Entera Bio Ltd.
For the period ended Jun 30, 2025. Filed Aug 8, 2025.
View on SEC.govAbout this filing
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, 2025 · Filed Aug 8, 2025
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-03-31; filed 2025-05-09.
0001178913-25-001674
Item 2. Management's Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-06-30; filed 2025-08-08.
0001178913-25-002702
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 108 previous paragraphs and 112 current paragraphs.
64 unchanged; 32 reworded; 16 added; 9 removed; 3 previous and 0 current paragraphs rearranged.
Tables are not compared: 18 previous and 22 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 (16)
Current report
On July 28, 2025, we announced that in a written response to a Type A meeting request, the FDA agreed with our proposal that the NDA filing for EB613 (oral PTH (1-34), teriparatide) would be supported by a single multinational, randomized, double-blind, placebo-controlled, 24-month 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.
Current report
While the FDA’s anticipated qualification of SABRE is still expected in 2025, the FDA’s concurrence with our proposal allows us to advance our clinical program without having to wait for such qualification.
Current report
On July 28, 2025, we announced that in a written response to a Type A meeting request, the FDA agreed with our proposal that the NDA filing for EB613 (oral PTH (1-34), teriparatide) would be supported by a single multinational, randomized, double-blind, placebo-controlled, 24-month 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.
Current report
While the FDA’s anticipated qualification of SABRE is still expected in 2025, the FDA’s concurrence with our proposal allows us to advance our clinical program without having to wait for such qualification.
Current report
Israel’s multi-front war with terrorist groups in neighboring countries, such as Hezbollah in Lebanon and Hamas in the Gaza Strip, and state actors such as Iran, and Israel’s responses thereto.
Current report
Internal and certain general external research and development expenses support multiple product candidate research and development programs, include:
Current report
External research and development expenses for our main clinical development programs include:
Current report
Our research and development expenses for the three and six months ended June 30, 2025 and June 30, 2024 are summarized as follows:
Current report
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 report
General and administrative expenses for both the three months ended June 30, 2025 and 2024 were $1.1 million. There were no material changes for the three months ended June 30, 2025 as compared to the same period in the previous year.
Current report
Comparison of Six Months Ended June 30, 2025 and 2024
Current report
Revenues
Current report
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 report
Cost of Revenues
Current report
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 report
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.
Removed paragraphs (9)
Previous report
Israel-Hamas War
Previous report
In April 2024, the Company entered into a material transfer and research project agreement (the “research services agreement”) with a third party. According to the agreement, the third party will pay the Company a monthly payment for the research services, as well as reimbursement for external expenses based on an agreed budget. For the three months ended March 31, 2025, the Company recognized total revenues of $42 thousand from this agreement.
Previous report
The Company concluded that, because the research services provided under the research services agreement have no alternative use (because, in nature, these services are unique to each customer), and the Company has the right to receive payment for performance completed to date, the Company recognizes revenue over the contract term using the input model method, which is labor hours expended and time lapsed.
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
Financial Expenses (Income), Net
Reworded paragraphs (32)
Previous wording
Following Type C and Type D meetings with the FDA, we announced in 2023 the FDA’s concurrence that a 2-year, placebo-controlled phase 3 (registrational) study with Total Hip BMD as primary endpoint could support a new drug application (“NDA”) for EB613, however the BMD endpoint remained unqualified as a surrogate endpoint by FDA. In November 2023, the American Society for Bone and Mineral Research (ASBMR) announced that the Study to Advance BMD as a Regulatory Endpoint (SABRE) project team had submitted its full qualification plan to the FDA for the use of BMD as a surrogate endpoint for fractures in future trials of new anti-osteoporosis drugs. 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 bone mineral density (BMD) as a surrogate endpoint for fractures in future trials of new anti-osteoporosis drugs would be provided within 10 months. The EB613 osteoporosis clinical program has been developed under the auspices of this new approach to osteoporosis drug development. We believe EB613 stands as the first program to potentially avail itself of the ASBMR-SABRE BMD endpoint. SABRE is expected to provide an update on its FDA interactions and the qualification of the BMD endpoint in 2025.
Current wording
Following Type C and Type D meetings with the FDA, we announced in 2023 the FDA’s concurrence that a 2-year, placebo-controlled phase 3 (registrational) study with Total Hip BMD as primary endpoint could support a new drug application (“NDA”) for EB613; however, the BMD endpoint remained unqualified as a surrogate endpoint by the FDA. In November 2023, the American Society for Bone and Mineral Research (ASBMR) announced that the Study to Advance BMD as a Regulatory Endpoint (SABRE) project team had submitted its full qualification plan to the FDA for the use of BMD as a surrogate endpoint for fractures in future trials of new anti-osteoporosis drugs. 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. The EB613 osteoporosis clinical program has been developed under the auspices of this new approach to osteoporosis drug development.
