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Item 7. Management’s Discussion and Analysis

2025-03-28 compared with 2024-03-08 · 125 added, 97 removed, 155 unchanged (59% of the section changed)

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These factors include those contained in “Item 1A—Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” of this Annual Report.

Our forward-looking statements reflect our views only as of the date they are made.

We do not undertake any obligation to update forward-looking statements except as required by applicable law.

We intend that all forward-looking statements be subject to the safe harbor provisions of PSLRA.

These forward-looking statements reflect our views only as of the date they are made.

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.

Currently, most protein therapies are administered via frequent intravenous, subcutaneous, or intramuscular injections.

Our pipeline includes five differentiated, first-in-class oral peptide programs targeting PTH(1-34), GLP-1 and GLP-2.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 therapeutic proteins is challenging due to the enzymatic degradation within the gastrointestinal tract and poor absorption into the blood stream due to the proteins’ polarity and molecular weight.

We leverage our N-Tab™ oral delivery technology which is designed to simultaneously stabilize the peptide in the gastrointestinal tract and promote its absorption into the bloodstream.

Our most advanced product candidate, EB613 (oral PTH (1-34), teriparatide), is being developed as the first oral, osteoanabolic (bone building) once-daily tablet treatment for post-menopausal women with low BMD and high-risk osteoporosis with no prior fracture.

We leverage our N-Tab™ platform which is designed to simultaneously stabilize the peptide in the gastrointestinal tract and promote its absorption into the bloodstream.

EB613 Program

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).

Following the completion of a Type C and a Type D meeting with the U.S.

Food and Drug Administration’s (FDA), we announced 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.

The EB612 program is being developed as the first oral PTH(1-34) tablet peptide replacement tablet therapy for 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 once or twice a day dosing regimens as well as collaborating with a third party on another peptide in this field.

In April 2024, the phase 2 data was published in the Journal of Bone and Mineral Research (JBMR).

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 SABRE BMD endpoint remained unqualified as a surrogate endpoint by FDA.

In November 2023, the ASBMR announced that the 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.

EB612 Program

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.

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.

Additionally, we are exploring the use of our PTH(1-34) tablets for the treatment of stress fractures in athletes and expect to collaborate with an investigator sponsored study in this area.

We expect to initiate a phase 2 trial for this indication in the second half of 2024.

In May 2023, the results from our oral GLP-2 program were published in the International Journal of Peptide Research and Therapeutics, “Oral Delivery Technology Enabling Gastro-Mucosal Absorption of Glucagon-Like-Peptide-2 Analog (Teduglutide) - A Novel Approach for Injection-Free Treatment of Short Bowel Syndrome.” We believe GLP-2 represents a strong candidate for our N-Tab™ Technology and warrants further development as an injection-free alternative to patients suffering from short bowel syndrome and other gastrointestinal disorders where GLP-2 plays a role.

In September 2023, we entered into a research collaboration agreement with OPKO.

Under the terms of this agreement, OPKO has agreed to supply its proprietary long-acting GLP-2 peptide and certain Oxyntomodulin analogs for the development of oral tablet formulations using our proprietary N-Tab™ technology.

Oxyntomodulin (OXM) is a naturally occurring peptide hormone found in the colon, with glucagon-like-peptide 1 (GLP-1) and glucagon dual agonist activity which suppresses appetite and induces weight loss.

OPKO has developed several proprietary, modified OXM analogs as potential candidates for treating obesity, including an injectable pegylated peptide which demonstrated significant reductions in weight loss and decreased plasma triglyceride levels in over 430 patients in phase 2/2B studies.

We expect in vivo PK/PD data from both the oral GLP-2 tablet program and the oral OXM tablet program in 2024.

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.

Since our inception, we have raised a total of $91.3 million from a combination of public and private equity offerings, grants and the exercise of options and warrants.

Our ability to deliver our oral PTH(1-34) peptide in a simple mini tablet format with reproduceable, dose dependent pharmacokinetics and rapid biological responses across gender, age, and health status was highlighted as part of two poster sessions at the ASBMR 2023 Annual Meeting.

We believe our work to date has built the foundation for our oral PTH (1-34) tablets to potentially treat diverse patient populations, including younger men and women athletes at risk of stress fractures.

