal tissue. Systemic exposure was maintained for more than 24 hours with relatively low variability, supporting once-daily oral dosing.

Current wording

In connection with the 2023 Collaboration Agreement, we and OPKO completed proof-of-concept pharmacokinetic studies in rodents and minipigs. Oral GLP-2 tablets exhibited significant systemic exposure with plasma levels about 10-fold higher than therapeutic plasma concentrations reported for subcutaneously administered teduglutide (Gattex® label).

Previous wording

In September 2023, we entered into the 2023 Collaboration Agreement with OPKO Biologics. Under the terms of this agreement, OPKO has agreed to supply its proprietary long-acting GLP-2 peptide and certain OXM analogs for the development of oral tablet candidates using our proprietary N-Tab® platform. Under this agreement, we and OPKO have each agreed to be responsible for specific phases of development of the two oral peptides to the point of demonstrated in vivo feasibility.

Current wording

In September 2023, we entered into the 2023 Collaboration Agreement with OPKO Biologics. Under the terms of this agreement, OPKO has agreed to supply a proprietary long-acting GLP-2 peptide and certain OXM analogs for the development of oral tablet candidates using our proprietary N-Tab® platform. Under this agreement, we and OPKO have each agreed to be responsible for specific phases of development of the two oral peptides to the point of demonstrated in vivo feasibility.

Previous wording

Under the terms of the 2025 Collaboration Agreement, we and OPKO will retain 40% and 60%, respectively, of all proceeds deriving from the EB618 Program, and will be responsible for 40% and 60% of the Program’s development costs, respectively. Following the completion of the Phase 1 stage, we may continue to fund our 40% share of the Program to maintain our right to proceeds or to opt-out (the “Opt-Out”). If we Opt-Out, then we and OPKO will retain 15% and 85%, respectively, of all proceeds deriving from the Program, while OPKO will be solely responsible for ongoing development and commercialization funding of the Program.

Current wording

Under the terms of the 2025 Collaboration Agreement, we and OPKO retain 40% and 60%, respectively, of all proceeds deriving from the EB618 Program, and will be responsible for 40% and 60% of the Program’s development costs, respectively. Following the completion of the Phase 1 stage, we may continue to fund our 40% share of the Program to maintain our right to proceeds or opt-out (the “Opt-Out”). If we Opt-Out, then we and OPKO will retain 15% and 85%, respectively, of all proceeds deriving from the Program, while OPKO will be solely responsible for ongoing development and commercialization funding of the Program.

Previous wording

In February 2026, we entered into the A&R Collaboration Agreement with OPKO which amends and restates the 2025 Collaboration Agreement to expand the scope of the agreement to include the collaboration with respect to the preclinical and clinical development of a daily LA-PTH for the treatment of hypoparathyroidism (EB612 Program) and other indications in addition to the original oral dual agonist GLP-1/glucagon peptide program. Development costs incurred by the parties with respect to the development of the LA-PTH EB612 program will be shared equally between the Company and OPKO.

Current wording

In February 2026, we entered into the A&R Collaboration Agreement with OPKO which amends and restates the 2025 Collaboration Agreement to expand the scope of the agreement to include the collaboration with respect to the preclinical and clinical development of long acting or acylated PTH(1-34) peptides for the treatment of hypoparathyroidism (EB612 Program) . Development costs incurred by the parties and proceeds relating to the EB612 program will be shared equally (50% / 50%) between Entera and OPKO.

