Entera Bio Ltd.

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 five differentiated, first-in-class oral peptide programs targeting PTH(1-34), GLP-1 and GLP-2.

Current wording

Entera is a clinical stage company focused on developing first-in-class oral tablet formats of peptides or protein replacement therapies. We concentrate 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 five differentiated, first-in-class oral peptide programs targeting PTH(1-34), GLP-1 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 post-menopausal women with low bone mineral density (“BMD”) and high-risk 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. A placebo controlled, dose ranging Phase 2 study of EB613 tablets (n= 161) met primary (pharmacodynamic/bone turnover biomarker) and secondary endpoints (BMD). In April 2024, the phase 2 data was published in the Journal of Bone and Mineral Research (JBMR).

Current wording

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. A placebo controlled, dose ranging Phase 2 study of EB613 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).

Previous wording

Our product candidate, EB612, is being developed as the first oral PTH(1-34) tablet peptide replacement therapy for patients with hypoparathyroidism. With respect to our EB612 program, we are currently testing new generations of our N-Tab™ Technology with the naked PTH(1-34) peptide to assess the effectiveness of once or twice a day dosing regimens, as well as collaborating with a third party on another peptide in this field. In June 2024, Phase 1 clinical data for EB612 was presented at the Endocrine Society ENDO 2024 Annual Meeting.

Current wording

Our product candidate, EB612, is being developed as the first oral PTH(1-34) tablet peptide replacement therapy for patients with hypoparathyroidism. With respect to our EB612 program, since 2023 we tested new generations of our N-Tab™ Technology with the naked PTH(1-34) peptide to assess the effectiveness of once or twice a day dosing regimens, and are collaborating with a third party on another peptide in this field. In June 2024, Phase 1 clinical data for a bid regimen of EB612 using unmodified PTH(1-34) was presented at the Endocrine Society ENDO 2024 Annual Meeting.

Previous wording

To date, Entera’s proprietary PTH tablets have been safely administered to a total of 102 healthy subjects in Phase 1 studies and 153 patients in Phase 2 studies in osteoporosis and hypoparathyroidism, two diseases that remain underserved with the current standard of care and which disproportionately affect women. We believe these product candidates, if approved, hold the potential to become standards of care for patients with osteoporosis and hypoparathyroidism.

Current wording

To date, Entera’s proprietary PTH tablets have been safely administered to a total of 255 subjects in Phase 1 studies and Phase 2 studies in osteoporosis and hypoparathyroidism, two diseases that remain underserved with the current standard of care and which disproportionately affect women. We believe these product candidates, if approved, hold the potential to become standards of care for patients with osteoporosis and hypoparathyroidism.

Previous wording

In September 2023, we entered into collaboration agreement with OPKO Biologics, Inc., a subsidiary of OPKO Health, Inc. (collectively, “OPKO”). Under the terms of this agreement, OPKO has agreed to supply its proprietary long-acting GLP-2 peptide and certain oxyntomodulin (OXM) analogs for the development of oral tablet candidates using our proprietary N-Tab™ technology. 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 a research and collaboration agreement with OPKO Biologics, Inc., a subsidiary of OPKO Health, Inc. (collectively, “OPKO”). Under the terms of this agreement, OPKO agreed to supply its proprietary long-acting GLP-2 peptide and certain oxyntomodulin (OXM) analogs for the development of oral tablet candidates using our proprietary N-Tab™ technology. 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

In March 2024, we announced positive in vivo pharmacokinetic (PK) results from our collaborative research, combining a proprietary long acting GLP-2 agonist developed by OPKO with Entera’s proprietary N-Tab™ technology. The program is focused on developing the first and only GLP-2 peptide tablet alternative for patients suffering from short bowel syndrome and additional disorders involving mucosal inflammation and nutrient malabsorption.

Current wording

In March 2024, we announced positive in vivo pharmacokinetic (PK) results from our collaborative research, combining a proprietary long acting GLP-2 agonist developed by OPKO with Entera’s proprietary N-Tab™ technology. The program is focused on developing the first and only GLP-2 peptide tablet alternative for patients suffering from short bowel syndrome and additional disorders involving mucosal inflammation and nutrient malabsorption. Currently, the only approved GLP-2 agonist requires daily subcutaneous injections.