Oral GLP-2 and Oral GLP-1/Glucagon Programs in Collaboration with OPKO Biologics

In September 2023, we entered into the 2023 Collaboration Agreement with OPKO Biologics, Inc., a subsidiary of OPKO.

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™ 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.

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.

OXM is a naturally occurring peptide hormone found in the colon, with glucagon-like-peptide 1 (GLP-1) and glucagon dual agonist activity that suppresses appetite and induces weight loss.

OPKO has developed several proprietary, modified OXM analogs as potential candidates for treating obesity, including an injectable pegylated peptide which demonstrated safety in over 430 subjects and significant reductions in weight loss and decreased plasma triglyceride levels in over 110 subjects in completed phase 2 studies.

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.

Financial Overview

We are primarily engaged in research and development activities, and we have not derived significant income from our activities.

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 exercise of options and warrants.

Since inception, we have incurred significant losses.

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As of December 31, 2024, we had an accumulated deficit of $113.9 million.

Our losses may fluctuate significantly from quarter to quarter and year to year, depending on the timing of our clinical trials, our expenditures on research and development activities, and payments under any future collaborations into which we may enter.

As a result of our recurring losses from operations, negative cash flows and lack of liquidity, management is of the opinion that there is substantial doubt as to the Company's ability to continue as a going concern.

Our recurring losses from operations, negative cash flows and lack of liquidity raise substantial doubt as to the Company’s ability to continue as a going concern.

Our independent registered public accounting firm included an explanatory paragraph in its report on our financial statements as of, and for the year ended, December 31, 2024, expressing the existence of substantial doubt about our ability to continue as a going concern.

The audited consolidated financial statements included herein have been prepared assuming that we will continue as a going concern and do not include adjustments that might result from the outcome of this uncertainty.

If we are unable to raise the requisite funds, we will need to delay certain program initiation, curtail or cease operations.

The audited consolidated financial statements included in this Annual Report have been prepared assuming that we will continue as a going concern and do not include adjustments that might result from the outcome of this uncertainty.

If we are unable to raise the requisite funds, we will need to delay certain programs or otherwise curtail or cease operations.

See “Item 1A—Risk Factors-Risks Related to Our Financial Position and Need for Additional Capital.”

As of December 31, 2024, we had cash and cash equivalents of $8.7 million.

We believe that our existing cash resources will be sufficient to meet our projected operating requirements through the second quarter of 2025, which include the capital required to fund our ongoing operations, including R&D, the completion of the Phase 1 study related to the new generation platform and the GLP-2/OXM collaborative research we are conducting with OPKO.

However, this does not include the capital required to fund our proposed Phase 3 pivotal study for EB613 in osteoporosis.

We currently do not have funding sufficient for this Phase 3 study, and our ability to commence the study requires additional funding, which may not be available on reasonable terms, or at all.

As of March 20, 2025 we had cash and cash equivalents of $21 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 into the third quarter of 2026, which include the capital required to fund our ongoing operations, including regulatory expenses and optimization related to the preparation for the planned EB613 phase 3 study in osteoporosis, research and development, the completion of an additional Phase 1 PK study related to our new generation platform and the GLP-2/OXM collaborative research we are conducting with OPKO.

Our ability to commence the Phase 3 study 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.

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In 2011, we entered into the Patent Transfer Agreement with Oramed, pursuant to which Oramed assigned to us all of its rights, title and interest in the patent rights that Oramed licensed to us when we were originally organized, subject to a worldwide, royalty-free, exclusive, irrevocable, perpetual and sub-licensable license granted to Oramed under the assigned patent rights to develop, manufacture and commercialize products or otherwise exploit such patent rights in the fields of diabetes and influenza.

Additionally, we agreed not to engage, directly or indirectly, in any activities in the fields of diabetes and influenza.

Additionally, we agreed not to engage, directly or indirectly, in any activities in the fields of diabetes and influenza that involve the use of, or utilize, the patents underlying the Patent Transfer Agreement.

Under the terms of the Patent Transfer Agreement, we agreed to pay Oramed royalties equal to 3% of our net revenues generated, directly or indirectly, from exploitation of the assigned patent rights, including the sale, lease or transfer of the assigned patent rights or sales of products or services covered by the assigned patent rights.

Israeli Innovation Authority Grants

We have received grants of approximately $0.5 million from the IIA to partially fund our research and development.

We have received grants of approximately $0.5 million from the IIA to partially fund our PTH research and development for Osteoporosis.