Previous wording

The amount that must be repaid may be increased up to six times the amount of the grant received and the interest. The rate of royalties may be accelerated and the royalty liability may increase (up to three times the amount of the grant amount and the interest), if manufacturing of the products developed with the grant money is transferred outside of the State of Israel. Moreover, a payment of up to 600% of the grant received may be required upon the transfer of any IIA-related know-how to a non-Israeli entity. We signed a contract with a U.K.-based contract manufacturing organization to produce and supply pills for trials performed worldwide. We believe that, because this production is not for commercial purposes, it will not affect the royalty rates to be paid to the IIA. Should the IIA successfully take a contrary position, the maximum royalties to be paid to the IIA will be approximately $1.5 million, which is three times the amount of the original grant (plus interest on the entire increased amount). Under a collaboration agreement that was previously mutually terminated in May 2023, from 2019 through March 31, 2023, we recognized an aggregate amount of $1.7 million of revenue in accordance with ASC 606, “Revenues from Contracts with Customers” with respect to revenue generated from the collaboration agreement. Prior to its termination, we had been required to pay to the IIA 5.38% of each payment made to us under such collaboration agreement with an ultimately liability of up to 600% of the grant received plus interest. As of June 30, 2026, we had paid royalties to the IIA in the amount of $96 thousand.

Current wording

The amount that must be repaid may be increased up to six times the amount of the grant received and the interest. The rate of royalties may be accelerated and the royalty liability may increase (up to three times the amount of the grant amount and the interest), if manufacturing of the products developed with the grant money is transferred outside of the State of Israel. Moreover, a payment of up to 600% of the grant received may be required upon the transfer of any IIA-related know-how to a non-Israeli entity. We signed a contract with a U.K.-based contract manufacturing organization to produce and supply tablets for trials performed worldwide. We believe that, because this production is not for commercial purposes, it will not affect the royalty rates to be paid to the IIA. Should the IIA successfully take a contrary position, the maximum royalties to be paid to the IIA will be approximately $1.5 million, which is three times the amount of the original grant (plus interest on the entire increased amount). Under a collaboration agreement that was previously mutually terminated in May 2023, from 2019 through March 31, 2023, we recognized an aggregate amount of $1.7 million of revenue in accordance with ASC 606, “Revenues from Contracts with Customers” with respect to revenue generated from the collaboration agreement. Prior to its termination, we had been required to pay to the IIA 5.38% of each payment made to us under such collaboration agreement with an ultimately liability of up to 600% of the grant received plus interest. As of September 30, 2026, we had paid royalties to the IIA in the amount of $96 thousand.

Previous wording

In early April 2026, a two-week ceasefire between the United States and Iran was agreed and on April 21, 2026, U.S. President Donald Trump announced that the United States would extend the ceasefire with Iran, to allow Iran's leadership to present a unified proposal for negotiations. However, the ceasefire's durability remains uncertain. The United States has maintained a naval blockade of Iranian ports, and Iran has responded by intermittently restricting commercial vessel passage through the Strait of Hormuz, declaring that the waterway would remain effectively closed until the blockade is lifted. There can be no assurance that this ceasefire will hold or be extended, and hostilities between the United States, Israel and Iran could resume at any time. On April 16, 2026, following direct talks between Israeli and Lebanese officials in Washington, D.C., a 10-day cessation of hostilities between Israel and Lebanon was announced, brokered by the United States. The parties have requested that the United States facilitate further direct negotiations with the objective of achieving a comprehensive agreement for lasting security and peace. Israeli forces remain stationed in southern Lebanon and Hezbollah has not accepted the terms as binding, stating that its fighters will remain deployed and will respond to any violations. The ceasefire remains fragile, with reports of continued military operations by both sides in southern Lebanon.