Previous wording

In September 2024, we jointly announced with OPKO topline pharmacokinetic/pharmacodynamic (PK/PD) results for the OXM program. The program is focused on developing the first oral dual agonist GLP-1/Glucagon peptide as a potential once-daily tablet treatment for patients with obesity and metabolic disorders using the N-Tab™ platform. Oral OXM exhibited significant systemic exposure across two in vivo models, a favorable PK profile and bioavailability. The high plasma concentrations with prolonged systemic exposure were consistent with the reported half-life for semaglutide (Rybelsus®), the only approved oral GLP-1 analog. Oral OXM showed a statistically significant reduction in plasma glucose levels compared with placebo.

Current wording

In September 2024, we announced topline pharmacokinetic/pharmacodynamic (PK/PD) results for the OXM program. The program is focused on developing the first oral dual agonist GLP-1/Glucagon peptide as a potential once-daily tablet treatment for patients with obesity and metabolic disorders using the N-Tab™ platform. Oral OXM exhibited significant systemic exposure across two in vivo models, a favorable PK profile and bioavailability. The high plasma concentrations with prolonged systemic exposure were consistent with the reported half-life for semaglutide (Rybelsus®), the only approved oral GLP-1 analog. Oral OXM showed a statistically significant reduction in plasma glucose levels compared with placebo.

Previous wording

Given the scarcity of oral peptide treatments and potential safety challenges attributed to small molecule approaches, we believe oral OXM may address a significant number of patients suffering from chronic metabolic diseases. We plan to file an Investigational New Drug (IND) application with the FDA later this year.

Current wording

Given the scarcity of oral peptide treatments and potential safety challenges attributed to small molecule approaches, we believe oral OXM may address a significant number of patients suffering from chronic metabolic diseases.

Previous wording

In October 2023, Israel was attacked by Hamas, a terrorist organization and entered a state of war. Since the commencement of these events, there have been continuous rocket strikes across Israel, including with Hezbollah in Lebanon, the Houthi movement which controls parts of Yemen, and with Iran. As of the date of this Quarterly Report, the war with Hamas is ongoing and continues to evolve. In response to ongoing Iranian aggression and support of proxy attacks against Israel, on June 12, 2025, Israel conducted a series of preemptive defensive air strikes in Iran targeting Iran’s nuclear program and military commanders. On June 21, 2025, U.S. President Donald Trump announced that the United States had conducted air strikes against three nuclear sites within Iran. On June 24, 2025, U.S. President Donald Trump announced that a ceasefire had been reached and, since such date, there has been no further escalation of hostilities between Israel and Iran; however, there is no assurance that the ceasefire will be upheld, and military activity and hostilities may continue or escalate. The Company’s research personnel and some management personnel are located in Israel; however, other core activities including clinical, regulatory and supply chain are outside of Israel.

Current wording

In October 2023, Israel was attacked by Hamas, a terrorist organization and entered a state of war. Since the commencement of these events, there have been continuous rocket strikes across Israel, including with Hezbollah in Lebanon, the Houthi movement which controls parts of Yemen, and with Iran. In response to ongoing Iranian aggression and support of proxy attacks against Israel, on June 12, 2025, Israel conducted a series of preemptive defensive air strikes in Iran targeting Iran’s nuclear program and military commanders. On June 21, 2025, U.S. President Donald Trump announced that the United States had conducted air strikes against three nuclear sites within Iran. On October 9, 2025, a ceasefire had been reached. Israel, Hamas, the United States and other countries in the region agreed to a framework for a ceasefire in Gaza between Israel and Hamas. However, there is no assurance that the ceasefire will be upheld. Military activity and hostilities may continue or escalate, including in Northern Israel, Lebanon, Iran or elsewhere in the region. Any renewed or expanded conflict involving Israel, Hamas, Hezbollah, Iran, or other militant groups or states could disrupt regional security and economic conditions and, depending on its scope and duration, could adversely affect our business and operations. The Company’s research personnel and some management personnel are located in Israel. However, other core activities, including clinical, regulatory and supply chain are outside of Israel.

Previous wording

Currently, such activities in Israel remain largely unaffected by the foregoing events. During the six months ended June 30, 2025 and as of December 31, 2024, the impact of such events on the Company’s results of operations and financial condition was immaterial.

Current wording

Currently, such activities in Israel remain largely unaffected by the foregoing events. During the nine months ended September 30, 2025 and as of December 31, 2024, the impact of such events on the Company’s results of operations and financial condition was immaterial.