The grants are subject to certain requirements and restrictions under the Research Law.

In general, until the grants are repaid with interest, royalties are payable to the Israeli government in the amount of 3% on revenues derived from sales of products or services developed in whole or in part using the IIA grants, including EB613, EB612 and any other oral PTH product candidates we may develop.

The royalty rate may increase to 5%, with respect to approved applications filed following any year in which we achieve sales of over $70 million.

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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-funded know-how to a non-Israeli entity.

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 (three times of the interest will also be added).

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 the collaboration agreement with an ultimately liability of up to 600% of the grant received plus interest.

As of December 31, 2023, we had paid royalties to the IIA in the amount of $83,000 related to a collaboration agreement and other material transfer agreements (“MTAs”).

As of December 31, 2023, we owed $13,000 to the IIA, which was paid in February 2024.

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 December 31, 2024, we had paid royalties to the IIA in the amount of $96 thousand.

In addition to paying any royalties due, we must abide by other restrictions associated with receiving such grants under the Research Law that continue to apply following repayment to the IIA.

Recent Developments Potentially Affecting Our Business

Collaboration and License Agreement with OPKO

On March 16, 2025, we entered into the 2025 Collaboration Agreement with OPKO and its wholly owned subsidiary, OPKO Biologics Ltd., to collaborate 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 (the “Program”).

The Program combines OPKO’s proprietary long-acting oxyntomodulin (OXM, dual targeted GLP-1/Glucagon agonist, OPK-88006) analog and Entera’s proprietary N-Tab™ technology.

Under the 2025 Collaboration Agreement, we granted to OPKO an exclusive, sublicensable and non-transferable, worldwide license to certain of our intellectual property and technology solely to develop, manufacture, and commercialize any GLP-1/Glucagon dual agonist as an oral treatment form for the treatment of obesity, metabolic, cardiovascular, and fibrotic disorders in humans, and OPKO has granted to us a non-exclusive, non-sublicensable and non-transferable license to certain of its intellectual property and technology to the extent necessary for us to perform our obligations in relation to the Program, in each case subject to the exceptions contained therein.

Under the terms of the 2025 Collaboration Agreement, we and OPKO will retain 40% and 60%, respectively, of all proceeds deriving from the 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.

In connection with the execution of the 2025 Collaboration Agreement, we issued and sold to OPKO an aggregate of 3,685,226 Ordinary Shares for a purchase price of $8.0 million, representing a purchase price per share equal to approximately $2.17, which was the volume weighted average price per share for the 30 trading days immediately preceding the date of such agreement.

OPKO has agreed to a customary lockup with respect to such shares, and may not sell or otherwise transfer them for a period of 12 months following the date of the 2025 Collaboration Agreement, and OPKO has additionally agreed to a customary “standstill” provision, pursuant to which, for a 24-month period following the date of the 2025 Collaboration Agreement, OPKO may not acquire additional equity in us or otherwise take certain other actions, in each case without our consent.

We have agreed to use the proceeds from the sale of the foregoing Ordinary Shares solely to fund our development cost obligations under the 2025 Collaboration Agreement, and we have agreed to enter into an escrow arrangement, together with OPKO and an escrow agent, into which such proceeds will be deposited and subsequently disbursed to fund such development costs.

If the 2025 Collaboration Agreement expires or is terminated for any reason, any funds remaining in such escrow will be disbursed to us.

Israel-Hamas War

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 headquarters and its R&D operations are located in Israel.

Currently, such activities in Israel remain largely unaffected.

During the years ended December 31, 2024 and December 31, 2023, the impact of this war on the Company’s results of operations and financial condition was immaterial.

See Item 1.A.

“Risk Factors—Risks Relating to Our Incorporation and Location in Israel — Security, political and economic instability in the Middle East may harm our business.”

Financial Overview

To date, we have not generated any revenue from sales of our products, and we do not expect to receive any revenue from any product candidates that we develop unless and until we obtain regulatory approval and successfully commercialize our products.

Revenues are recognized according to ASC 606, “Revenues from Contracts with Customers”.

According to ASC 606, a performance obligation is a promise to provide a distinct good or service or a series of distinct goods or services.

Goods and services that are not distinct are bundled with other goods or services in the contract until a bundle of goods or services that is distinct is created.