Previous wording
Additionally, in March 2025, we and OPKO entered into the 2025 Collaboration Agreement (as defined and further described below under “Recent Developments Potentially Affecting Our Business—Collaboration and License Agreement with OPKO”) with respect to the preclinical and clinical development and decision making related to the oral OXM program for the treatment of obesity, metabolic and fibrotic disorders in humans.
Current wording
Additionally, in March 2025, we and OPKO entered into the 2025 Collaboration Agreement (as defined and further described below under “Patent Transfer, Licensing Agreements and Grant Funding—Collaboration and License Agreement with OPKO”) with respect to the preclinical and clinical development and decision making related to the oral OXM program for the treatment of obesity, metabolic and fibrotic disorders in humans.
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 Annual Report, the war is ongoing and continues to evolve. 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. 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.
Previous wording
Currently, such activities in Israel remain largely unaffected. During the three months ended March 31, 2025 and 2024 and as of December 31, 2024, the impact of this war 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 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.
Previous wording
Since our inception, 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 March 31, 2025 and 2024, our operating losses were $2.6 million and $2.1 million, respectively, and we expect to continue to incur significant expenses and losses for the foreseeable future.
Current 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.
Previous wording
As of March 31, 2025, we had an accumulated deficit of $116.5 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, 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.
Previous wording
As of March 31, 2025, we had cash and cash equivalents and restricted cash of $20.6 million, of which $8 million has been designated to fund the collaboration activity with OPKO 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 depend on finalizing discussions with the FDA in connection with its anticipated qualification of the SABRE total hip BMD endpoint and 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 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.
Previous wording
As of March 31, 2025, we had a total of 20 employees, of whom 18 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 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.
Previous wording
Research and development expenses consist of costs incurred for the development of our N-Tab™ platform technology and our product candidates, including:
Current wording
Research and development expenses consist of costs incurred for the development of our N-Tab™ technology platform and our product candidates. We expense both internal and external research and development expenses to operations for the periods in which they are incurred. We mapped the majority of external research and development costs incurred for our product candidates and development programs.
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. For the three months ended March 31, 2025 and 2024, our research and development expenses were $1.1 million and $0.7 million, respectively. Research and development expenses for the three months ended March 31, 2025 and 2024 were primarily for the development of EB613 and EB612 and our collaboration with OPKO related to GLP-2 and OXM. 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 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:
Previous wording
A change in the outcome of any of these variables with respect to the development of EB613, EB612 or any other product candidate that we may develop could significantly change the costs and timing associated with the development of any such product candidate. For example, if the FDA or other regulatory authority were to require us to conduct preclinical or clinical studies beyond those that we currently anticipate will be required for the completion of clinical development, if we experience significant delays in enrollment in any clinical trials or if we encounter difficulties in manufacturing our clinical supplies, then we could be required to expend significant additional financial resources and time on the completion of the clinical development.
Current wording
A change in the outcome of any of these variables with respect to the development of EB613, OXM or any other product candidate that we may develop could significantly change the costs and timing associated with the development of any such product candidate. For example, if the FDA or other regulatory authority were to require us to conduct preclinical or clinical studies beyond those that we currently anticipate will be required for the completion of clinical development, if we experience significant delays in enrollment in any clinical trials or if we encounter difficulties in manufacturing our clinical supplies, then we could be required to expend significant additional financial resources and time on the completion of the clinical development.
Previous wording
We have not generated taxable income since our inception, and, as of March 31, 2025, we had carryforward tax losses of $85.6 million.
Current 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.
Previous wording
The Company’s subsidiary, Entera Bio, Inc., is taxed separately under U.S. tax laws. As of March 31, 2025, Entera Bio Inc. had tax loss carryforwards of $172 thousand.
Current wording
The Company’s subsidiary, Entera Bio, Inc., is taxed separately under U.S. tax laws. As of June 30, 2025, Entera Bio, Inc. had tax loss carryforwards of $174 thousand.
Previous wording
Revenues for the three months ended March 31, 2025 were $42 thousand, which were attributable to research services we provided pursuant tothe research services agreement. We did not recognize any revenue for the three months ended March 31, 2024.
Current 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.
Previous wording
Research and development expenses for the three months ended March 31, 2025 were $1.1 million, as compared to $0.7 million for the three months ended March 31, 2024. The increase of $0.4 million was primarily due to an increase of $0.2 million in other consulting fees, including regulatory required in connection with the optimization processes related to the preparation of the EB613 phase 3 study, $0.1 million in connection with our internal programs and collaboration programs and $0.1 million in share-based compensation.
Current 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.
Previous wording
Financial expenses (income), net for the three months ended March 31, 2025 was $4 thousand of expenses as compared to $45 thousand of income for the three months ended March 31, 2024. Our financial income, net for the three months ended March 31, 2024 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. Our financial expenses, net for the three months ended March 31, 2025 was composed mainly of 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 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.
Previous wording
Cost of revenues for the three months ended March 31, 2025 was $42 thousand, which was attributable to research services we provided pursuant to the research services agreement. We did not recognize any cost of revenues for the three months ended March 31, 2024.
Current 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.