Current wording

In early April 2026, a two-week ceasefire between the United States and Iran was agreed and on April 21, 2026, U.S. President Donald Trump announced that the United States would extend the ceasefire with Iran, to allow Iran's leadership to present a unified proposal for negotiations. On June 17, 2026, the United States and Iran signed a memorandum of understanding formalizing the ceasefire, which ended the U.S. naval blockade of Iranian ports and provided for the reopening of the Strait of Hormuz; however, negotiations subsequently stalled, the ceasefire broke down and, beginning in late June 2026, Iran resumed attacks on commercial vessels and U.S. military facilities in the region. In July 2026, Iran announced the closure of the Strait of Hormuz and the United States reinstated its naval blockade of Iranian ports. Iran has since continued restricting commercial vessel passage through the Strait of Hormuz, declaring that the waterway would remain effectively closed until the blockade is lifted. Since early September 2026, no major attacks on land-based targets have been reported, although Iranian attacks on commercial shipping in and around the Strait of Hormuz intensified in October 2026, and the U.S. naval blockade of Iranian ports remains in effect. Hostilities could resume or escalate at any time. On April 16, 2026, following direct talks between Israeli and Lebanese officials in Washington, D.C., a 10-day cessation of hostilities between Israel and Lebanon was announced, brokered by the United States. On June 26, 2026, Israel, Lebanon and the United States facilitated a framework agreement providing for the disarmament of Hezbollah and a phased withdrawal of Israeli forces from southern Lebanon; however, implementation has been limited. Israeli forces remain stationed in southern Lebanon and Hezbollah has not accepted the terms as binding, stating that its fighters will remain deployed and will respond to any violations. The ceasefire remains fragile, with reports of continued military operations by both sides in southern Lebanon. In August 2026, Iran and Oman entered advanced negotiations on a new shipping arrangement for the Strait of Hormuz; however, Iran has conditioned reopening the waterway on additional demands, including U.S. compensation and the cessation of hostilities, while the United States has similarly demanded compensation from Iran as a precondition for further talks. As of the date of this Quarterly Report, those negotiations remain unresolved and the Strait of Hormuz remains effectively closed to normal commercial traffic.

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 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.”

Current wording

The Company’s early research and development personnel and certain officers of the Company are located in Israel. The Company’s clinical operations and development team and our supply chain is located outside of Israel. During the three and nine months ended September 30, 2026 and 2025, the impact of these conflicts on the Company’s results of operations and financial condition was immaterial. See Item 1A. “Risk Factors—Security, political and economic instability in the Middle East may harm our business.”

Previous wording

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 wording

From our inception through September 30, 2026, we have financed our operations primarily through a combination of public and private equity offerings and the issuance of Ordinary Shares upon the exercise of options and warrants. Through September 30, 2026, we had raised an aggregate of approximately $397.3 million from these sources, including approximately $275.0 million of gross proceeds received in connection with the July 2026 Private Placement (as defined below).

Previous wording

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 wording

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 September 30, 2026 and 2025, our operating losses were $7.3 million and $3.3 million, respectively. For the nine months ended September 30, 2026 and 2025, our operating losses were $15.4 million and $8.5 million, respectively.

Previous 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.

Current wording

As of September 30, 2026, we had an accumulated deficit of $151.8 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 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.

Current wording

As of September 30, 2026, we had cash, cash equivalents and restricted cash of $272.4 million, of which $6.5 million has been designated to fund collaboration activities with OPKO under the A&R Collaboration Agreement.

Previous wording

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 wording

On July 28, 2026, we consummated the July 2026 Private Placement and received aggregate gross proceeds of approximately $275.0 million and aggregate net proceeds of approximately $260.9 million after deducting placement agent fees and other offering expenses. Based on our current operating plan, we believe that our existing cash resources will be sufficient to fund our planned operations into 2030.

Previous wording

As of June 30, 2026, we had a total of 22 employees, of whom 20 are full-time employees, and all are based in Israel. In addition, we employ a number of specialized clinical, non-clinical, statistical, regulatory and development advisors based in the United States, the United Kingdom and Europe. Our operations are located in Jerusalem, Israel.

Current wording

As of September 30, 2026, we had a total of 27 employees based in Israel, the U.S., Switzerland and Canada. In addition, we employ a team of dedicated clinical, non-clinical, statistics, CMC, regulatory and development advisors. Our laboratories are in Jerusalem, Israel.