A good or service promised to a customer is distinct if the customer can benefit from the good or service either on its own or together with other resources that are readily available to the customer and the entity’s promise to transfer the good or service to the customer is separately identifiable from other promises in the contract.

Options granted to the customer that do not provide a material right to the customer that it would not receive without entering into the contract do not give rise to performance obligations.

Under ASC 606, the consideration that we would be entitled to upon the achievement of contractual milestones, which are contingent upon the occurrence of future events of development and commercial progress, are a form of variable consideration.

When assessing the portion, if any, of such milestone-related consideration to be included in the transaction price, we first assess the most likely outcome for each milestone, and exclude the consideration related to milestones of which the occurrence is not considered the most likely outcome.

We then evaluate if any of the variable consideration determined in the first step is constrained.

Variable consideration is included in the transaction price if, in our judgment, it is probable that a significant future reversal of cumulative revenue under the contract will not occur.

Estimates of variable consideration and determination of whether to include estimated amounts in the transaction price are based largely on an assessment of our anticipated performance and all information (historical, current and forecasted) that is reasonably available.

We did not recognize any revenues from milestone payments.

An entity should recognize revenue for a sales-based or usage-based royalty promised in exchange for a license of intellectual property only when (or as) the later of the following events occurs:

• The subsequent sale or usage occurs;

• The performance obligation to which some or all of the sales-based or usage-based royalty has been allocated has been satisfied (or partially satisfied).

In April 2024, the Company entered into a material transfer and research project agreement (the “research services agreement”) with a third party in relation to its EB612 program.

Pursuant to the agreement, the third party has agreed to pay the Company a monthly payment for the research services, as well as reimbursement for external expenses based on an agreed budget.

For the year ended December 31, 2024, the Company recognized total revenues of $181 thousand from this agreement.

The Company recognize revenues according to ASC 606, “Revenues from Contracts with Customers”.

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.

Research and Development Expenses

We primarily focus on our research and development activities.

Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials.

We expect that our research and development expenses will increase significantly in future periods as we advance EB613, EB612 and other product candidates into later stages of clinical development and invest in additional preclinical candidates.

Research and development expenses consist of costs incurred for the development of our drug delivery technology and our product candidates, including:

Research and development expenses consist of costs incurred for the development of our N-Tab™ technology platform technology and our product candidates, including:

employee-related expenses, including salaries, bonuses and share-based compensation expenses for employees and service providers in the research and development function;

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other costs associated with pre-clinical and clinical activities.

Research and development activities are the primary focus of our business.

We expect that our research and development expenses will increase significantly in future periods as we advance our clinical candidates into later stages of clinical development and invest in additional preclinical candidates.

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 years ended December 31, 2024 and 2023, our research and development expenses were $4.5 million and $4.5 million, respectively.

Research and development expenses for the years ended December 31, 2023 and 2022 were primarily for the development of EB613, EB612, and development of our new generation platform.

Research and development expenses for the years ended December 31, 2024 and 2023 were primarily for the development of EB613, EB612 and our collaboration with OPKO related to GLP-2 and OXM.

The successful development of our product candidates is highly uncertain.

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the terms and timing of any collaborative, licensing and other arrangements that we may establish, including any milestone and royalty payments thereunder.

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 mean a significant change in the costs and timing associated with the development of such product candidate.

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 result in significant changes in the costs and timing associated with the development of our product candidates.

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 as necessary for 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.

General and Administrative Expenses

General and administrative expenses consist principally of salaries, benefits, share-based compensation and related costs for directors and personnel in executive and finance functions.

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.

We expect that our general and administrative expenses will increase in the future as we increase our headcount and expand our administrative function to support our operations.

Financial Expenses (Income), Net

Financial expenses (income), net are composed primarily of interest income from bank deposits and exchange rate differences of certain currencies against our functional currency.

Income Tax Expenses (Benefit)

Financial Income, Net

Financial income, net is composed primarily of interest income from bank deposits and exchange rate differences of certain currencies against our functional currency, which is the U.S.

Taxes on Income

We have not generated taxable income since our inception, and as of December 31, 2024, we had carry-forward tax losses of $83.5 million.

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Income tax expenses

Revenues for the year ended December 31, 2022 were mainly attributable to pre-clinical R&D services provided under our previously terminated collaboration agreement.

We did not recognize any revenue for the year ended December 31, 2023 due to the termination of the collaboration agreement, effective May 2, 2023.