Previous wording

From our inception through June 30, 2025, we have raised a total of $111.1 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 June 30, 2025 and 2024, our operating losses were $2.7 million and $2.2 million, respectively. For the six months ended June 30, 2025 and 2024, our operating losses were $5.2 million and $4.2 million, respectively, and we expect to continue to incur significant expenses and losses for the foreseeable future.

Current wording

From our inception through September 30, 2025, we have raised a total of $111.4 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 September 30, 2025 and 2024, our operating losses were $3.3 million and $3.0 million, respectively. For the nine months ended September 30, 2025 and 2024, our operating losses were $8.5 million and $7.2 million, respectively, and we expect to continue to incur significant expenses and losses for the foreseeable future.

Previous wording

As of June 30, 2025, we had an accumulated deficit of $119.2 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 September 30, 2025, we had an accumulated deficit of $122.4 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.

Previous wording

As of June 30, 2025, we had cash and cash equivalents and restricted cash of $18.9 million, of which $8.0 million has been designated to fund our obligations under the 2025 Collaboration Agreement. Given our current cash position and plans, we believe that our existing cash resources will be sufficient to meet our projected operating requirements through the middle of the third quarter of 2026, which include the capital required to fund our ongoing operations, including regulatory and intellectual property expenses, optimization related to the preparation of the EB613 phase 3 program in osteoporosis, ongoing N-Tab TM research and development, the completion of an additional Phase 1 PK study related to the Company’s new generation of EB613 and completion of SAD and MAD Phase 1 proposed studies of oral OXM (GLP1/Glucagon tablet) in collaboration with OPKO. Our ability to commence the Phase 3 program of EB613 in osteoporosis will require additional funding, which may not be available on reasonable terms, or at all. Any delay or our inability to secure such funding will delay or prevent the commencement of this study.

Current wording

As of September 30, 2025, we had cash and cash equivalents and restricted cash of $16.6 million, of which $8.0 million has been designated to fund our obligations under the 2025 Collaboration Agreement. Given our current cash position and plans, we believe that our existing cash resources will be sufficient to meet our projected operating requirements through the middle of the third quarter of 2026, which include the capital required to fund our ongoing operations, including manufacturing, research, development, and regulatory expenses related to the preparation of the EB613 phase 3 program in osteoporosis, ongoing N-Tab™ platform development and intellectual property expenses, completion of a Phase 1 PK study related to the Company’s next generation of EB613 and completion of SAD and MAD Phase 1 studies of oral OXM (GLP1/Glucagon tablet) in collaboration with OPKO. Our ability to commence the Phase 3 program of EB613 in osteoporosis will require additional funding, which may not be available on reasonable terms, or at all. Any delay or our inability to secure such funding will delay or prevent the commencement of this study.

Previous wording

As of June 30, 2025, we had a total of 21 employees, of whom 19 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, 2025, 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, Asia and Europe. Our operations are located 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 enrollment of patients in clinical trials. Research and development expenses for the three and six months ended June 30, 2025 were primarily for the development of EB613 and our collaboration with OPKO related to OXM and for the three and six months ended June 30, 2024 were primarily for the development of EB613. 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 enrollment of patients in clinical trials. Research and development expenses for the three and nine months ended September 30, 2025 were primarily for the development of EB613 and our collaboration with OPKO related to OXM and for the three and nine months ended September 30, 2024 were primarily for the development of EB613. 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, 2025 and June 30, 2024 are summarized as follows:

Current wording

Our research and development expenses for the three and nine months ended September 30, 2025 and September 30, 2024 are summarized as follows:

Previous wording

We have not generated taxable income since our inception, and, as of June 30, 2025, we had carryforward tax losses of $87.7 million.

Current wording

We have not generated taxable income since our inception, and, as of September 30, 2025, we had carryforward tax losses of $89.8 million.

Previous wording

Revenues for the three months ended June 30, 2024 were $57 thousand, which were attributable to research services we provided pursuant to a material transfer and research project agreement entered into in April 2024 (the “research services agreement”). The Company completed the first stage of its obligations under the research services agreement in the first quarter of 2025. As a result, we did not recognize any revenue for the three months ended June 30, 2025.

Current wording

Revenues for the three months ended September 30, 2024 were $42 thousand, which were attributable to research services we provided pursuant to a material transfer and research project agreement entered into in April 2024 (the “research services agreement”). The Company completed the first stage of its obligations under the research services agreement in the first quarter of 2025. As a result, we did not recognize any revenue for the three months ended September 30, 2025.