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 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:

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 September 30, 2026 and 2025, our research and development expenses were $4.9 million and $1.6 million, respectively. For the nine months ended September 30, 2026 and 2025, our research and development expenses were $10.4 million and $4.3 million, respectively. Research and development expenses for the three and nine months ended September 30, 2026 were primarily for the development of the EB613 program, including start-up activities for the registrational Phase 3 study of EB613, and expenses related to our EB612 and EB618 programs in collaboration with OPKO. 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 and six months ended June 30, 2026 and June 30, 2025 are summarized as follows:

Current wording

Our research and development expenses for the three and nine months ended September 30, 2026 and 2025 are summarized as follows:

Previous wording

General and administrative expenses consist principally of salaries and related expenses, share-based compensation and related costs for directors and personnel in executive and finance functions. Other general and administrative expenses include D&O insurance and other insurance, communication expenses, professional fees for legal and accounting services, costs associated with maintaining and prosecuting our intellectual property portfolio and business development expenses.

Current wording

General and administrative expenses consist principally of salaries and related expenses, share-based compensation and related costs for directors and personnel in executive and finance functions. Other general and administrative expenses include D&O insurance and other insurance, professional fees for legal and accounting services, costs associated with maintaining and prosecuting our intellectual property portfolio and business development expenses.

Previous 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.

Current wording

Financial expenses (income), net is composed primarily of changes in the fair value of the April 2026 Pre-Funded Warrants and the July 2026 Pre-Funded Warrants, which were classified as a financial liability until their reclassification to equity on August 21, 2026, the portion of offering costs allocated to such pre-funded warrants, interest income from bank deposits and exchange rate differences of certain currencies against our functional currency, which is the U.S. Dollar. Following the reclassification of the pre-funded warrants to equity, we do not expect to recognize further changes in their fair value, and we expect interest income on the net proceeds of the July 2026 Private Placement to be the primary component of financial expenses (income), net in future periods.

Previous 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.

Current wording

We have not generated taxable income since our inception, and, as of September 30, 2026, we had carryforward tax losses of $102.9 million.

Previous 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.

Current wording

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 in expenses of $3.3 million was primarily attributable to an increase of $2.3 million in costs associated with preparatory and start-up activities for the registrational Phase 3 program of EB613, including clinical drug supply and contract research organization (CRO) activity, an increase of $0.6 million in connection with our collaboration programs with OPKO, mainly for EB612, and an increase of $0.5 million in personnel-related expenses, reflecting the appointment of our Chief Medical Officer, the expansion of our clinical and early development teams and non-cash share-based compensation expenses. These were partially offset by $0.1 million in regulatory expenses.

Previous 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.

Current wording

Revenues for the nine months ended September 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 nine months ended September 30, 2026.

Previous 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.

Current wording

Cost of revenues for the nine months ended September 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 nine months ended September 30, 2026, we did not recognize any cost of revenues.

Previous wording

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 wording

Research and development expenses for the nine months ended September 30, 2026 were $10.4 million, as compared to $4.3 million for the nine months ended September 30, 2025. The increase in expenses of $6.1 million was mainly attributable to an increase of $3.6 million in costs associated with preparatory and start-up activities for the registrational Phase 3 program of EB613, including clinical drug supply and contract research organization (CRO) activity and related to our Phase 1 safety and PK bridging study for the Next Generation of EB613, an increase of $1.6 million in connection with our collaboration programs with OPKO for EB612 and EB618 and an increase of $0.9 million in personnel-related expenses, reflecting the appointment of our Chief Medical Officer, the expansion of our clinical and early development teams and non-cash share-based compensation expenses.

Previous wording

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 wording

Financial expenses, net for the nine months ended September 30, 2026 were $11.0 million, as compared to financial income, net of $64 thousand for the nine months ended September 30, 2025. The change was primarily driven by (i) a non-cash loss of $10.3 million from the remeasurement to fair value of the April 2026 and July 2026 Pre-Funded Warrants until their reclassification to equity on August 21, 2026, (ii) $2.1 million of offering costs related to the April and July 2026 Private Placements allocated to the Pre-Funded Warrants and expensed as incurred and (iii) exchange rate differences. These were partially offset by interest income of $1.4 million.