Revenues for the year ended December 31, 2024 were $181 thousand, which were attributable to research services we provided pursuant to the research services agreement.

We did not recognize any revenue for the year ended December 31, 2023.

Cost of Revenues

Cost of revenues for the year ended December 31, 2022 were mainly attributable to pre-clinical R&D services provided under our previously terminated collaboration agreement.

The decrease in cost was due to the lack of revenue, as described above, for the year ended December 31, 2023.

Cost of revenues for the year ended December 31, 2024 was $172 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 year ended December 31, 2023.

Research and Development Expenses

Research and development expenses for the year ended December 31, 2023 were $4.5 million, as compared to $5.8 million for the year ended December 31, 2022.

The decrease of $1.3 million was primarily due to a decrease of $1.5 million in pre-clinical activity and materials costs, a decrease of $0.6 million in employee compensation, including a one-time payment made to a former employee pursuant to the terms of his separation agreement.

The decrease was partially offset by an increase of $0.8 million in clinical expenses for our Phase 1 PK study related to our new generation platform and new formulations for EB612 .

Research and development expenses for the years ended December 31, 2024 and December 31, 2023 were each $4.5 million.

There was a decrease of $0.8 million in clinical expenses for our Phase 1 PK study related to our new formulations for EB612, which occurred in 2023.

The decrease was partially offset by an increase of $0.8 million in materials and other consulting, including regulatory required in connection with the optimization processes related to the preparation of the EB613 phase 3 study.

General and Administrative Expenses

General and administrative expenses for the year ended December 31, 2024 were $5.1 million, compared to $4.4 million for the year ended December 31, 2023.

The decrease of $2.8 million was mainly attributable to a decrease of $1.1 million in employee compensation, including a one-time payment to our former employee pursuant to the terms of his separation agreement, a decrease of $0.8 million as part of a restructuring of professional fees and other advisor expenses, a decrease in Board fees of $0.2 million due to the Board’s forfeiture of their fees for the third and fourth quarters of 2023 and a decrease of $0.7 million in D&O insurance costs.

The increase of $0.7 million was mainly attributable to an increase of $0.2 million in patents or other intellectual property rights costs, an increase of $0.3 million in other consultants’ fees and an increase of $0.4 million in compensation.

The increase was partially offset by a decrease of $0.2 million in D&O insurance costs and other costs.

Financial Income, Net

Financial income, net for the year ended December 31, 2024 was $58,000, compared to $31,000 for the year ended December 31, 2023.

Our financial income for 2023 was composed primarily of interest income from bank deposits and exchange rate differences of certain currencies against our functional currency, which is the U.S.

Our financial income is composed mainly of interest income from bank deposits and exchange rate differences of certain currencies against our functional currency, which is the U.S.

Financial income, net increased predominantly due to increased interest income on our bank deposits.

Liquidity and Capital Resources

Since inception, we have incurred significant losses.

As a result of our recurring losses from operations, negative cash flows from operating activities and lack of liquidity, our independent registered public accounting firm included an explanatory paragraph in its report on our financial statements as of, and for the year ended, December 31, 2023, expressing the existence of substantial doubt about our ability to continue as a going concern.

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.

For the years ended December 31, 2024 and 2023, our operating losses were $9.6 million and $8.9 million, respectively.

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As of December 31, 2024, we had an accumulated deficit of $113.9 million.

Since our inception, we have raised a total of $91.3 million, including $25.3 million through at-the-market-offering (“ATM”) programs, $6.6 million in our December 2023 Private Placement (as defined below), $14.3 million in our December 2019 private placement, $11.2 million in our IPO in 2018 and $33.9 million in aggregate funding from a combination of grants, exercise of options and warrants and private placements of Ordinary Shares, preferred shares and debt prior to our IPO.

In addition, as of December 31, 2023, we had received approximately $1.7 million under our previously terminated collaboration agreement.

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.

As of December 31, 2024, we had cash and cash equivalents of $8.7 million.

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Equity Offerings

On September 2, 2022, we entered into a Sales Agreement with SVB Securities LLC, as sales agent, to implement an ATM program under which we may from time to time offer and sell up to 5,000,000 Ordinary Shares (the “SVB ATM Program”) under our currently effective Registration Statement on Form S-3 and a related prospectus supplement forming a part thereof.