Previous wording

Cost of revenues for the three months ended June 30, 2025 was zero, as compared to $48 thousand for the three months ended June 30, 2024, which were attributable to research services we provided pursuant to the research services agreement. The Company completed the first stage of its obligations under the research services agreement in the first quarter of 2025, resulting in no revenue recognized for the three months ended June 30, 2025.

Current wording

Cost of revenues for the three months ended September 30, 2025 was zero, as compared to $42 thousand for the three months ended September 30, 2024, which were attributable to research services we provided pursuant to the research services agreement. The Company completed the first stage of its obligations under the research services agreement in the first quarter of 2025, resulting in no revenue recognized for the three months ended September 30, 2025.

Previous wording

Research and development expenses for the three months ended June 30, 2025 were $1.5 million, as compared to $1.1 million for the three months ended June 30, 2024. The increase of $0.4 million was primarily due to an increase of $0.3 million in other consulting fees, including regulatory required in connection with filing of a type A meeting and ongoing optimization processes related to the preparation of the EB613 phase 3 program and $0.1 million in connection with our internal programs and collaboration programs.

Current wording

Research and development expenses for the three months ended September 30, 2025 were $1.6 million, as compared to $1.5 million for the three months ended September 30, 2024. The increase of $0.1 million was attributed to an increase of $0.2 million in consulting fees, including regulatory expenses in connection with filing of a type A meeting and ongoing optimization processes related to the preparation of the EB613 phase 3 program, an increase of $0.1 million in connection with our internal programs and collaboration programs and an increase of $0.1 million in compensation, which increase was partially offset by a decrease of $0.3 million in materials and productions related to the preparation of the EB613 phase 3 study.

Previous wording

Financial income, net for the three months ended June 30, 2025 was $12 thousand as compared to $20 thousand for the three months ended June 30, 2024. Our financial income mainly included income from bank deposits and exchange rate differences of certain currencies against our functional currency, which is the U.S. Dollar.

Current wording

Financial income, net for the three months ended September 30, 2025 was $56 thousand as compared to zero for the three months ended September 30, 2024. Our financial income mainly included income from bank deposits and exchange rate differences of certain currencies against our functional currency, which is the U.S. Dollar.

Previous wording

Revenues for the six months ended June 30, 2025 and 2024 were $42 thousand and $57 thousand, respectively, which were attributable to research services we provided pursuant to the research services agreement. The Company completed the first stage of its obligations under the research services agreement in the first quarter of 2025.

Current wording

Revenues for the nine months ended September 30, 2025 and 2024 were $42 thousand and $99 thousand, respectively, which were attributable to research services we provided pursuant to the research services agreement. The Company completed the first stage of its obligations under the research services agreement in the first quarter of 2025.

Previous wording

Cost of revenues for the six months ended June 30, 2025 and 2024 was $42 thousand and $48 thousand, respectively, which was attributable to research services we provided pursuant to the research services agreement. The Company completed the first stage of its obligations under the research services agreement in the first quarter of 2025.

Current wording

Cost of revenues for the nine months ended September 30, 2025 and 2024 was $42 thousand and $90 thousand, respectively, which were attributable to research services we provided pursuant to the research services agreement. The Company completed the first stage of its obligations under the research services agreement in the first quarter of 2025.

Previous wording

Research and development expenses for six months ended June 30, 2025 were $2.6 million as compared to $1.8 million for the six months ended June 30, 2024. The increase of $0.8 million was primarily due to an increase of $0.6 million in other consulting fees, including regulatory required in connection with filing of a type A meeting and ongoing optimization processes related to the preparation of the EB613 phase 3 program and $0.2 million in connection with our internal programs and collaboration programs.

Current wording

Research and development expenses for the nine months ended September 30, 2025 were $4.3 million as compared to $3.3 million for the nine months ended September 30, 2024. The increase of $1.0 million was primarily due to an increase of $0.7 million in other consulting fees, including regulatory expenses in connection with filing of a type A meeting and ongoing optimization processes related to the preparation of the EB613 phase 3 program, an increase of $0.3 million in connection with our internal programs and collaboration programs, an increase of $0.2 million in compensation and an increase of $0.1 million in other expenses. This increase was partially offset by a decrease of $0.3 million in materials and productions related to the preparation of the EB613 phase 3 study.