Previous wording
General and administrative expenses for the three months ended March 31, 2025 were $1.4 million, as compared to $1.3 million for the three months ended March 31, 2024. The increase of $0.1 million was mainly attributable to an increase in intellectual property rights costs and legal expenses related to OPKO collaboration agreement and other potential strategic agreements.
Current 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.
Previous wording
Since inception, we have incurred significant losses from operations, negative cash flows from operating activities and lack of liquidity. 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 the Phase 3 program of EB613 in osteoporosis. See Part I, Item 1A-Risk Factors-Risks Related to Our Financial Position and Need for Additional Capital contained in our 2024 Annual Report.
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 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.
Previous wording
Since our inception, 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 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.
Previous wording
As of March 31, 2025, we had cash and cash equivalents and restricted cash of $20.6 million, of which $8 million has been designated to fund the collaboration activity with OPKO 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 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.
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 under our currently effective Registration Statement on Form S-3 and a related prospectus supplement forming a part thereof. The sales agent is entitled to a fixed commission of 3% of the aggregate gross proceeds as well as and reimbursement of expenses. In January 2025, we sold an additional 2,700,000 Ordinary Shares at $2.29 per share to Point 72 Asset Management, L.P. for aggregate proceeds of $6.0 million, net of issuance costs. As of March 31, 2025, we had sold 4,940,156 shares under the Leerink ATM Program for aggregate proceeds of $9.8 million, net of issuance costs. Subsequent to such sale, in January 2025, we filed a supplement to the prospectus supplement relating to the Leerink ATM Program, which provides us the ability, but not the obligation, to sell up to an additional 30,000,000 Ordinary Shares under the Leerink ATM Program.
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 under our currently effective Registration Statement on Form S-3 and a related prospectus supplement forming a part thereof. The sales agent is entitled to a fixed commission of 3% of the aggregate gross proceeds as well as and reimbursement of expenses. In January 2025, we sold an additional 2,700,000 Ordinary Shares at $2.29 per share to Point 72 Asset Management, L.P. for aggregate proceeds of $6.0 million, net of issuance costs. As of June 30, 2025, we had sold 4,940,156 shares under the Leerink ATM Program for aggregate proceeds of $9.8 million, net of issuance costs. In order to refresh the Leerink ATM program, in January 2025, we filed a supplement to the prospectus supplement, which provides us the ability, but not the obligation, to sell up to an additional 30,000,000 Ordinary Shares under the Leerink ATM Program.
Previous wording
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. This assumes 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 depend on finalizing discussions with the FDA in connection with their anticipated qualification of the SABRE total hip BMD endpoint and 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 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.
Previous wording
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 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. If we are unable to finance our operations, our business would be in jeopardy, and we might not be able to continue operations and might have to liquidate our assets. In that case, investors might receive less than the value at which those assets are carried on our financial statements, and it is likely that investors would lose all or a part of their investment.
Current wording
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. As of the date of this Quarterly Report, we believe that our existing cash resources will be sufficient to support the Company’s operations under its current plans through the middle of the third quarter of 2026. These factors raise substantial doubt as to the Company's 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. If we are unable to finance our operations, our business would be in jeopardy, and we might not be able to continue operations and might have to liquidate our assets. In that case, investors might receive less than the value at which those assets are carried on our financial statements, and it is likely that investors would lose all or a part of their investment.
Previous wording
Three Months Ended March 31, 2025 compared to Three Months Ended March 31, 2024
Current wording
Six Months Ended June 30, 2025 compared to Six Months Ended June 30, 2024
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 loss 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, 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.
Previous wording
Net cash used in operating activities for the three months ended March 31, 2024 was $1.9 million, consisting primarily of our operating loss of $2.1 million and an increase of $0.3 million in our operating assets and liabilities, which was partially offset by $0.5 million of share-based compensation and depreciation expenses.
Current 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.
Previous wording
The changes in cash used in operating activities for the three months ended March 31, 2025 compared to the same period in 2024 was mainly attributed to increase of $0.5 million in our operating loss which was offset by an increase of $0.1 million in share-based compensation and a decrease of $0.9 million in our operating assets and liabilities.
Current 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.
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, 2025 consisted primarily of the purchase of property and equipment.
Previous wording
There was no net cash generated or provided by investing activity for the three months ended March 31, 2024.
Current wording
There was no net cash used in or provided by investing activities for the six months ended June 30, 2024.
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 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 three months ended March 31, 2024 consisted of the net proceeds of $30 thousand from the issuance of Ordinary Shares upon the exercise of outstanding warrants.
Current 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.
Rearranged previous paragraphs (3)
Previous report — wording carried elsewhere
. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Previous report — wording carried elsewhere
The Company recognize revenues according to ASC 606, “Revenues from Contracts with Customers”.
Previous report — wording carried elsewhere
Since inception, we have incurred significant losses. For the three months ended March 31, 2025 and 2024, our operating losses were $2.6 million and $2.1 million, respectively. As of March 31, 2025, we had an accumulated deficit of $116.5 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.