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.

As of December 31, 2023, we had sold 4,030 shares under the SVB ATM Program for aggregate proceeds of $5 thousand, net of issuance costs.

As of December 31, 2024, we had sold 2,240,156 shares under the Leerink ATM Program for aggregate proceeds of $3.8 million, net of issuance costs.

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.

Subsequent to such sales, 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.

On December 20, 2023, we entered into a securities purchase agreement with certain investors (the “Purchasers”), providing for the private placement (the “December 2023 Private Placement”) to the Purchasers of an aggregate of 7,916,879 units (collectively, the “Units”), each Unit consisting of (i) one Ordinary Share (or, in lieu thereof, one pre-funded warrant to purchase one Ordinary Share (the “Pre-Funded Warrants”)) and (ii) one warrant to purchase one Ordinary Share (the “Ordinary Share Warrant”), for aggregate proceeds of approximately $6.6 million (or $0.835 per Unit, which represented the aggregate of the Nasdaq closing price on December 20, 2023 plus $0.125 per Ordinary Share Warrant).

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There can be no assurance that the holders of the Ordinary Share Warrants exercise their respective warrants for cash, or at all.

In connection with our entering into the 2025 Collaboration Agreement with OPKO, we issued to OPKO an aggregate of 3,685,226 Ordinary Shares for a purchase price of $8.0 million, representing a purchase price per share equal to approximately $2.17, which was the volume weighted average price per share for the 30 trading days immediately preceding the date of such agreement.

The proceeds received are not reflected in our cash balance as of December 31, 2024.

We have agreed to use the proceeds from the issuance of such Ordinary Shares solely to fund our development cost obligations under the 2025 Collaboration Agreement.

Funding Requirements

However, this does not include the capital required to fund our proposed Phase 3 pivotal study for EB613 in osteoporosis.

We currently do not have funding sufficient for the pivotal phase 3 study, and our ability to commence the study will require additional funding, which may not be available on reasonable terms, or at all.

Given our current plans, we believe that our existing cash resources will be sufficient to meet our projected operating requirements into the third quarter of 2026.

This assumes capital required to fund our ongoing operations, including regulatory expenses and optimization related to the preparation for the planned EB613 phase 3 study in osteoporosis, research and development, the completion of an additional Phase 1 PK study related to our new generation platform and the GLP-2/OXM collaborative research we are conducting with OPKO.

Our ability to commence the Phase 3 study 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.

We have based these estimates on assumptions that may prove to be wrong, and we may use our available capital resources sooner than we currently expect.

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Our future capital requirements will depend on many factors, including:

● the costs, timing and outcome of clinical trials for, and regulatory review of our five oral peptide programs, including EB613 and EB612 and any other product candidates we may develop;

the costs, timing and outcome of clinical trials for, and regulatory review of our oral peptide programs, including EB613 and EB612 and any other product candidates we may develop;

the costs of development activities for any other product candidates we may pursue;

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our ability to establish collaborations on favorable terms, if at all.

We are in the process of evaluating various financing alternatives in the public or private equity markets or through license of our N-Tab™ technology to additional external parties through partnerships or research collaborations as we will need to finance future research and development activities, general and administrative expenses and working capital through fund raising.

We continuously evaluate various financing alternatives in the public or private equity markets or through license of our N-Tab™ technology to additional external parties through partnerships or research collaborations as we will need to finance future research and development activities, general and administrative expenses and working capital through fund raising.

However, there is no certainty about our ability to obtain such funding.

Other than the SVB ATM Program, we do not have any committed external sources of funds.

Other than the Leerink ATM Program, we do not have any committed external sources of funds.

To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our then-existing shareholders will be diluted, and the terms of these securities may include liquidation or other preferences that may adversely affect our existing shareholders’ rights as shareholders.

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If we raise additional funds through collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams or research programs or grant licenses on terms that may not be favorable to us.

If we are unable to raise additional funds through equity or debt financings or collaborations, when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market our oral PTH product candidates and any other product candidates that we would otherwise prefer to develop and market ourselves.

Our audited consolidated financial statements for the year ended December 31, 2023, included elsewhere in this Annual Report, note that there is substantial doubt about our ability to continue as a going concern as of such date;

and in its report accompanying our audited consolidated financial statements included herein, our independent registered public accounting firm included an explanatory paragraph stating that our recurring losses from operations and our cash outflows from operating activities raise substantial doubt as to our ability to continue as a going concern.