Previous wording

General and administrative expenses for the six months ended June 30, 2025 were $2.6 million as compared to $2.4 million for the six months ended June 30, 2024. The increase was primarily due to an increase of $0.2 million in legal expenses related to the OPKO collaboration agreement and other potential strategic agreements.

Current wording

General and administrative expenses for the nine months ended September 30, 2025 were $4.2 million as compared to $4.0 million for the nine months ended September 30, 2024. The increase was primarily due to an increase of $0.2 million of other consultants and an increase of $0.2 million in compensation. This increase was partially offset by a decrease of $0.1 million in legal fees, mainly related to IP costs, and a decrease of $0.1 million in other expenses.

Previous wording

Financial income, net for the six months ended June 30, 2025 and 2024 was $8 thousand and $65 thousand, respectively. Our financial income was composed mainly 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 income, net for the nine months ended September 30, 2025 and 2024 was $64 thousand and $65 thousand, respectively. Our financial income was composed mainly of interest income from bank deposits and exchange rate differences of certain currencies against our functional currency, which is the U.S. Dollar.

Previous wording

Since inception, we have incurred significant losses from operations, negative cash flows from operating activities and lack of liquidity. For the three months ended June 30, 2025 and 2024, our operating losses were $2.7 million and $2.2 million, respectively. For the six months ended June 30, 2025 and 2024, our operating losses were $5.2 million and $4.2 million, respectively. As of June 30, 2025, we had an accumulated deficit of $119.2 million. We expect to continue to incur significant expenses and losses for the next several years as we advance our product candidates through development and provide administrative support for our operations. These factors raise substantial doubt about our ability to continue as a going concern. Given our current plans, we believe that our existing cash resources will be sufficient to meet our projected operating requirements through the middle of the third quarter of 2026 without additional funding, excluding the initiation of Phase 3 program of EB613 in osteoporosis.

Current wording

Since inception, we have incurred significant losses from operations, negative cash flows from operating activities and lack of liquidity. For the three months ended September 30, 2025 and 2024, our operating losses were $3.3 million and $3.0 million, respectively. For the nine months ended September 30, 2025 and 2024, our operating losses were $8.5 million and $7.2 million, respectively. As of September 30, 2025, we had an accumulated deficit of $122.4 million. We expect to continue to incur significant expenses and losses for the next several years as we advance our product candidates through development and provide administrative support for our operations. These factors raise substantial doubt about our ability to continue as a going concern. Given our current plans, we believe that our existing cash resources will be sufficient to meet our projected operating requirements through the middle of the third quarter of 2026 without additional funding, excluding the initiation of Phase 3 program of EB613 in osteoporosis.

Previous wording

From our inception through June 30, 2025, we have raised a total of $111.1 million, including $36.3 million through at-the-market-offering (“ATM”) programs, an aggregate of $28.9 million in private placements since our IPO, $11.2 million in our IPO in 2018 and $34.7 million in aggregate funding from a combination of IIA grants, exercise of options and warrants and private placements of Ordinary Shares, preferred shares and debt prior to our IPO.

Current wording

From our inception through September 30, 2025, we have raised a total of $111.4 million, including $36.3 million through at-the-market-offering (“ATM”) programs, an aggregate of $28.9 million in private placements since our IPO, $11.2 million in our IPO in 2018 and $35.0 million in aggregate funding from a combination of IIA grants, exercise of options and warrants and private placements of Ordinary Shares, preferred shares and debt prior to our IPO.

Previous wording

As of June 30, 2025, we had cash and cash equivalents and restricted cash of $18.9 million, of which $8.0 million has been designated to fund our obligations under the 2025 Collaboration Agreement. Our primary uses of cash have been to fund research and clinical development, general and administrative expenses and working capital requirements, and we expect these will continue to be our primary uses of cash.

Current wording

As of September 30, 2025, we had cash and cash equivalents and restricted cash of $16.6 million, of which $8.0 million has been designated to fund our obligations under the 2025 Collaboration Agreement. Our primary uses of cash have been to fund research and clinical development, general and administrative expenses and working capital requirements, and we expect these will continue to be our primary uses of cash.