This means that our management and our independent registered public accounting firm have expressed substantial doubt about our ability to continue our operations without an additional infusion of capital from external sources.

The audited consolidated financial statements 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.

Year Ended December 31, 2024 Compared to Year Ended December 31, 2023

The following table sets forth the primary sources and uses of cash for each of the periods set forth below:

The following table sets forth the primary sources and uses of cash for each of the years set forth below:

Year ended December 31,

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Net Cash Used in Operating Activities

Net Cash used in operating activities for the year ended December 31, 2023 was $ 7.3 million, consisting primarily of our operating loss of $8.9 million, and an increase of $ 0.2 million in our working capital which was partially offset by approximately $ 1.8 million of share-based compensation and depreciation expenses.

Net Cash used in operating activities for the year ended December 31, 2024 was $6.8 million, consisting primarily of our operating loss of $9.6 million, and a decrease of $0.2 million in our working capital and other expenses which was partially offset by approximately $2.6 million of share-based compensation and depreciation expenses.

Net Cash used in operating activities for the year ended December 31, 2023 was $7.3 million, consisting primarily of our operating loss of $8.9 million and an increase of $0.2 million in our working capital, which was partially offset by approximately $1.8 million of share-based compensation and depreciation expenses.

The decrease of $ 5.2 million in cash used in operating activities for the year ended December 31, 2023 compared to the same period in 2022 was mainly attributed to a decrease of $ 4.1 million in our operating loss, a decrease of $ 1.6 million in working capital primarily due to payments to suppliers and services providers, which was partially offset by a decrease of $ 0.5 million in share-based compensation and depreciation expenses.

The decrease of $0.5 million in cash used in operating activities for the year ended December 31, 2024 compared to the same period in 2023 was mainly attributed to an increase of $0.7 million in our operating loss and a decrease of $0.4 million in working capital and others primarily due to payments to suppliers and services providers, which was partially offset by a decrease of $0.8 million in share-based compensation and depreciation expenses.

Net Cash Used in Investing Activities

Net Cash used in investing activities for the years ended December 31, 2023 and December 31, 2022 primarily consisted of purchase of property and equipment.

Net Cash used in investing activities for the years ended December 31, 2024 and December 31, 2023 primarily consisted purchase of property and equipment

Net Cash Provided by Financing Activities

Net cash provided by financing activities for year ended December 31, 2024 consisted of the net proceeds of $3.8 million from the issuance of Ordinary Shares under the Leerink ATM Program and $0.8 million from the issuance of Ordinary Shares upon the exercise of outstanding options and warrants.

Net Cash provided by financing activities for the year ended December 31, 2023 primarily reflects net proceeds of $6 million from issuance of the Units in the December 2023 Private Placement.

Net Cash provided by financing activities for the year ended December 31, 2022 primarily reflects net proceeds of $13 thousand from the exercise of options to purchase Ordinary Shares.

Contractual Obligations

The following tables summarize our contractual obligations and commitments as of December 31, 2023 that will affect our future liquidity:

Payments due by period

Contractual Obligations

(In thousands)

Operating leases for facility

Severance Obligations

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The total amount is recognized as an expense ratably over the service period of the options, which is the period during which all vesting conditions are expected to be met.

We estimate the fair value of our share-based compensation to employees, directors and service providers using the Black-Scholes option pricing model, which requires the input of highly subjective assumptions, including (a) the expected volatility of our shares, (b) the expected term of the award, (c) the risk-free interest rate, (d) expected dividends and (e) the fair value of our Ordinary Shares at the date of grant.

We estimate the fair value of options granted to employees, directors and service providers using the Black-Scholes option pricing model, which requires the input of highly subjective assumptions, including (a) the expected volatility of our shares, (b) the expected term of the award, (c) the risk-free interest rate, (d) expected dividends and (e) the fair value of our Ordinary Shares at the date of grant.

The fair value of the RSU's were measured according to the market price at the grant date.

The following table summarizes the allocation of our share-based compensation expense:

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Certain recently issued accounting pronouncements are discussed in Note 2 to the consolidated financial statements included elsewhere in this Annual Report.

Quantitative and Qualitative Disclosures about Market Risk

Not required for smaller reporting companies.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 7. Management’s Discussion and Analysis