Previous wording

Given our current plans, we believe that our existing cash resources will be sufficient to support the Company’s operations through the middle of the third quarter of 2026. This assumes the use of the Company’s capital to fund our ongoing operations, including regulatory and intellectual property expenses, optimization related to the preparation of the EB613 phase 3 program in osteoporosis, ongoing N-Tab TM research and development, the completion of an additional Phase 1 PK study related to the Company’s new generation of EB613 and completion of SAD and MAD Phase 1 proposed studies of oral OXM (GLP1/Glucagon tablet) in collaboration with OPKO. Our ability to commence the Phase 3 program of EB613 in osteoporosis will require additional funding, which may not be available on reasonable 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

Given our current plans, we believe that our existing cash resources will be sufficient to support the Company’s operations through the middle of the third quarter of 2026. This assumes the use of the Company’s capital to fund our ongoing operations, including manufacturing, research, development, and regulatory expenses related to the preparation of the EB613 phase 3 program in osteoporosis, ongoing N-Tab™ platform development and intellectual property expenses, completion of a Phase 1 PK study related to the Company’s next generation of EB613 and completion of SAD and MAD Phase 1 studies of oral OXM (GLP1/Glucagon tablet) in collaboration with OPKO. Our ability to commence the Phase 3 program of EB613 in osteoporosis will require additional funding, which may not be available on reasonable 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.

Previous wording

Six Months Ended June 30, 2025 compared to Six Months Ended June 30, 2024

Current wording

Nine Months Ended September 30, 2025 compared to Nine Months Ended September 30, 2024

Previous wording

Net cash used in operating activities for the six months ended June 30, 2025 was $3.0 million, consisting primarily of our operating loss 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.

Current wording

Net cash used in operating activities for the nine months ended September 30, 2025 was $5.5 million, consisting primarily of our operating loss of $8.5 million, which was partially offset by approximately $2.1 million of share-based compensation and depreciation expenses and a decrease of approximately $0.9 million in our net operating assets and liabilities.

Previous wording

Net cash used in operating activities for the six months ended June 30, 2024 was $3.2 million, consisting primarily of our operating loss of $4.2 million and an increase of $0.1 million in our net operating assets and liabilities, which was partially offset by approximately $1.1 million of share-based compensation and depreciation expenses.

Current wording

Net cash used in operating activities for the nine months ended September 30, 2024 was $5.4 million, consisting primarily of our operating loss of $7.2 million and an increase of $0.2 million in our net operating assets and liabilities, which was partially offset by approximately $2.0 million of share-based compensation and depreciation expenses.

Previous wording

The change in cash used in operating activities for the six months ended June 30, 2025 compared to the same period in 2024 was mainly attributed to an increase of $1.0 million in our operating loss which was offset by a decrease of $0.9 million in our net operating assets and liabilities.

Current wording

The change in cash used in operating activities for the nine months ended September 30, 2025 compared to the same period in 2024 was mainly attributed to an increase of $1.3 million in our operating loss, which was partially offset by a decrease of $1.1 million in our net operating assets and liabilities and an increase of $0.1 million of share-based compensation and depreciation expense.

Previous wording

Net cash used in investing activities for the six months ended June 30, 2025 consisted primarily of the purchase of property and equipment.

Current wording

Net cash used in investing activities for the nine months ended September 30, 2025 consisted primarily of the purchase of property and equipment.

Previous wording

There was no net cash used in or provided by investing activities for the six months ended June 30, 2024.

Current wording

There was no net cash used in or provided by investing activities for the nine months ended September 30, 2024.

Previous 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 warrants and $7.1 million from issuance of Ordinary Shares under the 2025 Collaboration Agreement.

Current wording

Net cash provided by financing activities for the nine months ended September 30, 2025 consisted of the net proceeds of $6.0 million from the issuance of Ordinary Shares under the Leerink ATM Program, $0.4 million from the issuance of Ordinary Shares upon the exercise of warrants and $7.1 million from issuance of Ordinary Shares under the 2025 Collaboration Agreement.

Previous wording

Net cash provided by financing activities for the six months ended June 30, 2024 consisted of the net proceeds of $0.6 million from the issuance of Ordinary Shares under the Leerink ATM Program and $0.6 million from the issuance of Ordinary Shares upon the exercise of options and warrants.

Current wording

Net cash provided by financing activities for the nine months ended September 30, 2024 consisted of the net proceeds of $0.6 million from the issuance of Ordinary Shares under the Leerink ATM Program and $0.7 million from the issuance of Ordinary Shares upon the exercise of options and warrants.